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Peer-reviewed works with DOI and abstract, discovered from MEDLINE-indexed literature. Candidates: no tier, no stated finding, not yet read.
Psychosocial interventions following self-harm in adults: a systematic review and meta-analysis.
Background: Self-harm (intentional acts of non-fatal self-poisoning or self-injury) is common, particularly in young adults aged 15-35 years, often repeated, and strongly associated with suicide. Effective aftercare of individuals who self-harm is therefore important. We have undertaken a Cochrane systematic review and meta-analysis of the effectiveness of psychosocial interventions for self-harm in adults.
Methods: We searched five electronic databases (CCDANCTR-Studies and References, CENTRAL, MEDLINE, Embase, and PsycINFO) between Jan 1, 1998, and April 29, 2015, for randomised controlled trials of psychosocial interventions for adults after a recent (within 6 months) episode of self-harm. Most interventions were assessed in single trials. We report results for interventions for which at least three randomised controlled trials comparing interventions with treatment as usual have been published and hence might contribute to clinical guidance. The primary outcome was repetition of self-harm at the conclusion of treatment and at 6, 12, and 24 months' follow-up analysed, when available, with the intention-to-treat method; if this was not possible, we analysed with all available case data.
Findings: We identified 29 non-overlapping randomised controlled trials with three independent trials of the same intervention. Cognitive-behavioural-based psychotherapy (CBT; comprising cognitive-behavioural and problem-solving therapy) was associated with fewer participants repeating self-harm at 6 months' (odds ratio 0·54, 95% CI 0·34-0·85; 12 trials; n=1317) and at 12 months' follow-up (0·80, 0·65-0·98; ten trials; n=2232). There were also significant improvements in the secondary outcomes of depression, hopelessness, suicidal ideation, and problem solving. Patients receiving dialectical behaviour therapy (in three trials) were not less likely to repeat self-harm compared with those provided with treatment as usual at 6 months (odds ratio [OR] 0·59, 95% CI 0·16-2·15; n=267, three trials) or at 12 months (0·36, 0·05-2·47; n=172, two trials). However, the secondary endpoint of frequency of self-harm was associated with a significant reduction with use of dialectical behaviour therapy (mean difference -18·82, 95% CI -36·68 to -0·95). Four trials each of case management (OR 0·78, 95% CI 0·47-1·30; n=1608) and sending regular postcards (OR 0·87, 95% CI 0·62-1·23; n=3277) did not reduce repetition of self-harm.
Interpretation: CBT seems to be effective in patients after self-harm. Dialectical behaviour therapy did not reduce the proportion of patients repeating self-harm but did reduce the frequency of self-harm. However, aside from CBT, there were few trials of other promising interventions, precluding firm conclusions as to their effectiveness.
Funding: National Institute for Health Research.
The lancet. Psychiatry · meta-analysis · 141 citationsread the source →
Gilbody S, Peckham E, Bailey D, Arundel C, Heron P, Crosland S, Fairhurst C, Hewitt C, Li J, Parrott S, Bradshaw T, Horspool M, Hughes E, Hughes T, Ker S, Leahy M, McCloud T, Osborn D, Reilly J, Steare T, Ballantyne E, Bidwell P, Bonner S, Brennan D, Callen T, Carey A, Colbeck C, Coton D, Donaldson E, Evans K, Herlihy H, Khan W, Nyathi L, Nyamadzawo E, Oldknow H, Phiri P, Rathod S, Rea J, Romain-Hooper CB, Smith K, Stribling A, Vickers C. (2019)MEDLINE-indexed journal, not yet read by usThe lancet. Psychiatry · randomised controlled trial Smoking cessation for people with severe mental illness (SCIMITAR+): a pragmatic randomised controlled trial.
Background: People with severe mental illnesses such as schizophrenia are three times more likely to smoke than the wider population, contributing to widening health inequalities. Smoking remains the largest modifiable risk factor for this health inequality, but people with severe mental illness have not historically engaged with smoking cessation services. We aimed to test the effectiveness of a combined behavioural and pharmacological smoking cessation intervention targeted specifically at people with severe mental illness.
Methods: In the smoking cessation intervention for severe mental illness (SCIMITAR+) trial, a pragmatic, randomised controlled study, we recruited heavy smokers with bipolar disorder or schizophrenia from 16 primary care and 21 community-based mental health sites in the UK. Participants were eligible if they were aged 18 years or older, and smoked at least five cigarettes per day. Exclusion criteria included substantial comorbid drug or alcohol problems and people who lacked capacity to consent at the time of recruitment. Using computer-generated random numbers, participants were randomly assigned (1:1) to a bespoke smoking cessation intervention or to usual care. Participants, mental health specialists, and primary care physicians were unmasked to assignment. The bespoke smoking cessation intervention consisted of behavioural support from a mental health smoking cessation practitioner and pharmacological aids for smoking cessation, with adaptations for people with severe mental illness-such as, extended pre-quit sessions, cut down to quit, and home visits. Access to pharmacotherapy was via primary care after discussion with the smoking cessation specialist. Under usual care participants were offered access to local smoking cessation services not specifically designed for people with severe mental illnesses. The primary endpoint was smoking cessation at 12 months ascertained via carbon monoxide measurements below 10 parts per million and self-reported cessation for the past 7 days. Secondary endpoints were biologically verified smoking cessation at 6 months; number of cigarettes smoked per day, Fagerström Test for Nicotine Dependence (FTND) and Motivation to Quit (MTQ) questionnaire; general and mental health functioning determined via the Patient Health Questionnaire-9 (PHQ-9), the Generalised Anxiety Disorder-7 (GAD-7) questionnaire, and 12-Item Short Form Health Survey (SF-12); and body-mass index (BMI). This trial was registerd with the ISRCTN registry, number ISRCTN72955454, and is complete.
Findings: Between Oct 7, 2015, and Dec 16, 2016, 526 eligible patients were randomly assigned to the bespoke smoking cessation intervention (n=265) or usual care (n=261). 309 (59%) participants were male, median age was 47·2 years (IQR 36·3-54·5), with high nicotine dependence (mean 24 cigarettes per day [SD 13·2]), and the most common severe mental disorders were schizophrenia or other psychotic illness (n=343 [65%]), bipolar disorder (n=115 [22%]), and schizoaffective disorder (n=66 [13%]). 234 (88%) of intervention participants engaged with the treatment programme and attended 6·4 (SD 3·5) quit smoking sessions, with an average duration of 39 min (SD 17; median 35 min, range 5-120). Verified quit data at 12 months were available for 219 (84%) of 261 usual care and 223 (84%) of 265 intervention participants. The proportion of participants who had quit at 12 months was higher in the intervention group than in the usual care group, but non-significantly (34 [15%] of 223 [13% of those assigned to group] vs 22 [10%] of 219 [8% of those assigned to group], risk difference 5·2%, 95% CI -1·0 to 11·4; odds ratio [OR] 1·6, 95% CI 0·9 to 2·9; p=0·10). The proportion of participants who quit at 6 months was significantly higher in the intervention group than in the usual care group (32 [14%] of 226 vs 14 [6%] of 217; risk difference 7·7%, 95% CI 2·1 to 13·3; OR 2·4, 95% CI 1·2 to 4·6; p=0·010). The incidence rate ratio for number of cigarettes smoked per day at 6 months was 0·90 (95% CI 0·80 to 1·01; p=0·079), and at 12 months was 1·00 (0·89 to 1·13; p=0·95). At both 6 months and 12 months, the intervention group was non-significantly favoured in the FTND (adjusted mean difference 6 months -0·18, 95% CI -0·53 to 0·17, p=0·32; and 12 months -0·01, -0·39 to 0·38, p=0·97) and MTQ questionnaire (adjusted mean difference 0·58, -0·01 to 1·17, p=0·056; and 12 months 0·64, 0·04 to 1·24, p=0·038). The PHQ-9 showed no difference between the groups (adjusted mean difference at 6 months 0·20, 95% CI -0·85 to 1·24 vs 12 months -0·12, -1·18 to 0·94). For the SF-12 survey, we saw evidence of improvement in physical health in the intervention group at 6 months (adjusted mean difference 1·75, 95% CI 0·21 to 3·28), but this difference was not evident at 12 months (0·59, -1·07 to 2·26); and we saw no difference in mental health between the groups at 6 or 12 months (adjusted mean difference at 6 months -0·73, 95% CI -2·82 to 1·36, and 12 months -0·41, -2·35 to 1·53). The GAD-7 questionnaire showed no difference between the groups (adjusted mean difference at 6 months -0·32 95% CI -1·26 to 0·62 vs 12 months -0·10, -1·05 to 0·86). No difference in BMI was seen between the groups (adjusted mean difference 6 months 0·16, 95% CI -0·54 to 0·85; 12 months 0·25, -0·62 to 1·13).
Interpretation: This bespoke intervention is a candidate model of smoking cessation for clinicians and policy makers to address high prevalence of smoking. The incidence of quitting at 6 months shows that smoking cessation can be achieved, but the waning of this effect by 12 months means more effort is needed for sustained quitting.
Funding: National Institute for Health Research Health Technology Assessment Programme.
The lancet. Psychiatry · randomised controlled trial · 134 citationsread the source →
Effectiveness of a self-guided web-based cannabis treatment program: randomized controlled trial.
Background: Self-help strategies offer a promising way to address problems with access to and stigma associated with face-to-face drug and alcohol treatment, and the Internet provides an excellent delivery mode for such strategies. To date, no study has tested the effectiveness of a fully self-guided web-based treatment for cannabis use and related problems.
Objectives: The current study was a two-armed randomized controlled trial aimed at testing the effectiveness of Reduce Your Use, a fully self-guided web-based treatment program for cannabis use disorder consisting of 6 modules based on cognitive, motivational, and behavioral principles.
Methods: 225 individuals who wanted to cease or reduce their cannabis use were recruited using both online and offline advertising methods and were randomly assigned to receive: (1) the web-based intervention, or (2) a control condition consisting of 6 modules of web-based educational information on cannabis. Assessments of cannabis use, dependence symptoms, and abuse symptoms were conducted through online questionnaires at baseline, and at 6-week and 3-month follow-ups. Two sets of data analyses were undertaken--complier average causal effect (CACE) modeling and intention to treat (ITT).
Results: Two thirds (149) of the participants completed the 6-week postintervention assessment, while 122 (54%) completed the 3-month follow-up assessment. Participants in the intervention group completed an average of 3.5 of the 6 modules. The CACE analysis revealed that at 6 weeks, the experimental group reported significantly fewer days of cannabis use during the past month (P=.02), significantly lower past-month quantity of cannabis use (P=.01), and significantly fewer symptoms of cannabis abuse (P=.047) relative to controls. Cannabis dependence symptoms (number and severity) and past-month abstinence did not differ significantly between groups (Ps>.05). Findings at 3 months were similar, except that the experimental group reported significantly fewer and less severe cannabis dependence symptoms (Ps<.05), and past-month quantity of cannabis consumed no longer differed significantly between groups (P=.16). ITT analyses yielded similar outcomes.
Conclusion: Findings suggest that web-based interventions may be an effective means of treating uncomplicated cannabis use and related problems and reducing the public health burden of cannabis use disorders.
Trial registration: ACTRN12609000856213, Australian New Zealand Clinical Trials Registry.
Journal of medical Internet research · randomised controlled trial · 79 citationsread the source →
Harald M. Stauss (2003)MEDLINE-indexed journal, not yet read by usAmerican Journal of Physiology-Regulatory, Integrative and Comparative Physiology · review Heart rate variability
IN FOCUSHeart rate variabilityHarald M. StaussHarald M. StaussDepartment of Exercise Science, University of Iowa, Iowa City, Iowa 52242Published Online:01 Nov 2003https://doi.org/10.1152/ajpregu.00452.2003MoreSectionsPDF (59 KB)Download PDF ToolsExport citationAdd to favoritesGet permissionsTrack citations the rhythm of the heart has not only fascinated cardiologists but also inspired poets and musicians. Indeed, the periodic beat of the heart was used to define the speed of music. In music notation, the traditional Italian term "moderato" originally referred to one beat of the measure per walking pace (76-80 paces/min) or heartbeat (∼72 beats/min). The use of the heartbeat to define the speed of music may imply that the periodicity of the beat of the heart is very constant. However, this is not necessarily the case. In fact, loss of heart rate variability can indicate severe cardiovascular diseases and reliably predict poor outcome of such conditions (18, 22, 27, 47a). This In Focus article reviews sources of heart rate variability, its role as a prognostic marker for cardiovascular diseases, and its application in estimation of cardiac autonomic nervous system activity. All of these topics have been addressed intensely in articles published in the American Journal of Physiology-Regulatory, Integrative and Comparative Physiology during the last two years. In healthy subjects, the sinoatrial node located at the posterior wall of the right atrium initiates each beat of the heart. Due to the unstable membrane potential of the myocytes located in this region, action potentials are generated periodically at a fairly constant frequency. This relatively constant frequency generated by the autorhythmicity of the sinoatrial node is modulated by many factors that add variability to the heart rate signal at different frequencies. According to the Task Force of The European Society of Cardiology and The North American Society of Pacing and Electrophysiology (47a) these frequencies are classified into 1) ultra-low frequencies (ULF; >5-h cycle length) that include the circadian rhythm (6, 9, 34, 54); 2) very low frequencies (VLF; >25-s cycle length) that are supposed to be affected by temperature regulation (1, 7, 34, 52, 54) and humoral systems (9, 36); 3) low frequencies (LF; >6-s cycle length in humans) that are sensitive to changes in cardiac sympathetic (and presumably parasympathetic) nerve activity (27, 30); and 4) high frequencies (HF; 2.5- to 6.0-s cycle length in humans) that are synchronized to the respiratory rhythm (5) and are primarily modulated by cardiac parasympathetic innervation (38).The most prominent oscillation in the ULF band of the heart rate spectrum is the circadian rhythm. The autonomic nervous system contributes significantly to circadian heart rate variability. Using long-term recordings in conscious rabbits, Barrett et al. (6) demonstrated a strong circadian rhythm in heart rate, mean arterial blood pressure, renal blood flow, and renal sympathetic nerve activity. The importance of this study is that it clearly demonstrates that sympathetic nerve discharges exhibit a strong circadian rhythmicity. The paraventricular nucleus of the hypothalamus (PVN) appears to play a central role in mediating the circadian rhythm of autonomic nervous system activity. First, GABAergic and glutamatergic neurons project from the suprachiasmatic nuclei of the hypothalamus (SCN) to spinal-projecting neurons of the PVN (12). The SCN is the major central oscillator that triggers the day/night cycle. It receives photic input from the retina (47) and drives many neuroendocrine, metabolic, autonomic, and behavioral circadian rhythms (14, 16, 21, 31, 35, 44, 46, 50). In addition, microinjections of the inhibitory neurotransmitter GABA into the PVN of anesthetized rats elicit dose-dependent decreases in renal sympathetic nerve activity, whereas bicuculline (a GABA antagonist) increases renal sympathetic nerve activity (56). Second, from the PVN, neurons project to the nucleus of the solitary tract (that integrates inputs from the baroreceptors), the nucleus ambiguus (origin of preganglionic parasympathetic neurons to the heart), the rostroventrolateral medulla (location of sympathetic premotor neurons), and the intermediolateral cell column of the thoracolumbar spinal cord (location of preganglionic sympathetic neurons). Thus PVN neurons can modulate autonomic nervous system activity by sending inputs to major sites of autonomic nervous system regulation. As an example, a pivotal role of the PVN for sympathoexcitation during parturition was recently demonstrated in sheep. The increase in sympathetic nerve activity that accompanies birth in maternal animals was prevented by stereotactic lesioning of the PVN (43). Taken together, a major component of the circadian heart rate variability is elicited by diurnal fluctuations in autonomic nervous system activity, generated by corresponding fluctuations of neuronal activity within the PVN, which depend on circadian inputs originating from the SCN.It has been suggested that thermoregulation affects VLF heart rate variability (10, 26). Cooling the heart causes bradycardia, a mechanism used in heart surgeries. Conversely, fever is known to increase heart rate. Raising body core temperature from 36.0 to 36.6°C caused an increase in heart rate by almost 40 beats/min in male subjects (1), whereas acutely reducing ambient temperature from thermoneutral conditions (35°C) to 29, 23, and 17°C, reduced heart rate from 400 to 250 beats/min in 8-day-old rats (7). In addition, lowering temperature in the isolated working rat heart from 37 to 31°C reduced heart rate from 332 to 215 beats/min and markedly increased heart rate variability (28), indicating that parts of the temperature effects on heart rate and heart rate variability are independent from the autonomic nervous system. In contrast to the tachycardia that accompanies acute elevations in temperature, chronically raising ambient temperature in adult rodents from a standard housing temperature of 21-23°C to thermoneutral conditions (29-30°C) reduced heart rate by roughly 50 beats/min in rats (34) and by 200-300 beats/min in mice (54). The authors of these articles (34, 54) suggested that standard housing temperatures are associated with cold stress that causes parallel activation of brown adipose tissue, cardiac, and vasomotor sympathetic drives that elicits nonshivering thermogenesis and tonically elevates heart rate and arterial blood pressure. These and other studies indicate that both direct effects of temperature on pacemaker activity of the sinus node (28) and indirect effects mediated via the autonomic nervous system (11, 25, 51, 55) mediate temperature effects on heart rate and heart rate variability. Thus fluctuation in temperature is an important source of heart rate variability that should not be underestimated. In a more recent study, this was taken into account by core body temperature correction of heart rate variability (3).Endocrine factors affecting heart rate variability include thyroxine, reproductive hormones, the renin-angiotensin system, steroids, and others. Chronic subcutaneous infusion of angiotensin II in rats markedly increased blood pressure and heart rate variability, expressed as standard deviation (9). In contrast, chronic corticosterone treatment is likely to reduce baroreflex-mediated heart rate variability, because baroreceptor-heart rate (39) and baroreceptor-renal sympathetic nerve activity reflex sensitivity (41) were blunted in chronically corticosterone-treated rats. Furthermore, an interaction between angiotensin II and glucocorticoids was recently described. Intracerebro-ventricular microinjections of angiotensin II AT1 receptor antagonists caused marked decreases in mean blood pressure and heart rate in rats chronically treated with corticosterone but not in control animals (40). This interaction is likely to take place in the central nervous system, because peripheral angiotensin II AT1 receptor blockade did not alter the effects of betamethasone treatment on blood pressure, heart rate, and baroreceptor-heart rate reflex sensitivity in newborn lambs (42).Adenosine is a substance less known to affect heart rate variability. It is produced locally in the heart (53) and binds to A1-adenosinergic receptors, which are among the earliest expressed G protein-coupled receptors in the heart (36). The A1-adenosinergic agonist N6-cyclopentyladenosine dose dependently reduced heart rate in murine embryos, whereas 1,3-dipropyl-8-cyclopentylxanthine, an A1-adenosinergic antagonist, increased heart rate (36). Adenosine also exerts central nervous system effects in various brain areas (15, 20). Microinjections of adenosine into the nucleus of the solitary tract of awake rats caused dose-dependent changes in heart rate: low doses (0.01 nmol) produced a bradycardic response, whereas high doses (2.5-5.0 nmol) elicited a tachycardic response (15). Thus adenosine may indeed be involved in the regulation of heart rate and modulate heart rate variability via local cardiac and central nervous system effects. It has been proposed that the intrinsic cardiac nervous system plays an active role in regulating cardiac function (4, 37, 45, 57). This nervous system consists of sympathetic and parasympathetic neurons and interconnecting local circuits (37). Neurons in the canine right atrial ganglionated plexus (RAGP) spontaneously generate activity even after chronic cardiac autonomic denervation (45). Right atrial neurons in patients undergoing coronary artery bypass surgery generated spontaneous activity that was unrelated to the cardiac cycle but sensitive to changes in systemic arterial pressure, indicating that these neurons receive pressure-sensitive sensory inputs (4). In addition, it has been suggested that substance P acts as a neuromodulator and neurotransmitter in intracardiac ganglia of the guinea pig, modulates the response to vagal inputs, and triggers action potentials at the site of parasympathetic ganglia independent of acetylcholine (57). Furthermore, the right atrial (RAGP) and the posterior atrial ganglionated plexus (PAGP) appear to have different functions. Ablation of the PAGP reduced vagally mediated bradycardia by 26%, whereas RAGP ablation completely abolished this response. Inhibition of sympathetically mediated tachycardia by vagal stimulation was attenuated by ablation of either plexus (37). Thus parasympathetic efferent neurons are primarily located in the RAGP, whereas prejunctional parasympathetic-sympathetic interactions also involve neurons within the PAGP (37). The spontaneous activity of neurons in the intrinsic cardiac nervous system, even after cardiac denervation (45), suggests an active role of this system in regulating heart rate. However, the impact of the intrinsic cardiac nervous system on heart rate variability remains to be elucidated. The importance of the autonomic nervous system for heart rate variability in humans becomes apparent in patients following cardiac transplantation, in whom heart rate variability is markedly reduced (49). Although reinnervation is possible after months and years, initially transplanted hearts can be considered to be denervated. Thus the reduced heart rate variability in cardiac transplanted patients (49) underlines the importance of an intact autonomic innervation for spontaneously occurring heart rate variability. A major component of the chronotropic effect of the autonomic nervous system is linked to cAMP. Intracellular cAMP increases the inward current of Na+ (funny current, If), which determines the rate of the slow diastolic depolarization that precedes each action potential. The activity of adenylate cyclase and thus intracellular cAMP levels are increased by stimulation of sympathetic β1-adrenergic receptors and decreased (via a Gi protein) by stimulation of parasympathetic muscarinic receptors. Thus cardiac sympathetic innervation increases the rate of the slow diastolic depolarization and accelerates heart rate, while cardiac parasympathetic innervation elicits opposite effects. Interestingly, parasympathetic-mediated changes in heart rate occur much faster than sympathetic-mediated effects on heart rate (27, 30, 47a). As a result, cardiac sympathetic nervous system activity can only affect LF components of heart rate variability, whereas the parasympathetic nervous system can also modulate HF components. A hitherto unsolved question in this context is if the rapid heart rate response to parasympathetic stimulation compared with the slow effect of sympathetic inputs is due to 1) different kinetics of β1-adrenergic vs. muscarinic receptors, 2) different kinetics of adenylate cyclase vs. phosphodiesterase, the enzyme that cleaves cAMP, or 3) fast parasympathetic-mediated opening of KACh channels (via muscarinic receptors and a GK protein). Support for the latter possibility comes from experiments in the rabbit sinoatrial node that demonstrated that activation of KACh channels contributes to the initial slowing of heart rate as a result of vagal stimulation (8).On the basis of the different frequency response characteristics of sympathetic and parasympathetic modulation of heart rate, frequency analysis of heart rate variability is often used as a tool to determine "autonomic balance" or sympathetic and parasympathetic nervous system activity (27, 47a). As an example, the wavelet transform was recently used to determine cardiac autonomic responses to reperfusion in patients with thrombolysis after coronary thrombosis. Depending on the location of the infarct, marked alterations in LF or HF spectral power of heart rate or in the LF/HF ratio was observed in all successful reperfusions (48).The HF component corresponds to the frequency of respiration and is driven by the vagus as indicated by the strong respiratory pattern of cardiac vagal motoneurons in the nucleus ambiguus (38). The LF component has been ascribed to sympathetic modulation of cardiac pacemaker activity, because a variety of studies demonstrated that acute interventions that increase sympathetic nervous system activity, such as orthostatic perturbations (17, 19, 33), mental stress (32), or handgrip exercise (13, 24) increases LF spectral power of heart rate (27, 30). In addition to acute perturbations of cardiac sympathetic nerve activity, feedback oscillations generated by the baroreceptor reflex also appear to contribute to LF spectral power of heart rate as it was demonstrated that sinoaortic denervation markedly reduces the LF component (27, 30). Despite the strong modulation of heart rate by the autonomic nervous system, the LF and HF spectral components of heart rate variability may not always be very reliable markers for cardiac sympathetic and parasympathetic "tone" (30). In a recent study, muscle sympathetic nerve activity was recorded together with heart rate variability during application of lower body negative pressure that is known to increase muscle sympathetic nerve activity (17, 33). At higher levels of lower body negative pressure (-15 mmHg), both muscle sympathetic nerve activity and relative LF spectral power of heart rate increased significantly, whereas HF spectral power decreased (17). These findings suggest that LF spectral power reflects cardiac sympathetic "tone." However, no correlation within subjects was found between changes in LF/HF ratio and muscle sympathetic nerve activity (17). Thus heart rate variability does not reliably reflect the sympathetic response to orthostatic stress. Respiration-related fluctuation of heart rate (respiratory sinus arrhythmia) is probably the most often investigated component of heart rate variability, as it is believed that this component reflects respiration-driven vagal modulation of sinus arrhythmia (27). In a recent study, Rentero et al. (38) recorded the electrical activity from cardiac vagal motoneurons in the nucleus ambiguus. Firing of these neurons was modulated by the central respiratory cycle. This and other studies support the view that respiratory sinus arrhythmia is generated by central coupling of the respiratory oscillator with autonomic centers in the brain stem. However, a mechanical cardiopulmonary coupling as a source of respiration-related heart rate variability has also been suggested (5). The Bainbridge reflex causes a tachycardia in response to hypervolemia. This reflex is initiated by atrial mechanoreceptors and uses efferent sympathetic and parasympathetic pathways to modulate heart rate in response to changes in central venous pressure (23). Thus respiratory changes in central blood volume cause corresponding respiratory fluctuations in cardiac autonomic nervous system activity via the Bainbridge reflex. Only the parasympathetic component of the efferent pathway of the reflex can contribute to respiratory sinus arrhythmia, because sympathetic actions on heart rate are too damped to follow the respiratory frequency. The gain and phase of the transfer function between respiratory changes in lung volume and R-R intervals of the ECG were calculated in human subjects during graded changes in central blood volume (5). At the respiratory frequency, the phase was -180 degree, indicating that an inspiratory increase in central blood volume was associated with a decrease in R-R interval (increase in heart rate). Furthermore, the gain of the transfer function at the respiratory frequency steadily increased with increasing central volumes (except at the highest volume). Both of these findings confirm the presence of the Bainbridge reflex in humans (5). Thus, in addition to the central coupling of respiratory oscillators with cardiovascular centers, the Bainbridge reflex may contribute to respiration-related heart rate variability by mechanical cardiopulmonary coupling. There is general agreement that low heart rate variability is an unfavorable prognostic marker for cardiovascular diseases, such as diabetic autonomic neuropathy, hypertension, myocardial infarction, and heart failure (18, 22, 27, 29, 47a). Heart rate variability (variance of R-R intervals) was reduced in patients with mild hypertension (29) compared with normal values (1,134 ± 202 vs. 3,466 ± 1,018 ms2) provided by the Task Force (47a). In the rat model of myocardial infarction-induced congestive heart failure, Francis and colleagues (18) reported loss of spontaneous heart rate variability 6 wk after coronary artery ligation. Interestingly, reduced heart rate variability was also observed in a rat model of depression that is based on chronic (4 wk) mild stress application (22). Because depression is an independent risk factor for coronary artery disease, this finding may realistically model a human disease process. The reduction in heart rate variability was abolished by β-adrenergic receptor blockade, indicating that the reduced heart rate variability in this model of depression is related to elevated cardiac sympathetic tone (22).In summary, heart rate variability is generated by multiple factors not exclusively limited to the autonomic nervous system. Specific frequency components of heart rate variability mirror acute perturbations of the autonomic nervous system but do not always reflect autonomic nervous system activity. Simple statistics of heart rate variability, such as the standard deviation of R-R intervals in the ECG, can reliably predict the prognosis of cardiovascular diseases.I thank Dr. R. McAllen for critically reviewing the manuscript. References 1 Aoki K, Stephens DP, and Johnson JM. Diurnal variation in cutaneous vasodilator and vasoconstrictor systems during heat stress. 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American Journal of Physiology-Regulatory, Integrative and Comparative Physiology · review · 309 citationsread the source →
Tjokrowijoto P, Stolwyk RJ, Ung D, Kneebone I, Kilkenny MF, Kim J, Olaiya MT, Dalli LL, Cadilhac DA, Nelson MR, Lannin NA, Andrew NE, PRECISE Investigators*. (2023)MEDLINE-indexed journal, not yet read by usStroke · cohort or longitudinal Receipt of Mental Health Treatment in People Living With Stroke: Associated Factors and Long-Term Outcomes.
