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المكتبة البحثية60 results
Peer-reviewed works with DOI and abstract, discovered from MEDLINE-indexed literature. Candidates: no tier, no stated finding, not yet read.
Aman MG, Arnold LE, McDougle CJ, Vitiello B, Scahill L, Davies M, McCracken JT, Tierney E, Nash PL, Posey DJ, Chuang S, Martin A, Shah B, Gonzalez NM, Swiezy NB, Ritz L, Koenig K, McGough J, Ghuman JK, Lindsay RL. (2005)MEDLINE-indexed journal, not yet read by usJournal of child and adolescent psychopharmacology · randomised controlled trial Acute and long-term safety and tolerability of risperidone in children with autism.
Treatment-emergent adverse events (AEs) were monitored during an 8-week, double-blind, placebo-controlled trial of risperidone (0.5-3.5 mg/day) in 101 children and adolescents with a lifetime diagnosis of autistic disorder. In addition, 37 placebo nonresponders received open-label risperidone for another 8 weeks. Of all the risperidone responders (n=65), 63 entered an open extension of another 16 weeks (6 months total risperidone exposure), and 32 of them were rerandomized to either continued risperidone therapy (n=16) or gradual replacement with placebo (n=16) over 8 weeks. We collected the following measures of safety and tolerability: (1) laboratory blood assessments (CBC with differential, electrolytes, and liver function tests) and urinalyses, (2) vital signs, (3) Side Effects Review of AEs thought to be associated with risperidone, (4) sleep records, (5) Simpson Angus Neurological Rating Scale (SARS), (6) Abnormal Involuntary Movement Scale (AIMS), and (7) height and weight. No clinically significant changes were found on the lab tests. During the 8-week acute trial, the most common AEs on the Side Effects Review, scored as moderate or higher, were as follows (placebo and risperidone, respectively): Somnolence (12% and 37%), enuresis (29% and 33%), excessive appetite (10% and 33%), rhinitis (8% and 16%), difficulty waking (8% and 12%), and constipation (12% and 10%). "Difficulty falling asleep" and anxiety actually favored the risperidone condition at statistically significant levels. The same AEs tended to recur through 6 months of treatment, although often at reduced levels. Using Centers for Disease Control (CDC) standardized scores, both weight and body mass index (BMI) increased with risperidone during the acute trial (0.5 and 0.6 SDs, respectively, for risperidone; 0.0 and 0.1 SDs, respectively, for placebo) and into open-label extension (0.19 and 0.16 SDs, respectively), although the amount of gain decelerated with time. Extrapyramidal symptoms, as assessed by the SARS, were no more common for drug than placebo, although drooling was reported more often in the risperidone group. There were no differences between groups on the AIMS. Two subjects had seizures (one taking placebo), but these were considered unrelated to active drug. Most AEs were mild to moderate and failed to interfere with therapeutic changes; there were no unanticipated AEs. The side effects of most concern were somnolence and weight gain.
Journal of child and adolescent psychopharmacology · randomised controlled trial · 92 citationsread the source →
Protective Factors for Psychotic Symptoms Among Poly-victimized Children.
Background: Experiencing victimization in early life has been repeatedly shown to be associated with the emergence of psychotic symptoms in childhood. However, most victimized children do not develop psychotic symptoms and why this occurs is not fully understood. This study investigated which individual, family-level, and wider community characteristics were associated with an absence of psychotic symptoms among children at risk for psychosis by virtue of their exposure to multiple victimization experiences (poly-victimization).
Methods: Participants were from the Environmental Risk Longitudinal Twin Study, a nationally representative cohort of 2232 UK-born twins. Exposure to maltreatment, bullying and domestic violence prior to age 12 was determined from interviews with mothers, children, and observations by research workers at ages 5, 7, 10, and 12. Children were interviewed about psychotic symptoms at age 12. Protective factors were measured at ages 5, 7, 10, and 12.
Results: Childhood poly-victimization was associated with age-12 psychotic symptoms (OR = 4.61, 95% CI 2.82-7.52), but the majority of poly-victimized children did not report symptoms (80.7%). Having a relatively high IQ, more positive atmosphere at home, and higher levels of neighborhood social cohesion were found to be protective against childhood psychotic symptoms among poly-victimized children and also in the whole sample. However, "protected" poly-victimized children displayed elevated levels of other mental health problems compared to nonvictimized children.
Conclusions: Children's characteristics, family context, and the wider community were all found to protect children from developing early psychotic symptoms, even when they were victimized multiple times. These findings indicate targets for multilevel preventive interventions.
Schizophrenia bulletin · cohort or longitudinal · 41 citationsread the source →
Use of multidomain management strategies by community dwelling adults with chronic pain: evidence from a systematic review.
Background and aims Multidomain strategies (i.e. two or more strategies) for managing chronic pain are recommended to avoid excessive use of opioids while producing the best outcomes possible. The aims of this systematic review were to: 1) determine if patient-reported pain management is consistent with the use of multidomain strategies; and 2) identify the role of opioids and non-steroidal anti-inflammatory drugs (NSAIDs) in patient-reported pain management. Methods Bibliographic databases, websites, and reference lists of included studies were searched to identify published articles reporting community-based surveys of pain self-management from January 1989 to June 2017 using controlled vocabulary (and synonyms): pain; self-care; self-management; self-treatment; and adult. Two independent reviewers screened studies and extracted data on subject demographics, pain characteristics, pain self-management strategies, and pain outcomes. Pain self-management strategies were organized according to our conceptual model. Included studies were assessed for risk of bias. Differences between the researchers were resolved by consensus. Results From the 3,235 unique records identified, 18 studies published between 2002 and 2017 from 10 countries were included. Twenty-two types of pharmacological strategies were identified (16 prescription, six non-prescription). NSAIDs (15 studies, range of use 10-72%) and opioids (12 studies, range of use 5-72%) were the most commonly reported prescription pharmacological strategies. Other prescription pharmacological strategies included analgesics, acetaminophen, anticonvulsants, antidepressants, anxiolytics, salicylates, β-blockers and calcium channel blockers, disease-modifying anti-rheumatic drugs and steroids, muscle relaxants, topical products, triptans, and others. Twenty-two types of non-pharmacological strategies were identified: four medical strategies (10 studies), 10 physical strategies (15 studies), four psychological strategies (12 studies), and four self-initiated strategies (15 studies). Medical strategies included consulting a medical practitioner, chiropractic, and surgery. Physical strategies included exercise, massage, hot and cold modalities, acupuncture, physical therapy, transcutaneous electrical nerve stimulation, activity modification or restriction, assistive devices, and altering body position/posture. Psychological strategies included relaxation, prayer or meditation, therapy, and rest/sleep. Self-initiated strategies included dietary or herbal supplements, dietary modifications, and complementary and alternative medicine. Overall, the number of strategies reported among the studies ranged from five to 28 (out of 44 identified strategies). Limited data on pain outcomes was reported in 15 studies, and included satisfaction with pain management strategies, pain interference on daily activities, adverse events, lost work or restricted activity days, emergency department visits, and disabilities. Conclusions A wide variety and large number of pharmacological and non-pharmacological strategies to manage chronic pain were reported, consistent with the use of multidomain strategies. High levels of use of both NSAIDs and opioids also were reported. Implications Comprehensive review and consultation with patients about their pain management strategies is likely needed for optimal outcomes. Additional research is needed to determine: how many, when, and why multidomain strategies are used; the relationship between opioid use, multidomain management strategies, and level of pain; how multidomain strategies relate to outcomes; and if adding strategies to a pain management plan increases the risk of adverse events or interactions, and increases an individuals pain management burden.
