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المكتبة البحثية21 results
Peer-reviewed works with DOI and abstract, discovered from MEDLINE-indexed literature. Candidates: no tier, no stated finding, not yet read.
Internet-based cognitive behavior therapy vs. cognitive behavioral group therapy for social anxiety disorder: a randomized controlled non-inferiority trial.
Background and aims: Cognitive behavioral group therapy (CBGT) is an effective, well-established, but not widely available treatment for social anxiety disorder (SAD). Internet-based cognitive behavior therapy (ICBT) has the potential to increase availability and facilitate dissemination of therapeutic services for SAD. However, ICBT for SAD has not been directly compared with in-person treatments such as CBGT and few studies investigating ICBT have been conducted in clinical settings. Our aim was to investigate if ICBT is at least as effective as CBGT for SAD when treatments are delivered in a psychiatric setting.
Methods: We conducted a randomized controlled non-inferiority trial with allocation to ICBT (n=64) or CBGT (n=62) with blinded assessment immediately following treatment and six months post-treatment. Participants were 126 individuals with SAD who received CBGT or ICBT for a duration of 15 weeks. The Liebowitz Social Anxiety Scale (LSAS) was the main outcome measure. The following non-inferiority margin was set: following treatment, the lower bound of the 95 % confidence interval (CI) of the mean difference between groups should be less than 10 LSAS-points.
Results: Both groups made large improvements. At follow-up, 41 (64%) participants in the ICBT group were classified as responders (95% CI, 52%-76%). In the CBGT group, 28 participants (45%) responded to the treatment (95% CI, 33%-58%). At post-treatment and follow-up respectively, the 95 % CI of the LSAS mean difference was 0.68-17.66 (Cohen's d between group=0.41) and -2.51-15.69 (Cohen's d between group=0.36) favoring ICBT, which was well within the non-inferiority margin. Mixed effects models analyses showed no significant interaction effect for LSAS, indicating similar improvement across treatments (F=1.58; df=2, 219; p=.21).
Conclusions: ICBT delivered in a psychiatric setting can be as effective as CBGT in the treatment of SAD and could be used to increase availability to CBT.
Trial registration: ClinicalTrials.gov NCT00564967.
PloS one · randomised controlled trial · 155 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 →
Connection to Nature and Psychological Wellbeing: The Role of Mindfulness and Spirituality.
This study examined mindfulness and spirituality as potential explanatory mechanisms underlying the associations between connection to nature and young adults' psychological wellbeing (depression, anxiety, perceived stress, life satisfaction, and positive states of mind). Two studies employed structural equation modeling (SEM) to test these pathways using different conceptualizations and measures of mindfulness and spirituality. Participants (Study 1: N = 219, 69.4% female; Study 2: N = 180, 75% female) completed self-report measures of connection to nature, mindfulness, spirituality, and psychological wellbeing. In Study 1, mindful attention functioned as a significant mediating mechanism reducing anxiety and perceived stress, while mindful awareness mediated reductions in depression and increases in positive states of mind. Conversely, spirituality (life scheme and self-efficacy) was not a significant mediator. In Study 2, using alternative measures, spirituality (self-transcendence) significantly operated as a mediating mechanism across all wellbeing outcomes except anxiety, whereas none of the five facets of mindfulness acted as significant mediating mechanisms. Overall, these findings suggest that the roles of mindfulness and spirituality in linking connection to nature and psychological wellbeing may vary depending on how these constructs are conceptualized and measured, highlighting the need for greater conceptual clarity in future research.
International journal of environmental research and public healthread the source →
Ouweneel DM, Schotborgh JV, Limpens J, Sjauw KD, Engström AE, Lagrand WK, Cherpanath TGV, Driessen AHG, de Mol BAJM, Henriques JPS. (2016)MEDLINE-indexed journal, not yet read by usIntensive care medicine · meta-analysis Extracorporeal life support during cardiac arrest and cardiogenic shock: a systematic review and meta-analysis.
Purpose: Veno-arterial extracorporeal life support (ECLS) is increasingly used in patients during cardiac arrest and cardiogenic shock, to support both cardiac and pulmonary function. We performed a systematic review and meta-analysis of cohort studies comparing mortality in patients treated with and without ECLS support in the setting of refractory cardiac arrest and cardiogenic shock complicating acute myocardial infarction.
Methods: We systematically searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and the publisher subset of PubMed updated to December 2015. Thirteen studies were included of which nine included cardiac arrest patients (n = 3098) and four included patients with cardiogenic shock after acute myocardial infarction (n = 235). Data were pooled by a Mantel-Haenzel random effects model and heterogeneity was examined by the I 2 statistic.
Results: In cardiac arrest, the use of ECLS was associated with an absolute increase of 30 days survival of 13 % compared with patients in which ECLS was not used [95 % CI 6-20 %; p < 0.001; number needed to treat (NNT) 7.7] and a higher rate of favourable neurological outcome at 30 days (absolute risk difference 14 %; 95 % CI 7-20 %; p < 0.0001; NNT 7.1). Propensity matched analysis, including 5 studies and 438 patients (219 in both groups), showed similar results. In cardiogenic shock, ECLS showed a 33 % higher 30-day survival compared with IABP (95 % CI, 14-52 %; p < 0.001; NNT 13) but no difference when compared with TandemHeart/Impella (-3 %; 95 % CI -21 to 14 %; p = 0.70; NNH 33).