Background: Untreated poststroke mood problems may influence long-term outcomes. We aimed to investigate factors associated with receiving mental health treatment following stroke and impacts on long-term outcomes.
Methods: Observational cohort study derived from the Australian Stroke Clinical Registry (AuSCR; Queensland and Victorian registrants: 2012-2016) linked with hospital, primary care billing and pharmaceutical dispensing claims data. Data from registrants who completed the AuSCR 3 to 6 month follow-up survey containing a question on anxiety/depression were analyzed. We assessed exposures at 6 to 18 months and outcomes at 18 to 30 months. Factors associated with receiving treatment were determined using staged multivariable multilevel logistic regression models. Cox proportional hazards regression models were used to assess the impact of treatment on outcomes.
Results: Among 7214 eligible individuals, 39% reported anxiety/depression at 3 to 6 months following stroke. Of these, 54% received treatment (88% antidepressant medication). Notable factors associated with any mental health treatment receipt included prestroke psychological support (odds ratio [OR], 1.80 [95% CI, 1.37-2.38]) or medication (OR, 17.58 [95% CI, 15.05-20.55]), self-reported anxiety/depression (OR, 2.55 [95% CI, 2.24-2.90]), younger age (OR, 0.98 [95% CI, 0.97-0.98]), and being female (OR, 1.30 [95% CI, 1.13-1.48]). Those who required interpreter services (OR, 0.49 [95% CI, 0.25-0.95]) used a health benefits card (OR, 0.73 [95% CI, 0.59-0.92]) or had continuity of primary care visits (ie, with a consistent physician; OR, 0.78 [95% CI, 0.62-0.99]) were less likely to access mental health services. Among those who reported anxiety/depression, those who received mental health treatment had an increased risk of presenting to hospital (hazard ratio, 1.06 [95% CI, 1.01-1.11]) but no difference in survival (hazard ratio, 0.86 [95% CI, 0.58-1.27]).
Conclusions: Nearly half of the people living with mood problems following stroke did not receive mental health treatment. We have highlighted subgroups who may benefit from targeted mood screening and factors that may improve treatment access.
Stroke · cohort or longitudinal · 10 citationsread the source →
Prevalence, comorbidities, and factors associated with prolonged grief disorder, posttraumatic stress disorder and complex posttraumatic stress disorder in refugees: a systematic review.
Background: The number of refugees worldwide is at an all-time high with many being exposed to potentially traumatic events and the loss of loved ones. The 11th revision of the International Statistical Classification of Diseases and Related Health Problems now includes prolonged grief disorder and complex posttraumatic stress disorder and revised criteria for posttraumatic stress disorder. An overview of these stress-related disorders among people who have become refugees is therefore needed. Consequently, we conducted a systematic review to determine prevalence rates, comorbidities, and associated factors for each of the disorders.
Method: We systematically searched PubMed, Web of Science, and PsycArticles to identify studies that reported prevalence rates, predictors or associated factors, and/or comorbid mental disorders for either (1) prolonged grief disorder, (2) posttraumatic stress disorder, or (3) complex posttraumatic stress disorder among refugees. The selection process followed the PRISMA guidelines.
Results: A total of 36 studies met the inclusion criteria. Most of the studies were of high quality. There was substantial variation in prevalence rates by disorder, with prolonged grief ranging from 6 to 54%, posttraumatic stress disorder ranging from 0.4 to 80%, and complex posttraumatic stress disorder ranging from 3 to 74.6%. Pooled prevalence for posttraumatic stress disorder was estimated at 29.8% in treatment seeking samples and 9.92% in population samples. For complex posttraumatic stress disorder, it was estimated at 57.4% in treatment seeking samples and 7.8% in population samples. Posttraumatic stress disorder was among the most frequent comorbidities for prolonged grief disorder while depressive symptoms were the most frequently occurring co-morbidity across all three disorders. Sociodemographic variables, trauma exposure, and loss characteristics were associated with higher symptom severity. Postmigration living difficulties played an important role in prolonged grief and complex posttraumatic stress disorder.
Conclusion: The review revealed substantial differences in prevalence rates between the three studied disorders but underscored a very high prevalence of ICD-11 stress-related disorders among refugees. The identified associated factors point to subgroups that may be particularly at risk and establishes a foundational basis for targeted interventions and potential policy changes. Future research should incorporate longitudinal investigations and emphasize culturally sensitive assessments.
Conflict and health · review · 21 citationsread the source →
Solmi M, Monaco F, Højlund M, Monteleone AM, Trott M, Firth J, Carfagno M, Eaton M, De Toffol M, Vergine M, Meneguzzo P, Collantoni E, Gallicchio D, Stubbs B, Girardi A, Busetto P, Favaro A, Carvalho AF, Steinhausen HC, Correll CU. (2024)MEDLINE-indexed journal, not yet read by usWorld psychiatry : official journal of the World Psychiatric Association (WPA) Outcomes in people with eating disorders: a transdiagnostic and disorder-specific systematic review, meta-analysis and multivariable meta-regression analysis.
Eating disorders (EDs) are known to be associated with high mortality and often chronic and severe course, but a recent comprehensive systematic review of their outcomes is currently missing. In the present systematic review and meta-analysis, we examined cohort studies and clinical trials published between 1980 and 2021 that reported, for DSM/ICD-defined EDs, overall ED outcomes (i.e., recovery, improvement and relapse, all-cause and ED-related hospitalization, and chronicity); the same outcomes related to purging, binge eating and body weight status; as well as mortality. We included 415 studies (N=88,372, mean age: 25.7±6.9 years, females: 72.4%, mean follow-up: 38.3±76.5 months), conducted in persons with anorexia nervosa (AN), bulimia nervosa (BN), binge eating disorder (BED), other specified feeding and eating disorders (OSFED), and/or mixed EDs, from all continents except Africa. In all EDs pooled together, overall recovery occurred in 46% of patients (95% CI: 44-49, n=283, mean follow-up: 44.9±62.8 months, no significant ED-group difference). The recovery rate was 42% at <2 years, 43% at 2 to <4 years, 54% at 4 to <6 years, 59% at 6 to <8 years, 64% at 8 to <10 years, and 67% at ≥10 years. Overall chronicity occurred in 25% of patients (95% CI: 23-29, n=170, mean follow-up: 59.3±71.2 months, no significant ED-group difference). The chronicity rate was 33% at <2 years, 40% at 2 to <4 years, 23% at 4 to <6 years, 25% at 6 to <8 years, 12% at 8 to <10 years, and 18% at ≥10 years. Mortality occurred in 0.4% of patients (95% CI: 0.2-0.7, n=214, mean follow-up: 72.2±117.7 months, no significant ED-group difference). Considering observational studies, the mortality rate was 5.2 deaths/1,000 person-years (95% CI: 4.4-6.1, n=167, mean follow-up: 88.7±120.5 months; significant difference among EDs: p<0.01, range: from 8.2 for mixed ED to 3.4 for BN). Hospitalization occurred in 26% of patients (95% CI: 18-36, n=18, mean follow-up: 43.2±41.6 months; significant difference among EDs: p<0.001, range: from 32% for AN to 4% for BN). Regarding diagnostic migration, 8% of patients with AN migrated to BN and 16% to OSFED; 2% of patients with BN migrated to AN, 5% to BED, and 19% to OSFED; 9% of patients with BED migrated to BN and 19% to OSFED; 7% of patients with OSFED migrated to AN and 10% to BN. Children/adolescents had more favorable outcomes across and within EDs than adults. Self-injurious behaviors were associated with lower recovery rates in pooled EDs. A higher socio-demographic index moderated lower recovery and higher chronicity in AN across countries. Specific treatments associated with higher recovery rates were family-based therapy, cognitive-behavioral therapy (CBT), psychodynamic therapy, and nutritional interventions for AN; self-help, CBT, dialectical behavioral therapy (DBT), psychodynamic therapy, nutritional and pharmacological treatments for BN; CBT, nutritional and pharmacological interventions, and DBT for BED; and CBT and psychodynamic therapy for OSFED. In AN, pharmacological treatment was associated with lower recovery, and waiting list with higher mortality. These results should inform future research, clinical practice and health service organization for persons with EDs.
World psychiatry : official journal of the World Psychiatric Association (WPA) · 148 citationsread the source →
Meadows G, Brophy L, Shawyer F, Enticott JC, Fossey E, Thornton CD, Weller PJ, Wilson-Evered E, Edan V, Slade M. (2019)MEDLINE-indexed journal, not yet read by usThe lancet. Psychiatry · randomised controlled trial REFOCUS-PULSAR recovery-oriented practice training in specialist mental health care: a stepped-wedge cluster randomised controlled trial.
Background: Recovery-oriented practice promotes the strengths and recovery potential of individuals. We aimed to establish whether individuals who access mental health services where staff have received the REFOCUS-PULSAR intervention, an adaptation of the UK's REFOCUS recovery-oriented staff intervention for use in Australia, show increased recovery compared with people using non-intervention services.
Methods: We did a pragmatic, two-step, stepped-wedge, randomised controlled trial at 18 sites grouped into 14 clusters across public mental health services and mental health community support services in Victoria, Australia. Eligible staff were working part-time or full-time in a direct service role at one of the 18 sites and had consumers being recruited for this study. Eligible consumers were receiving care from a participating cluster, with contact in the 3 months before data collection; aged 18-75 years; and not imprisoned. Clusters were randomly assigned with a web-based randomisation tool to receive the REFOCUS-PULSAR intervention in either the first year (step one) or second year (step two). Consumers, but not staff, were masked to treatment assignment. The primary outcome was the Questionnaire about the Process of Recovery (QPR), for which cross-sectional data were collected across three timepoints (baseline [T0], year 1 [T1], and year 2 [T2]). The primary analysis was done by intention to treat. This trial is registered with ANZCTR, number ACTRN12614000957695.
Findings: 190 staff (111 from public mental health services and 79 from mental health community support services) received the REFOCUS-PULSAR recovery-oriented training intervention. Between Sept 18, 2014, and May 19, 2017, 942 consumers were recruited across the three timepoints (T0: n=301; T1: n=334; T2: n=307). The mean QPR score was 53·6 (SD 16·3) in the control group and 54·4 (16·2) in the intervention group (adjusted difference 3·7, 95% CI 0·5-6·8; p=0·023). The Cohen's d value for the intervention effect was small (d=0·23).
Interpretation: The REFOCUS-PULSAR intervention had a small but significant effect on the QPRs of individuals using community mental health services and might be effective in promotion of recovery-oriented practice across sectors.
Funding: Victorian Government Mental Illness Research Fund.
The lancet. Psychiatry · randomised controlled trial · 39 citationsread the source →
Psychosocial interventions for smoking cessation in patients with coronary heart disease.
Background: This is an update of a Cochrane review previously published in 2008. Smoking increases the risk of developing atherosclerosis but also acute thrombotic events. Quitting smoking is potentially the most effective secondary prevention measure and improves prognosis after a cardiac event, but more than half of the patients continue to smoke, and improved cessation aids are urgently required.
Objectives: This review aimed to examine the efficacy of psychosocial interventions for smoking cessation in patients with coronary heart disease in short-term (6 to 12 month follow-up) and long-term (more than 12 months). Moderators of treatment effects (i.e. intervention types, treatment dose, methodological criteria) were used for stratification.
Search methods: The Cochrane Central Register of Controlled Trials (Issue 12, 2012), MEDLINE, EMBASE, PsycINFO and PSYNDEX were searched from the start of the database to January 2013. This is an update of the initial search in 2003. Results were supplemented by cross-checking references, and handsearches in selected journals and systematic reviews. No language restrictions were applied.
Selection criteria: Randomised controlled trials (RCTs) in patients with CHD with a minimum follow-up of 6 months.
Data collection and analysis: Two authors independently assessed trial eligibility and risk of bias. Abstinence rates were computed according to an intention to treat analysis if possible, or if not according to completer analysis results only. Subgroups of specific intervention strategies were analysed separately. The impact of study quality on efficacy was studied in a moderator analysis. Risk ratios (RR) were pooled using the Mantel-Haenszel and random-effects model with 95% confidence intervals (CI).
Main results: We found 40 RCTs meeting inclusion criteria in total (21 trials were new in this update, 5 new trials contributed to long-term results (more than 12 months)). Interventions consist of behavioural therapeutic approaches, telephone support and self-help material and were either focused on smoking cessation alone or addressed several risk factors (eg. obesity, inactivity and smoking). The trials mostly included older male patients with CHD, predominantly myocardial infarction (MI). After an initial selection of studies three trials with implausible large effects of RR > 5 which contributed to substantial heterogeneity were excluded. Overall there was a positive effect of interventions on abstinence after 6 to 12 months (risk ratio (RR) 1.22, 95% confidence interval (CI) 1.13 to 1.32, I² 54%; abstinence rate treatment group = 46%, abstinence rate control group 37.4%), but heterogeneity between trials was substantial. Studies with validated assessment of smoking status at follow-up had similar efficacy (RR 1.22, 95% CI 1.07 to 1.39) to non-validated trials (RR 1.23, 95% CI 1.12 to 1.35). Studies were stratified by intervention strategy and intensity of the intervention. Clustering reduced heterogeneity, although many trials used more than one type of intervention. The RRs for different strategies were similar (behavioural therapies RR 1.23, 95% CI 1.12 to 1.34, I² 40%; telephone support RR 1.21, 95% CI 1.12 to 1.30, I² 44%; self-help RR 1.22, 95% CI 1.12 to 1.33, I² 40%). More intense interventions (any initial contact plus follow-up over one month) showed increased quit rates (RR 1.28, 95% CI 1.17 to 1.40, I² 58%) whereas brief interventions (either one single initial contact lasting less than an hour with no follow-up, one or more contacts in total over an hour with no follow-up or any initial contact plus follow-up of less than one months) did not appear effective (RR 1.01, 95% CI 0.91 to 1.12, I² 0%). Seven trials had long-term follow-up (over 12 months), and did not show any benefits. Adverse side effects were not reported in any trial. These findings are based on studies with rather low risk of selection bias but high risk of detection bias (namely unblinded or non validated assessment of smoking status).
Authors' conclusions: Psychosocial smoking cessation interventions are effective in promoting abstinence up to 1 year, provided they are of sufficient duration. After one year, the studies showed favourable effects of smoking cessation intervention, but more studies including cost-effectiveness analyses are needed. Further studies should also analyse the additional benefit of a psychosocial intervention strategy to pharmacological therapy (e.g. nicotine replacement therapy) compared with pharmacological treatment alone and investigate economic outcomes.
The Cochrane database of systematic reviews · meta-analysis · 32 citationsread the source →
Psychiatric and neuropsychiatric presentations associated with severe coronavirus infections: a systematic review and meta-analysis with comparison to the COVID-19 pandemic.
Background: Before the COVID-19 pandemic, coronaviruses caused two noteworthy outbreaks: severe acute respiratory syndrome (SARS), starting in 2002, and Middle East respiratory syndrome (MERS), starting in 2012. We aimed to assess the psychiatric and neuropsychiatric presentations of SARS, MERS, and COVID-19.
Methods: In this systematic review and meta-analysis, MEDLINE, Embase, PsycINFO, and the Cumulative Index to Nursing and Allied Health Literature databases (from their inception until March 18, 2020), and medRxiv, bioRxiv, and PsyArXiv (between Jan 1, 2020, and April 10, 2020) were searched by two independent researchers for all English-language studies or preprints reporting data on the psychiatric and neuropsychiatric presentations of individuals with suspected or laboratory-confirmed coronavirus infection (SARS coronavirus, MERS coronavirus, or SARS coronavirus 2). We excluded studies limited to neurological complications without specified neuropsychiatric presentations and those investigating the indirect effects of coronavirus infections on the mental health of people who are not infected, such as those mediated through physical distancing measures such as self-isolation or quarantine. Outcomes were psychiatric signs or symptoms; symptom severity; diagnoses based on ICD-10, DSM-IV, or the Chinese Classification of Mental Disorders (third edition) or psychometric scales; quality of life; and employment. Both the systematic review and the meta-analysis stratified outcomes across illness stages (acute vs post-illness) for SARS and MERS. We used a random-effects model for the meta-analysis, and the meta-analytical effect size was prevalence for relevant outcomes, I2 statistics, and assessment of study quality.