Scandinavian journal of pain · systematic review · 39 citationsread the source →
Schrantee A, Tamminga HG, Bouziane C, Bottelier MA, Bron EE, Mutsaerts HJ, Zwinderman AH, Groote IR, Rombouts SA, Lindauer RJ, Klein S, Niessen WJ, Opmeer BC, Boer F, Lucassen PJ, Andersen SL, Geurts HM, Reneman L. (2016)MEDLINE-indexed journal, not yet read by usJAMA psychiatry · randomised controlled trial Age-Dependent Effects of Methylphenidate on the Human Dopaminergic System in Young vs Adult Patients With Attention-Deficit/Hyperactivity Disorder: A Randomized Clinical Trial.
Importance: Although numerous children receive methylphenidate hydrochloride for the treatment of attention-deficit/hyperactivity disorder (ADHD), little is known about age-dependent and possibly lasting effects of methylphenidate on the human dopaminergic system.
Objectives: To determine whether the effects of methylphenidate on the dopaminergic system are modified by age and to test the hypothesis that methylphenidate treatment of young but not adult patients with ADHD induces lasting effects on the cerebral blood flow response to dopamine challenge, a noninvasive probe for dopamine function.
Design, setting, and participants: A randomized, double-blind, placebo-controlled trial (Effects of Psychotropic Drugs on Developing Brain-Methylphenidate) among ADHD referral centers in the greater Amsterdam area in the Netherlands between June 1, 2011, and June 15, 2015. Additional inclusion criteria were male sex, age 10 to 12 years or 23 to 40 years, and stimulant treatment-naive status.
Interventions: Treatment with either methylphenidate or a matched placebo for 16 weeks.
Main outcomes and measures: Change in the cerebral blood flow response to an acute challenge with methylphenidate, noninvasively assessed using pharmacological magnetic resonance imaging, between baseline and 1 week after treatment. Data were analyzed using intent-to-treat analyses.
Results: Among 131 individuals screened for eligibility, 99 patients met DSM-IV criteria for ADHD, and 50 participants were randomized to receive methylphenidate and 49 to placebo. Sixteen weeks of methylphenidate treatment increased the cerebral blood flow response to methylphenidate within the thalamus (mean difference, 6.5; 95% CI, 0.4-12.6; P = .04) of children aged 10 to 12 years old but not in adults or in the placebo group. In the striatum, the methylphenidate condition differed significantly from placebo in children but not in adults (mean difference, 7.7; 95% CI, 0.7-14.8; P = .03).
Conclusions and relevance: We confirm preclinical data and demonstrate age-dependent effects of methylphenidate treatment on human extracellular dopamine striatal-thalamic circuitry. Given its societal relevance, these data warrant replication in larger groups with longer follow-up.
Trial registration: identifier: NL34509.000.10 and trialregister.nl identifier: NTR3103.
JAMA psychiatry · randomised controlled trial · 66 citationsread the source →
Kaul I, Sawchak S, Correll CU, Kakar R, Breier A, Zhu H, Miller AC, Paul SM, Brannan SK. (2024)MEDLINE-indexed journal, not yet read by usLancet (London, England) · randomised controlled trial Efficacy and safety of the muscarinic receptor agonist KarXT (xanomeline-trospium) in schizophrenia (EMERGENT-2) in the USA: results from a randomised, double-blind, placebo-controlled, flexible-dose phase 3 trial.
Background: New treatments with new mechanisms are urgently needed for people with schizophrenia. Xanomeline is a dual M1 and M4-preferring muscarinic receptor agonist that does not block D2 dopamine receptors, unlike all currently approved treatments for schizophrenia. Xanomeline-trospium (KarXT) combines xanomeline with the peripherally restricted muscarinic receptor antagonist trospium chloride with the goal of ameliorating xanomeline-related adverse events associated with peripheral muscarinic receptors. The EMERGENT-2 trial aimed to assess the efficacy and safety of KarXT in people with schizophrenia experiencing acute psychosis.
Methods: EMERGENT-2 was a randomised, double-blind, placebo-controlled, flexible-dose, 5-week, inpatient, phase 3 trial in people with schizophrenia. Participants were adults aged 18-65 years with a diagnosis of schizophrenia who had a recent worsening of psychosis warranting hospital admission, a Positive and Negative Syndrome Scale (PANSS) score of 80 or higher, and a Clinical Global Impression-Severity score of 4 or higher. The participants were recruited from 22 inpatient sites in the USA, and were randomly assigned (1:1) to KarXT or placebo twice per day. Participants randomly assigned to KarXT received 50 mg xanomeline and 20 mg trospium twice per day for the first 2 days and then 100 mg xanomeline and 20 mg trospium twice per day for days 3-7. Beginning on day 8, KarXT dosing was flexible with an optional increase to 125 mg xanomeline and 30 mg trospium twice per day and the option to return to 100 mg xanomeline and 20 mg trospium based on tolerability. The primary endpoint was change from baseline to week 5 in PANSS total score. Efficacy analyses used the modified intention-to-treat population (all randomly assigned participants who received at least one trial medication dose and had at least one post-baseline PANSS assessment). Least squares mean change from baseline, SE, and least squares mean difference between the KarXT and placebo groups at week 5, along with the 95% CI and two-sided p values were calculated for the primary and secondary continuous efficacy endpoints. Safety analyses included all participants receiving at least one trial medication dose and used descriptive statistics. This trial is registered with ClinicalTrials.gov (NCT04659161).