Conclusions: In cardiac arrest, the use of ECLS was associated with an increased survival rate as well as an increase in favourable neurological outcome. In the setting of cardiogenic shock there was an increased survival with ECLS compared with IABP.
Intensive care medicine · meta-analysis · 353 citationsread the source →
Covariance between psychological and endocrine responses to pharmacological challenge and psychosocial stress: a question of timing.
Objective: To test if the covariance of hypothalamus-pituitary-adrenal (HPA) axis and subjective-psychological responses to stress is dependent on different dynamics of these systems. Although stress theories typically assume substantial correlations of psychological and endocrine stress responses, studies have produced inconsistent results. One reason for this might be imperfect coupling of the different stress response systems. However, inconsistent correlations might also be a result of different on-/offsets of these stress responses, i.e., specific dynamics of the systems.
Methods: HPA axis indicators and subjective-psychological states were repeatedly and synchronously measured in a pharmacological challenge test (injection of corticotropin-releasing hormone and infusion of arginine vasopressin; Study 1; n = 42) and a psychosocial stress situation (Trier Social Stress Test; Study 2; n = 219). Cross-correlation analysis was used to test for lag effects in HPA axis reactivity and psychoendocrine responses.
Results: Analyses revealed high cross-correlations of adrenocorticotropic hormone with cortisol responses (up to r = .80 in Study 1 and r = .56 in Study 2) and positive associations of psychological with endocrine stress responses (up to r = .48 in Study 1 and r = .54 in Study 2) at nonzero lags. Subjective-psychological responses preceded HPA axis responses. Moreover, high levels of cortisol were associated with lower later levels of anxiety and activation.
Conclusions: The findings suggest that psychoendocrine stress responses are more closely coupled than previous studies suggested. Due to different dynamics of the systems, endocrine responses lag behind psychological responses.
Psychosomatic medicine · 158 citationsread the source →
Järvelä-Reijonen E, Karhunen L, Sairanen E, Muotka J, Lindroos S, Laitinen J, Puttonen S, Peuhkuri K, Hallikainen M, Pihlajamäki J, Korpela R, Ermes M, Lappalainen R, Kolehmainen M. (2018)MEDLINE-indexed journal, not yet read by usThe international journal of behavioral nutrition and physical activity · randomised controlled trial The effects of acceptance and commitment therapy on eating behavior and diet delivered through face-to-face contact and a mobile app: a randomized controlled trial.
Background: Internal motivation and good psychological capabilities are important factors in successful eating-related behavior change. Thus, we investigated whether general acceptance and commitment therapy (ACT) affects reported eating behavior and diet quality and whether baseline perceived stress moderates the intervention effects.
Methods: Secondary analysis of unblinded randomized controlled trial in three Finnish cities. Working-aged adults with psychological distress and overweight or obesity in three parallel groups: (1) ACT-based Face-to-face (n = 70; six group sessions led by a psychologist), (2) ACT-based Mobile (n = 78; one group session and mobile app), and (3) Control (n = 71; only the measurements). At baseline, the participants' (n = 219, 85% females) mean body mass index was 31.3 kg/m2 (SD = 2.9), and mean age was 49.5 years (SD = 7.4). The measurements conducted before the 8-week intervention period (baseline), 10 weeks after the baseline (post-intervention), and 36 weeks after the baseline (follow-up) included clinical measurements, questionnaires of eating behavior (IES-1, TFEQ-R18, HTAS, ecSI 2.0, REBS), diet quality (IDQ), alcohol consumption (AUDIT-C), perceived stress (PSS), and 48-h dietary recall. Hierarchical linear modeling (Wald test) was used to analyze the differences in changes between groups.
Results: Group x time interactions showed that the subcomponent of intuitive eating (IES-1), i.e., Eating for physical rather than emotional reasons, increased in both ACT-based groups (p = .019); the subcomponent of TFEQ-R18, i.e., Uncontrolled eating, decreased in the Face-to-face group (p = .020); the subcomponent of health and taste attitudes (HTAS), i.e., Using food as a reward, decreased in the Mobile group (p = .048); and both subcomponent of eating competence (ecSI 2.0), i.e., Food acceptance (p = .048), and two subcomponents of regulation of eating behavior (REBS), i.e., Integrated and Identified regulation (p = .003, p = .023, respectively), increased in the Face-to-face group. Baseline perceived stress did not moderate effects on these particular features of eating behavior from baseline to follow-up. No statistically significant effects were found for dietary measures.
Conclusions: ACT-based interventions, delivered in group sessions or by mobile app, showed beneficial effects on reported eating behavior. Beneficial effects on eating behavior were, however, not accompanied by parallel changes in diet, which suggests that ACT-based interventions should include nutritional counseling if changes in diet are targeted.