Findings: 1963 studies and 87 preprints were identified by the systematic search, of which 65 peer-reviewed studies and seven preprints met inclusion criteria. The number of coronavirus cases of the included studies was 3559, ranging from 1 to 997, and the mean age of participants in studies ranged from 12·2 years (SD 4·1) to 68·0 years (single case report). Studies were from China, Hong Kong, South Korea, Canada, Saudi Arabia, France, Japan, Singapore, the UK, and the USA. Follow-up time for the post-illness studies varied between 60 days and 12 years. The systematic review revealed that during the acute illness, common symptoms among patients admitted to hospital for SARS or MERS included confusion (36 [27·9%; 95% CI 20·5-36·0] of 129 patients), depressed mood (42 [32·6%; 24·7-40·9] of 129), anxiety (46 [35·7%; 27·6-44·2] of 129), impaired memory (44 [34·1%; 26·2-42·5] of 129), and insomnia (54 [41·9%; 22·5-50·5] of 129). Steroid-induced mania and psychosis were reported in 13 (0·7%) of 1744 patients with SARS in the acute stage in one study. In the post-illness stage, depressed mood (35 [10·5%; 95% CI 7·5-14·1] of 332 patients), insomnia (34 [12·1%; 8·6-16·3] of 280), anxiety (21 [12·3%; 7·7-17·7] of 171), irritability (28 [12·8%; 8·7-17·6] of 218), memory impairment (44 [18·9%; 14·1-24·2] of 233), fatigue (61 [19·3%; 15·1-23·9] of 316), and in one study traumatic memories (55 [30·4%; 23·9-37·3] of 181) and sleep disorder (14 [100·0%; 88·0-100·0] of 14) were frequently reported. The meta-analysis indicated that in the post-illness stage the point prevalence of post-traumatic stress disorder was 32·2% (95% CI 23·7-42·0; 121 of 402 cases from four studies), that of depression was 14·9% (12·1-18·2; 77 of 517 cases from five studies), and that of anxiety disorders was 14·8% (11·1-19·4; 42 of 284 cases from three studies). 446 (76·9%; 95% CI 68·1-84·6) of 580 patients from six studies had returned to work at a mean follow-up time of 35·3 months (SD 40·1). When data for patients with COVID-19 were examined (including preprint data), there was evidence for delirium (confusion in 26 [65%] of 40 intensive care unit patients and agitation in 40 [69%] of 58 intensive care unit patients in one study, and altered consciousness in 17 [21%] of 82 patients who subsequently died in another study). At discharge, 15 (33%) of 45 patients with COVID-19 who were assessed had a dysexecutive syndrome in one study. At the time of writing, there were two reports of hypoxic encephalopathy and one report of encephalitis. 68 (94%) of the 72 studies were of either low or medium quality.
Interpretation: If infection with SARS-CoV-2 follows a similar course to that with SARS-CoV or MERS-CoV, most patients should recover without experiencing mental illness. SARS-CoV-2 might cause delirium in a significant proportion of patients in the acute stage. Clinicians should be aware of the possibility of depression, anxiety, fatigue, post-traumatic stress disorder, and rarer neuropsychiatric syndromes in the longer term.
Funding: Wellcome Trust, UK National Institute for Health Research (NIHR), UK Medical Research Council, NIHR Biomedical Research Centre at University College London Hospitals NHS Foundation Trust and University College London.
The lancet. Psychiatry · meta-analysis · 1531 citationsread the source →
Impulse control disorder related behaviours during long-term rotigotine treatment: a post hoc analysis.
Background and purpose: Dopamine agonists in Parkinson's disease (PD) are associated with impulse control disorders (ICDs) and other compulsive behaviours (together called ICD behaviours). The frequency of ICD behaviours reported as adverse events (AEs) in long-term studies of rotigotine transdermal patch in PD was evaluated.
Methods: This was a post hoc analysis of six open-label extension studies up to 6 years in duration. Analyses included patients treated with rotigotine for at least 6 months and administered the modified Minnesota Impulse Disorders Interview. ICD behaviours reported as AEs were identified and categorized.
Results: For 786 patients, the mean (±SD) exposure to rotigotine was 49.4 ± 17.6 months. 71 (9.0%) patients reported 106 ICD AEs cumulatively. Occurrence was similar across categories: 2.5% patients reported 'compulsive sexual behaviour', 2.3% 'buying disorder', 2.0% 'compulsive gambling', 1.7% 'compulsive eating' and 1.7% 'punding behaviour'. Examining at 6-month intervals, the incidence was relatively low during the first 30 months; it was higher over the next 30 months, peaking in the 54-60-month period. No ICD AEs were serious, and 97% were mild or moderate in intensity. Study discontinuation occurred in seven (9.9%) patients with ICD AEs; these then resolved in five patients. Dose reduction occurred for 23 AEs, with the majority (73.9%) resolving.
Conclusions: In this analysis of >750 patients with PD treated with rotigotine, the frequency of ICD behaviour AEs was 9.0%, with a specific incidence timeline observed. Active surveillance as duration of treatment increases may help early identification and management; once ICD behaviours are present rotigotine dose reduction may be considered.
European journal of neurology · meta-analysis · 52 citationsread the source →
Zandieh S, Abdollahzadeh SM, Sadeghirad B, Wang L, McCabe RE, Yao L, Inness BE, Pathak A, Couban RJ, Crandon H, Torabiardakani K, Bieling P, Busse JW. (2024)MEDLINE-indexed journal, not yet read by usCMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · meta-analysis Therapist-guided remote versus in-person cognitive behavioural therapy: a systematic review and meta-analysis of randomized controlled trials.
Background: Cognitive behavioural therapy (CBT) has been shown to be effective for several psychiatric and somatic conditions; however, most randomized controlled trials (RCTs) have administered treatment in person and whether remote delivery is similarly effective remains uncertain. We sought to compare the effectiveness of therapist-guided remote CBT and in-person CBT.
Methods: We systematically searched MEDLINE, Embase, PsycINFO, CINAHL, and the Cochrane Central Register of Controlled Trials from inception to July 4, 2023, for RCTs that enrolled adults (aged ≥ 18 yr) presenting with any clinical condition and that randomized participants to either therapist-guided remote CBT (e.g., teleconference, videoconference) or in-person CBT. Paired reviewers assessed risk of bias and extracted data independently and in duplicate. We performed random-effects model meta-analyses to pool patient-important primary outcomes across eligible RCTs as standardized mean differences (SMDs). We used Grading of Recommendations Assessment, Development and Evaluation (GRADE) guidance to assess the certainty of evidence and used the Instrument to Assess the Credibility of Effect Modification Analyses (ICEMAN) to rate the credibility of subgroup effects.
Results: We included 54 RCTs that enrolled a total of 5463 patients. Seventeen studies focused on treatment of anxiety and related disorders, 14 on depressive symptoms, 7 on insomnia, 6 on chronic pain or fatigue syndromes, 5 on body image or eating disorders, 3 on tinnitus, 1 on alcohol use disorder, and 1 on mood and anxiety disorders. Moderate-certainty evidence showed little to no difference in the effectiveness of therapist-guided remote and in-person CBT on primary outcomes (SMD -0.02, 95% confidence interval -0.12 to 0.07).
Interpretation: Moderate-certainty evidence showed little to no difference in the effectiveness of in-person and therapist-guided remote CBT across a range of mental health and somatic disorders, suggesting potential for the use of therapist-guided remote CBT to facilitate greater access to evidence-based care. Systematic review registration: Open Science Framework (https://osf.io/7asrc).
CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · meta-analysis · 24 citationsread the source →
The association of gait speed and self-reported difficulty walking with social isolation: A nationally-representative study.
Background: Mobility assessments are commonly used among older adults as risk stratification for falls, preoperative function, frailty, and mortality. We determined if gait speed and self-reported difficulty walking are similarly associated with social isolation and loneliness, which are key markers of social well-being and linked to health outcomes.
Methods: We used 2015-2016 data from the National Social life Health and Aging Project (NSHAP), an in-person nationally-representative survey of 2640 community-dwelling adults ≥65 years old. We measured gait speed (timed 3-m walk: unable to walk, ≥5.7 s, and <5.7 s), and self-reported difficulty walking one block or across the room (unable, "much," "some," or "no" difficulty). Social measures included loneliness (3-item UCLA scale), social isolation (12-item scale), and individual social activities (frequency socializing, religious participation, community participation, and volunteering). We used logistic regression to determine the adjusted probability of each social measure by gait speed and difficulty walking, adjusting for sociodemographic and health characteristics, and tested for interaction terms with age.
Results: Participants were on average 75 years old (SD = 7.1), 54% female, 9% Black/African American, and 6% Hispanic. Difficulty walking one block was associated with (p < 0.05): social isolation (much difficulty: 26% vs no difficulty: 18%), low socializing (33% vs 19%), low volunteering (67% vs 53%), low community participation (54% vs 43%), low religious participation (51% vs 46%), and loneliness (25% vs 14%). Difficulty walking across the room was similarly strongly associated with social isolation and individual activities. The association between self-reported difficulty walking and social isolation was stronger at older ages (p-value of interaction <0.001).
Conclusions: Self-reported mobility difficulty is a widely used clinical assessment that is strongly associated with loneliness and social isolation, particularly at older ages. Among persons with limited mobility, clinicians should consider a careful social history to identify social needs and interventions addressing mobility to enhance social connections.
Journal of the American Geriatrics Society · 17 citationsread the source →
Comparative effectiveness of continuation and maintenance treatments for persistent depressive disorder in adults.
Background: Persistent depressive disorder (PDD) is defined as a depressive disorder with a minimum illness duration of two years, including four diagnostic subgroups (dysthymia, chronic major depression, recurrent major depression with incomplete remission between episodes, and double depression). Persistent forms of depression represent a substantial proportion of depressive disorders, with a lifetime prevalence ranging from 3% to 6% in the Western world. Growing evidence indicates that PDD responds well to several acute interventions, such as combined psychological and pharmacological treatments. Yet, given the high rates of relapse and recurrences of depression following response to acute treatment, long-term continuation and maintenance therapy are of great importance. To date, there has been no evidence synthesis available on continuation and maintenance treatments of PDDs.
Objectives: To assess the effects of pharmacological and psychological (either alone or combined) continuation and maintenance treatments for persistent depressive disorder, in comparison with each other, placebo (drug/attention placebo/non-specific treatment control), and treatment as usual (TAU). Continuation treatments are defined as treatments given to currently remitted people (remission is defined as depressive symptoms dropping below case level) or to people who previously responded to an antidepressant treatment. Maintenance therapy is given during recovery (which is defined as remission lasting longer than six months).
Search methods: We searched Ovid MEDLINE (1950- ), Embase (1974- ), PsycINFO (1967- ) and the Cochrane Central Register of Controlled Trials (CENTRAL) to 28 September 2018. An earlier search of these databases was also conducted for RCTs via the Cochrane Common Mental Disorders Controlled Trial Register (CCMD-CTR) (all years to 11 Dec 2015). In addition we searched grey literature resources as well as the international trial registers ClinicalTrials.gov and ICTRP to 28 September 2018. We screened reference lists of included studies and contacted the first author of all included studies.
Selection criteria: We included randomized (RCTs) and non-randomized controlled trials (NRCTs) in adults with formally diagnosed PDD, receiving pharmacological, psychological, or combined continuation and maintenance interventions.
Data collection and analysis: Two review authors independently selected studies and extracted and analyzed data. The primary efficacy outcome was relapse/recurrence rate of depression. The primary acceptance outcome was dropout due to any reason other than relapse/recurrence. We performed random-effects meta-analyses using risk ratios (RR) for dichotomous outcomes and mean differences (MD) for continuous outcomes, with 95% confidence intervals (CI).
Main results: We included 10 studies (seven RCTs, three NRCTs) involving 840 participants in this review, from which five studies investigated continuation treatments and five studies investigated maintenance treatments. Overall, the included studies were at low-to-moderate risk of bias. For the three NRCTs, the most common source of risk of bias was selection of reported results. For the seven RCTs, the most common sources of risk of bias was non-blinding of outcome assessment and other bias (especially conflict of interest due to pharmaceutical sponsoring).Pharmacological continuation and maintenance therapiesThe most common comparison was antidepressant medication versus tablet placebo (five studies). Participants taking antidepressant medication were probably less likely to relapse or to experience a recurrent episode compared to participants in the placebo group at the end of the intervention (13.9% versus 33.8%, RR 0.41, 95% CI 0.21 to 0.79; participants = 383; studies = 4; I² = 54%, moderate quality evidence). Overall dropout rates may be similar between participants in the medication and placebo group (23.0% versus 25.5%, RR 0.90, 95% CI 0.39 to 2.11; RCTs = 4; participants = 386; I² = 64%, low quality evidence). However, sensitivity analyses showed that the primary outcome (rate of relapse/recurrence) showed no evidence of a difference between groups when only including studies with low risk of bias. None of the studies compared pharmacological or psychological treatments versus TAU.Psychological continuation and maintenance therapiesOne study compared psychological therapies versus attention placebo/non-specific control. One study compared psychotherapy with medication. The results of the studies including psychotherapy might indicate that continued or maintained psychotherapy could be a useful intervention compared to no treatment or antidepressant medication. However, the body of evidence for these comparisons was too small and uncertain to draw any high quality conclusions. Combined psychological and pharmacological continuation and maintenance therapiesThree studies compared combined psychological and pharmacological therapies with pharmacological therapies alone. One study compared combined psychological and pharmacological therapies with psychotherapeutic therapies alone. However, the body of evidence for these comparisons was too small and uncertain to draw any high quality conclusionsComparison of different antidepressant medications Two studies reported data on the direct comparison of two antidepressants. However, the body of evidence for this comparison was too small and uncertain to draw any high quality conclusions.
Authors' conclusions: Currently, it is uncertain whether continued or maintained pharmacotherapy (or both) with the reviewed antidepressant agents is a robust treatment for preventing relapse and recurrence in people with PDD, due to moderate or high risk of bias as well as clinical heterogeneity in the analyzed studies. For all other comparisons, the body of evidence was too small to draw any final conclusions, although continued or maintained psychotherapy might be effective compared to no treatment. There is need for more high quality trials of psychological interventions. Further studies should address health-related quality of life and adverse events more precisely, as well as assessing follow-up data.
The Cochrane database of systematic reviews · systematic review · 29 citationsread the source →
Continuing education meetings and workshops: effects on professional practice and healthcare outcomes.
Background: Educational meetings are used widely by health personnel to provide continuing medical education and to promote implementation of innovations or translate new knowledge to change practice within healthcare systems. Previous reviews have concluded that educational meetings can result in small changes in behaviour, but that effects vary considerably. Investigations into which characteristics of educational meetings might lead to greater impact have yielded varying results, and factors that might explain heterogeneity in effects remain unclear. This is the second update of this Cochrane Review.
Objectives: • To assess the effects of educational meetings on professional practice and healthcare outcomes • To investigate factors that might explain the heterogeneity of these effects SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, ERIC, Science Citation Index Expanded (ISI Web of Knowledge), and Social Sciences Citation Index (last search in November 2016).
Selection criteria: We sought randomised trials examining the effects of educational meetings on professional practice and patient outcomes.
Data collection and analysis: Two review authors independently extracted data and assessed risk of bias. One review author assessed the certainty of evidence (GRADE) and discussed with a second review author. We included studies in the primary analysis that reported baseline data and that we judged to be at low or unclear risk of bias. For each comparison of dichotomous outcomes, we measured treatment effect as risk difference adjusted for baseline compliance. We expressed adjusted risk difference values as percentages, and we noted that values greater than zero favour educational meetings. For continuous outcomes, we measured treatment effect as per cent change relative to the control group mean post test, adjusted for baseline performance; we expressed values as percentages and noted that values greater than zero favour educational meetings. We report means and 95% confidence intervals (CIs) and, when appropriate, medians and interquartile ranges to facilitate comparisons to previous versions of this review. We analysed professional and patient outcomes separately and analysed 22 variables that were hypothesised a priori to explain heterogeneity. We explored heterogeneity by using univariate meta-regression and by inspecting violin plots.
Main results: We included 215 studies involving more than 28,167 health professionals, including 142 new studies for this update. Educational meetings as the single intervention or the main component of a multi-faceted intervention compared with no intervention • Probably slightly improve compliance with desired practice when compared with no intervention (65 comparisons, 7868 health professionals for dichotomous outcomes (adjusted risk difference 6.79%, 95% CI 6.62% to 6.97%; median 4.00%; interquartile range 0.29% to 13.00%); 28 comparisons, 2577 health professionals for continuous outcomes (adjusted relative percentage change 44.36%, 95% CI 41.98% to 46.75%; median 20.00%; interquartile range 6.00% to 65.00%)) • Probably slightly improve patient outcomes compared with no intervention (15 comparisons, 2530 health professionals for dichotomous outcomes (adjusted risk difference 3.30%, 95% CI 3.10% to 3.51%; median 0.10%; interquartile range 0.00% to 4.00%); 28 comparisons, 2294 health professionals for continuous outcomes (adjusted relative percentage change 8.35%, 95% CI 7.46% to 9.24%; median 2.00%; interquartile range -1.00% to 21.00%)) The certainty of evidence for this comparison is moderate. Educational meetings alone compared with other interventions • May improve compliance with desired practice when compared with other interventions (6 studies, 1402 health professionals for dichotomous outcomes (adjusted risk difference 9.99%, 95% CI 9.47% to 10.52%; median 16.5%; interquartile range 0.80% to 16.50%); 2 studies, 72 health professionals for continuous outcomes (adjusted relative percentage change 12.00%, 95% CI 9.16% to 14.84%; median 12.00%; interquartile range 0.00% to 24.00%)) No studies met the inclusion criteria for patient outcome measurements. The certainty of evidence for this comparison is low. Interactive educational meetings compared with didactic (lecture-based) educational meetings • We are uncertain of effects on compliance with desired practice (3 studies, 370 health professionals for dichotomous outcomes; 1 study, 192 health professionals for continuous outcomes) or on patient outcomes (1 study, 54 health professionals for continuous outcomes), as the certainty of evidence is very low Any other comparison of different formats and durations of educational meetings • We are uncertain of effects on compliance with desired practice (1 study, 19 health professionals for dichotomous outcomes; 1 study, 20 health professionals for continuous outcomes) or on patient outcomes (1 study, 113 health professionals for continuous outcomes), as the certainty of evidence is very low. Factors that might explain heterogeneity of effects Meta-regression suggests that larger estimates of effect are associated with studies judged to be at high risk of bias, with studies that had unit of analysis errors, and with studies in which the unit of analysis was the provider rather than the patient. Improved compliance with desired practice may be associated with: shorter meetings; poor baseline compliance; better attendance; shorter follow-up; professionals provided with additional take-home material; explicit building of educational meetings on theory; targeting of low- versus high-complexity behaviours; targeting of outcomes with high versus low importance; goal of increasing rather than decreasing behaviour; teaching by opinion leaders; and use of didactic versus interactive teaching methods. Pre-specified exploratory analyses of behaviour change techniques suggest that improved compliance with desired practice may be associated with use of a greater number of behaviour change techniques; goal-setting; provision of feedback; provision for social comparison; and provision for social support. Compliance may be decreased by the use of follow-up prompts, skills training, and barrier identification techniques.
Authors' conclusions: Compared with no intervention, educational meetings as the main component of an intervention probably slightly improve professional practice and, to a lesser extent, patient outcomes. Educational meetings may improve compliance with desired practice to a greater extent than other kinds of behaviour change interventions, such as text messages, fees, or office systems. Our findings suggest that multi-strategy approaches might positively influence the effects of educational meetings. Additional trials of educational meetings compared with no intervention are unlikely to change the review findings; therefore we will not further update this review comparison in the future. However, we note that randomised trials comparing different types of education are needed.
The Cochrane database of systematic reviews · systematic review · 139 citationsread the source →
Treating chronic insomnia in postmenopausal women: a randomized clinical trial comparing cognitive-behavioral therapy for insomnia, sleep restriction therapy, and sleep hygiene education.
Study objectives: Insomnia is a leading cause of disability in postmenopausal women. Multicomponent cognitive-behavioral therapy for insomnia (CBTI) is a first-line treatment for chronic insomnia, but support for its efficacy in treating menopause-related insomnia is scarce. The present study evaluated whether CBTI is an efficacious treatment for menopause-related chronic insomnia, and whether sleep restriction therapy (SRT)-a single component of CBTI-is equally efficacious compared with CBTI.
Methods: In a single-site, randomized controlled trial, 150 postmenopausal women (56.44 ± 5.64 years) with chronic DSM-5 insomnia disorder related to menopause were randomized to three treatment conditions: sleep hygiene education (SHE), SRT, or CBTI. Blinded assessments were performed at baseline, posttreatment, and 6 months after treatment. The Insomnia Severity Index (ISI) and sleep diaries served as primary outcomes.
Results: From baseline to posttreatment, ISI decreased 7.70 points in the CBTI group (p < .001), 6.56 points in the SRT group (p < .001), and 1.12 in the SHE group (p = .01). Although average sleep duration increased in all groups by 6 month follow-up, CBTI patients obtained 40-43 more minutes of nightly sleep than those who received SHE or SRT. Remission rates in the CBTI (54%-84%) and SRT (38%-57%) groups were higher than SHE patients (4%-33%) at posttreatment and 6 month follow-up. CBTI patients were generally more likely to remit than SRT patients.
Conclusions: CBTI and SRT effectively treat menopause-related insomnia disorder and are superior to SHE. Response to CBTI and SRT is similar, but CBTI outperforms SRT in improving sleep maintenance, which may increase likelihood of remission. Clinical Trial Name: Behavioral Treatment of Menopausal Insomnia: Sleep and Daytime Outcomes. URL: clinicaltrials.gov. Registration: NCT01933295.
Sleep · randomised controlled trial · 66 citationsread the source →
Preventing a first episode of psychosis: meta-analysis of randomized controlled prevention trials of 12 month and longer-term follow-ups.
Over the last decade many studies were conducted to assess the feasibility of early detection of people at risk of developing psychosis and intervention to prevent or delay a first psychotic episode. Most of these studies were small and underpowered. A meta-analysis can demonstrate the effectiveness of the efforts to prevent or postpone a first episode of psychosis. A search conducted according the PRISMA guideline identified 10 studies reporting 12-month follow-up data on transition to psychosis, and 5 studies with follow-ups varying from 24 to 48 months. Both random and fixed effects meta-analyses were conducted. The quality of the studies varied from poor to excellent. Overall the risk reduction at 12 months was 54% (RR=0.463; 95% CI=0.33-0.64) with a Number Needed to Treat (NNT) of 9 (95% CI=6-15). Although the interventions differed, there was only mild heterogeneity and publication bias was small. All sub-analyses demonstrated effectiveness. Also 24 to 48-month follow-ups were associated with a risk reduction of 37% (RR=.635; 95% CI=0.44-0.92) and a NNT of 12 (95% CI=7-59). Sensitivity analysis excluding the methodologically weakest study showed that the findings were robust. Early detection and intervention in people at ultra-high risk of developing psychosis can be successful to prevent or delay a first psychosis. Antipsychotic medication showed efficacy, but more trials are needed. Omega-3 fatty acid needs replication. Integrated psychological interventions need replication with more methodologically sound studies. The findings regarding CBT appear robust, but the 95% confidence interval is still wide.
Schizophrenia research · meta-analysis · 246 citationsread the source →
Circumcision versus preputioplasty for balanitis xerotica obliterans: a randomised controlled feasibility trial.
Objectives: To determine: (i) feasibility for a randomised controlled trial (RCT) comparing circumcision to preputioplasty and intralesional triamcinolone (PIT) to treat balanitis xerotica obliterans (BXO) and (ii) patient outcomes to inform future study design.
Patients and methods: Approval was obtained from the UK Health Research Authority and local Research Ethics Committee (Reference 16/NW/0364) and the trial protocol registered with ClinicalTrials.gov (NCT02854995). A total of 20 boys (aged 2-16 years) with BXO were randomised to either circumcision or PIT (online parallel group 1:1 allocation, non-blinded). Exclusion criteria were: (i) previous penile surgery and (ii) contraindication for either treatment. Follow-up (including satisfaction questionnaire) was at 6 weeks, 3 and 12 months. Data are presented as median (interquartile range [IQR]), continuous variables were compared by t-test.