Findings: From Dec 16, 2020, to April 13, 2022, of 407 people who were screened, 252 participants meeting enrolment criteria were randomly assigned to the KarXT (n=126) or placebo (n=126). Baseline PANSS total scores were 98·3 (KarXT; n=126) and 97·9 (placebo; n=125). The trial met the primary endpoint with a mean change from baseline to week 5 in PANSS total score that favoured KarXT (-21·2 points, SE 1·7) versus placebo (-11·6 points, 1·6; least squares mean difference -9·6; 95% CI -13·9 to -5·2; p<0·0001, Cohen's d effect size=0·61). All secondary endpoints were also met, and favoured KarXT versus placebo (p<0·05). The most common adverse events with KarXT versus placebo were constipation (27 [21%] vs 13 [10%]), dyspepsia (24 [19%] vs 10 [8%]), headache (17 [14%] vs 15 [12%]), nausea (24 [19%] vs seven [6%]), vomiting (18 [14%] vs one [1%]), hypertension (12 [10%] vs one [1%]), dizziness (11 [9%] vs four [3%]), gastro-oesophageal reflux disease (eight [6%] vs zero [0%]), and diarrhoea (seven [6%] vs four [3%]). Treatment-emergent adverse event rates of extrapyramidal motor symptoms (KarXT, zero [0%] vs placebo, zero [0%]), akathisia (one [1%] vs one [1%]), weight gain (zero [0%] vs one [1%]), and somnolence (six [5%] vs five [4%]) were similar between the KarXT and placebo groups, as were adverse event-related discontinuation rates (nine [7%] vs seven [6%]).
Interpretation: In the EMERGENT-2 trial, KarXT was effective in reducing positive and negative symptoms and was generally well tolerated. These results support the potential for KarXT to represent a new class of effective and well tolerated antipsychotic medicines based on activating muscarinic receptors, not the D2 dopamine receptor-blocking mechanism of all current antipsychotic medications. Results from additional trials, including the identical EMERGENT-3 trial and the 52-week, open-label EMERGENT-4 and EMERGENT-5 trials, will provide additional information on the efficacy and safety of KarXT in people with schizophrenia.
Funding: Karuna Therapeutics.
Lancet (London, England) · randomised controlled trial · 144 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 →
Relationship between Resilience, Psychological Distress and Physical Activity in Cancer Patients: A Cross-Sectional Observation Study.
Objective: Psychological distress remains a major challenge in cancer care. The complexity of psychological symptoms in cancer patients requires multifaceted symptom management tailored to individual patient characteristics and active patient involvement. We assessed the relationship between resilience, psychological distress and physical activity in cancer patients to elucidate potential moderators of the identified relationships.
Method: A cross-sectional observational study to assess the prevalence of symptoms and supportive care needs of oncology patients undergoing chemotherapy, radiotherapy or chemo-radiation therapy in a tertiary oncology service. Resilience was assessed using the 10-item Connor-Davidson Resilience Scale (CD-RISC 10), social support was evaluated using the 12-item Multidimensional Scale of Perceived Social Support (MSPSS) and both psychological distress and activity level were measured using corresponding subscales of the Rotterdam Symptom Checklist (RSCL). Socio-demographic and medical data were extracted from patient medical records. Correlation analyses were performed and structural equation modeling was employed to assess the associations between resilience, psychological distress and activity level as well as selected socio-demographic variables.
Results: Data from 343 patients were included in the analysis. Our revised model demonstrated an acceptable fit to the data (χ2(163) = 313.76, p = .000, comparative fit index (CFI) = .942, Tucker-Lewis index (TLI) = .923, root mean square error of approximation (RMSEA) = .053, 90% CI [.044.062]). Resilience was negatively associated with psychological distress (β = -.59), and positively associated with activity level (β = .20). The relationship between resilience and psychological distress was moderated by age (β = -0.33) but not social support (β = .10, p = .12).
Conclusion: Cancer patients with higher resilience, particularly older patients, experience lower psychological distress. Patients with higher resilience are physically more active. Evaluating levels of resilience in cancer patients then tailoring targeted interventions to facilitate resilience may help improve the effectiveness of psychological symptom management interventions.
PloS one · cohort or longitudinal · 113 citationsread the source →
Greenwood SA, Young HML, Briggs J, Castle EM, Walklin C, Haggis L, Balkin C, Asgari E, Bhandari S, Burton JO, Billany RE, Bishop NC, Bramham K, Campbell J, Chilcot J, Cooper NJ, Deelchand V, Graham-Brown MPM, Hamilton A, Jesky M, Kalra PA, Koufaki P, McCafferty K, Nixon AC, Noble H, Saynor Z, Taal MW, Tollit J, Wheeler DC, Wilkinson TJ, Worboys H, Macdonald JH. (2024)MEDLINE-indexed journal, not yet read by usThe Lancet. Digital health · randomised controlled trial Evaluating the effect of a digital health intervention to enhance physical activity in people with chronic kidney disease (Kidney BEAM): a multicentre, randomised controlled trial in the UK.
Background: Remote digital health interventions to enhance physical activity provide a potential solution to improve the sedentary behaviour, physical inactivity, and poor health-related quality of life that are typical of chronic conditions, particularly for people with chronic kidney disease. However, there is a need for high-quality evidence to support implementation in clinical practice. The Kidney BEAM trial evaluated the clinical effect of a 12-week physical activity digital health intervention on health-related quality of life.
Methods: In a single-blind, randomised controlled trial conducted at 11 centres in the UK, adult participants (aged ≥18 years) with chronic kidney disease were recruited and randomly assigned (1:1) to the Kidney BEAM physical activity digital health intervention or a waiting list control group. Randomisation was performed with a web-based system, in randomly permuted blocks of six. Outcome assessors were masked to treatment allocation. The primary outcome was the difference in the Kidney Disease Quality of Life Short Form version 1.3 Mental Component Summary (KDQoL-SF1.3 MCS) between baseline and 12 weeks. The trial was powered to detect a clinically meaningful difference of 3 arbitrary units (AU) in KDQoL-SF1.3 MCS. Outcomes were analysed by an intention-to-treat approach using an analysis of covariance model, with baseline measures and age as covariates. The trial was registered with ClinicalTrials.gov, NCT04872933.
Findings: Between May 6, 2021, and Oct 30, 2022, 1102 individuals were assessed for eligibility, of whom 340 participants were enrolled and randomly assigned to the Kidney BEAM intervention group (n=173) or the waiting list control group (n=167). 268 participants completed the trial (112 in the Kidney BEAM group and 156 in the waiting list control group). All 340 randomly assigned participants were included in the intention-to treat population. At 12 weeks, there was a significant improvement in KDQoL-SF.13 MCS score in the Kidney BEAM group (from mean 44·6 AU [SD 10·8] at baseline to 47·0 AU [10·6] at 12 weeks) compared with the waiting list control group (from 46·1 AU [10·5] to 45·0 AU [10·1]; between-group difference of 3·1 AU [95% CI 1·8-4·4]; p<0·0001).
Interpretation: The Kidney BEAM physical activity platform is an efficacious digital health intervention to improve mental health-related quality of life in patients with chronic kidney disease. These findings could facilitate the incorporation of remote digital health interventions into clinical practice and offer a potential intervention worthy of investigation in other chronic conditions.
Funding: Kidney Research UK.