Trial registration: ClinicalTrials.gov ( NCT01738256 ), registered 17 August, 2012.
The international journal of behavioral nutrition and physical activity · randomised controlled trial · 49 citationsread the source →
Physical Therapy Informed by Acceptance and Commitment Therapy (PACT) Versus Usual Care Physical Therapy for Adults With Chronic Low Back Pain: A Randomized Controlled Trial.
Chronic low back pain (CLBP) is a major cause of global disability and improving management is essential. Acceptance and commitment therapy (ACT) is a promising treatment for chronic pain but has not been modified for physical therapy. This randomized controlled trial (RCT) compared physical therapy informed by ACT (PACT) against standard care physical therapy for patients with CLBP. Patients with CLBP (duration ≥12 weeks, mean 3 years) were recruited from physical therapy clinics in 4 UK public hospitals. The Roland-Morris Disability Questionnaire (RMDQ) at 3 months' post-randomization was the primary outcome. Two hundred forty-eight participants (59% female, mean age = 48) were recruited and 219 (88.3%) completed measures at 3 and/or 12 months' follow-up. At 3 months, PACT participants reported better outcomes for disability (RMDQ mean difference = 1.07, p = .037, 95% CI = -2.08 to -.07, d = .2), Patient Specific Functioning (p = .008), SF12 physical health (p = .032), and treatment credibility (p < .001). At 12 months' follow-up, there were no significant differences between groups. PACT was acceptable to patients and clinicians and feasible to deliver. Physical therapists incorporated psychological principles successfully and treatment was delivered with high (≥80%) fidelity. Our results may inform the management of CLBP, with potential benefits for patients, health care providers, and society. PERSPECTIVE: Psychologically informed physical therapy has great potential but there are challenges in implementation. The training and support included in the PACT trial enabled the intervention to be delivered as planned. This successfully reduced disability in the short but not long term. Findings could inform physical therapists' treatment of CLBP.
The journal of pain · randomised controlled trial · 64 citationsread the source →
Medoff Cooper B, Marino BS, Fleck DA, Lisanti AJ, Golfenshtein N, Ravishankar C, Costello JM, Huang L, Hanlon AL, Curley MAQ. (2020)MEDLINE-indexed journal, not yet read by usPediatrics · randomised controlled trial Telehealth Home Monitoring and Postcardiac Surgery for Congenital Heart Disease.
Objectives: To test the effect of a 4-month telehealth home monitoring program (REACH), layered on usual care, on postdischarge outcomes in parents of infants recovering from cardiac surgery and their infants.
Methods: Randomized trial of infants discharged from the hospital after cardiac surgery for congenital heart disease. Consecutive infants with complex congenital heart disease undergoing cardiac surgery within 21 days of life were enrolled at 3 university-affiliated pediatric cardiac centers.
Results: From 2012 to 2016, 219 parent-infant dyads were enrolled; 109 were randomly assigned to the intervention group and 110 to the control group. At 4 months postdischarge, parenting stress was not significantly different between groups (total Parenting Stress Index in the intervention group was 220 and in the control group was 215; P = .61). The percentages of parents who met posttraumatic stress disorder (PTSD) criteria and parent quality of life inventory scores were also not significantly different between the 2 groups (PTSD in the intervention group was 18% and was 18% in the control group; P =.56; the mean Ulm Quality of Life Inventory for Parents in the intervention group was 71 andwas 70 in the control group; P = .88). Infant growth in both groups was suboptimal (the mean weight-for-age z scores were -1.1 in the intervention group and -1.2 in the control group; P = .56), and more infants in the intervention group were readmitted to the hospital (66% in the intervention group versus 57% in the control group; P < .001).
Conclusions: When added to usual care, the REACH intervention was not associated with an improvement in parent or infant outcomes. Four months after neonatal heart surgery, ∼20% of parents demonstrate PTSD symptoms. Suboptimal infant growth and hospital readmissions were common.
Pediatrics · randomised controlled trial · 26 citationsread the source →
Richards DA, Ekers D, McMillan D, Taylor RS, Byford S, Warren FC, Barrett B, Farrand PA, Gilbody S, Kuyken W, O'Mahen H, Watkins ER, Wright KA, Hollon SD, Reed N, Rhodes S, Fletcher E, Finning K. (2016)MEDLINE-indexed journal, not yet read by usLancet (London, England) · randomised controlled trial Cost and Outcome of Behavioural Activation versus Cognitive Behavioural Therapy for Depression (COBRA): a randomised, controlled, non-inferiority trial.
Background: Depression is a common, debilitating, and costly disorder. Many patients request psychological therapy, but the best-evidenced therapy-cognitive behavioural therapy (CBT)-is complex and costly. A simpler therapy-behavioural activation (BA)-might be as effective and cheaper than is CBT. We aimed to establish the clinical efficacy and cost-effectiveness of BA compared with CBT for adults with depression.