Results: A total of 54 boys were approached over 18 months: 23 (45%) were recruited and randomised. The commonest reason for non-entry was treatment preference: 12 preferred circumcision, 18 preferred PIT. Four patients withdrew after randomisation, three did not want circumcision and one did not want PIT. The groups were similar in terms of age (median [IQR] 11 [6-12] vs 8 [7-10] years, P = 0.53) and duration of symptoms (median [IQR] 6 [6-15] vs 6 [2-24] months, P = 0.77). There were no protocol breaches, serious adverse events or postoperative meatal stenosis. There was one self-resolving haematoma after PIT and one suture granuloma after circumcision. Two boys went on to have a circumcision after PIT. Overall, satisfaction levels were high for both groups.
Conclusion: A definitive RCT of circumcision vs PIT for BXO appears feasible, with 39% of those approached completing the trial. More families preferred PIT. A robust comparison in the form of a multicentred RCT is required.
BJU international · randomised controlled trial · 5 citationsread the source →
Effectiveness of a bite-sized web-based intervention to improve healthcare worker wellbeing: A randomized clinical trial of WISER.
Importance: Problems with the wellbeing of healthcare workers (HCWs) are widespread and associated with detrimental consequences for the workforce, organizations, and patients.
Objective: This study tested the effectiveness of the Web-based Implementation for the Science of Enhancing Resilience (WISER) intervention, a positive psychology program, to improve six dimensions of the wellbeing of HCWs.
Design: We conducted a randomized controlled trial of HCWs between 1 April 2018 and 22 July 2019. Cohort 1 received WISER daily for 10 days. Cohort 2 acted as a waitlist control before receiving WISER.
Setting: Web-based intervention for actively employed HCWs across the United States.
Participants: Eligibility criteria included being ≥18 years old and working as a HCW. Each participant was randomized to start the intervention or serve as a waitlist control for 14 days before starting the intervention.
Interventions: Cohorts received links via 10 texts exposing them to introductory videos and positive psychology exercises (3 good things, cultivating awe, random acts of kindness, cultivating relationships, and gratitude letters).
Main outcomes and measures: The primary outcome was emotional exhaustion; secondary outcomes included depressive symptoms, work-life integration, happiness, emotional thriving, and emotional recovery. All outcomes were assessed at baseline, 1-week post-intervention (primary endpoint), and 1, 6, and 12-month post-intervention. Outcomes were measured using six validated wellbeing instruments, rescaled to 100-point scales for comparison. Six items assessed participants' WISER experience. The analysis employed mixed-effects models.
Results: In cohorts 1 and 2, 241 and 241 initiated WISER, and 178 (74%) and 186 (77%) completed the 6-month follow-up, respectively. Cohort populations were similar at baseline, mostly female (81; 76%) and nurses (34; 32%) or physicians (22; 23%), with 1-10 years of experience in their current position (54; 52%). Relative to control, WISER significantly improved depressive symptoms [-7.5 (95%CI: -11.0, -4.0), p < 0.001], work-life integration [6.5 (95%CI: 4.1, 8.9), p < 0.001], happiness [5.7 (95%CI: 3.0, 8.4), p < 0.001], emotional thriving [6.4 (95%CI: 2.5, 10.3), p = 0.001], and emotional recovery [5.3 (95%CI: 1.7, 8.9), p = 0.004], but not emotional exhaustion [-3.7 (95%CI: -8.2, 0.8), p = 0.11] at 1 week. Combined cohort results at 1, 6, and 12 months showed that all six wellbeing outcomes were significantly improved relative to baseline (p < 0.05 for all). Favorable impressions of WISER were reported by 87% of participants at the 6-month post-assessment.
Conclusion and relevance: WISER improved HCW depressive symptoms, work-life integration, happiness, emotional thriving, and emotional recovery. Improvements in all HCW wellbeing outcomes endured at the 1-, 6-, and 12-month follow-ups. HCW's impressions of WISER were positive.
Clinical trials number: https://clinicaltrials.gov/ct2/show/, identifier: NCT02603133. Web-based Implementation for the Science of Enhancing Resilience Study (WISER).
Frontiers in public health · randomised controlled trial · 17 citationsread the source →
Effect of a stepped-care intervention delivered by lay health workers on major depressive disorder among primary care patients in Nigeria (STEPCARE): a cluster-randomised controlled trial.
Background: Little is known about how to scale up care for depression in settings where non-physician lay workers constitute the bulk of frontline providers. We aimed to compare a stepped-care intervention package for depression with usual care enhanced by use of the WHO Mental Health Gap Action Programme intervention guide (mhGAP-IG).
Methods: We did a cluster-randomised trial in primary care clinics in Ibadan, Nigeria. Eligible clinics were those with adequate staffing to provide various 24-h clinical services and with regular physician supervision. Clinics (clusters), anonymised and stratified by local government area, were randomly allocated (1:1) with a computer-generated random number sequence to one of two groups: an intervention group in which patients received a stepped-care intervention (eight sessions of individual problem-solving therapy, with an extra two to four sessions if needed) plus enhanced usual care, and a control group in which patients received enhanced usual care only. Patients from enrolled clinics could participate if they were aged 18 years or older, not pregnant, and had moderate to severe depression (scoring ≥11 on the nine-item patient health questionnaire [PHQ-9]). The primary outcome was the proportion of patients with remission of depression at 12 months (a score of ≤6 on the PHQ-9, with assessors masked to group allocation) in the intention-to-treat population. This trial is registered with the International Standard Randomised Controlled Trials Number registry (ISRCTN46754188) and is completed.
Findings: 35 of 97 clinics approached were eligible and agreed to participate, of which 18 were allocated to the intervention group and 17 to the control group. 1178 patients (631 [54%] in the intervention group and 547 [46%] in the control group) were recruited between Dec 2, 2013, and June 29, 2015, among whom 976 (83%) were female and baseline mean PHQ-9 score was 13·7 (SD 2·6). Of the 562 (89%) patients in the intervention group and 473 (86%) in the control group who completed 12-month follow-up, similar proportions in each group had remission of depression (425 [76%] in the intervention group vs 366 [77%] in the control group; adjusted odds ratio 1·0 [95% CI 0·70-1·40]). At 12 months, 17 (3%) deaths, one (<1%) psychotic illness, and one (<1%) case of bipolar disorder in the intervention group, and 16 deaths (3%) and one (<1%) case of bipolar disorder in the control group were recorded. No adverse events were judged to be related to the study procedures.
Interpretation: For patients with moderate to severe depression receiving care from non-physician primary health-care workers in Nigeria, a stepped-care, problem-solving intervention combined with enhanced usual care is similarly effective to enhanced usual care alone. Enhancing usual care with mhGAP-IG might provide simple and affordable approach to scaling up depression care in sub-Saharan Africa.
Funding: UK Medical Research Council.
The Lancet. Global health · randomised controlled trial · 49 citationsread the source →
Intermittent fasting, Paleolithic, or Mediterranean diets in the real world: exploratory secondary analyses of a weight-loss trial that included choice of diet and exercise.
Background: Intermittent fasting (IF) and Paleolithic (Paleo) diets produce weight loss in controlled trials, but minimal evidence exists regarding long-term efficacy under free-living conditions without intense dietetic support.
Objectives: This exploratory, observational analysis examined adherence, dietary intake, weight loss, and metabolic outcomes in overweight adults who could choose to follow Mediterranean, IF, or Paleo diets, and standard exercise or high-intensity interval training (HIIT) programs, as part of a 12-mo randomized controlled trial investigating how different monitoring strategies influenced weight loss (control, daily self-weighing, hunger training, diet/exercise app, brief support).
Methods: A total of 250 overweight [BMI (in kg/m2) ≥27] healthy adults attended an individualized dietary education session (30 min) relevant to their self-selected diet. Dietary intake (3-d weighed diet records), weight, body composition, blood pressure, physical activity (0, 6, and 12 mo), and blood indexes (0 and 12 mo) were assessed. Mean (95% CI) changes from baseline were estimated using regression models. No correction was made for multiple tests.
Results: Although 54.4% chose IF, 27.2% Mediterranean, and 18.4% Paleo diets originally, only 54% (IF), 57% (Mediterranean), and 35% (Paleo) participants were still following their chosen diet at 12 mo (self-reported). At 12 mo, weight loss was -4.0 kg (95% CI: -5.1, -2.8 kg) in IF, -2.8 kg (-4.4, -1.2 kg) in Mediterranean, and -1.8 kg (-4.0, 0.5 kg) in Paleo participants. Sensitivity analyses showed that, due to substantial dropout, these may be overestimated by ≤1.2 kg, whereas diet adherence increased mean weight loss by 1.1, 1.8, and 0.3 kg, respectively. Reduced systolic blood pressure was observed with IF (-4.9 mm Hg; -7.2, -2.6 mm Hg) and Mediterranean (-5.9 mm Hg; -9.0, -2.7 mm Hg) diets, and reduced glycated hemoglobin with the Mediterranean diet (-0.8 mmol/mol; -1.2, -0.4 mmol/mol). However, the between-group differences in most outcomes were not significant and these comparisons may be confounded due to the nonrandomized design.
Conclusions: Small differences in metabolic outcomes were apparent in participants following self-selected diets without intensive ongoing dietary support, even though dietary adherence declined rapidly. However, results should be interpreted with caution given the exploratory nature of analyses. This trial was registered with the Australian New Zealand Clinical Trials Registry as ACTRN12615000010594 at https://www.anzctr.org.au.
The American journal of clinical nutrition · randomised controlled trial · 46 citationsread the source →
Is Self-Help Dangerous? Examination of Adverse Effects of a Psychological Internet-Based Self-Help Intervention for Body-Focused Repetitive Behavior (Free From BFRB).
Despite the proven effectiveness of psychotherapy for psychiatric disorders, adverse events or unwanted effects may occur. Unwanted effects, however, are rarely assessed. In self-help interventions, which usually are not supported by a therapist, such effects have received even less attention even though special caution is needed regarding unwanted effects such as those related to misapplication. For the present study, we present the newly developed Positive and Negative Effects of Psychotherapy Scale for Internet-Based Intervention (PANEPS-I) and examine possible unwanted effects of an internet-based self-help intervention in individuals with body-focused repetitive behaviors (BFRBs), aggregating three different techniques: habit reversal training (HRT), decoupling (DC), and decoupling in sensu (DC-is). Some HRT users have expressed concern that the suppression of the problematic behavior could lead to rebound effects, but this has not been examined rigorously. Following baseline assessment, 141 participants with at least one BFRB were randomly assigned to two intervention groups that differed only with respect to the delivery mode (video, manual); the content was the same. After 6 weeks, a post-assessment was conducted. Unwanted effects were assessed using the PANEPS-I. A total of 70% of the participants (both treatment groups combined) reported at least one positive effect of the intervention. Negative effects were reported by 14-92% of participants, depending on the effect. The highest agreement rates were found for "no positive goal orientation" (52.5%), "did not address personal problems" (48.8%), "time/performance pressure" (20.9%), shame (16.3%), and concerns about data privacy (14.3%). Participants in the manual intervention group reported unethical procedures (e.g., data privacy concerns) more often (Cohen's d = .44) than those in the video intervention group. Responders reported more positive effects and nonresponders more malpractice (|d| = .80, .54, respectively). HRT users (self-report) showed no significant differences compared to nonusers regarding negative effects. Stepwise hierarchical regression analyses indicated a dose-response relationship for reported positive effects and malpractice. Side effects may occur in any kind of intervention. Usage of HRT did not lead to more reported negative effects compared to nonusage. To improve the quality and effectiveness and ensure the safety of the user, especially those using digital self-help interventions, it is important to regularly assess unintended effects since there is no supervision of the patient in unguided self-help interventions.
Behavior therapy · randomised controlled trial · 5 citationsread the source →
Bahadoer RR, Dijkstra EA, van Etten B, Marijnen CAM, Putter H, Kranenbarg EM, Roodvoets AGH, Nagtegaal ID, Beets-Tan RGH, Blomqvist LK, Fokstuen T, Ten Tije AJ, Capdevila J, Hendriks MP, Edhemovic I, Cervantes A, Nilsson PJ, Glimelius B, van de Velde CJH, Hospers GAP, RAPIDO collaborative investigators. (2021)MEDLINE-indexed journal, not yet read by usThe Lancet. Oncology · randomised controlled trial Short-course radiotherapy followed by chemotherapy before total mesorectal excision (TME) versus preoperative chemoradiotherapy, TME, and optional adjuvant chemotherapy in locally advanced rectal cancer (RAPIDO): a randomised, open-label, phase 3 trial.
Background: Systemic relapses remain a major problem in locally advanced rectal cancer. Using short-course radiotherapy followed by chemotherapy and delayed surgery, the Rectal cancer And Preoperative Induction therapy followed by Dedicated Operation (RAPIDO) trial aimed to reduce distant metastases without compromising locoregional control.
Methods: In this multicentre, open-label, randomised, controlled, phase 3 trial, participants were recruited from 54 centres in the Netherlands, Sweden, Spain, Slovenia, Denmark, Norway, and the USA. Patients were eligible if they were aged 18 years or older, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, had a biopsy-proven, newly diagnosed, primary, locally advanced rectal adenocarcinoma, which was classified as high risk on pelvic MRI (with at least one of the following criteria: clinical tumour [cT] stage cT4a or cT4b, extramural vascular invasion, clinical nodal [cN] stage cN2, involved mesorectal fascia, or enlarged lateral lymph nodes), were mentally and physically fit for chemotherapy, and could be assessed for staging within 5 weeks before randomisation. Eligible participants were randomly assigned (1:1), using a management system with a randomly varying block design (each block size randomly chosen to contain two to four allocations), stratified by centre, ECOG performance status, cT stage, and cN stage, to either the experimental or standard of care group. All investigators remained masked for the primary endpoint until a prespecified number of events was reached. Patients allocated to the experimental treatment group received short-course radiotherapy (5 × 5 Gy over a maximum of 8 days) followed by six cycles of CAPOX chemotherapy (capecitabine 1000 mg/m2 orally twice daily on days 1-14, oxaliplatin 130 mg/m2 intravenously on day 1, and a chemotherapy-free interval between days 15-21) or nine cycles of FOLFOX4 (oxaliplatin 85 mg/m2 intravenously on day 1, leucovorin [folinic acid] 200 mg/m2 intravenously on days 1 and 2, followed by bolus fluorouracil 400 mg/m2 intravenously and fluorouracil 600 mg/m2 intravenously for 22 h on days 1 and 2, and a chemotherapy-free interval between days 3-14) followed by total mesorectal excision. Choice of CAPOX or FOLFOX4 was per physician discretion or hospital policy. Patients allocated to the standard of care group received 28 daily fractions of 1·8 Gy up to 50·4 Gy or 25 fractions of 2·0 Gy up to 50·0 Gy (per physician discretion or hospital policy), with concomitant twice-daily oral capecitabine 825 mg/m2 followed by total mesorectal excision and, if stipulated by hospital policy, adjuvant chemotherapy with eight cycles of CAPOX or 12 cycles of FOLFOX4. The primary endpoint was 3-year disease-related treatment failure, defined as the first occurrence of locoregional failure, distant metastasis, new primary colorectal tumour, or treatment-related death, assessed in the intention-to-treat population. Safety was assessed by intention to treat. This study is registered with the EudraCT, 2010-023957-12, and ClinicalTrials.gov, NCT01558921, and is now complete.
Findings: Between June 21, 2011, and June 2, 2016, 920 patients were enrolled and randomly assigned to a treatment, of whom 912 were eligible (462 in the experimental group; 450 in the standard of care group). Median follow-up was 4·6 years (IQR 3·5-5·5). At 3 years after randomisation, the cumulative probability of disease-related treatment failure was 23·7% (95% CI 19·8-27·6) in the experimental group versus 30·4% (26·1-34·6) in the standard of care group (hazard ratio 0·75, 95% CI 0·60-0·95; p=0·019). The most common grade 3 or higher adverse event during preoperative therapy in both groups was diarrhoea (81 [18%] of 460 patients in the experimental group and 41 [9%] of 441 in the standard of care group) and neurological toxicity during adjuvant chemotherapy in the standard of care group (16 [9%] of 187 patients). Serious adverse events occurred in 177 (38%) of 460 participants in the experimental group and, in the standard of care group, in 87 (34%) of 254 patients without adjuvant chemotherapy and in 64 (34%) of 187 with adjuvant chemotherapy. Treatment-related deaths occurred in four participants in the experimental group (one cardiac arrest, one pulmonary embolism, two infectious complications) and in four participants in the standard of care group (one pulmonary embolism, one neutropenic sepsis, one aspiration, one suicide due to severe depression).
Interpretation: The observed decreased probability of disease-related treatment failure in the experimental group is probably indicative of the increased efficacy of preoperative chemotherapy as opposed to adjuvant chemotherapy in this setting. Therefore, the experimental treatment can be considered as a new standard of care in high-risk locally advanced rectal cancer.
Funding: Dutch Cancer Foundation, Swedish Cancer Society, Spanish Ministry of Economy and Competitiveness, and Spanish Clinical Research Network.
The Lancet. Oncology · randomised controlled trial · 1212 citationsread the source →
Irungu EM, Mugwanya KK, Mugo NR, Bukusi EA, Donnell D, Odoyo J, Wamoni E, Peacock S, Morton JF, Ngure K, Mugambi M, Mukui I, O'Malley G, Baeten JM, Partners Scale-Up Project Team. (2021)MEDLINE-indexed journal, not yet read by usThe Lancet. Global health · randomised controlled trial Integration of pre-exposure prophylaxis services into public HIV care clinics in Kenya: a pragmatic stepped-wedge randomised trial.
Background: Successful and sustainable models for HIV pre-exposure prophylaxis (PrEP) delivery in public health systems in Africa are needed. We aimed to evaluate the implementation of PrEP delivery integrated in public HIV care clinics in Kenya.
Methods: As part of Kenya's national PrEP roll-out, we conducted a stepped-wedge cluster-randomised pragmatic trial to catalyse scale-up of PrEP delivery integrated in 25 public HIV care clinics. We selected high-volume clinics in these regions (ie, those with a high number of people living with HIV enrolled in HIV care and treatment). Clinics (each representing a cluster) were stratified by region and randomly assigned to the order in which clinic staff would receive PrEP training and ongoing technical support using numbered opaque balls picked from a bag. There was no masking. PrEP provision was done by clinic staff without additional financial support. Data were abstracted from records of individuals initiating PrEP. The primary outcome was the number of people initiating PrEP per clinic per month comparing intervention to control periods. Other outcomes included PrEP continuation, adherence, and incident HIV infections. This trial is registered with ClinicalTrials.gov, NCT03052010.
Findings: After the baseline period, which started in January, 2017, every month two to six HIV care clinics crossed over from control to intervention, until August, 2017, when all clinics were implementing the intervention. Of 4898 individuals initiating PrEP (27 during the control period and 4871 during the intervention period), 2640 (54%) were women, the median age was 31 years (IQR 25-39), and 4092 (84%) reported having a partner living with HIV. The mean monthly number of PrEP initiations per clinic was 0·1 (SD 0·5) before the intervention and 7·5 (2·7) after intervention introduction (rate ratio 23·7, 95% CI 14·2-39·5, p<0·0001). PrEP continuation was 57% at 1 month, 44% at 3 months, and 34% at 6 months, and 12% of those who missed a refill returned later for PrEP re-initiation. Tenofovir diphosphate was detected in 68 (96%) of 71 blood samples collected from a randomly selected subset of participants. Six HIV infections were observed over 2531 person-years of observation (incidence 0·24 cases per 100 person-years), three of which occurred at the first visit after PrEP initiation.
Interpretation: We observed high uptake, reasonable continuation with high adherence, frequent PrEP restarts, and low HIV incidence. Integration of PrEP services within public HIV care clinics in Africa is feasible.
Funding: National Institute of Mental Health and Bill & Melinda Gates Foundation.
The Lancet. Global health · randomised controlled trial · 40 citationsread the source →
Sampaio-Junior B, Tortella G, Borrione L, Moffa AH, Machado-Vieira R, Cretaz E, Fernandes da Silva A, Fraguas R, Aparício LV, Klein I, Lafer B, Goerigk S, Benseñor IM, Lotufo PA, Gattaz WF, Brunoni AR. (2018)MEDLINE-indexed journal, not yet read by usJAMA psychiatry · randomised controlled trial Efficacy and Safety of Transcranial Direct Current Stimulation as an Add-on Treatment for Bipolar Depression: A Randomized Clinical Trial.
Importance: More effective, tolerable interventions for bipolar depression treatment are needed. Transcranial direct current stimulation (tDCS) is a novel therapeutic modality with few severe adverse events that showed promising results for unipolar depression.
Objective: To determine the efficacy and safety of tDCS as an add-on treatment for bipolar depression.
Design, setting, and participants: A randomized, sham-controlled, double-blind trial (the Bipolar Depression Electrical Treatment Trial [BETTER]) was conducted from July 1, 2014, to March 30, 2016, at an outpatient, single-center academic setting. Participants included 59 adults with type I or II bipolar disorder in a major depressive episode and receiving a stable pharmacologic regimen with 17-item Hamilton Depression Rating Scale (HDRS-17) scores higher than 17. Data were analyzed in the intention-to-treat sample.
Interventions: Ten daily 30-minute, 2-mA, anodal-left and cathodal-right prefrontal sessions of active or sham tDCS on weekdays and then 1 session every fortnight until week 6.
Main outcomes and measures: Change in HDRS-17 scores at week 6.
Results: Fifty-nine patients (40 [68%] women), with a mean (SD) age of 45.9 (12) years participated; 36 (61%) with bipolar I and 23 (39%) with bipolar II disorder were randomized and 52 finished the trial. In the intention-to-treat analysis, patients in the active tDCS condition showed significantly superior improvement compared with those receiving sham (βint = -1.68; number needed to treat, 5.8; 95% CI, 3.3-25.8; P = .01). Cumulative response rates were higher in the active vs sham groups (67.6% vs 30.4%; number needed to treat, 2.69; 95% CI, 1.84-4.99; P = .01), but not remission rates (37.4% vs 19.1%; number needed to treat, 5.46; 95% CI, 3.38-14.2; P = .18). Adverse events, including treatment-emergent affective switches, were similar between groups, except for localized skin redness that was higher in the active group (54% vs 19%; P = .01).
Conclusions and relevance: In this trial, tDCS was an effective, safe, and tolerable add-on intervention for this small bipolar depression sample. Further trials should examine tDCS efficacy in a larger sample.
Trial registration: clinicaltrials.gov Identifier: NCT02152878.