The Lancet. Digital health · randomised controlled trial · 48 citationsread the source →
Toward a Neuroimaging Treatment Selection Biomarker for Major Depressive Disorder
IMPORTANCE: Currently, fewer than 40% of patients treated for major depressive disorder achieve remission with initial treatment. Identification of a biological marker that might improve these odds could have significant health and economic impact. OBJECTIVE: To identify a candidate neuroimaging "treatment-specific biomarker" that predicts differential outcome to either medication or psychotherapy. DESIGN: Brain glucose metabolism was measured with positron emission tomography prior to treatment randomization to either escitalopram oxalate or cognitive behavior therapy for 12 weeks. Patients who did not remit on completion of their phase 1 treatment were offered enrollment in phase 2 comprising an additional 12 weeks of treatment with combination escitalopram and cognitive behavior therapy. SETTING: Mood and anxiety disorders research program at an academic medical center. PARTICIPANTS: Men and women aged 18 to 60 years with currently untreated major depressive disorder. INTERVENTION: Randomized assignment to 12 weeks of treatment with either escitalopram oxalate (10-20 mg/d) or 16 sessions of manual-based cognitive behavior therapy. MAIN OUTCOME AND MEASURE: Remission, defined as a 17-item Hamilton depression rating scale score of 7 or less at both weeks 10 and 12, as assessed by raters blinded to treatment. RESULTS: Positive and negative predictors of remission were identified with a 2-way analysis of variance treatment (escitalopram or cognitive behavior therapy) × outcome (remission or nonresponse) interaction. Of 65 protocol completers, 38 patients with clear outcomes and usable positron emission tomography scans were included in the primary analysis: 12 remitters to cognitive behavior therapy, 11 remitters to escitalopram, 9 nonresponders to cognitive behavior therapy, and 6 nonresponders to escitalopram. Six limbic and cortical regions were identified, with the right anterior insula showing the most robust discriminant properties across groups (effect size = 1.43). Insula hypometabolism (relative to whole-brain mean) was associated with remission to cognitive behavior therapy and poor response to escitalopram, while insula hypermetabolism was associated with remission to escitalopram and poor response to cognitive behavior therapy. CONCLUSIONS AND RELEVANCE: If verified with prospective testing, the insula metabolism-based treatment-specific biomarker defined in this study provides the first objective marker, to our knowledge, to guide initial treatment selection for depression. TRIAL REGISTRATION: Registered at clinicaltrials.gov (NCT00367341).
JAMA Psychiatry · randomised controlled trial · 566 citationsread the source →
Effect of creatine supplementation and resistance-exercise training on muscle insulin-like growth factor in young adults.
The purpose of this study was to compare changes in muscle insulin-like growth factor-I (IGF-I) content resulting from resistance-exercise training (RET) and creatine supplementation (CR). Male (n=24) and female (n=18) participants with minimal resistance-exercise-training experience (=1 year) who were participating in at least 30 min of structured physical activity (i.e., walking, jogging, cycling) 3-5 x/wk volunteered for the study. Participants were randomly assigned in blocks (gender) to supplement with creatine (CR: 0.25 g/kg lean-tissue mass for 7 days; 0.06 g/kg lean-tissue mass for 49 days; n=22, 12 males, 10 female) or isocaloric placebo (PL: n=20, 12 male, 8 female) and engage in a whole-body RET program for 8 wk. Eighteen participants were classified as vegetarian (lacto-ovo or vegan; CR: 5 male, 5 female; PL: 3 male, 5 female). Muscle biopsies (vastus lateralis) were taken before and after the intervention and analyzed for IGF-I using standard immunohistochemical procedures. Stained muscle cross-sections were examined microscopically and IGF-I content quantified using image-analysis software. Results showed that RET increased intramuscular IGF-I content by 67%, with greater accumulation from CR (+78%) than PL (+54%; p=.06). There were no differences in IGF-I between vegetarians and nonvegetarians. These findings indicate that creatine supplementation during resistance-exercise training increases intramuscular IGF-I concentration in healthy men and women, independent of habitual dietary routine.
International journal of sport nutrition and exercise metabolism · randomised controlled trial · 52 citationsread the source →
Dray J, Bowman J, Campbell E, Freund M, Hodder R, Wolfenden L, Richards J, Leane C, Green S, Lecathelinais C, Oldmeadow C, Attia J, Gillham K, Wiggers J. (2017)MEDLINE-indexed journal, not yet read by usJournal of adolescence · randomised controlled trial Effectiveness of a pragmatic school-based universal intervention targeting student resilience protective factors in reducing mental health problems in adolescents.
Worldwide, 10-20% of adolescents experience mental health problems. Strategies aimed at strengthening resilience protective factors provide a potential approach for reducing mental health problems in adolescents. This study evaluated the effectiveness of a universal, school-based intervention targeting resilience protective factors in reducing mental health problems in adolescents. A cluster randomised controlled trial was conducted in 20 intervention and 12 control secondary schools located in socio-economically disadvantaged areas of NSW, Australia. Data were collected from 3115 students at baseline (Grade 7, 2011), of whom 2149 provided data at follow up (Grade 10, 2014; enrolments in Grades 7 to 10 typically aged 12-16 years; 50% male; 69.0% retention). There were no significant differences between groups at follow-up for three mental health outcomes: total SDQ, internalising problems, and prosocial behaviour. A small statistically significant difference in favour of the control group was found for externalising problems. Findings highlight the continued difficulties in developing effective, school-based prevention programs for mental health problems in adolescents.
Trial registration: ANZCTR (Ref no: ACTRN12611000606987).
Journal of adolescence · randomised controlled trial · 36 citationsread the source →
Taylor A, Taylor RS, Ingram W, Dean SG, Jolly K, Mutrie N, Lambert J, Yardley L, Streeter A, Greaves C, McAdam C, Price L, Anokye NK, Campbell J. (2021)MEDLINE-indexed journal, not yet read by usBritish journal of sports medicine · randomised controlled trial Randomised controlled trial of an augmented exercise referral scheme using web-based behavioural support for inactive adults with chronic health conditions: the e-coachER trial.
Objective: To determine whether adding web-based support (e-coachER) to an exercise referral scheme (ERS) increases objectively assessed physical activity (PA).
Design: Multicentre trial with participants randomised to usual ERS alone (control) or usual ERS plus e-coachER (intervention).
Setting: Primary care and ERS in three UK sites from 2015 to 2018.
Participants: 450 inactive ERS referees with chronic health conditions.
Interventions: Participants received a pedometer, PA recording sheets and a user guide for the web-based support. e-coachER interactively encouraged the use of the ERS and other PA options.
Main outcome measures: Primary and key secondary outcomes were: objective moderate-to-vigorous PA (MVPA) minutes (in ≥10 min bouts and without bouts), respectively, after 12 months. Secondary outcomes were: other accelerometer-derived and self-reported PA measures, ERS attendance, EQ-5D-5L, Hospital Anxiety and Depression Scale and beliefs about PA. All outcomes were collected at baseline, 4 and 12 months. Primary analysis was an intention to treat comparison between intervention and control arms at 12-month follow-up.