Methods: In this randomised, controlled, non-inferiority trial, we recruited adults aged 18 years or older meeting Diagnostic and Statistical Manual of Mental Disorders IV criteria for major depressive disorder from primary care and psychological therapy services in Devon, Durham, and Leeds (UK). We excluded people who were receiving psychological therapy, were alcohol or drug dependent, were acutely suicidal or had attempted suicide in the previous 2 months, or were cognitively impaired, or who had bipolar disorder or psychosis or psychotic symptoms. We randomly assigned participants (1:1) remotely using computer-generated allocation (minimisation used; stratified by depression severity [Patient Health Questionnaire 9 (PHQ-9) score of <19 vs ≥19], antidepressant use, and recruitment site) to BA from junior mental health workers or CBT from psychological therapists. Randomisation done at the Peninsula Clinical Trials Unit was concealed from investigators. Treatment was given open label, but outcome assessors were masked. The primary outcome was depression symptoms according to the PHQ-9 at 12 months. We analysed all those who were randomly allocated and had complete data (modified intention to treat [mITT]) and also all those who were randomly allocated, had complete data, and received at least eight treatment sessions (per protocol [PP]). We analysed safety in the mITT population. The non-inferiority margin was 1·9 PHQ-9 points. This trial is registered with the ISCRTN registry, number ISRCTN27473954.
Findings: Between Sept 26, 2012, and April 3, 2014, we randomly allocated 221 (50%) participants to BA and 219 (50%) to CBT. 175 (79%) participants were assessable for the primary outcome in the mITT population in the BA group compared with 189 (86%) in the CBT group, whereas 135 (61%) were assessable in the PP population in the BA group compared with 151 (69%) in the CBT group. BA was non-inferior to CBT (mITT: CBT 8·4 PHQ-9 points [SD 7·5], BA 8·4 PHQ-9 points [7·0], mean difference 0·1 PHQ-9 points [95% CI -1·3 to 1·5], p=0·89; PP: CBT 7·9 PHQ-9 points [7·3]; BA 7·8 [6·5], mean difference 0·0 PHQ-9 points [-1·5 to 1·6], p=0·99). Two (1%) non-trial-related deaths (one [1%] multidrug toxicity in the BA group and one [1%] cancer in the CBT group) and 15 depression-related, but not treatment-related, serious adverse events (three in the BA group and 12 in the CBT group) occurred in three [2%] participants in the BA group (two [1%] patients who overdosed and one [1%] who self-harmed) and eight (4%) participants in the CBT group (seven [4%] who overdosed and one [1%] who self-harmed).
Interpretation: We found that BA, a simpler psychological treatment than CBT, can be delivered by junior mental health workers with less intensive and costly training, with no lesser effect than CBT. Effective psychological therapy for depression can be delivered without the need for costly and highly trained professionals.
Funding: National Institute for Health Research.
Lancet (London, England) · randomised controlled trial · 354 citationsread the source →
Efficacy and tolerability of extended release quetiapine fumarate monotherapy in the acute treatment of generalized anxiety disorder: a randomized, placebo controlled and active-controlled study.
The main objective of this study was to evaluate efficacy and tolerability of once-daily extended release quetiapine fumarate (quetiapine XR) monotherapy in generalized anxiety disorder (GAD). This was a 8 week randomized, 2-week follow-up, double-blind, placebo-controlled, and active-controlled study. Patients were randomized to quetiapine XR 150 (n=219) or 300 mg/day (n=207); escitalopram, 10 mg/day (n=213); or placebo (n=215). The primary endpoint was the change from randomization at week 8 in Hamilton Anxiety Rating (HAM-A) total score. Week 8 mean HAM-A total score was significantly reduced from randomization with quetiapine XR 150 mg/day (-13.9, P<0.001), 300 mg/day (-12.3, P<0.05) and escitalopram (-12.3, P<0.05) versus placebo (-10.7); significant improvements with quetiapine XR (150 and 300 mg/day) versus placebo (P<0.001) were also shown at day 4. At week 8, significant improvements versus placebo were observed in HAM-A psychic [quetiapine XR (both doses) and escitalopram] and somatic (quetiapine XR 150 mg/day and escitalopram) cluster scores and HAM-A response and remission rates (quetiapine XR 150 mg/day). Most common adverse events were dry mouth, somnolence and sedation (quetiapine XR), headache, and nausea (escitalopram). In patients with GAD, quetiapine XR (150 and 300 mg/day) demonstrated significant efficacy at week 8 with symptom improvement as early as day 4. We concluded that quetiapine XR safety and tolerability results were consistent with the known profile of quetiapine.
International clinical psychopharmacology · randomised controlled trial · 51 citationsread the source →
Benefits of mindfulness at work: the role of mindfulness in emotion regulation, emotional exhaustion, and job satisfaction.