JAMA psychiatry · randomised controlled trial · 103 citationsread the source →
Gilbody S, Littlewood E, McMillan D, Atha L, Bailey D, Baird K, Brady S, Burke L, Chew-Graham CA, Coventry P, Crosland S, Fairhurst C, Henry A, Hollingsworth K, Newbronner E, Ryde E, Shearsmith L, Wang HI, Webster J, Woodhouse R, Clegg A, Dexter-Smith S, Gentry T, Hewitt C, Hill A, Lovell K, Sloan C, Traviss-Turner G, Pratt S, Ekers D, BASIL trials collective. (2024)MEDLINE-indexed journal, not yet read by usThe lancet. Healthy longevity · randomised controlled trial Behavioural activation to mitigate the psychological impacts of COVID-19 restrictions on older people in England and Wales (BASIL+): a pragmatic randomised controlled trial.
Background: Older adults were more likely to be socially isolated during the COVID-19 pandemic, with increased risk of depression and loneliness. We aimed to investigate whether a behavioural activation intervention delivered via telephone could mitigate depression and loneliness in at-risk older people during the COVID-19 pandemic.
Methods: BASIL+ (Behavioural Activation in Social Isolation) was a pragmatic randomised controlled trial conducted among patients recruited from general practices in England and Wales, and was designed to assess the effectiveness of behavioural activation in mitigating depression and loneliness among older people during the COVID-19 pandemic. Eligible participants were aged 65 years and older, socially isolated, with a score of 5 or higher on the Patient Health Questionnaire-9 (PHQ-9), and had multiple long-term conditions. Participants were allocated in a 1:1 ratio to the intervention (behavioural activation) or control groups by use of simple randomisation without stratification. Behavioural activation was delivered by telephone; participants were offered up to eight weekly sessions with trained BASIL+ Support Workers. Behavioural activation was adapted to maintain social connections and encourage socially reinforcing activities. Participants in the control group received usual care with existing COVID-19 wellbeing resources. The primary clinical outcome was self-reported depression severity, assessed by the PHQ-9, at 3 months. Outcomes were assessed masked to allocation and analysis was by treatment allocation. This trial is registered with the ISRCTN registry (ISRCTN63034289).
Findings: Between Feb 8, 2021, and Feb 28, 2022, 449 eligible participants were identified and 435 from 26 general practices were recruited and randomly assigned (1:1) to the behavioural activation intervention (n=218) or to the control group (usual care with signposting; n=217). The mean age of participants was 75·7 years (SD 6·7); 270 (62·1%) of 435 participants were female, and 418 (96·1%) were White. Participants in the intervention group attended an average of 5·2 (SD 2·9) of eight remote behavioural activation sessions. The adjusted mean difference in PHQ-9 scores between the control and intervention groups at 3 months was -1·65 (95% CI -2·54 to -0·75, p=0·0003). No adverse events were reported that were attributable to the behavioural activation intervention.
Interpretation: Behavioural activation is an effective and potentially scalable intervention that can reduce symptoms of depression and emotional loneliness in at-risk groups in the short term. The findings of this trial add to the range of strategies to improve the mental health of older adults with multiple long-term conditions. These results can be helpful to policy makers beyond the pandemic in reducing the global burden of depression and addressing the health impacts of loneliness, particularly in at-risk groups.
Funding: UK National Institute for Health and Care Research.
The lancet. Healthy longevity · randomised controlled trial · 19 citationsread the source →
Norman SB, Capone C, Panza KE, Haller M, Davis BC, Schnurr PP, Shea MT, Browne K, Norman GJ, Lang AJ, Kline AC, Golshan S, Allard CB, Angkaw A. (2022)MEDLINE-indexed journal, not yet read by usDepression and anxiety · randomised controlled trial A clinical trial comparing trauma-informed guilt reduction therapy (TrIGR), a brief intervention for trauma-related guilt, to supportive care therapy.
Introduction: Trauma-related guilt is common, associated with posttraumatic mental health problems, and can persist after posttraumatic stress disorder (PTSD) treatment. We compared the efficacy of two six-session psychotherapies, Trauma-Informed Guilt Reduction (TrIGR) and Supportive Care Therapy (SCT), for reducing trauma-related guilt. TrIGR helps patients accurately appraise their role in the trauma and re-engage in values. In SCT, patients guide session content.
Methods: A total of 184 veterans seeking VA mental health services were enrolled across two sites; 145 veterans (mean age: 39.2 [8.1]; 92.4% male; 84.8% with PTSD) who endorsed guilt related to a traumatic event that occurred during a post 9/11 Iraq or Afghanistan deployment were randomized and assessed at baseline, posttreatment, 3- and 6-month follow-up.
Results: Linear mixed models using intent-to-treat analyses showed guilt decreased in both conditions with a greater decrease for TrIGR (treatment × time, -0.22; F 1, 455.2 = 18.49, p = .001; d = 0.92) than supportive therapy. PTSD and depressive symptoms showed the same pattern. TrIGR had significantly higher likelihood of PTSD treatment response (67% vs. 40%), loss of PTSD diagnosis (50% vs. 14%), and meaningful change in depression (54% vs. 27%) than supportive therapy. Psychological distress and trait shame improved in both conditions. Quality of life did not change.
Conclusions: Targeting guilt appears to be an effective means for reducing posttraumatic symptoms and distress.
Depression and anxiety · randomised controlled trial · 30 citationsread the source →
Philip KEJ, Owles H, McVey S, Pagnuco T, Bruce K, Brunjes H, Banya W, Mollica J, Lound A, Zumpe S, Abrahams AM, Padmanaban V, Hardy TH, Lewis A, Lalvani A, Elkin S, Hopkinson NS. (2022)MEDLINE-indexed journal, not yet read by usThe Lancet. Respiratory medicine · randomised controlled trial An online breathing and wellbeing programme (ENO Breathe) for people with persistent symptoms following COVID-19: a parallel-group, single-blind, randomised controlled trial.
Background: There are few evidence-based interventions for long COVID; however, holistic approaches supporting recovery are advocated. We assessed whether an online breathing and wellbeing programme improves health related quality-of-life (HRQoL) in people with persisting breathlessness following COVID-19.
Methods: We conducted a parallel-group, single-blind, randomised controlled trial in patients who had been referred from one of 51 UK-based collaborating long COVID clinics. Eligible participants were aged 18 years or older; were recovering from COVID-19 with ongoing breathlessness, with or without anxiety, at least 4 weeks after symptom onset; had internet access with an appropriate device; and were deemed clinically suitable for participation by one of the collaborating COVID-19 clinics. Following clinical assessment, potential participants were given a unique online portal code. Participants were randomly assigned (1:1) to either immediate participation in the English National Opera (ENO) Breathe programme or to usual care. Randomisation was done by the research team using computer-generated block randomisation lists, with block size 10. The researcher responsible for randomisation was masked to responses. Participants in the ENO Breathe group participated in a 6-week online breathing and wellbeing programme, developed for people with long COVID experiencing breathlessness, focusing on breathing retraining using singing techniques. Those in the deferred group received usual care until they exited the trial. The primary outcome, assessed in the intention-to-treat population, was change in HRQoL, assessed using the RAND 36-item short form survey instrument mental health composite (MHC) and physical health composite (PHC) scores. Secondary outcome measures were the chronic obstructive pulmonary disease assessment test score, visual analogue scales (VAS) for breathlessness, and scores on the dyspnoea-12, the generalised anxiety disorder 7-item scale, and the short form-6D. A thematic analysis exploring participant experience was also conducted using qualitative data from focus groups, survey responses, and email correspondence. This trial is registered with ClinicalTrials.gov, NCT04830033.
Findings: Between April 22 and May 25, 2021, 158 participants were recruited and randomly assigned. Of these, eight (5%) individuals were excluded and 150 participants were allocated to a treatment group (74 in the ENO Breathe group and 76 in the usual care group). Compared with usual care, ENO Breathe was associated with an improvement in MHC score (regression coefficient 2·42 [95% CI 0·03 to 4·80]; p=0·047), but not PHC score (0·60 [-1·33 to 2·52]; p=0·54). VAS for breathlessness (running) favoured ENO Breathe participation (-10·48 [-17·23 to -3·73]; p=0·0026). No other statistically significant between-group differences in secondary outcomes were observed. One minor self-limiting adverse event was reported by a participant in the ENO Breathe group who felt dizzy using a computer for extended periods. Thematic analysis of ENO Breathe participant experience identified three key themes: (1) improvements in symptoms; (2) feeling that the programme was complementary to standard care; and (3) the particular suitability of singing and music to address their needs.
Interpretation: Our findings suggest that an online breathing and wellbeing programme can improve the mental component of HRQoL and elements of breathlessness in people with persisting symptoms after COVID-19. Mind-body and music-based approaches, including practical, enjoyable, symptom-management techniques might have a role supporting recovery.
Funding: Imperial College London.
The Lancet. Respiratory medicine · randomised controlled trial · 74 citationsread the source →
Serra-Paya N, Ensenyat A, Castro-Viñuales I, Real J, Sinfreu-Bergués X, Zapata A, Mur JM, Galindo-Ortego G, Solé-Mir E, Teixido C. (2015)MEDLINE-indexed journal, not yet read by usPloS one · randomised controlled trial Effectiveness of a Multi-Component Intervention for Overweight and Obese Children (Nereu Program): A Randomized Controlled Trial.
Introduction: Treatment of childhood obesity is a complex challenge for primary health care professionals.
Objectives: To evaluate the effectiveness of the Nereu Program in improving anthropometric parameters, physical activity and sedentary behaviours, and dietary intake.
Methods: Randomized, controlled, multicentre clinical trial comparing Nereu Program and usual counselling group interventions in primary care settings. The 8-month study recruited 113 children aged 6 to 12 years with overweight/obesity. Before recruitment, eligible participants were randomly allocated to an intensive, family-based multi-component behavioural intervention (Nereu Program group) or usual advice from their paediatrician on healthy eating and physical activity. Anthropometric parameters, objectively measured sedentary and physical activity behaviours, and dietary intake were evaluated pre- and post-intervention.
Results: At the end of the study period, both groups achieved a similar decrease in body mass index (BMIsd) compared to baseline. Nereu Program participants (n = 54) showed greater increases in moderate-intense physical activity (+6.27% vs. -0.61%, p<0.001) and daily fruit servings (+0.62 vs. +0.13, p<0.026), and decreased daily soft drinks consumption (-0.26 vs. -0.02, p<0.047), respectively, compared to the counselling group (n = 59).
Conclusions: At the end of the 8-month intervention, participants in the Nereu Program group showed improvement in physical activity and dietary behaviours, compared to the counselling group.
Trial registration: ClinicalTrials.gov NCT01878994.
PloS one · randomised controlled trial · 30 citationsread the source →
Behavioral Counseling and Pharmacotherapy Interventions for Tobacco Cessation in Adults, Including Pregnant Women: A Review of Reviews for the U.S. Preventive Services Task Force.
Background: Tobacco use is the leading cause of preventable death in the United States.
Purpose: To review the effectiveness and safety of pharmacotherapy and behavioral interventions for tobacco cessation.
Data sources: 5 databases and 8 organizational Web sites were searched through 1 August 2014 for systematic reviews, and PubMed was searched through 1 March 2015 for trials on electronic nicotine delivery systems.
Study selection: Two reviewers examined 114 articles to identify English-language reviews that reported health, cessation, or adverse outcomes.
Data extraction: One reviewer abstracted data from good- and fair-quality reviews, and a second checked for accuracy.
Data synthesis: 54 reviews were included. Behavioral interventions increased smoking cessation at 6 months or more (physician advice had a pooled risk ratio [RR] of 1.76 [95% CI, 1.58 to 1.96]). Nicotine replacement therapy (RR, 1.60 [CI, 1.53 to 1.68]), bupropion (RR, 1.62 [CI, 1.49 to 1.76]), and varenicline (RR, 2.27 [CI, 2.02 to 2.55]) were also effective for smoking cessation. Combined behavioral and pharmacotherapy interventions increased cessation by 82% compared with minimal intervention or usual care (RR, 1.82 [CI, 1.66 to 2.00]). None of the drugs were associated with major cardiovascular adverse events. Only 2 trials addressed efficacy of electronic cigarettes for smoking cessation and found no benefit. Among pregnant women, behavioral interventions benefited cessation and perinatal health; effects of nicotine replacement therapy were not significant.
Limitation: Evidence published after each review's last search date was not included.
Conclusion: Behavioral and pharmacotherapy interventions improve rates of smoking cessation among the general adult population, alone or in combination. Data on the effectiveness and safety of electronic nicotine delivery systems are limited.
Primary funding source: Agency for Healthcare Research and Quality.
Annals of internal medicine · review · 128 citationsread the source →
Effectiveness of interventions to promote physical activity among socioeconomically disadvantaged women: a systematic review and meta-analysis.
Physical activity is important for preventing weight gain and obesity, but women experiencing socioeconomic disadvantage are at high risk of inactivity. This study aimed to determine the effectiveness of interventions to increase physical activity among women experiencing disadvantage, and the intervention factors (i.e. physical activity measure, delivery mode, delivery channel, setting, duration, use of theory, behavioural techniques, participant age, risk of bias) associated with effectiveness. We conducted a meta-analysis of controlled trials using random-effects models and meta-regression. Seven databases were searched for trials among healthy women (18-64 years), which included a physical activity intervention, any control group, and statistical analyses of a physical activity outcome at baseline and post-intervention. Nineteen studies were included (n = 6,339). Because of substantial statistical heterogeneity (χ(2) = 53.61, df = 18, P < 0.0001, I(2) = 66%), an overall pooled effect is not reported. In subgroup analyses, between-group differences were evident for delivery mode, which modestly reduced heterogeneity (to 54%). Studies with a group delivery component had a standardized mean difference of 0.38 greater than either individual or community-based delivery. Programs with a group delivery mode significantly increase physical activity among women experiencing disadvantage, and group delivery should be considered an essential element of physical activity promotion programs targeting this population group.
Obesity reviews : an official journal of the International Association for the Study of Obesity · meta-analysis · 43 citationsread the source →
The Social Epidemiology of Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome
Social epidemiology is defined as the study of the distribution of health outcomes and their social determinants (1). It builds on the classic epidemiologic triangle of host, agent, and environment to focus explicitly on the role of social determinants in infectious disease transmission and progression. These determinants are the “features of and pathways by which societal conditions affect health” (2, p. 697). Early studies of human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) focused on individual characteristics and behaviors in determining HIV risk, an approach that Fee and Krieger (3) refer to as “biomedical individualism.” Biomedical individualism is the basis of risk factor epidemiology; by contrast, the social epidemiology perspective emphasizes social conditions as fundamental causes of disease (4) (table 1). Social epidemiologists examine how persons become exposed to risk or protective factors and under what social conditions individual risk factors are related to disease. Social factors are thus the focus of analysis and are not simply adjusted for as potentially confounding factors or used as proxies for unavailable individual-level data. Social factors are indeed critical to understanding nonuniform infectious disease patterns that emerge as a result of the dependent nature of disease transmission or the idea that an outcome in one person is dependent upon outcomes and exposures in others (5, 6). Contact patterns that enhance HIV/AIDS vulnerability may be conceptualized at multiple levels. Figure 1 distinguishes determinants of HIV/AIDS at three levels: individual, social, and structural. Individual factors include biologic, demographic, and behavioral risk factors that may influence the risk of HIV acquisition and disease progression. Social-level factors include critical pathways by which community and network structures link persons to society. These structures are central to understanding the diffusion and differential distribution of HIV/AIDS in population subgroups. Structural-level factors include social and economic factors, as well as laws and policies. These factors, in turn, affect HIV transmission dynamics and the differential distribution of HIV/AIDS. Infectious disease epidemiology provides models of the mechanisms through which social determinants affect HIV transmission (7). For example, the basic reproductive number of an infectious disease, R0 (8), describes secondary infections that arise from a primary infection. In the equation R0 = βCD, β is the probability of infection per contact, C is the number of contacts, and D is the duration of infectivity. The goal of intervention efforts is to reduce the empirical value of these terms by modifying the social conditions under which individual risk factors lead to disease. Examples of factors that affect the component terms of R0 in HIV epidemiology are presented in table 2. In this review, we present existing evidence linking social and structural determinants to HIV/AIDS. In addition, we discuss the implications of these findings for future social epidemiology research on HIV/AIDS as well as the design of more effective HIV/AIDS interventions. We searched the published literature to identify conceptual and empirical research reports on the social epidemiology of HIV/AIDS. Five databases were searched: PsycINFO (American Psychological Association, Washington, DC), PubMed (MEDLINE; National Institutes of Health, Bethesda, Maryland), Social Science Citation Index (Web of Science; Thomson ISI, Stamford, Connecticut), Sociological Abstracts (CSA, Bethesda, Maryland), and Digital Dissertations (ProQuest; UMI, Ann Arbor, Michigan). Searches were designed to include the factors we specified in our framework as social or structural factors (figure 1). Searches were limited to published articles in the English language for the period 1981–2003. The following keywords were included in each search: AIDS/acquired immunodeficiency syndrome, HIV, and epidemiol*. Additional searches were conducted by using combinations of keywords listed in Appendix table 1 corresponding with our framework. We identified four categories of social-level factors of importance to HIV/AIDS epidemiology: cultural context, social networks, neighborhood effects, and social capital. Each uses different conceptual and methodological approaches to examine the effects of social forces on population HIV/AIDS vulnerability. Anthropologist Edward Tylor defined culture as “that complex whole which includes knowledge, belief, art, law, morals, custom, and any other capabilities and habits acquired by man as a member of society” (9, p. 1). Anthropologic and epidemiologic approaches may be integrated in a variety of ways to identify features of the social environment that affect HIV/AIDS risk. One way to explore how the social environment affects HIV/AIDS epidemiology is through the use of mixed research methods. Mixed-methods study designs integrate qualitative and quantitative research methods either sequentially or concurrently (10). In sequential study designs, qualitative methods may be used to explore a topic under study or to explain quantitative epidemiologic findings. Concurrent study designs are meant to confirm, cross-validate, or corroborate findings within a single study. A common type of concurrent mixed methods study is “triangulation,” and this approach has been used extensively in rapid assessments of illicit drug use and HIV/AIDS (11–13). Mixed methods approaches are particularly well suited to the investigation of the often hidden and stigmatizing behavioral and social factors underlying HIV epidemics. One exemplary study combining qualitative methods with quantitative methods was conducted by Beyrer et al. (14) to examine the role of overland heroin trafficking routes in shaping explosive HIV/AIDS epidemics among injection drug users in Southeast Asia. Piecing together data from a variety of sources, including existing epidemiologic data, key informant interviews, and laboratory data, this study revealed that distinct HIV subtypes emerged and recombined along drug trafficking routes originating in Myanmar, one of the world’s largest heroin producers. Along these trafficking routes, communities of injection drug users formed, facilitating the spread of HIV into local communities in Laos, Thailand, Vietnam, India, and China (refer, for example, to Panda et al. (15)). This illustration highlights the broader understanding of HIV/AIDS epidemiology that can be achieved by examining the interplay between contextual factors and social and behavioral factors. Investigation of social networks in HIV/AIDS began with the mapping of relationships between one of the first identified AIDS cases, an airline steward, and a large number of his male sex partners in the early 1980s (16). Social network analysis generates measures of the quality, density, position, and structure of relationships between persons, including dyads (partnerships), personal networks (“egocentric” networks), and larger communities (“sociometric” networks) (17, 18). Social networks can influence health outcomes in direct and indirect ways, including 1) social influence, 2) social engagement and participation, 3) prevalence of infectious disease and network member mixing, 4) access to material goods and informational resources, and 5) social support (19). Researchers have demonstrated that patterns in the structure of relationships—rather than differences in individual risk behaviors alone—explain observed HIV patterns (20, 21). The theoretical foundation for examining social networks in HIV research is closely tied to advances in sexually transmitted disease (STD) epidemiology. A key concept from STD epidemiology is the notion of the “core group,” a small group of disease transmitters responsible for a large proportion of cases (22). Friedman et al. (23) found that individuals’ locations within sociometric risk networks were associated with HIV risk among a group of injection drug users in New York City. Other concepts from STD epidemiology, such as partner concurrency, bridging, and mixing patterns, are also important in understanding HIV risk (24–29). Specific network characteristics that have been associated with HIV/AIDS include the size of subgroups and their distribution in a network (23), the centrality of HIV-positive persons within networks (30), partner selection patterns (24, 31–33), and concurrent sexual partnerships (28). Inclusion of these variables has been shown to improve transmission estimates in mathematical modeling (34, 35). Social and normative influences have also been associated with individual HIV risks (36, 37). Network-related social and normative influences are predictive of illicit drug use (38) and condom use behavior (37, 39), highlighting the importance of network-based interventions for HIV prevention (18). Kelly et al. (40, 41) developed a popular opinion leader model that has been effective in reducing HIV risk in several populations, including men who have sex with men and women in low-income housing (42). The success of this model has led to its adaption for international use by the National Institute of Mental Health Collaborative HIV/STD Prevention Trial in China, India, Peru, Russia, and Zimbabwe. Neighborhoods represent the intersection of social networks and physical spatial locations, a confluence Wallace (43) has called the “sociogeographic networks” through which infectious diseases spread. Early interest in the role of neighborhood social environment in disease transmission was sparked by a study in Colorado Springs, Colorado, in which researchers found that gonorrhea was highly focused geographically in core residential neighborhoods (44). Both direct and indirect mechanisms may determine how neighborhood-level factors shape population HIV/AIDS patterns. Direct mechanisms are those that increase the likelihood of a person coming into contact with someone who is HIV positive, for example, through residential segregation and the social isolation of marginalized populations. Indirect mechanisms include those that increase population vulnerability to HIV/AIDS, such as exposure to poor socioeconomic conditions, high unemployment, or the proliferation of illicit drug markets. A range of neighborhood-level factors have been examined in relation to infectious disease, including poverty and income (45, 46), residential segregation (47), and neighborhood physical environment (48, 49). Current research in neighborhood and area effects on health emphasizes the importance of moving beyond documentation of associations to analyze the social and epidemiologic mechanisms through which neighborhood effects might operate (50–54). Increasing concentrations of affluence and poverty are contributing to what demographer Douglas Massey has called “a radical change in the geographic basis of human society” (55, p. 395). Powerful social and economic forces in US cities are increasing neighborhood segregation by class and race/ethnicity (56, 57). Resulting social disorganization and loss of resources and services in poor neighborhoods are in turn shaping HIV/AIDS patterns at the neighborhood level. In a number of studies in New York City, for example, Wallace (58–63) has examined the complex interplay of public policies such as “planned shrinkage” with HIV epidemic dynamics in the Bronx, documenting the “synergy of plagues” that has accompanied rapid social change and the destruction of essential protective networks in poor communities. Using AIDS surveillance data, ecologic studies conducted in various US cities have also consistently found significant associations between income and poverty measures and neighborhood-level AIDS incidence and prevalence rates, and these findings have been consistent across census block groups (46), census tracts (64), and zip codes (65, 66). Length of survival an AIDS has also been with neighborhood measures of income and the of highly a of health at the population may also a role in shaping HIV/AIDS patterns, associations between HIV/AIDS and income at the neighborhood have not been well segregation by race/ethnicity is neighborhood-level that may an important role in HIV/AIDS may affect infectious disease patterns through the and isolation of persons in one increasing the probability of transmission within that For example, found that measures of residential isolation were protective for at risk of disease. Indirect effects of segregation are associated with of neighborhood and with for those in poor neighborhoods segregation may to understanding disease we of studies examining neighborhood segregation in relation to HIV/AIDS that have been The physical environment of neighborhoods has also been examined in relation to infectious disease. et al. examined gonorrhea and neighborhood physical environment in New by using an of physical to explore and to this the of physical such as and a in social in a of community this concept to public et al. found a significant between neighborhood physical and gonorrhea rates, a by a ecologic study of US physical environment may HIV risk by illicit drug use such as injection behaviors and of the mechanisms through which the observed associations may be and associations between the physical environment and HIV/AIDS is research is to support the design of neighborhood-level HIV/AIDS interventions. has differences are not result from social and economic by policies. are and to p. The of evidence ecologic associations between neighborhood-level factors and infectious disease that to be to identify of and defined social as of social structures that that is the of that in its not be p. Social may affect health through 1) the of 2) access to services and 3) of in a and 4) participation, to policies that are more to published studies have explicitly examined social in the of HIV/AIDS. 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Epidemiologic Reviews · meta-analysis · 394 citationsread the source →
Cost-effectiveness of interventions to prevent and control diabetes mellitus: a systematic review.