Results: There was no significant effect of the intervention on weekly MVPA at 12 months between the groups recorded in ≥10 min bouts (mean difference 11.8 min of MVPA, 95% CI: -2.1 to 26.0; p=0.10) or without bouts (mean difference 13.7 min of MVPA, 95% CI: -26.8 to 54.2; p=0.51) for 232 participants with usable data. There was no difference in the primary or secondary PA outcomes at 4 or 12 months.
Conclusion: Augmenting ERS referrals with web-based behavioural support had only a weak, non-significant effect on MVPA.
Trial registration number: ISRCTN15644451.
British journal of sports medicine · randomised controlled trial · 15 citationsread the source →
Online positive-oriented counseling, taking vitamin D3 tablet, online lifestyle modification training on premenstrual syndrome: a 3-armed randomized clinical trial.
Lack of absolute treatment for premenstrual syndrome (PMS), its cyclic nature, considerable prevalence (70-90%), and its mental and physical burden imply necessity of effectiveness comparison of various treatments. Although antidepressant and hormonal drugs are well-known medications for PMS, in affected women who can't tolerate, or don't have compatibility or compliance with these drugs, other effective treatments have always been important concern. This study aimed to compare effectiveness of online positive-oriented counseling, taking vitamin D3 tablet, and online lifestyle modification training on alleviating PMS. 3-armed parallel randomized clinical trial was performed on 84 20-40-year-old eligible women with PMS. 84 women were randomly ( www.random.org/sequenc ) allocated into three groups, but data of 77 women (1, n = 25) online positive-oriented counseling group (6 sessions), (2, n = 27) vitamin D3 tablet group (one vitamin D3 tablet weekly for 6 weeks), and (3, n = 25) online lifestyle training group (6 sessions) were analyzed. Vitamin D3 was measured at baseline, week6 and fallow up week10. Primary outcome variable PMS was measured with Premenstrual Symptoms Screening Tool (PSST) at baseline, week 6, and follow-up week 10. Primary outcome satisfaction with intervention method was measured using satisfaction scale at week 6 and follow-up week 10. ANOVA, Repeated Measures, and Paired samples t-test were used for statistical analysis. There was no statistically significant difference in PMS at baseline between three groups respectively (33 ± 5.8, 34.1 ± 7.1, & 35.2 ± 6.4, P = 0.500). However, at follow-up week 10, there was statistically significant difference between three groups (22.3 ± 4.3, 25.4 ± 6.5, & 31.8 ± 6.5; P < 0.001), with greatest improvement in online positive-oriented counseling group (P < 0.001). Satisfaction differed significantly among three groups at week 6 (51 ± 6.8, 46.4 ± 12, & 42.3 ± 6.3, P = 0.001) and follow-up week 10 (55.7 ± 11.6, 51.4 ± 12; & 43 ± 3.3, P < 0.001), with most satisfaction in positive-oriented counseling group (P < 0.001). All three interventions alleviated PMS, but online positive-oriented counseling was more effective and satisfying. Superiority of positive-oriented counseling implies mechanism of adaptation, better relationships, forgiveness, self-mood-regulation, and feasibility of its skills that could be continued individually by women after counseling completion. It is recommended health providers, health policymakers and managers support use of these interventions in treatment program and clinical guidelines. Trial registration: RCT registration number: IRCT20191231045967N1, Registration date:11/02/2020, Registration timing: prospective (IRCT | Survey the effect of vitamin D3 tablet intake, positivism group consulting with changing in life style in the treatment of premenstrual syndrome in women).
Scientific reports · randomised controlled trial · 4 citationsread the source →
Koenig HG, Ames D, Youssef NA, Oliver JP, Volk F, Teng EJ, Haynes K, Erickson ZD, Arnold I, O'Garo K, Pearce M. (2018)MEDLINE-indexed journal, not yet read by usMilitary medicine · randomised controlled trial Screening for Moral Injury: The Moral Injury Symptom Scale - Military Version Short Form.
Introduction: To develop a short form (SF) of the 45-item multidimensional Moral Injury Symptom Scale - Military Version (MISS-M) to use when screening for moral injury and monitoring treatment response in veterans and active duty military with PTSD.
Methods: A total of 427 veterans and active duty military with PTSD symptoms were recruited from VA Medical Centers in Augusta, GA; Los Angeles, CA; Durham, NC; Houston, TX; and San Antonio, TX; and from Liberty University, Lynchburg, Virginia. The sample was randomly split in two. In the first half (n = 214), exploratory factor analysis identified the highest loading item on each of the 10 MISS scales (guilt, shame, moral concerns, loss of meaning, difficulty forgiving, loss of trust, self-condemnation, religious struggle, and loss of religious faith) to form the 10-item MISS-M-SF; confirmatory factor analysis was then performed to replicate results in the second half of the sample (n = 213). Internal reliability, test-retest reliability, and convergent, discriminant, and concurrent validity were examined in the overall sample. The study was approved by the institutional review boards and the Research & Development (R&D) Committees at Veterans Administration medical centers in Durham, Los Angeles, Augusta, Houston, and San Antonio, and the Liberty University and Duke University Medical Center institutional review boards.
Findings: The 10-item MISS-M-SF had a median of 50 and a range of 12-91 (possible range 10-100). Over 70% scored a 9 or 10 (highest possible) on at least one item. Cronbach's alpha was 0.73 (95% CI 0.69-0.76), and test-retest reliability was 0.87 (95% CI 0.79-0.92). Convergent validity with the 45-item MISS-M was r = 0.92. Discriminant validity was demonstrated by relatively weak correlations with social, religious, and physical health constructs (r = 0.21-0.35), and concurrent validity was indicated by strong correlations with PTSD, depression, and anxiety symptoms (r = 0.54-0.58).
Discussion: The MISS-M-SF is a reliable and valid measure of MI symptoms that can be used to screen for MI and monitor response to treatment in veterans and active duty military with PTSD.
Military medicine · randomised controlled trial · 58 citationsread the source →
Methods of usability testing in the development of eHealth applications: A scoping review.
Background: The number of eHealth applications has exponentially increased in recent years, with over 325,000 health apps now available on all major app stores. This is in addition to other eHealth applications available on other platforms such as PC software, web sites and even gaming consoles. As with other digital applications, usability is one of the key factors in the successful implementation of eHealth apps. Reviews of the literature on empirical methods of usability testing in eHealth were last published in 2015. In the context of an exponentially increasing rate of App development year on year, an updated review is warranted.
Objective: To identify, explore, and summarize the current methods used in the usability testing of eHealth applications.
Methods: A scoping review was conducted on literature available from April 2014 up to October 2017. Four databases were searched. Literature was considered for inclusion if it was (1) focused on an eHealth application (which includes websites, PC software, smartphone and tablet applications), (2) provided information about usability of the application, (3) provided empirical results of the usability testing, (4) a full or short paper (not an abstract) published in English after March 2014. We then extracted data pertaining to the usability evaluation processes described in the selected studies.