Mindfulness describes a state of consciousness in which individuals attend to ongoing events and experiences in a receptive and non-judgmental way. The present research investigated the idea that mindfulness reduces emotional exhaustion and improves job satisfaction. The authors further suggest that these associations are mediated by the emotion regulation strategy of surface acting. Study 1 was a 5-day diary study with 219 employees and revealed that mindfulness negatively related to emotional exhaustion and positively related to job satisfaction at both the within- and the between-person levels. Both relationships were mediated by surface acting at both levels of analysis. Study 2 was an experimental field study, in which participants (N = 64) were randomly assigned to a self-training mindfulness intervention group or a control group. Results revealed that participants in the mindfulness intervention group experienced significantly less emotional exhaustion and more job satisfaction than participants in the control group. The causal effect of mindfulness self-training on emotional exhaustion was mediated by surface acting. Implications for using mindfulness and mindfulness training interventions in organizational research and practice are discussed in conclusion.
The Journal of applied psychology · randomised controlled trial · 249 citationsread the source →
Tyrer P, Cooper S, Salkovskis P, Tyrer H, Crawford M, Byford S, Dupont S, Finnis S, Green J, McLaren E, Murphy D, Reid S, Smith G, Wang D, Warwick H, Petkova H, Barrett B. (2014)MEDLINE-indexed journal, not yet read by usLancet (London, England) · randomised controlled trial Clinical and cost-effectiveness of cognitive behaviour therapy for health anxiety in medical patients: a multicentre randomised controlled trial.
Background: Health anxiety has been treated by therapists expert in cognitive behaviour therapy with some specific benefit in some patients referred to psychological services. Those in hospital care have been less often investigated. Following a pilot trial suggesting efficacy we carried out a randomised study in hospital medical clinics.
Methods: We undertook a multicentre, randomised trial on health anxious patients attending cardiac, endocrine, gastroenterological, neurological, and respiratory medicine clinics in secondary care. We included those aged 16-75 years, who satisfied the criteria for excessive health anxiety, and were resident in the area covered by the hospital, were not under investigation for new pathology or too medically unwell to take part. We used a computer-generated random scheme to allocate eligible medical patients to an active treatment group of five-to-ten sessions of adapted cognitive behaviour therapy (CBT-HA group) delivered by hospital-based therapists or to standard care in the clinics. The primary outcome was change in health anxiety symptoms measured by the Health Anxiety Inventory at 1 year and the main secondary hypothesis was equivalence of total health and social care costs over 2 years, with an equivalence margin of £150. Analysis was by intention to treat. The study is registered with controlled-trials.com, ISRCTN14565822.
Findings: Of 28,991 patients screened, 444 were randomly assigned to receive either adapted cognitive behaviour therapy (CBT-HA group, 219 participants) or standard care (standard care group, 225), with 205 participants in the CBT-HA group and 212 in the standard care group included in the analyses of the primary endpoints. At 1 year, improvement in health anxiety in the patients in the CBT-HA group was 2·98 points greater than in those in the standard care group (95% CI 1·64-4·33, p<0·0001), and twice as many patients receiving cognitive behaviour therapy achieved normal levels of health anxiety compared with those in the control group (13·9% vs 7·3%; odds ratio 2·15, 95% CI 1·09-4·23, p=0·0273). Similar differences were observed at 6 months and 2 years, and there were concomitant reductions in generalised anxiety and, to a lesser extent, depression. Of nine deaths, six were in the control group; all were due to pre-existing illness. Social functioning or health-related quality of life did not differ significantly between groups. Equivalence in total 2-year costs was not achieved, but the difference was not significant (adjusted mean difference £156, 95% CI -1446 to 1758, p=0·848).
Interpretation: This form of adapted cognitive behaviour therapy for health anxiety led to sustained symptomatic benefit over 2 years, with no significant effect on total costs. It deserves wider application in medical care.
Funding: National Institute for Health Research Health Technology Assessment Programme.
Lancet (London, England) · randomised controlled trial · 96 citationsread the source →
Behavioral therapy intervention trial to improve sleep quality and cancer-related fatigue.
Background: To determine whether sleep quality and fatigue associated with breast cancer adjuvant chemotherapy treatments can be improved with behavioral therapy (BT) [Individualized Sleep Promotion Plan (ISPP)] including modified stimulus control, modified sleep restriction, relaxation therapy, and sleep hygiene.
Methods: Randomized-controlled trial based on Piper Integrated Fatigue Model, 219 stages I-IIIA breast cancer patients. Prior to the initial chemotherapy treatment, BT participants developed an ISPP plan that was regularly reinforced and revised. Controls received healthy eating information and attention. Pittsburgh Sleep Quality Index (PSQI), daily diary, actigraph, and Piper Fatigue Scale (PFS) data were collected 2 days prior, during the 7 days after each treatment, and 30 days after the last treatment. Repeated measures analysis of variance was used.
Results: Prior to chemotherapy, participants reported mild fatigue and fairly poor sleep quality. All variables changed over time. A group by time interaction was found for sleep quality (PSQI) improving in the BT group. Diary revealed group differences on number of awakenings, minutes awake after sleep onset, and sleep efficiency. Fatigue (PFS) was similar between groups.
Conclusions: The BT group showed improved sleep quality over time and better sleep (diary). Perceptions of improved sleep quality over time are not consistently associated with diary or actigraph, or result in lower fatigue.