Objective: To synthesize the cost-effectiveness (CE) of interventions to prevent and control diabetes, its complications, and comorbidities.
Research design and methods: We conducted a systematic review of literature on the CE of diabetes interventions recommended by the American Diabetes Association (ADA) and published between January 1985 and May 2008. We categorized the strength of evidence about the CE of an intervention as strong, supportive, or uncertain. CEs were classified as cost saving (more health benefit at a lower cost), very cost-effective (<or=$25,000 per life year gained [LYG] or quality-adjusted life year [QALY]), cost-effective ($25,001 to $50,000 per LYG or QALY), marginally cost-effective ($50,001 to $100,000 per LYG or QALY), or not cost-effective (>$100,000 per LYG or QALY). The CE classification of an intervention was reported separately by country setting (U.S. or other developed countries) if CE varied by where the intervention was implemented. Costs were measured in 2007 U.S. dollars.
Results: Fifty-six studies from 20 countries met the inclusion criteria. A large majority of the ADA recommended interventions are cost-effective. We found strong evidence to classify the following interventions as cost saving or very cost-effective: (I) Cost saving- 1) ACE inhibitor (ACEI) therapy for intensive hypertension control compared with standard hypertension control; 2) ACEI or angiotensin receptor blocker (ARB) therapy to prevent end-stage renal disease (ESRD) compared with no ACEI or ARB treatment; 3) early irbesartan therapy (at the microalbuminuria stage) to prevent ESRD compared with later treatment (at the macroalbuminuria stage); 4) comprehensive foot care to prevent ulcers compared with usual care; 5) multi-component interventions for diabetic risk factor control and early detection of complications compared with conventional insulin therapy for persons with type 1 diabetes; and 6) multi-component interventions for diabetic risk factor control and early detection of complications compared with standard glycemic control for persons with type 2 diabetes. (II) Very cost-effective- 1) intensive lifestyle interventions to prevent type 2 diabetes among persons with impaired glucose tolerance compared with standard lifestyle recommendations; 2) universal opportunistic screening for undiagnosed type 2 diabetes in African Americans between 45 and 54 years old; 3) intensive glycemic control as implemented in the UK Prospective Diabetes Study in persons with newly diagnosed type 2 diabetes compared with conventional glycemic control; 4) statin therapy for secondary prevention of cardiovascular disease compared with no statin therapy; 5) counseling and treatment for smoking cessation compared with no counseling and treatment; 6) annual screening for diabetic retinopathy and ensuing treatment in persons with type 1 diabetes compared with no screening; 7) annual screening for diabetic retinopathy and ensuing treatment in persons with type 2 diabetes compared with no screening; and 8) immediate vitrectomy to treat diabetic retinopathy compared with deferred vitrectomy.
Conclusions: Many interventions intended to prevent/control diabetes are cost saving or very cost-effective and supported by strong evidence. Policy makers should consider giving these interventions a higher priority.
Diabetes care · systematic review · 306 citationsread the source →
Rosner R, Sachser C, Hornfeck F, Kilian R, Kindler H, Muche R, Müller LRF, Thielemann J, Waldmann T, Ziegenhain U, Unterhitzenberger J, Pfeiffer E. (2020)MEDLINE-indexed journal, not yet read by usTrials · clinical trial Improving mental health care for unaccompanied young refugees through a stepped-care approach versus usual care+: study protocol of a cluster randomized controlled hybrid effectiveness implementation trial.
Background: More than half of the unaccompanied young refugees (UYRs) resettled in Europe report elevated levels of posttraumatic stress symptoms (PTSS) and comorbid symptoms. Earlier studies have highlighted the effectiveness of the trauma-focused preventive group intervention "Mein Weg" (English "My Way"), and the feasibility of trauma-focused cognitive behavioral therapy (TF-CBT) for UYRs. Both interventions are deemed to be empirically supported treatments (ESTs). However, UYRs seldom receive ESTs or, in fact, any treatment at all. In view of the high need and the limited treatment resources available, a stepped-care approach is indicated but has not been evaluated so far. The purpose of this trial is to compare the stepped-care approach BETTER CARE with usual care enhanced with screening and indication (usual care+).
Methods: In a cluster randomized controlled trial involving N = 540 UYRs living in up to N = 54 child and youth welfare service (CYWS) facilities, BETTER CARE will be compared with usual care+. We will randomize clusters comprising a CYWS facility with at least one eligible psychotherapist. BETTER CARE consists of step (1) screening and indication and either step (2) preventive trauma-focused group intervention "Mein Weg" delivered by trained CYWS staff or step (3) TF-CBT delivered by trained community therapists and supported by trained translators if necessary. Participants will be assessed 6 and 12 months after randomization. The primary outcome is the severity of PTSS after 12 months. Secondary outcomes are depressive and anxiety symptoms, quality of life, and proxy reported PTSS. Furthermore, drug use, health costs, benefits, and long-term effects on integration/acculturation will be assessed.
Discussion: The trial will directly integrate a stepped-care approach into existing structures of the German child welfare and (mental) health system. It could, therefore, serve as a blueprint for how to implement ESTs for UYRs. If successful, screening, prevention, and intervention will be sustainably implemented in CYWS in southern Germany.
Trial registration: German Clinical Trials Register DRKS00017453 . Registered on 11 December 2019.
Trials · clinical trial · 26 citationsread the source →
Association of Early-Life Antibiotic Use and Protective Effects of Breastfeeding: Role of the Intestinal Microbiota.
Importance: Long duration of breastfeeding is known to reduce the frequency of infections and the risk of overweight, both of which are prevalent health problems among children, but the mechanisms are unclear.
Objectives: To test whether early-life antibiotic use in children prevents the beneficial long-term effects of breastfeeding on weight development and lifetime antibiotic use, and to investigate whether the duration of breastfeeding is associated with long-term microbiota development.
Design, setting, and participants: Retrospective cohort study, conducted from June 2015 to December 2015, of the association between the duration of breastfeeding and lifetime antibiotic use by children as well as body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) z score in a cohort of 226 healthy children aged 2 to 6 years attending day care at the study area in northern Finland and participating in a probiotic trial from October 1, 2009, through April 30, 2010. Fecal microbiota composition analysis was performed in a subcohort of 42 of these children.
Exposures: Duration of breastfeeding and the number of different antibiotic courses purchased for the child.
Main outcomes and measures: The BMI z score, lifetime antibiotic use after weaning, and fecal microbiota composition.
Results: A total of 226 children (mean [SD] age, 55 [1.4] months; 54% male) were included in the study. Among the 113 children with no antibiotics before weaning, each month of breastfeeding decreased the mean number of postweaning antibiotic courses by 5% (95% CI, 2% to 8%; P = .001) and mean BMI z scores by 0.08 unit (95% CI, 0.04 to 0.11; P < .001). Among the 113 early-life antibiotic users, the effect of breastfeeding on postweaning antibiotic use was borderline significant (estimated 4% decrease per month; 95% CI, 0% to 7%; P = .04) and the effect on BMI z score disappeared (estimated 1% increase; 95% CI, -3% to 5%; P = .50). In the subcohort of 42 children with fecal microbiota composition analysis, the children with short breastfeeding duration (0-6 months) and no early-life antibiotic use or with long breastfeeding duration (8-16 months) and early-life use of antibiotics had a significantly lower abundance of Bifidobacterium (by 55%; 95% CI, 43% to 87%; P = .006; and 39%, 95% CI, 30% to 68%; P < .001, respectively) and Akkermansia (by 71%; 95% CI, 28% to 87%; P = .008; and 69%; 95% CI, 22% to 90%; P = .02, respectively) compared with those with long duration of breastfeeding and no early-life antibiotics.
Conclusions and relevance: Antibiotic use in a child during breastfeeding may weaken the beneficial effects of long breastfeeding duration. The results suggest that particularly the long-term metabolic benefits of breastfeeding are conveyed by the intestinal microbiota.
JAMA pediatrics · clinical trial · 75 citationsread the source →
Fung IC, Blankenship EB, Ahweyevu JO, Cooper LK, Duke CH, Carswell SL, Jackson AM, Jenkins JC, Duncan EA, Liang H, Fu KW, Tse ZTH. (2020)MEDLINE-indexed journal, not yet read by usThe Permanente journal · review Public Health Implications of Image-Based Social Media: A Systematic Review of Instagram, Pinterest, Tumblr, and Flickr.
Introduction: Image-based social media Instagram, Pinterest, Tumblr, and Flickr have become sources of health-related information and tools for health communication. No known systematic review exists that summarizes the existing research and its health implications.
Methods: We searched EBSCOhost Academic Search Complete, PubMed, and Web of Science in January 2016, April 2017, and November 2017, with the following keywords: Pinterest, Instagram, Tumblr, or Flickr. Only public health-related, peer-reviewed research articles were included (excluding surveys of self-reported social media use).
Results: Sixty-six research articles were included. All 12 experimental studies used Instagram. Of the 54 observational studies, 38 studied Instagram; 12, Pinterest; 7, Tumblr; and 6, Flickr; some studies investigated more than 1 platform. More than half of the included articles were related to mental health and substance abuse (n = 39, 59%). Other topics included chronic diseases, infectious diseases, surgery, injury prevention, pharmacovigilance, sexual and reproductive health, and adolescent psychology with functional magnetic resonance imaging.
Discussion: Public health-oriented research on Instagram, Pinterest, Tumblr, and Flickr is increasing. Most observational studies investigated questions ranging from public perception of diseases or interventions (vaccination) and undesirable media exposure ("echo chamber," distorted body image, underage substance use, and pro-suicide messages) to information dissemination and online engagement (likes and comments). A few studies attempted to use image-based social media as intervention tools, but the results were mainly exploratory.
Conclusion: More research is needed to study how social media users discuss health through sharing images online, and how public health professionals can communicate effectively using image-sharing social media.
The Permanente journal · review · 47 citationsread the source →
Fisher R, Salanova V, Witt T, Worth R, Henry T, Gross R, Oommen K, Osorio I, Nazzaro J, Labar D, Kaplitt M, Sperling M, Sandok E, Neal J, Handforth A, Stern J, DeSalles A, Chung S, Shetter A, Bergen D, Bakay R, Henderson J, French J, Baltuch G, Rosenfeld W, Youkilis A, Marks W, Garcia P, Barbaro N, Fountain N, Bazil C, Goodman R, McKhann G, Babu Krishnamurthy K, Papavassiliou S, Epstein C, Pollard J, Tonder L, Grebin J, Coffey R, Graves N, SANTE Study Group. (2010)MEDLINE-indexed journal, not yet read by usEpilepsia · randomised controlled trial Electrical stimulation of the anterior nucleus of thalamus for treatment of refractory epilepsy.
Purpose: We report a multicenter, double-blind, randomized trial of bilateral stimulation of the anterior nuclei of the thalamus for localization-related epilepsy.
Methods: Participants were adults with medically refractory partial seizures, including secondarily generalized seizures. Half received stimulation and half no stimulation during a 3-month blinded phase; then all received unblinded stimulation.
Results: One hundred ten participants were randomized. Baseline monthly median seizure frequency was 19.5. In the last month of the blinded phase the stimulated group had a 29% greater reduction in seizures compared with the control group, as estimated by a generalized estimating equations (GEE) model (p = 0.002). Unadjusted median declines at the end of the blinded phase were 14.5% in the control group and 40.4% in the stimulated group. Complex partial and "most severe" seizures were significantly reduced by stimulation. By 2 years, there was a 56% median percent reduction in seizure frequency; 54% of patients had a seizure reduction of at least 50%, and 14 patients were seizure-free for at least 6 months. Five deaths occurred and none were from implantation or stimulation. No participant had symptomatic hemorrhage or brain infection. Two participants had acute, transient stimulation-associated seizures. Cognition and mood showed no group differences, but participants in the stimulated group were more likely to report depression or memory problems as adverse events.
Discussion: Bilateral stimulation of the anterior nuclei of the thalamus reduces seizures. Benefit persisted for 2 years of study. Complication rates were modest. Deep brain stimulation of the anterior thalamus is useful for some people with medically refractory partial and secondarily generalized seizures.
Epilepsia · randomised controlled trial · 1314 citationsread the source →
A double-blind, randomized study of minocycline for the treatment of negative and cognitive symptoms in early-phase schizophrenia.
Background: Current antipsychotics have only a limited effect on 2 core aspects of schizophrenia: negative symptoms and cognitive deficits. Minocycline is a second-generation tetracycline that has a beneficial effect in various neurologic disorders. Recent findings in animal models and human case reports suggest its potential for the treatment of schizophrenia. These findings may be linked to the effect of minocycline on the glutamatergic system, through inhibition of nitric oxide synthase and blocking of nitric oxide-induced neurotoxicity. Other proposed mechanisms of action include effects of minocycline on the dopaminergic system and its inhibition of microglial activation.
Objective: To examine the efficacy of minocycline as an add-on treatment for alleviating negative and cognitive symptoms in early-phase schizophrenia.
Method: A longitudinal double-blind, randomized, placebo-controlled design was used, and patients were followed for 6 months from August 2003 to March 2007. Seventy early-phase schizophrenia patients (according to DSM-IV) were recruited and 54 were randomly allocated in a 2:1 ratio to minocycline 200 mg/d. All patients had been initiated on treatment with an atypical antipsychotic < or = 14 days prior to study entry (risperidone, olanzapine, quetiapine, or clozapine; 200-600 mg/d chlorpromazine-equivalent doses). Clinical, cognitive, and functional assessments were conducted, with the Scale for the Assessment of Negative Symptoms (SANS) as the primary outcome measure.
Results: Minocycline was well tolerated, with few adverse events. It showed a beneficial effect on negative symptoms and general outcome (evident in SANS, Clinical Global Impressions scale). A similar pattern was found for cognitive functioning, mainly in executive functions (working memory, cognitive shifting, and cognitive planning).
Conclusions: Minocycline treatment was associated with improvement in negative symptoms and executive functioning, both related to frontal-lobe activity. Overall, the findings support the beneficial effect of minocycline add-on therapy in early-phase schizophrenia.
Trial registration: clinicaltrials.gov Identifier: NCT00733057.
The Journal of clinical psychiatry · randomised controlled trial · 289 citationsread the source →
Hershman DL, Greenlee H, Awad D, Kalinsky K, Maurer M, Kranwinkel G, Brafman L, Jayasena R, Tsai WY, Neugut AI, Crew KD. (2013)MEDLINE-indexed journal, not yet read by usBreast cancer research and treatment · randomised controlled trial Randomized controlled trial of a clinic-based survivorship intervention following adjuvant therapy in breast cancer survivors.
In 2006, the IOM released a report citing the importance of "survivorship plans" to improve quality of life and care coordination for cancer survivors, but little has been done to evaluate their efficacy. Women with early-stage breast cancer were randomized within 6 weeks of completing adjuvant therapy to a survivorship intervention group (SI) or control group (CG). All subjects were given the NCI publication, "Facing Forward: Life after Cancer Treatment." The SI also met with a nurse/nutritionist to receive a treatment summary, surveillance, and lifestyle recommendations. Both groups completed questionnaires on the impact of cancer (IOC), patient satisfaction (FACIT-TS-PS), and assessment of survivor concerns (ASC) at baseline, 3 and 6 months. Within and between group t tests and linear regression analyses were performed. Among 126 women (60 CG, 66 SI), mean age was 54 years, 48 % were Hispanic, and the groups were well-balanced by baseline characteristics. No significant differences between the CG and SI on the FACIT-TS-PS or IOC at 3 and 6 months were seen. The ASC health worry subscale was lower (less worry) in the SI compared to CG (p = 0.02). At all time-points, Hispanic women had higher (worse) health worry (p = 0.0008), social-life interference (p = 0.009), and meaning of cancer scales (p = 0.0004), and more trust in medical professionals (p = 0.03) compared to non-Hispanic women. While the SI did not lead to significant improvements in most patient-reported outcomes, it was associated with decreased health worry. Future interventions should determine the most efficient and effective method for delivering survivorship care plans.
Breast cancer research and treatment · randomised controlled trial · 95 citationsread the source →
Clark MM, Rummans TA, Atherton PJ, Cheville AL, Johnson ME, Frost MH, Miller JJ, Sloan JA, Graszer KM, Haas JG, Hanson JM, Garces YI, Piderman KM, Lapid MI, Netzel PJ, Richardson JW, Brown PD. (2013)MEDLINE-indexed journal, not yet read by usCancer · randomised controlled trial Randomized controlled trial of maintaining quality of life during radiotherapy for advanced cancer.
Background: Psychosocial interventions often address only 1 domain of quality of life (QOL), are offered to patients with early-stage cancer, do not include the caregiver, and are delivered after cancer treatment has been completed.
Methods: In the current randomized controlled trial, 131 patients with advanced cancer who received radiotherapy and their caregivers were randomly assigned to either a 6-session, structured, multidisciplinary intervention arm or a standard care arm. The average age of the patients was 58 years, the majority were male (63%), and tumor types varied (gastrointestinal [37%], brain [22%], head and neck [16%], lung [13%], and other [12%]). The six 90-minute sessions addressed the 5 domains of QOL: cognitive, physical, emotional, social, and spiritual. The in-person intervention was followed by 10 brief telephone counseling sessions that took place over the next 6 months.
Results: Of the 117 patients who completed the study, overall QOL (assessed by Functional Assessment of Cancer Therapy-General [FACT-G]) at week 4 was significantly higher in the intervention group (n = 54) compared with the standard arm control group (n = 63) (75.2 vs 68.7; P = .02). The 10 brief telephone contacts did not appear to impact QOL because at week 27 the groups had identical QOL (means of 77.6 and 77.7, respectively). There was no effect of the intervention noted on caregiver QOL.
Conclusions: Participating in a 6-session multidisciplinary intervention was found to be effective in maintaining the QOL of patients with advanced cancer who were actively receiving radiotherapy. The QOL and symptom burden of this population is striking, making it important to identify effective QOL strategies to implement in conjunction with cancer care.
Cancer · randomised controlled trial · 91 citationsread the source →
A parent-led family-focused treatment program for overweight children aged 5 to 9 years: the PEACH RCT.
Objective: To evaluate a healthy lifestyle intervention to reduce adiposity in children aged 5 to 9 years and assess whether adding parenting skills training would enhance this effect.
Participants and methods: We conducted a single-blinded randomized controlled trial of prepubertal moderately obese (International Obesity Task Force cut points) children, aged 5 to 9 years. The 6-month program targeted parents as the agents of change for implementing family lifestyle changes. Only parents attended group sessions. We measured BMI and waist z scores and parenting constructs at baseline, 6, 12, 18, 24 months.
Results: Participants (n = 169; 56% girls) were randomized to a parenting skills plus healthy lifestyle group (n = 85) or a healthy lifestyle-only group (n = 84). At final 24-month assessment 52 and 54 children remained in the parenting skills plus healthy lifestyle and the healthy lifestyle-only groups respectively. There were reductions (P < .001) in BMI z score (0.26 [95% confidence interval: 0.22-0.30]) and waist z score (0.33 [95% confidence interval: 0.26-0.40]). There was a 10% reduction in z scores from baseline to 6 months that was maintained to 24 months with no additional intervention. Overall, there was no significant group effect. A similar pattern of initial improvement followed by stability was observed for parenting outcomes and no group effect.
Conclusions: Using approaches that specifically target parent behavior, relative weight loss of ∼10% is achievable in moderately obese prepubertal children and can be maintained for 2 years from baseline. These results justify an investment in treatment as an effective secondary obesity-prevention strategy.
Pediatrics · randomised controlled trial · 91 citationsread the source →
Rummans TA, Clark MM, Sloan JA, Frost MH, Bostwick JM, Atherton PJ, Johnson ME, Gamble G, Richardson J, Brown P, Martensen J, Miller J, Piderman K, Huschka M, Girardi J, Hanson J. (2006)MEDLINE-indexed journal, not yet read by usJournal of clinical oncology : official journal of the American Society of Clinical Oncology · randomised controlled trial Impacting quality of life for patients with advanced cancer with a structured multidisciplinary intervention: a randomized controlled trial.
Purpose: The primary goal of this study was to evaluate the feasibility and effectiveness of a structured, multidisciplinary intervention targeted to maintain the overall quality of life (QOL), which is more comprehensive than psychosocial distress, of patients undergoing radiation therapy for advanced-stage cancer.
Patients and methods: Radiation therapy patients with advanced cancer and an estimated 5-year survival rate of 0% to 50% were randomly assigned to either an eight-session structured multidisciplinary intervention arm or a standard care arm. The eight 90-minute sessions addressed the five domains of QOL including cognitive, physical, emotional, spiritual, and social functioning. The primary end point of maintaining overall QOL was assessed by a single-item linear analog scale (Linear Analog Scale of Assessment or modified Spitzer Uniscale). QOL was assessed at baseline, week 4 (end of multidisciplinary intervention), week 8, and week 27.
Results: Of the 103 participants, overall QOL at week 4 was maintained by the patients in the intervention (n = 49), whereas QOL at week 4 significantly decreased for patients in the control group (n = 54). This change reflected a 3-point increase from baseline in the intervention group and a 9-point decrease from baseline in the control group (P = .009). Intervention participants maintained their QOL, and controls gradually returned to baseline by the end of the 6-month follow-up period.