Results: 133 articles met the inclusion criteria. The methods used for usability testing, in decreasing order of frequency were: questionnaires (n = 105), task completion (n = 57), 'Think-Aloud' (n = 45), interviews (n = 37), heuristic testing (n = 18) and focus groups (n = 13). Majority of the studies used one (n = 45) or two (n = 46) methods of testing. The rest used a combination of three (n = 30) or four (n = 12) methods of testing usability. None of the studies used automated mechanisms to test usability. The System Usability Scale (SUS) was the most frequently used questionnaire (n = 44). The ten most frequent health conditions or diseases where eHealth apps were being evaluated for usability were the following: mental health (n = 12), cancer (n = 10), nutrition (n = 10), child health (n = 9), diabetes (n = 9), telemedicine (n = 8), cardiovascular disease (n = 6), HIV (n = 4), health information systems (n = 4) and smoking (n = 4). Further iterations of the app were reported in a minority of the studies (n = 41). The use of the 'Think-Aloud' (Pearson Chi-squared test: χ2 = 11.15, p < 0.05) and heuristic walkthrough (Pearson Chi-squared test: χ2 = 4.48, p < 0.05) were significantly associated with at least one further iteration of the app being developed.
Conclusion: Although there has been an exponential increase in the number of eHealth apps, the number of studies that have been published that report the results of usability testing on these apps has not increased at an equivalent rate. The number of digital health applications that publish their usability evaluation results remains only a small fraction. Questionnaires are the most prevalent method of evaluating usability in eHealth applications, which provide an overall measure of usability but do not pinpoint the problems that need to be addressed. Qualitative methods may be more useful in this regard. The use of multiple evaluation methods has increased. Automated methods such as eye tracking have not gained traction in evaluating health apps. Further research is needed into which methods are best suited for the different types of eHealth applications, according to their target users and the health conditions being addressed.
International journal of medical informatics · review · 297 citationsread the source →
E-Health interventions for anxiety and depression in children and adolescents with long-term physical conditions.
Background: Long-term physical conditions affect 10% to 12% of children and adolescents worldwide; these individuals are at greater risk of developing psychological problems, particularly anxiety and depression. Access to face-to-face treatment for such problems is often limited, and available interventions usually have not been tested with this population. As technology improves, e-health interventions (delivered via digital means, such as computers and smart phones and ranging from simple text-based programmes through to multimedia and interactive programmes, serious games, virtual reality and biofeedback programmes) offer a potential solution to address the psychological needs of this group of young people.
Objectives: To assess the effectiveness of e-health interventions in comparison with attention placebos, psychological placebos, treatment as usual, waiting-list controls, or non-psychological treatments for treating anxiety and depression in children and adolescents with long-term physical conditions.
Search methods: We searched the Cochrane Common Mental Disorders Group's Controlled Trials Register (CCMDTR to May 2016), the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 8, 2017), Web of Science (1900 - 18 August 2016, updated 31 August 2017) and Ovid MEDLINE, Embase, PsycINFO (cross-search 2016 to 18 Aug 2017). We hand-searched relevant conference proceedings, reference lists of included articles, and the grey literature to May 2016. We also searched international trial registries to identify unpublished or ongoing trials.
Selection criteria: We included randomised controlled trials (RCTs), cluster-randomised trials, and cross-over trials of e-health interventions for treating any type of long-term physical condition in children and adolescents (aged 0 to 18 years), and that measured changes in symptoms or diagnoses of anxiety, depression, or subthreshold depression. We defined long-term physical conditions as those that were more than three-months' duration. We assessed symptoms of anxiety and depression using patient- or clinician-administered validated rating scales based on DSM III, IV or 5 (American Psychological Association 2013), or ICD 9 or 10 criteria (World Health Organization 1992). Formal depressive and anxiety disorders were diagnosed using structured clinical interviews. Attention placebo, treatment as usual, waiting list, psychological placebo, and other non-psychological therapies were eligible comparators.
Data collection and analysis: Two review authors independently reviewed titles, abstracts, and full-text articles; discrepancies were resolved through discussion or addressed by a third author. When available, we used odds ratio (OR) to compare dichotomous data and standardised mean differences (SMD) to analyse continuous data, both with 95% confidence intervals (CI). We undertook meta-analysis when treatments, participants, and the underlying clinical question were adequately similar. Otherwise, we undertook a narrative analysis.
Main results: We included five trials of three interventions (Breathe Easier Online, Web-MAP, and multimodal cognitive behavioural therapy (CBT)), which included 463 participants aged 10 to 18 years. Each trial contributed to at least one meta-analysis. Trials involved children and adolescents with long-term physical conditions, such as chronic headache (migraine, tension headache, and others), chronic pain conditions (abdominal, musculoskeletal, and others), chronic respiratory illness (asthma, cystic fibrosis, and others), and symptoms of anxiety or depression. Participants were recruited from community settings and hospital clinics in high income countries. For the primary outcome of change in depression symptoms versus any control, there was very low-quality evidence meaning that it could not be determined whether e-health interventions were clearly better than any comparator (SMD -0.06, 95% CI -0.35 to 0.23; five RCTs, 441 participants). For the primary outcome of change in anxiety symptoms versus any comparator, there was very low-quality evidence meaning that it could not be determined whether e-health interventions were clearly better than any comparator (SMD -0.07, 95% CI -0.29 to 0.14; two RCTs, 324 participants). For the primary outcome of treatment acceptability, there was very low-quality evidence that e-health interventions were less acceptable than any comparator (SMD 0.46, 95% CI 0.23 to 0.69; two RCTs, 304 participants).For the secondary outcome of quality of life, there was very low-quality evidence meaning that it could not be determined whether e-health interventions were clearly better than any comparator (SMD -0.83, 95% CI -1.53 to -0.12; one RCT, 34 participants). For the secondary outcome of functioning, there was very low-quality evidence meaning that it could not be determined whether e-health interventions were clearly better than any comparator (SMD -0.08, 95% CI -0.33 to 0.18; three RCTs, 368 participants). For the secondary outcome of status of long-term physical condition, there was very low-quality evidence meaning that it could not be determined whether e-health interventions were clearly better than any comparator (SMD 0.06, 95% CI -0.12 to 0.24; five RCTs, 463 participants).The risk of selection bias was considered low in most trials. However, the risk of bias due to inadequate blinding of participants or outcome assessors was considered unclear or high in all trials. Only one study had a published protocol; two trials had incomplete outcome data. All trials were conducted by the intervention developers, introducing another possible bias. No adverse effects were reported by any authors.
Authors' conclusions: At present, the field of e-health interventions for the treatment of anxiety or depression in children and adolescents with long-term physical conditions is limited to five low quality trials. The very low-quality of the evidence means the effects of e-health interventions are uncertain at this time, especially in children aged under 10 years. Although it is too early to recommend e-health interventions for this clinical population, given their growing number, and the global improvement in access to technology, there appears to be room for the development and evaluation of acceptable and effective technologically-based treatments to suit children and adolescents with long-term physical conditions.