Psycho-oncology · randomised controlled trial · 110 citationsread the source →
Belle SH, Burgio L, Burns R, Coon D, Czaja SJ, Gallagher-Thompson D, Gitlin LN, Klinger J, Koepke KM, Lee CC, Martindale-Adams J, Nichols L, Schulz R, Stahl S, Stevens A, Winter L, Zhang S, Resources for Enhancing Alzheimer's Caregiver Health (REACH) II Investigators. (2006)MEDLINE-indexed journal, not yet read by usAnnals of internal medicine · randomised controlled trial Enhancing the quality of life of dementia caregivers from different ethnic or racial groups: a randomized, controlled trial.
Background: Caring for a family member with dementia is extremely stressful, contributes to psychiatric and physical illness among caregivers, and increases the risk for caregiver death. Finding better ways to support family caregivers is a major public health challenge.
Objective: To test the effects of a structured multicomponent intervention on quality of life and clinical depression in caregivers and on rates of institutional placement of care recipients in 3 diverse racial or ethnic groups.
Design: Randomized, controlled trial.
Setting: In-home caregivers in 5 U.S. cities.
Participants: 212 Hispanic or Latino, 219 white or Caucasian, and 211 black or African-American caregivers and their care recipients with Alzheimer disease or related disorders.
Intervention: Caregivers within each racial or ethnic group were randomly assigned to an intervention or to a control group. The intervention addressed caregiver depression, burden, self-care, and social support and care recipient problem behaviors through 12 in-home and telephone sessions over 6 months. Caregivers in the control group received 2 brief "check-in" telephone calls during the 6-month intervention.
Measurements: The primary outcome was a quality-of-life indicator comprising measures of 6-month caregiver depression, burden, self-care, and social support and care recipient problem behaviors. Secondary outcomes were caregiver clinical depression and institutional placement of the care recipient at 6 months.
Results: Hispanic or Latino and white or Caucasian caregivers in the intervention group experienced significantly greater improvement in quality of life than those in the control group (P < 0.001 and P = 0.037, respectively). Black or African-American spouse caregivers also improved significantly more (P = 0.003). Prevalence of clinical depression was lower among caregivers in the intervention group (12.6% vs. 22.7%; P = 0.001). There were no statistically significant differences in institutionalization at 6 months.
Limitations: The study used only a single 6-month follow-up assessment, combined heterogeneous cultures and ethnicities into a single group, and excluded some ethnic groups.
Conclusions: A structured multicomponent intervention adapted to individual risk profiles can increase the quality of life of ethnically diverse dementia caregivers. ClinicalTrials.gov identifier: NCT00177489.
Annals of internal medicine · randomised controlled trial · 476 citationsread the source →
Clifton JDW, Baker JD, Park CL, Yaden DB, Clifton ABW, Terni P, Miller JL, Zeng G, Giorgi S, Schwartz HA, Seligman MEP. (2019)MEDLINE-indexed journal, not yet read by usPsychological assessment Primal world beliefs.
Beck's insight-that beliefs about one's self, future, and environment shape behavior-transformed depression treatment. Yet environment beliefs remain relatively understudied. We introduce a set of environment beliefs-primal world beliefs or primals-that concern the world's overall character (e.g., the world is interesting, the world is dangerous). To create a measure, we systematically identified candidate primals (e.g., analyzing tweets, historical texts, etc.); conducted exploratory factor analysis (N = 930) and two confirmatory factor analyses (N = 524; N = 529); examined sequence effects (N = 219) and concurrent validity (N = 122); and conducted test-retests over 2 weeks (n = 122), 9 months (n = 134), and 19 months (n = 398). The resulting 99-item Primals Inventory (PI-99) measures 26 primals with three overarching beliefs-Safe, Enticing, and Alive (mean α = .93)-that typically explain ∼55% of the common variance. These beliefs were normally distributed; stable (2 weeks, 9 months, and 19 month test-retest results averaged .88, .75, and .77, respectively); strongly correlated with many personality and wellbeing variables (e.g., Safe and optimism, r = .61; Enticing and depression, r = -.52; Alive and meaning, r = .54); and explained more variance in life satisfaction, transcendent experience, trust, and gratitude than the BIG 5 (3%, 3%, 6%, and 12% more variance, respectively). In sum, the PI-99 showed strong psychometric characteristics, primals plausibly shape many personality and wellbeing variables, and a broad research effort examining these relationships is warranted. (PsycINFO Database Record (c) 2018 APA, all rights reserved).
Psychological assessment · 48 citationsread the source →
The relationship of compassion and self-compassion with personality and emotional intelligence.
The two studies presented in this article examine the relationships of personality traits and trait emotional intelligence (EI) with compassion and self-compassion in samples of Italian workers. Study 1 explored the relationship between trait EI and both compassion and self-compassion, controlling for the effects of personality traits in 219 workers of private Italian organizations. Hierarchical regression analyses revealed that trait EI explained variance beyond that accounted for by personality traits in relation to both compassion and self-compassion. Study 2 analyzed the contribution of trait EI in mediating the relationship between personality traits and both compassion and self-compassion of 231 workers from public Italian organizations with results supporting the mediating role of trait EI.