Conclusion: Although intervention participants maintained and actually improved their QOL during radiation therapy, control participants experienced a significant decrease in their QOL. Thus, a structured multidisciplinary intervention can help maintain or even improve QOL in patients with advanced cancer who are undergoing cancer treatment.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology · randomised controlled trial · 244 citationsread the source →
Mouthaan J, Sijbrandij M, de Vries GJ, Reitsma JB, van de Schoot R, Goslings JC, Luitse JS, Bakker FC, Gersons BP, Olff M. (2013)MEDLINE-indexed journal, not yet read by usJournal of medical Internet research · randomised controlled trial Internet-based early intervention to prevent posttraumatic stress disorder in injury patients: randomized controlled trial.
Background: Posttraumatic stress disorder (PTSD) develops in 10-20% of injury patients. We developed a novel, self-guided Internet-based intervention (called Trauma TIPS) based on techniques from cognitive behavioral therapy (CBT) to prevent the onset of PTSD symptoms.
Objective: To determine whether Trauma TIPS is effective in preventing the onset of PTSD symptoms in injury patients.
Methods: Adult, level 1 trauma center patients were randomly assigned to receive the fully automated Trauma TIPS Internet intervention (n=151) or to receive no early intervention (n=149). Trauma TIPS consisted of psychoeducation, in vivo exposure, and stress management techniques. Both groups were free to use care as usual (nonprotocolized talks with hospital staff). PTSD symptom severity was assessed at 1, 3, 6, and 12 months post injury with a clinical interview (Clinician-Administered PTSD Scale) by blinded trained interviewers and self-report instrument (Impact of Event Scale-Revised). Secondary outcomes were acute anxiety and arousal (assessed online), self-reported depressive and anxiety symptoms (Hospital Anxiety and Depression Scale), and mental health care utilization. Intervention usage was documented.
Results: The mean number of intervention logins was 1.7, SD 2.5, median 1, interquartile range (IQR) 1-2. Thirty-four patients in the intervention group did not log in (22.5%), 63 (41.7%) logged in once, and 54 (35.8%) logged in multiple times (mean 3.6, SD 3.5, median 3, IQR 2-4). On clinician-assessed and self-reported PTSD symptoms, both the intervention and control group showed a significant decrease over time (P<.001) without significant differences in trend. PTSD at 12 months was diagnosed in 4.7% of controls and 4.4% of intervention group patients. There were no group differences on anxiety or depressive symptoms over time. Post hoc analyses using latent growth mixture modeling showed a significant decrease in PTSD symptoms in a subgroup of patients with severe initial symptoms (n=20) (P<.001).
Conclusions: Our results do not support the efficacy of the Trauma TIPS Internet-based early intervention in the prevention of PTSD symptoms for an unselected population of injury patients. Moreover, uptake was relatively low since one-fifth of individuals did not log in to the intervention. Future research should therefore focus on innovative strategies to increase intervention usage, for example, adding gameplay, embedding it in a blended care context, and targeting high-risk individuals who are more likely to benefit from the intervention.
Trial registration: International Standard Randomized Controlled Trial Number (ISRCTN): 57754429; http://www.controlled-trials.com/ISRCTN57754429 (Archived by WebCite at http://webcitation.org/6FeJtJJyD).
Journal of medical Internet research · randomised controlled trial · 62 citationsread the source →
Early intervention program reduces stress in parents of preterms during childhood, a randomized controlled trial.
Background: It is well documented that heightened levels of parenting stress have a negative influence on children's socio-emotional and behavioral development. Parenting stress may therefore be regarded as an outcome variable in its own right. This study investigated whether a sensitizing intervention influences stress reported by parents of prematurely born children until the children were age nine.
Methods: Preterm infants (N = 146, birth weight <2,000 g) were randomized to intervention (N = 72) with the Mother-Infant Transaction Program (MITP) or a preterm control group (N = 74) that received standard hospital care. A term reference group comprised 75 healthy, full-term neonates. Parents reported on the Parenting Stress Index (PSI) when the children were 6 months, 1, 2, 3, 5, 7 years old and on the PSI-Short Form (PSI-SF) at age 9. Main outcomes were the mother's and father's reports of total, child and parent-related stress. Cross-sectional and longitudinal analyses were performed using linear mixed models (LMM), taking dependency in the data caused by twin pairs and repeated measures into account. Response rates were high across all follow-ups, and still reached 85% from mothers and 72% from fathers at 9 years.
Results: Mothers in the intervention group reported better longitudinal development of child-related stress than mothers of preterm controls, as they perceived their children as being more adaptable and less moody throughout childhood until the age of seven. Less stress in the intervention group was revealed by cross-sectional analysis of maternal reports at all ages, while fathers reported similar differences at ages three and five. Parents in the intervention group reported stronger agreement on several stress scores on several occasions. Fathers with high interventional participation (mean 54%) reported significantly less stress at age nine than those who participated less. Both parents in the intervention group reported levels of stress similar to those experienced by the term reference group at all follow-ups, while differences between the preterm control and term reference groups increased.
Conclusions: This early intervention reduces stress among parents of prematurely born children to a level reported by parents of term-born children and enhances agreement between parents.
Trial registration: Clinical Trials Gov identifier NCT00222456, 05.09.2005.
Trials · randomised controlled trial · 37 citationsread the source →
Endurance training guided individually by daily heart rate variability measurements.
Purpose of this study was to test utility of heart rate variability (HRV) in daily endurance exercise prescriptions. Twenty-six healthy, moderately fit males were randomized into predefined training group (TRA, n = 8), HRV-guided training group (HRV, n = 9), and control group (n = 9). Four-week training period consisted of running sessions lasting 40 min each at either low- or high-intensity level. TRA group trained on 6 days a week, with two sessions at low and four at high intensity. Individual training program for HRV group was based on individual changes in high-frequency R-R interval oscillations measured every morning. Increase or no change in HRV resulted in high-intensity training on that day. If there was significant decrease in HRV (below reference value [10-day mean-SD] or decreasing trend for 2 days), low-intensity training or rest was prescribed. Peak oxygen consumption (VO(2peak)) and maximal running velocity (Load(max)) were measured in maximal treadmill test before and after the training. In TRA group, Load(max) increased from 15.1 +/- 1.3 to 15.7 +/- 1.2 km h(-1) (P = 0.004), whereas VO(2peak) did not change significantly (54 +/- 4 pre and 55 +/- 3 ml kg(-1) min(-1) post, P = 0.224). In HRV group, significant increases were observed in both Load(max) (from 15.5 +/- 1.0 to 16.4 +/- 1.0 km h(-1), P < 0.001) and VO(2peak) (from 56 +/- 4 to 60 +/- 5 ml kg(-1) min(-1), P = 0.002). The change in Load(max) was significantly greater in HRV group compared to TRA group (0.5 +/- 0.4 vs. 0.9 +/- 0.2 km h(-1), P = 0.048, adjusted for baseline values). No significant differences were observed in the changes of VO(2peak) between the groups. We concluded that cardiorespiratory fitness can be improved effectively by using HRV for daily training prescription.
European journal of applied physiology · randomised controlled trial · 193 citationsread the source →
Cognitive behavioural therapy in addition to antispasmodic therapy for irritable bowel syndrome in primary care: randomised controlled trial.
Objectives: To determine whether cognitive behavioural therapy (CBT) in addition to antispasmodic treatment offers a cost-effective benefit to primary care patients with irritable bowel syndrome (IBS) and to identify predictors of outcome.
Design: This was a randomised controlled trial in primary care of the addition of CBT to standard general practice management of IBS, using the antispasmodic agent mebeverine hydrochloride. The study set out to compare the addition of a standardised package of IBS-specific CBT to treatment with mebeverine hydrochloride.
Setting: Ten general practices, serving a population of around 45,000 patients, located principally in south London, with some patients resident in north London.
Participants: Patients identified as having IBS by their GPs, aged between 17 and 54 (mean 34) years and predominantly white; 82% were female and half had had IBS for more than 5 years.
Interventions: Practice nurses delivered CBT in a randomised trial of the addition of CBT to mebeverine in patients who had IBS of moderate or greater severity after 2 weeks of GP care and 4 weeks of mebeverine. The Symptom Severity Scale (SSS) was used to identify patients with moderate or severe IBS. Patients who continued to report moderate or severe IBS after 4 weeks of mebeverine at a dose of 270 mg three times a day were randomised to receive six sessions of CBT in addition to mebeverine (72 patients) or mebeverine alone (77 patients). These patients were followed at 3, 6 and 12 months after treatment. As part of the baseline evaluation, blood tests for antiendomysial and antigliadin antibodies were carried out on 141 patients to determine the prevalence of coeliac disease in this population.
Main outcome measures: The principal outcome measure was the SSS. Others included the Hospital Anxiety and Depression Scale, psychopathology, the Work and Social Adjustment Scale (WASA, disability), a modified version of the Illness Perception Questionnaire (illness perceptions), the Beliefs about Medicine Questionnaire (attitudes to medication), the Reported Adherence to Medication Scale (adherence to prescribed medication), the Client Service Receipt Inventory (economic analysis), the Cognitive Scale for Functional Bowel Disorders (illness cognitions) and the Behaviour Scale for IBS (IBS coping behaviour).
Results: The addition of CBT produced a significant benefit compared with the mebeverine-only group at 3 months after treatment on all outcome measures, except for the adherence to medication scales. The difference between the groups was 107.8 points on the SSS, 24.5 points on question 4 of the SSS and 6.3 points on the WASA, representing therapeutic gains of approximately 20%, 28% and 40%, respectively. However, there was also evidence that these improvements began to wane, so that at 6 and 12 months follow-up significant therapeutic benefit of the addition of CBT could only be detected on question 4 of the SSS and on the WASA. The behaviour scale for IBS detected significant, positive changes in coping behaviours at up to 6 months after treatment. Three factors predicting a poor outcome were identified: male gender, believing that IBS had serious consequences and belief in an external aetiology, all of which were associated with greater than average disability at follow-up. The addition of CBT to mebeverine did not reduce overall treatment or social costs. The nested study on testing for coeliac disease provides cautious support for the inclusion of antiendomysial and antigliadin antibody testing in the investigation of patients thought to have IBS.
Conclusions: Specially trained practice nurses can provide effective CBT to primary care patients with a clinical diagnosis of IBS, which although effective does not reduce service or social costs. Using a variety of measures the beneficial therapeutic effects of the addition of CBT to antispasmodic therapy persist for up to 6 months. Future research might include studies of the long-term follow-up of IBS patients treated with CBT, cost-benefit analyses comparing CBT with other therapeutic approaches to IBS, and evaluating means of training both non-specialist health professionals and GPs to deliver CBT.
Health technology assessment (Winchester, England) · randomised controlled trial · 48 citationsread the source →
Happy ending: a randomized controlled trial of a digital multi-media smoking cessation intervention.
Aims: To assess the long-term efficacy of a fully automated digital multi-media smoking cessation intervention.
Design: Two-arm randomized control trial (RCT). Setting World Wide Web (WWW) study based in Norway.
Participants: Subjects (n = 396) were recruited via internet advertisements and assigned randomly to conditions. Inclusion criteria were willingness to quit smoking and being aged 18 years or older.
Intervention: The treatment group received the internet- and cell-phone-based Happy Ending intervention. The intervention programme lasted 54 weeks and consisted of more than 400 contacts by e-mail, web-pages, interactive voice response (IVR) and short message service (SMS) technology. The control group received a self-help booklet. Additionally, both groups were offered free nicotine replacement therapy (NRT).
Measurements: Abstinence was defined as 'not even a puff of smoke, for the last 7 days', and assessed by means of internet surveys or telephone interviews. The main outcome was repeated point abstinence at 1, 3, 6 and 12 months following cessation.
Findings: Participants in the treatment group reported clinically and statistically significantly higher repeated point abstinence rates than control participants [22.3% versus 13.1%; odds ratio (OR) = 1.91, 95% confidence interval (CI): 1.12-3.26, P = 0.02; intent-to-treat). Improved adherence to NRT and a higher level of post-cessation self-efficacy were observed in the treatment group compared with the control group.
Conclusions: As the first RCT documenting the long-term treatment effects of such an intervention, this study adds to the promise of digital media in supporting behaviour change.
Addiction (Abingdon, England) · randomised controlled trial · 193 citationsread the source →
Teerlink JR, Metra M, Felker GM, Ponikowski P, Voors AA, Weatherley BD, Marmor A, Katz A, Grzybowski J, Unemori E, Teichman SL, Cotter G. (2009)MEDLINE-indexed journal, not yet read by usLancet (London, England) · randomised controlled trial Relaxin for the treatment of patients with acute heart failure (Pre-RELAX-AHF): a multicentre, randomised, placebo-controlled, parallel-group, dose-finding phase IIb study.
Background: Most patients admitted for acute heart failure have normal or increase blood pressure. Relaxin is a natural human peptide that affects multiple vascular control pathways, suggesting potential mechanisms of benefit for such patients. We assessed the dose response of relaxin's effect on symptom relief, other clinical outcomes, and safety.
Methods: In a placebo-controlled, parallel-group, dose-ranging study, 234 patients with acute heart failure, dyspnoea, congestion on chest radiograph, and increased brain natriuretic peptide (BNP) or N-terminal prohormone of BNP, mild-to-moderate renal insufficiency, and systolic blood pressure greater than 125 mm Hg were recruited from 54 sites in eight countries and enrolled within 16 h of presentation. Patients were randomly assigned, in a double-blind manner via a telephone-based interactive voice response system, to standard care plus 48-h intravenous infusion of placebo (n=62) or relaxin 10 microg/kg (n=40), 30 microg/kg (n=43), 100 microg/kg (n=39), or 250 microg/kg (n=50) per day. Several clinical endpoints were explored to assess whether intravenous relaxin should be pursued in larger studies of acute heart failure, to identify an optimum dose, and to help to assess endpoint selection and power calculations. Analysis was by modified intention to treat. This study is registered with ClinicalTrials.gov, number NCT00520806.
Findings: In the modified intention-to-treat population, 61 patients were assessed in the placebo group, 40 in the relaxin 10 microg/kg per day group, 42 in the relaxin 30 microg/kg per day group, 37 in the relaxin 100 microg/kg per day group, and 49 in the relaxin 250 microg/kg per day group. Dyspnoea improved with relaxin 30 microg/kg compared with placebo, as assessed by Likert scale (17 of 42 patients [40%] moderately or markedly improved at 6 h, 12 h, and 24 h vs 14 of 61 [23%]; p=0.044) and visual analogue scale through day 14 (8214 mm x h [SD 8712] vs 4622 mm x h [9003]; p=0.053). Length of stay was 10.2 days (SD 6.1) for relaxin-treated patients versus 12.0 days (7.3) for those given placebo, and days alive out of hospital were 47.9 (10.1) versus 44.2 (14.2). Cardiovascular death or readmission due to heart or renal failure at day 60 was reduced with relaxin (2.6% [95% CI 0.4-16.8] vs 17.2% [9.6-29.6]; p=0.053). The number of serious adverse events was similar between groups.
Interpretation: When given to patients with acute heart failure and normal-to-increased blood pressure, relaxin was associated with favourable relief of dyspnoea and other clinical outcomes, with acceptable safety.
Lancet (London, England) · randomised controlled trial · 314 citationsread the source →
The 'Healthy Dads, Healthy Kids' randomized controlled trial: efficacy of a healthy lifestyle program for overweight fathers and their children.
Objective: To evaluate the feasibility and efficacy of the 'Healthy Dads, Healthy Kids' (HDHK) program, which was designed to help overweight fathers lose weight and be a role model of positive health behaviors for their children.
Design: Randomized controlled trial.
Participants: A total of 53 overweight/obese men (mean (s.d.) age=40.6 (7.1) years; body mass index (BMI)=33.2 (3.9)) and their primary school-aged children (n=71, 54% boys; mean (s.d.) age=8.2 (2.0) years) were randomly assigned (family unit) to either (i) the HDHK program (n=27 fathers, n=39 children) or (ii) a wait-list control group (n=26 fathers, n=32 children).
Intervention: Fathers in the 3-month program attended eight face-to-face education sessions. Children attended three of these sessions.
Outcomes: The primary outcome was fathers' weight. Fathers and their children were assessed at baseline, and at 3- and 6-month follow-up, for weight, waist circumference, BMI, blood pressure, resting heart rate (RHR), objectively measured physical activity and self-reported dietary intake.
Results: Intention-to-treat analysis revealed significant between-group differences at 6 months for weight loss (P<0.001), with HDHK fathers losing more weight (-7.6 kg; 95% confidence interval (CI) -9.2, -6.0; d=0.54) than control group fathers (0.0 kg; 95% CI -1.4, 1.6). Significant treatment effects (P<0.05) were also found for waist circumference (d=0.62), BMI (d=0.53), systolic blood pressure (d=0.92), RHR (d=0.66) and physical activity (d=0.91), but not for dietary intake. In children, significant treatment effects (P<0.05) were found for physical activity (d=0.74), RHR (d=0.51) and dietary intake (d=0.84).
Conclusion: The HDHK program resulted in significant weight loss and improved health-related outcomes in fathers and improved eating and physical activity among children. Targeting fathers is a novel and efficacious approach to improving health behavior in their children.
International journal of obesity (2005) · randomised controlled trial · 140 citationsread the source →
Cognitive behavioural treatment for women who have menopausal symptoms after breast cancer treatment (MENOS 1): a randomised controlled trial.
Background: Hot flushes and night sweats (HFNS) affect 65-85% of women after breast cancer treatment; they are distressing, causing sleep problems and decreased quality of life. Hormone replacement therapy is often either undesirable or contraindicated. Safe, effective non-hormonal treatments are needed. We investigated whether cognitive behavioural therapy (CBT) can help breast cancer survivors to effectively manage HFNS.
Methods: In this randomised controlled trial, we recruited women from breast clinics in London, UK, who had problematic HFNS (minimum ten problematic episodes a week) after breast-cancer treatment. Participants were randomly allocated to receive either usual care or usual care plus group CBT (1:1). Randomisation was done in blocks of 12-20 participants, stratifying by age (younger than 50 years, 50 years or older), and was done with a computer-generated sequence. The trial statistician and researchers collecting outcome measures were masked to group allocation. Group CBT comprised one 90 min session a week for 6 weeks, and included psycho-education, paced breathing, and cognitive and behavioural strategies to manage HFNS. Assessments were done at baseline, 9 weeks, and 26 weeks after randomisation. The primary outcome was the adjusted mean difference in HFNS problem rating (1-10) between CBT and usual care groups at 9 weeks after randomisation. Analysis of the primary endpoint was done by modified intention to treat. The trial is registered, ISRCTN13771934, and was closed March 15, 2011.
Findings: Between May 5, 2009, and Aug 27, 2010, 96 women were randomly allocated to group CBT (n=47) or usual care (n=49). Group CBT significantly reduced HFNS problem rating at 9 weeks after randomisation compared with usual care (mean difference -1·67, 95% CI -2·43 to -0·91; p<0·0001) and improvements were maintained at 26 weeks (mean difference -1·76, -2·54 to -0·99; p<0·0001). We recorded no CBT-related adverse events.
Interpretation: Group CBT seems to be a safe and effective treatment for women who have problematic HFNS after breast cancer treatment with additional benefits to mood, sleep, and quality of life. The treatment could be incorporated into breast cancer survivorship programmes and delivered by trained breast cancer nurses.
Funding: Cancer Research UK.
The Lancet. Oncology · randomised controlled trial · 190 citationsread the source →
Self-monitoring using mobile phones in the early stages of adolescent depression: randomized controlled trial.
Background: The stepped-care approach, where people with early symptoms of depression are stepped up from low-intensity interventions to higher-level interventions as needed, has the potential to assist many people with mild depressive symptoms. Self-monitoring techniques assist people to understand their mental health symptoms by increasing their emotional self-awareness (ESA) and can be easily distributed on mobile phones at low cost. Increasing ESA is an important first step in psychotherapy and has the potential to intervene before mild depressive symptoms progress to major depressive disorder. In this secondary analysis we examined a mobile phone self-monitoring tool used by young people experiencing mild or more depressive symptoms to investigate the relationships between self-monitoring, ESA, and depression.
Objectives: We tested two main hypotheses: (1) people who monitored their mood, stress, and coping strategies would have increased ESA from pretest to 6-week follow-up compared with an attention comparison group, and (2) an increase in ESA would predict a decrease in depressive symptoms.
Methods: We recruited patients aged 14 to 24 years from rural and metropolitan general practices. Eligible participants were identified as having mild or more mental health concerns by their general practitioner. Participants were randomly assigned to either the intervention group (where mood, stress, and daily activities were monitored) or the attention comparison group (where only daily activities were monitored), and both groups self-monitored for 2 to 4 weeks. Randomization was carried out electronically via random seed generation, by an in-house computer programmer; therefore, general practitioners, participants, and researchers were blinded to group allocation at randomization. Participants completed pretest, posttest, and 6-week follow-up measures of the Depression Anxiety Stress Scale and the ESA Scale. We estimated a parallel process latent growth curve model (LGCM) using Mplus to test the indirect effect of the intervention on depressive symptoms via the mediator ESA, and calculated 95% bias-corrected bootstrapping confidence intervals (CIs).
Results: Of the 163 participants assessed for eligibility, 118 were randomly assigned and 114 were included in analyses (68 in the intervention group and 46 in the comparison group). A parallel process LGCM estimated the indirect effect of the intervention on depressive symptoms via ESA and was shown to be statistically significant based on the 95% bias-corrected bootstrapping CIs not containing zero (-6.366 to -0.029). The proportion of the maximum possible indirect effect estimated was κ(2 )=.54 (95% CI .426-.640).
Conclusions: This study supported the hypothesis that self-monitoring increases ESA, which in turn decreases depressive symptoms for young people with mild or more depressive symptoms. Mobile phone self-monitoring programs are ideally suited to first-step intervention programs for depression in the stepped-care approach, particularly when ESA is targeted as a mediating factor.
Trial registration: ClinicalTrials.gov NCT00794222; http://clinicaltrials.gov/ct2/show/NCT00794222 (Archived by WebCite at http://www.webcitation.org/65lldW34k).
Journal of medical Internet research · randomised controlled trial · 260 citationsread the source →
Lewis SJ, Arseneault L, Caspi A, Fisher HL, Matthews T, Moffitt TE, Odgers CL, Stahl D, Teng JY, Danese A. (2019)MEDLINE-indexed journal, not yet read by usThe lancet. Psychiatry · cohort or longitudinal The epidemiology of trauma and post-traumatic stress disorder in a representative cohort of young people in England and Wales.
Background: Despite the emphasis placed on childhood trauma in psychiatry, comparatively little is known about the epidemiology of trauma and trauma-related psychopathology in young people. We therefore aimed to evaluate the prevalence, clinical features, and risk factors associated with trauma exposure and post-traumatic stress disorder (PTSD) in young people.