The Cochrane database of systematic reviews · meta-analysis · 73 citationsread the source →
Sustained-release bupropion versus naltrexone in the treatment of pathological gambling: a preliminary blind-rater study.
Background: Pathological gambling (PG) is a relatively common and highly disabling impulse control disorder. A range of psychotherapeutic agents, including selective serotonin reuptake inhibitors, mood stabilizers, and opioid antagonists, has been shown to be effective in the treatment of PG. The use of selective serotonin reuptake inhibitors and opioid antagonists for PG is consistent with the observation that PG shares features of both the obsessive-compulsive spectrum disorders and addictive disorders. The aim of the study is to compare the effectiveness of sustained-release bupropion versus naltrexone in the treatment of PG.
Methods: Thirty-six male pathological gamblers were enrolled in our study. A comprehensive psychiatric diagnostic evaluation was performed at baseline on all patients, and patients were screened for symptoms of gambling, depression, and anxiety using the South Oaks Gambling Screen, the Hamilton Depression Rating Scale, the Hamilton Anxiety Rating Scale, and the Clinical Global Impression-Severity Scale. In addition, the patients completed self-report questionnaires about their demographic status. Patients were randomized in 2 groups and received either naltrexone (n = 19) or sustained-release bupropion (n = 17) for 12 weeks in a parallel fashion. Treatment response was monitored using the Clinical Global Impression-Improvement Scale which was performed at weeks 2, 4, 8, and 12. Patients were also assessed for the presence of gambling behavior via an unstructured interview, which was also performed at weeks 2, 4, 6, 8, and 12. Raters were blind to the study treatment.
Results: The majority of patients responded well to the drug treatment. Twelve of 17 patients in the sustained-release bupropion group completed the 12-week study, and 13 of 19 naltrexone patients completed the study. Nine (75%) of the 12 completers were rated as full responders in the sustained-release bupropion group versus 10 (76%) of 12 in the naltrexone group. Three (25%) of 12 completers in the bupropion group were rated as partial responders. In the naltrexone group, 3 (23%) of 13 completers were rated as partial responders. Full response was defined as the absence of gambling for a 2-week duration together with improvement on the Clinical Global Impression-Improvement Scale. Partial response was defined as a decrease in the frequency of gambling behavior and a decrease in the amount of money spent on gambling.
Conclusion: This preliminary study shows that sustained-release bupropion may be effective as naltrexone in the treatment of PG. Further studies are needed to confirm our findings.
Journal of clinical psychopharmacology · randomised controlled trial · 51 citationsread the source →
Probiotics for the prevention of pediatric antibiotic-associated diarrhea.
Background: Antibiotics alter the microbial balance commonly resulting in antibiotic-associated diarrhea (AAD). Probiotics may prevent AAD via providing gut barrier, restoration of the gut microflora, and other potential mechanisms of action.
Objectives: The primary objectives were to assess the efficacy and safety of probiotics (any specified strain or dose) used for the prevention of AAD in children.
Search methods: MEDLINE, Embase, CENTRAL, CINAHL, and the Web of Science (inception to 28 May 2018) were searched along with registers including the ISRCTN and Clinicaltrials.gov. We also searched the NICE Evidence Services database as well as reference lists from relevant articles.
Selection criteria: Randomized, parallel, controlled trials in children (0 to 18 years) receiving antibiotics, that compare probiotics to placebo, active alternative prophylaxis, or no treatment and measure the incidence of diarrhea secondary to antibiotic use were considered for inclusion.
Data collection and analysis: Study selection, data extraction, and risk of bias assessment were conducted independently by two authors. Dichotomous data (incidence of AAD, adverse events) were combined using a pooled risk ratio (RR) or risk difference (RD), and continuous data (mean duration of diarrhea) as mean difference (MD), along with corresponding 95% confidence interval (95% CI). We calculated the number needed to treat for an additional beneficial outcome (NNTB) where appropriate. For studies reporting on microbiome characteristics using heterogeneous outcomes, we describe the results narratively. The certainty of the evidence was evaluated using GRADE.
Main results: Thirty-three studies (6352 participants) were included. Probiotics assessed included Bacillus spp., Bifidobacterium spp., Clostridium butyricum, Lactobacilli spp., Lactococcus spp., Leuconostoc cremoris, Saccharomyces spp., orStreptococcus spp., alone or in combination. The risk of bias was determined to be high in 20 studies and low in 13 studies. Complete case (patients who did not complete the studies were not included in the analysis) results from 33 trials reporting on the incidence of diarrhea show a precise benefit from probiotics compared to active, placebo or no treatment control. After 5 days to 12 weeks of follow-up, the incidence of AAD in the probiotic group was 8% (259/3232) compared to 19% (598/3120) in the control group (RR 0.45, 95% CI 0.36 to 0.56; I² = 57%, 6352 participants; NNTB 9, 95% CI 7 to 13; moderate certainty evidence). Nineteen studies had loss to follow-up ranging from 1% to 46%. After making assumptions for those lost, the observed benefit was still statistically significant using an extreme plausible intention-to-treat (ITT) analysis, wherein the incidence of AAD in the probiotic group was 12% (436/3551) compared to 19% (664/3468) in the control group (7019 participants; RR 0.61; 95% CI 0.49 to 0.77; P <0.00001; I² = 70%). An a priori available case subgroup analysis exploring heterogeneity indicated that high dose (≥ 5 billion CFUs per day) is more effective than low probiotic dose (< 5 billion CFUs per day), interaction P value = 0.01. For the high dose studies the incidence of AAD in the probiotic group was 8% (162/2029) compared to 23% (462/2009) in the control group (4038 participants; RR 0.37; 95% CI 0.30 to 0.46; P = 0.06; moderate certainty evidence). For the low dose studies the incidence of AAD in the probiotic group was 8% (97/1155) compared to 13% (133/1059) in the control group (2214 participants; RR 0.68; 95% CI 0.46 to 1.01; P = 0.02). Again, assumptions for loss to follow-up using an extreme plausible ITT analysis was statistically significant. For high dose studies the incidence of AAD in the probiotic group was 13% (278/2218) compared to 23% (503/2207) in control group (4425 participants; RR 0.54; 95% CI 0.42 to 0.70; P <0.00001; I² = 68%; moderate certainty evidence).None of the 24 trials (4415 participants) that reported on adverse events reported any serious adverse events attributable to probiotics. Adverse event rates were low. After 5 days to 4 weeks follow-up, 4% (86/2229) of probiotics participants had an adverse event compared to 6% (121/2186) of control participants (RD 0.00; 95% CI -0.01 to 0.01; P < 0.00001; I² = 75%; low certainty evidence). Common adverse events included rash, nausea, gas, flatulence, abdominal bloating, and constipation. After 10 days to 12 weeks of follow-up, eight studies recorded data on our secondary outcome, the mean duration of diarrhea; with probiotics reducing diarrhea duration by almost one day (MD -0.91; 95% CI -1.38 to -0.44; P <0.00001; low certainty evidence). One study reported on microbiome characteristics, reporting no difference in changes with concurrent antibiotic and probiotic use.