Personality and individual differences · 47 citationsread the source →
The role of social risk factors and engagement with maternity services in ethnic disparities in maternal mortality: A retrospective case note review.
Background: Reasons for ethnic disparities in maternal death in the UK are unclear and may be explained by differences in social risk factors and engagement with maternity services.
Methods: In this retrospective systematic case note review, we used anonymised medical records from MBRRACE-UK for all Other than White, and White European/Other women plus a random sample of White British/Irish women who died in pregnancy or up to 1 year afterwards from 01/01/2015 to 12/31/2017. We used a standardised data extraction tool developed from a scoping review to explore social risk factors and engagement with maternity services.
Findings: Of 489 women identified, 219 were eligible for the study and 196 case notes were reviewed, including 103/119 from Other than White groups, 33/37 White European/Other and a random sample of 60/333 White British/Irish. The presence of three or more social risk factors was 11⋅7% (12/103) in Other than White women, 18⋅2% (6/33) for White European/Other women and 36⋅7% (22/60) in White British/Irish women. Across all groups engagement with maternity services was good with 85⋅5% (148/196) receiving the recommended number of antenatal appointments as was completion of antenatal mental health assessment (123/173, 71⋅1%). 15⋅5% (16/103) of Other than White groups had pre-existing co-morbidities and 51⋅1% (47/92) had previous pregnancy problems while women across White ethnic groups had 3⋅2% (3/93) and 33⋅3% (27/81) respectively. Three or more unscheduled healthcare attendances occurred in 60⋅0% (36/60) of White British/Irish, 39⋅4% (13/33) in White European/Other and 35⋅9% (37/103) of Other than White women. Evidence of barriers to following healthcare advice was identified for a fifth of all women. None of the 17 women who required an interpreter received appropriate provision at all key points throughout their maternity care.
Interpretation: Neither increased social risk factors or barriers to engagement with maternity services appear to underlie disparities in maternal mortality. Management of complex social factors and interpreter services need improvement.
Funding: National Institute for Health Research (NIHR) Applied Research Collaboration West Midlands.
EClinicalMedicine · 6 citationsread the source →
"The greedy I that gives"-The paradox of egocentrism and altruism: Terror management and system justification perspectives on the interrelationship between mortality salience and charitable donations amid the COVID-19 pandemic.
Why do people give and help others in face of their own mortality salience? The existential struggle with the awareness of death impacts the gamut of human cognition, emotion, and behavior. This multi-method research (∑N = 1,219) explains the psychosocial impact of COVID-19-related mortality salience on altruism. Drawing from terror management theory, two studies tested death-thought accessibility, mortality salience, and anxiety buffer hypotheses. Study 1 (cross-sectional survey), using structural equation modeling, confirms death anxiety and fear are predictors of powerlessness and materialism which, in turn, predict charitable donations. Study 2 (between-subjects experiment) confirms the causal effects of COVID-19-induced mortality salience on altruism. Controlling income and socioeconomic status, people in the mortality salience treatment condition indicate greater monetary donations ($), ratio of prosocial (altruistic) to proself (egocentric) spending (%), donation of time (hour), monetary valuation of time (hourly rate = $/hour), and economic value of donated time (hourly rate*hour) than the controls. These effects are mediated by powerlessness. Moderating effects of relevant individual difference factors are significant: the greedier, more selfish, narcissistic, materialistic, and system-justifying the donor is, the higher monetary donations, volunteer time, and perceived value of donated time are, only when the COVID-19-induced mortality is made salient but not in the controls. Environmental and dispositional factors jointly influence vulnerability to mortality salience. The paradox of egocentrism and altruism, as an evolutionarily adaptive protective buffer against existential insecurity for social and cultural animals, can help revitalize resilience, thus shedding some lights on the sociopsychological mechanism of consumers' subjective well-being. Implications for consumer affairs, social marketers, and policymakers are discussed.
The Journal of consumer affairs · 18 citationsread the source →
Flavonoid Intakes in the US Diet Are Linked to Higher Socioeconomic Status and to Tea Consumption: Analyses of NHANES 2011-16 Data.
Background: Many of the health benefits of tea have been attributed to its flavonoid content. Tea consumption in US adults varies by socioeconomic status (SES).
Objectives: The present objective was to explore intakes of total flavonoids and flavonoid subclasses by participant sociodemographics and by patterns of tea consumption.
Methods: The present analyses were based on 2 d of dietary recalls for 17,506 persons aged >9 y in the 2011-2016 NHANES. The What We Eat in America nutrient composition database was merged with the USDA Expanded Flavonoid database, which included total flavonoids and flavan-3-ols (including catechins), flavanones, flavonols, anthocyanidins, flavones, and isoflavones. Flavonoid intakes were compared by sex, age, race/ethnicity, education, and income-to-poverty ratio (IPR) in univariate analyses. Flavonoid intakes of children and adults were also compared by tea consumption status. Time trends in flavonoid intakes were also examined.