Methods: We carried out a comprehensive epidemiological study based on participants from the Environmental Risk Longitudinal Twin Study, a population-representative birth-cohort of 2232 children born in England and Wales in 1994-95. At the follow-up home visit at age 18 years, participants were assessed with structured interviews for trauma exposure, PTSD, other psychopathology, risk events, functional impairment, and service use. Risk factors for PTSD were measured prospectively over four previous assessments between age 5 and 12 years. The key outcomes were the prevalence, clinical features, and risk factors associated with trauma exposure and PTSD. We also derived and tested the internal validity of a PTSD risk calculator.
Findings: We found that 642 (31·1%) of 2064 participants reported trauma exposure and 160 (7·8%) of 2063 experienced PTSD by age 18 years. Trauma-exposed participants had high rates of psychopathology (187 [29·2%] of 641 for major depressive episode, 146 [22·9%] of 638 for conduct disorder, and 102 [15·9%] of 641 for alcohol dependence), risk events (160 [25·0%] of 641 for self-harm, 53 [8·3%] of 640 for suicide attempt, and 42 [6·6%] of 640 for violent offence), and functional impairment. Participants with lifetime PTSD had even higher rates of psychopathology (87 [54·7%] of 159 for major depressive episode, 43 [27·0%] of 159 for conduct disorder, and 41 [25·6%] of 160 for alcohol dependence), risk events (78 [48·8%] of 160 for self-harm, 32 [20·1%] of 159 for suicide attempt, and 19 [11·9%] of 159 for violent offence), and functional impairment. However, only 33 (20·6%) of 160 participants with PTSD received help from mental health professionals. The PTSD risk calculator had an internally validated area under the receiver operating characteristic curve of 0·74, indicating adequate discrimination of trauma-exposed participants with and without PTSD, and internally validated calibration-in-the-large of -0·10 and calibration slope of 0·90, indicating adequate calibration.
Interpretation: Trauma exposure and PTSD are associated with complex psychiatric presentations, high risk, and significant impairment in young people. Improved screening, reduced barriers to care provision, and comprehensive clinical assessment are needed to ensure that trauma-exposed young people and those with PTSD receive appropriate treatment.
Funding: The Medical Research Council, the National Institute of Child Health and Development, the Jacobs Foundation, the Nuffield Foundation, the National Society for Prevention of Cruelty to Children, the Economic and Social Research Council, the National Institute for Health Research, MQ, and Canadian Institutes for Advanced Research.
The lancet. Psychiatry · cohort or longitudinal · 287 citationsread the source →
Is clinician-supported use of a mindfulness smartphone app a feasible treatment for depression? A mixed-methods feasibility study.
Depression is the leading cause of disability globally and has serious consequences for the individual, their family and for society. Effective, accessible and affordable treatments are urgently needed. In-person group-based mindfulness-based interventions are an effective treatment for depression, but are not widely available and can be costly. Clinician supported use of mindfulness self-help resources such as mindfulness smartphone applications could widen access at a reduced cost, but there are key feasibility questions that need answering. This is a mixed-methods feasibility study of a blended intervention involving the mindfulness smartphone app Headspace alongside six clinician support sessions with mental health treatment seeking adults experiencing moderate to moderately severe symptoms of depression. In line with recommendations for feasibility studies, we examine whether: (1) it is possible to recruit participants to this novel intervention, (2) participants engage with the intervention, (3) participants and clinicians find the intervention acceptable, and (4) pre-post outcomes on measures of depression (primary outcome), anxiety, wellbeing, mindfulness, self-compassion, rumination and worry indicate effectiveness. Findings show that recruitment is feasible with 54 participants enrolled in the intervention within a 6-month window. In terms of engagement, 44.4% completed at least 80% of recommended Headspace sessions and 72.2% of participants attended at least three clinician support sessions. Clinician-supported Headspace was deemed acceptable by participants and clinicians. Pre-post effect sizes were statistically significant and in the small-medium or medium-large range on all outcomes, with an effect size of d = 0.69 (95% CI: 0.34-1.04) for the primary outcome of depression symptom severity. The number of Headspace sessions engaged with was associated with greater reduction in depression symptom severity. Findings suggest that a blended intervention combining Headspace with clinician support has potential as a first-line treatment for moderate/moderately severe depression, but findings are too preliminary to recommend the intervention outside of a research trial. Important caveats are noted including the need for future research to examine predictors of engagement with Headspace sessions so that engagement can be enhanced, to measure the longer term effects of such interventions and to better understand the potential for lasting negative effects of the intervention so that these can be minimised.
Internet interventions · 11 citationsread the source →
The associations of socioeconomic status, social activities, and loneliness with depressive symptoms in adults aged 50 years and older across 24 countries: findings from five prospective cohort studies.
Background: Depression is the leading cause of mortality among mental health disorders. Evidence about the associations of socioeconomic status, social activities, and loneliness with depression is scarce. We aimed to identify whether social activities and loneliness mediate the association between socioeconomic status and depression, and the extent of interactive or joint relationships between social activities, loneliness, and socioeconomic status on depression.
Methods: In this population-based, cross-national cohort study we used data from five nationally representative surveys across 24 countries between Feb 15, 2008, and Feb 27, 2019: the Health and Retirement Study (HRS); the English Longitudinal Study of Ageing (ELSA); the Survey of Health, Ageing and Retirement in Europe (SHARE); the China Health and Retirement Longitudinal Study (CHARLS); and the Mexican Health and Ageing Study (MHAS). We included participants who were aged 50 years and older with reported information on socioeconomic status, social activities, and loneliness at baseline, and who had been assessed at least twice. We excluded participants with depressive symptoms at baseline; those with missing data on depressive symptoms and covariates; and those lost to follow-up. We defined socioeconomic status as high and low using latent class analysis based on family income, education, and employment status. Depression was assessed using the Center for Epidemiological Studies Depression Scale (CES-D) or EURO-D. We applied Cox proportional hazard models to estimate the association of socioeconomic status with depression. We used random-effects models to obtain pooled results. Joint and interactive effects of socioeconomic status, social activities, and loneliness on depression were explored, and the mediating roles of social activities and loneliness in the association between socioeconomic status and depression were explored using causal mediation analysis.
Findings: A total of 69 160 participants were included in our study and, during a median follow-up of 5 years, a total of 20 237 participants developed depression with a pooled incidence of 7·2 (95% CI 4·4-10·0) per 100 person-years. Compared with participants with high socioeconomic status, those with low socioeconomic status had a higher risk of depression (pooled hazard ratio [HR] 1·34; 95% CI 1·23-1·44). The proportion of the associations between socioeconomic status and depression mediated by social activities and loneliness were 6·12% (1·14-28·45) and 5·54% (0·71-27·62), respectively. We only observed a significant multiplicative interaction of socioeconomic status and loneliness with depression (pooled HR 0·84; 0·79-0·90). Compared with participants with high socioeconomic status and who were socially active and not lonely, those with low socioeconomic status and who were socially inactive and lonely had a higher risk of depression (pooled HR 2·45; 2·08-2·82).
Interpretation: Social inactivity and loneliness positively mediated a small proportion of the association between socioeconomic status and depression, indicating that other approaches in addition to interventions targeting social isolation and loneliness are required to mitigate the risk of depression in older adults. Additionally, the joint effects of socioeconomic status, social activities, and loneliness highlight the benefits of simultaneous and integrated interventions to reduce the global burden of depression.
Funding: National Natural Science Foundation of China.
The lancet. Healthy longevity · 98 citationsread the source →
Treatment of Opioid Use Disorder in Pregnant Women via Telemedicine: A Nonrandomized Controlled Trial.
Importance: There are high rates of maternal and newborn morbidity and mortality associated with opioid use disorder (OUD). Integrating OUD treatment in obstetric practices for pregnant and postpartum women via telemedicine can increase access to care and reduce the consequences of OUD. Evaluation of this care delivery model, however, is needed before widespread adoption.
Objective: To compare maternal and newborn outcomes among pregnant women with OUD receiving care via telemedicine vs in person.
Design, setting, and participants: A nonrandomized controlled trial including 98 women receiving perinatal OUD treatment in 4 outpatient obstetric practices by telemedicine or in person and followed up until 6 to 8 weeks post partum was conducted from September 4, 2017, to December 31, 2018. Logistic regression with propensity score adjustment was applied to reduce group selection bias and control for potentially confounding variables.
Interventions: Participants were seen weekly for 4 weeks, every 2 weeks for 4 weeks, and monthly thereafter and provided relapse prevention therapy and buprenorphine.
Main outcomes and measures: The outcomes were retention in treatment, defined as uninterrupted addiction treatment during pregnancy through 6 to 8 weeks post partum; urine drug screen results at delivery and 6 to 8 weeks post partum; and a neonatal abstinence syndrome (NAS) diagnosis collected via electronic health records.
Results: The mean (SD) age of the 98 pregnant women was 30.23 (5.12) years. Of these, 41 of 44 women (93.2%) in the telemedicine group and 48 of 54 women (88.9%) in the in-person group chose to continue treatment in the program after an initial evaluation. After propensity score weighting and doubly robust estimation, no significant differences were found between groups in retention in treatment at 6 to 8 weeks post partum (telemedicine: 80.4% vs in person: 92.7%; treatment effect, -12.2%; 95% CI, -32.3% to -4.4%). Similarly, after propensity score weighting and doubly robust estimation, there were no significant group differences in rates of NAS (telemedicine: 45.4% vs in person: 63.2%; treatment effect, -17.8%; 95% CI, -41.0% to 8.9%).
Conclusions and relevance: In this nonrandomized controlled trial, virtually integrated OUD care in obstetric practices produced similar maternal and newborn outcomes compared with in-person care. These findings may have important public health implications for combatting the opioid crisis and its consequences on pregnant women and their families. Future large randomized clinical trials are needed.
Clinical trial registration: ClinicalTrials.gov identifier: NCT04049032.
JAMA network open · cohort or longitudinal · 43 citationsread the source →
Hand Posturing Is a Nonverbal Indicator of Catastrophic Thinking for Finger, Hand, or Wrist Injury.
Background: Prior research documents that greater psychologic distress (anxiety/depression) and less effective coping strategies (catastrophic thinking, kinesophobia) are associated with greater pain intensity and greater limitations. Recognition and acknowledgment of verbal and nonverbal indicators of psychologic factors might raise opportunities for improved psychologic health. There is evidence that specific patient words and phrases indicate greater catastrophic thinking. This study tested proposed nonverbal indicators (such as flexion of the wrist during attempted finger flexion or extension of uninjured fingers as the stiff and painful finger is flexed) for their association with catastrophic thinking.
Questions/purposes: (1) Do patients with specific protective hand postures during physical examination have greater pain interference (limitation of activity in response to nociception), limitations, symptoms of depression, catastrophic thinking (protectiveness, preparation for the worst), and kinesophobia (fear of movement)? (2) Do greater numbers of protective hand postures correlate with worse scores on these measures?
Methods: Between October 2014 and September 2016, 156 adult patients with stiff or painful fingers within 2 months after sustaining a finger, hand, or wrist injury were invited to participate in this study. Six patients chose not to participate as a result of time constraints and one patient was excluded as a result of inconsistent scoring of a possible hand posture, leaving 149 patients for analysis. We asked all patients to complete a set of questionnaires and a sociodemographic survey. We used Patient Reported Outcomes Measurement Information System (PROMIS) Depression, Upper Extremity Physical Function, and Pain Interference computer adaptive test (CAT) questionnaires. We used the Abbreviated Pain Catastrophizing Scale (PCS-4) to measure catastrophic thinking in response to nociception. Finally, we used the Tampa Scale of Kinesophobia (TSK) to assess fear of movement. The occurrence of protective hand postures during the physical examination was noted by both the physician and researcher. For uncertainty or disagreement, a video of the physical examination was recorded and a group decision was made.
Results: Patients with one or more protective hand postures did not score higher on the PROMIS Pain Interference CAT (hand posture: 59 [56-64]; no posture: 59 [54-63]; difference of medians: 0; p = 0.273), Physical Function CAT (32 ± 8 versus 34 ± 8; mean difference: 2 [confidence interval {CI}, -0.5 to 5]; p = 0.107), nor the Depression CAT (48 [41-55] versus 48 [42-53]; difference of medians: 0; p = 0.662). However, having at least one hand posture was associated with a higher degree of catastrophic thinking (PCS scores: 13 [6-26] versus 10 [3-16]; difference of medians: 3; p = 0.0104) and a higher level of kinesophobia (TSK: 40 ± 6 versus 38 ± 6; mean difference: -2 [CI, -4 to -1]; p = 0.0420). Greater catastrophic thinking was associated with a greater number of protective hand postures on average (rho: 0.20, p = 0.0138).
Conclusions: Protective hand postures and (based on prior research) specific words and phrases are associated with catastrophic thinking and kinesophobia, less effective coping strategies that hinder recovery. Surgeons can learn to recognize these signs and begin to treat catastrophic thinking and kinesophobia starting with compassion, empathy, and patience and be prepared to add formal support (such as cognitive-behavioral therapy) to help facilitate recovery.
Level of evidence: Level III, diagnostic study.
Clinical orthopaedics and related research · cohort or longitudinal · 35 citationsread the source →
Comparison of mental health screening tools for detecting antenatal depression and anxiety disorders in South African women.
Background: Antenatal depression and anxiety disorders are highly prevalent in low and middle-income countries. Screening of pregnant women in primary care antenatal settings provides an opportunity for entry to care, but data are needed on the performance of different screening tools. We compared five widely-used questionnaires in a sample of pregnant women in urban South Africa.
Method: Pregnant women attending a primary care antenatal clinic were administered five tools by trained research assistants: the Edinburgh Postnatal Depression Scale (EPDS), the Patient Health Questionnaire (PHQ-9), the Kessler Psychological Distress scale (K10) and a shortened 6-item version (K6), the Whooley questions and the two-item Generalised Anxiety Disorder scale (GAD-2). Following this, a registered mental health counsellor administered the MINI Plus, a structured clinical diagnostic interview. The Area Under the Curve (AUC) from Receiver Operator Characteristic curve analysis was used to summarise screening test performance and Cronbach's α used to assess internal consistency.
Results: Of 376 participants, 32% were diagnosed with either MDE and/or anxiety disorders. All five questionnaires demonstrated moderate to high performance (AUC = 0.78-0.85). The EPDS was the best performing instrument for detecting MDE and the K10 and K6 for anxiety disorder. For MDE and/or anxiety disorders, the EPDS had the highest AUC (0.83). Of the short instruments, the K10 (AUC = 0.85) and the K6 (AUC = 0.85) performed the best, with the K6 showing good balance between sensitivity (74%) and specificity (85%) and a good positive predictive value (70%). The Whooley questions (AUC = 0.81) were the best performing ultra-short instrument. Internal consistency ranged from good to acceptable (α = 0.89-0.71). However, the PPV of the questionnaires compared with the diagnostic interview, ranged from 54% to 71% at the optimal cut-off scores.
Conclusions: Universal screening for case identification of antenatal depression and anxiety disorders in low-resource settings can be conducted with a number of commonly used screening instruments. Short and ultra-short screening instruments such as the K6 and the Whooley questions may be feasible and acceptable for use in these settings.
PloS one · cohort or longitudinal · 60 citationsread the source →
Resilience in Survivors of Critical Illness in the Context of the Survivors' Experience and Recovery.
Rationale: Post-intensive care syndrome (PICS), defined as new or worsening impairment in cognition, mental health, or physical function after critical illness, is an important development in survivors. Although studies to date have focused on the frequency of these impairments, fundamental questions remain unanswered regarding the survivor experience and the impact of the critical illness event on survivor resilience and recovery.
Objectives: To examine the association between resilience and neuropsychological and physical function and to contextualize these findings within the survivors' recovery experience.
Methods: We conducted a mixed-methods pilot investigation of resilience among 43 survivors from two medical intensive care units (ICUs) within an academic health-care system. We interviewed survivors to identify barriers to and facilitators of recovery in the ICU, on the medical ward, and at home, using qualitative methods. We used a telephone battery of standardized tests to examine resilience, neuropsychological and physical function, and quality of life. We examined PICS in two ways. First, we identified how frequently survivors were impaired in one or more domains 6-12 months postdischarge. Second, we identified how frequently survivors reported that neuropsychological or physical function was worse.
Measurements and main results: Resilience was low in 28% of survivors, normal in 63% of survivors, and high in 9% of survivors. Resilience was inversely correlated with self-reported executive dysfunction, symptoms of anxiety, depression, and post-traumatic stress disorder, difficulty with self-care, and pain (P < 0.05). PICS was present in 36 survivors (83.7%; 95% confidence interval, 69.3-93.2%), whereas 23 survivors (53.5%; 95% confidence interval, 37.6-68.8%) reported worsening of neuropsychological or physical function after critical illness. We identified challenges along the recovery path of ICU survivors, finding that physical limitations and functional dependence were the most frequent challenges experienced in the ICU, medical ward, and on return to home. Spiritual and family support facilitated recovery.
Conclusions: Resilience was inversely correlated with neuropsychological impairment, pain, and difficulty with self-care. PICS was present in most survivors of critical illness, and 54% reported neuropsychological or physical function to be worse, yet resilience was normal or high in most survivors. Survivors experienced many challenges during recovery, while spiritual and family support facilitated recovery.
Annals of the American Thoracic Society · cohort or longitudinal · 113 citationsread the source →
Herrick-Reynolds KM, Punchhi G, Greenberg RS, Strauss AT, Boyarsky BJ, Weeks-Groh SR, Krach MR, Anders RA, Gurakar A, Chen PH, Segev DL, King EA, Philosophe B, Ottman SE, Wesson RN, Garonzik-Wang JM, Cameron AM. (2021)MEDLINE-indexed journal, not yet read by usJAMA surgery · cohort or longitudinal Evaluation of Early vs Standard Liver Transplant for Alcohol-Associated Liver Disease.
Importance: Traditionally, liver transplant (LT) for alcohol-associated liver disease (ALD) requires 6 months of abstinence. Although early LT before 6 months of abstinence has been associated with decreased mortality for decompensated ALD, this practice remains controversial and concentrated at a few centers.
Objective: To define patient, allograft, and relapse-free survival in early LT for ALD, and to investigate the association between these survival outcomes and early vs standard LT.
Design, setting, and participants: This cohort study analyzed all patients with ALD who underwent their first LT at a single academic referral center between October 1, 2012, and November 13, 2020. Patients with known pretransplant hepatocellular carcinoma, hepatitis B or C, or an alternative cause of liver failure were excluded. Follow-up period was defined as the time from LT to the most recent encounter with a transplant center or death.
Exposures: The exposure of interest was early LT, which was defined as less than 180 days of pre-LT abstinence. Standard LT was defined as 180 days or more of pre-LT abstinence. Patients were separated into early LT and standard LT by time from abstinence to LT.
Main outcomes and measures: The outcomes were patient, allograft, relapse-free, and hazardous relapse-free survival for patients who underwent early LT or standard LT. These groups were compared by log-rank testing of Kaplan-Meier estimates. Hazardous relapse was defined as binge, at-risk, or frequent drinking. Abstinence was reassessed at the most recent follow-up visit for all patients.
Results: Of the 163 patients with ALD included in this study, 88 (54%) underwent early LT and 75 (46%) underwent standard LT. This cohort had a mean (SD) age at transplant of 52 (10) years and was predominantly composed of 108 male patients (66%). Recipients of early LT vs standard LT were younger (median [interquartile range (IQR)] age, 49.7 [39.0-54.2] years vs 54.6 [48.7-60.0] years; P < .001) and had a higher median (IQR) Model for End-stage Liver Disease score at listing (35.0 [29.0-39.0] vs 20.0 [13.0-26.0]; P < .001). Both recipients of early LT and standard LT had similar 1-year patient survival (94.1% [95% CI, 86.3%-97.5%] vs 95.9% [95% CI, 87.8%-98.7%]; P = .60), allograft survival (92.7% [95% CI, 84.4%-96.7%] vs 90.5% [95% CI, 81.0%-95.3%]; P = .42), relapse-free survival (80.4% [95% CI, 69.1%-88.0%] vs 83.5% [95% CI, 72.2%-90.6%]; P = .41), and hazardous relapse-free survival (85.8% [95% CI, 75.1%-92.2%] vs 89.6% [95% CI, 79.5%-94.9%]; P = .41).
Conclusions and relevance: Adherence to the 6-month rule was not associated with superior patient survival, allograft survival, or relapse-free survival among selected patients. This finding suggests that patients with ALD should not be categorically excluded from LT solely on the basis of 6 months of abstinence, but rather alternative selection criteria should be identified that are based on need and posttransplant outcomes.
JAMA surgery · cohort or longitudinal · 63 citationsread the source →
Schmidt M, Zogheib E, Rozé H, Repesse X, Lebreton G, Luyt CE, Trouillet JL, Bréchot N, Nieszkowska A, Dupont H, Ouattara A, Leprince P, Chastre J, Combes A. (2013)MEDLINE-indexed journal, not yet read by usIntensive care medicine · clinical trial The PRESERVE mortality risk score and analysis of long-term outcomes after extracorporeal membrane oxygenation for severe acute respiratory distress syndrome.
Purpose: This study was designed to identify factors associated with death by 6 months post-intensive care unit (ICU) discharge and to develop a practical mortality risk score for extracorporeal membrane oxygenation (ECMO)-treated acute respiratory distress syndrome (ARDS) patients. We also assessed long-term survivors' health-related quality of life (HRQL), respiratory symptoms, and anxiety, depression and post-traumatic stress disorder (PTSD) frequencies.
Methods: Data from 140 ECMO-treated ARDS patients admitted to three French ICUs (2008-2012) were analyzed. ICU survivors contacted >6 months post-ICU discharge were assessed for HRQL, psychological and PTSD status.
Results: Main ARDS etiologies were bacterial (45%), influenza A[H₁N₁] (26%) and post-operative (17%) pneumonias. Six months post-ICU discharge, 84 (60%) patients were still alive. Based on multivariable logistic regression analysis, the PRESERVE (PRedicting dEath for SEvere ARDS on VV-ECMO) score (0-14 points) was constructed with eight pre-ECMO parameters, i.e. age, body mass index, immunocompromised status, prone positioning, days of mechanical ventilation, sepsis-related organ failure assessment, plateau pressure andpositive end-expiratory pressure. Six-month post-ECMO initiation cumulative probabilities of survival were 97, 79, 54 and 16% for PRESERVE classes 0-2, 3-4, 5-6 and ≥7 (p < 0.001), respectively. HRQL evaluation in 80% of the 6-month survivors revealed satisfactory mental health but persistent physical and emotional-related difficulties, with anxiety, depression or PTSD symptoms reported, by 34, 25 or 16%, respectively.
Conclusions: The PRESERVE score might help ICU physicians select appropriate candidates for ECMO among severe ARDS patients. Future studies should also focus on physical and psychosocial rehabilitation that could lead to improved HRQL in this population.
Intensive care medicine · clinical trial · 441 citationsread the source →