Results: Mean total flavonoid intake was 219 mg/d, of which flavan-3-ols provided 174 mg/d, or 79%. The highest total flavonoid intakes were found in adults aged 51-70 y (293 mg/d), non-Hispanic whites (251 mg/d) and in groups with college education (251 mg/d) and higher income (IPR >3.5: 249 mg/d) (P < 0.001 for all). The socioeconomic gradient was significant for anthocyanidins, flavonols, and flavones (P < 0.001 for all) but not for flavan-3-ols, and persisted across 3 cycles of NHANES. Adult tea consumers had higher intakes of total flavonoids (610 mg/d compared with 141 mg/d) and flavan-3-ols (542 mg/d compared with 97.8 mg/d) than did nonconsumers (P < 0.001). Time trend analyses showed that both tea consumption and flavonoid intakes were unchanged from 2011 to 2016.
Conclusions: Flavonoid intakes in children and adults in the NHANES 2011-16 sample were associated with higher SES and were largely determined by tea consumption. Studies of diet and disease risk need to take sociodemographic gradients and eating and drinking habits into account.
The Journal of nutrition · 26 citationsread the source →
Hu D, Kong Y, Li W, Han Q, Zhang X, Zhu LX, Wan SW, Liu Z, Shen Q, Yang J, He HG, Zhu J. (2020)MEDLINE-indexed journal, not yet read by usEClinicalMedicine Frontline nurses' burnout, anxiety, depression, and fear statuses and their associated factors during the COVID-19 outbreak in Wuhan, China: A large-scale cross-sectional study.
Background: During the Coronavirus Disease 2019 (COVID-19) pandemic, frontline nurses face enormous mental health challenges. Epidemiological data on the mental health statuses of frontline nurses are still limited. The aim of this study was to examine mental health (burnout, anxiety, depression, and fear) and their associated factors among frontline nurses who were caring for COVID-19 patients in Wuhan, China.
Methods: A large-scale cross-sectional, descriptive, correlational study design was used. A total of 2,014 eligible frontline nurses from two hospitals in Wuhan, China, participated in the study. Besides sociodemographic and background data, a set of valid and reliable instruments were used to measure outcomes of burnout, anxiety, depression, fear, skin lesion, self-efficacy, resilience, and social support via the online survey in February 2020.
Findings: On average, the participants had a moderate level of burnout and a high level of fear. About half of the nurses reported moderate and high work burnout, as shown in emotional exhaustion (n = 1,218, 60.5%), depersonalization (n = 853, 42.3%), and personal accomplishment (n = 1,219, 60.6%). The findings showed that 288 (14.3%), 217 (10.7%), and 1,837 (91.2%) nurses reported moderate and high levels of anxiety, depression, and fear, respectively. The majority of the nurses (n = 1,910, 94.8%) had one or more skin lesions, and 1,950 (96.8%) nurses expressed their frontline work willingness. Mental health outcomes were statistically positively correlated with skin lesion and negatively correlated with self-efficacy, resilience, social support, and frontline work willingness.
Interpretation: The frontline nurses experienced a variety of mental health challenges, especially burnout and fear, which warrant attention and support from policymakers. Future interventions at the national and organisational levels are needed to improve mental health during this pandemic by preventing and managing skin lesions, building self-efficacy and resilience, providing sufficient social support, and ensuring frontline work willingness.
EClinicalMedicine · 491 citationsread the source →
A longitudinal study of variations in and predictors of fatigue in multiple sclerosis.
Objectives: To describe variations in fatigue over the course of 2 years in a sample of persons with multiple sclerosis (MS), and to investigate the predictive value of the following variables on variations in fatigue: sex, age, sense of coherence, living with a partner, living with children, work status, immunomodulatory treatment, mood, disease severity, disease course, time since diagnosis and time.
Methods: Every 6 months, 219 outpatients at an MS specialist clinic were assessed using the Fatigue Severity Scale (FSS). Predictive values were explored with Generalised Estimating Equation employing proportional odds models; FSS scores were categorised as non-fatigue, borderline fatigue or fatigue.
Results: FSS scores varied significantly (p = 0.02); 54% changed FSS category one or several times, 27% were persistently fatigued and 19% persistently non-fatigued. Independent predictors of increased fatigue were depressive symptoms, weak/moderate sense of coherence, living with a partner and not working. Furthermore, moderate disease severity predicted increase when combined with >10 years since diagnosis or a progressive course. Independent predictors of decreased fatigue were no depressive symptoms, strong sense of coherence, living alone and working. Moreover, mild and severe disease predicted a decrease when combined with >10 years since diagnosis, and mild severity combined with a progressive course.
Conclusion: Mood, sense of coherence and living with a partner were independent predictors of fatigue in persons with MS. In addition to monitoring disease related variables, health related services should apply a broad range of approaches and repeatedly assess fatigue in persons with MS, to provide preventive care and appropriate interventions.
Journal of neurology, neurosurgery, and psychiatry · 68 citationsread the source →