Authors' conclusions: The overall evidence suggests a moderate protective effect of probiotics for preventing AAD (NNTB 9, 95% CI 7 to 13). Using five criteria to evaluate the credibility of the subgroup analysis on probiotic dose, the results indicate the subgroup effect based on high dose probiotics (≥ 5 billion CFUs per day) was credible. Based on high-dose probiotics, the NNTB to prevent one case of diarrhea is 6 (95% CI 5 to 9). The overall certainty of the evidence for the primary endpoint, incidence of AAD based on high dose probiotics was moderate due to the minor issues with risk of bias and inconsistency related to a diversity of probiotic agents used. Evidence also suggests that probiotics may moderately reduce the duration of diarrhea, a reduction by almost one day. The benefit of high dose probiotics (e.g. Lactobacillus rhamnosus orSaccharomyces boulardii) needs to be confirmed by a large well-designed multi-centered randomized trial. It is premature to draw firm conclusions about the efficacy and safety of 'other' probiotic agents as an adjunct to antibiotics in children. Adverse event rates were low and no serious adverse events were attributable to probiotics. Although no serious adverse events were observed among inpatient and outpatient children, including small studies conducted in the intensive care unit and in the neonatal unit, observational studies not included in this review have reported serious adverse events in severely debilitated or immuno-compromised children with underlying risk factors including central venous catheter use and disorders associated with bacterial/fungal translocation.
The Cochrane database of systematic reviews · meta-analysis · 162 citationsread the source →
Assessment of parasympathetic reactivation after exercise.
The objective of this study was to evaluate whether heart rate variability (HRV) can be used as an index of parasympathetic reactivation after exercise. Heart rate recovery after exercise has recently been shown to have prognostic significance and has been postulated to be related to abnormal recovery of parasympathetic tone. Ten normal subjects [5 men and 5 women; age 33 +/- 5 yr (mean +/- SE)] exercised to their maximum capacity, and 12 subjects (10 men and 2 women; age 61 +/- 10 yr) with coronary artery disease exercised for 16 min on two separate occasions, once in the absence of atropine and once with atropine (0.04 mg/kg) administered during exercise. The root mean square residual (RMS), which measures the deviation of the R-R intervals from a straight line, as well as the standard deviation (SD) and the root mean square successive difference of the R-R intervals (MSSD), were measured on successive 15-, 30-, and 60-s segments of a 5-min ECG obtained immediately after exercise. In recovery, the R-R interval was shorter with atropine (P < 0.0001). Without atropine, HRV, as measured by the MSSD and RMS, increased early in recovery from 4.1 +/- 0.4 and 3.7 +/- 0.4 ms in the first 15 s to 7.2 +/- 1.0 and 7.4 +/- 0.9 ms after 1 min, respectively (P < 0.0001). RMS (range 1.7-2.1 ms) and MSSD were less with atropine (P < 0.0001). RMS remained flat throughout recovery, whereas MSSD showed some decline over time from 3.0 to 2.2 ms (P < 0.002). RMS and MSSD were both directly related (r(2) = 0.47 and 0.56, respectively; P < 0.0001) to parasympathetic effect, defined as the difference in R-R interval without and with atropine. In conclusion, RMS and MSSD are parameters of HRV that can be used in the postexercise recovery period as indexes of parasympathetic reactivation after exercise. These tools may improve our understanding of parasympathetic reactivation after exercise and the prognostic significance of heart rate recovery.
American journal of physiology. Heart and circulatory physiology · clinical trial · 167 citationsread the source →
Zhang L, Ssewanyana D, Martin MC, Lye S, Moran G, Abubakar A, Marfo K, Marangu J, Proulx K, Malti T. (2021)MEDLINE-indexed journal, not yet read by usFrontiers in public health · meta-analysis Supporting Child Development Through Parenting Interventions in Low- to Middle-Income Countries: An Updated Systematic Review.
Background: Over 250 million children in low- and middle-income countries are at risk of not achieving their fullest developmental potential due to co-occurring risks such as poor nutrition and inadequate learning opportunities. Early intervention programs integrating the aspects of nurturing care, that is, good health, adequate nutrition, safety and security, responsive caregiving, and learning opportunities, may ameliorate against the negative impact of these adverse conditions. Methods: This meta-analytic review updates the evidence base of parenting interventions comprising stimulation and responsive caregiving components on developmental outcomes for children under age 2 years in low- and middle-income countries. It also describes and assesses the moderation effects of population characteristics and implementation features on the intervention effectiveness. Studies were identified based on previous systematic reviews and an updated literature search in eight databases and the gray literature up to December 2020. A random-effect model was used to explore the pooled effect sizes accounted for by the intervention for developmental outcome of cognition, language, motor, and social-emotional capacities. Exploratory moderation analyses were also conducted. Results: Twenty-one randomized controlled trials representing over 10,400 children from 12 low- and middle-income countries and regions across three continents (Africa, Latin America, and Asia) were identified. The interventions showed overall small-to-moderate effects on children's cognitive development (ES = 0.44; 95% CI = [0.30, 0.57]); language development (ES = 0.33; 95% CI = [0.18, 0.49]); and motor skills (ES = 0.21; 95% CI = [0.10, 0.32]). The overall effect on social-emotional development was non-significant (ES = 0.17; 95% CI = [-0.01, 0.34]). Effect sizes (ES) varied significantly across the studies. Parenting programs that targeted vulnerable groups, including rural communities and caregivers with lower education levels, had more significant effects on children's development. Group sessions (vs. individual visits) and high program dose (≥12 sessions) were also associated with stronger effects on child development. Further research is needed to determine the effectiveness of the workforce and training on programmatic outcomes. Conclusion: The findings indicate that parenting interventions that encourage nurturing care are effective in improving the early development of children, especially among vulnerable populations. We discuss opportunities to strengthen the implementation of research-based parenting interventions in such contexts.
Frontiers in public health · meta-analysis · 47 citationsread the source →
The effectiveness of Stepping Stones Triple P parenting support in parents of children with borderline to mild intellectual disability and psychosocial problems: a randomized controlled trial.
Background: Children with borderline to mild intellectual disability (BMID) have been shown to be at increased risk for psychosocial problems. The presence of these psychosocial problems leads to parenting stress. Stepping Stones Triple P (SSTP) is a parenting support program to support parents with children with BMID and psychosocial problems. The aim of this study was to evaluate the effectiveness of SSTP compared to Care as Usual (CAU) in reducing psychosocial problems in children with BMID.
Method: We conducted a randomized controlled trial in the Northern provinces of the Netherlands. Parents of children aged 5 to 12 with borderline (IQ 70 to 85) or mild (IQ 70 to 50) ID and psychosocial problems were invited. Psychosocial problems were identified using the Strengths and Difficulties Questionnaire (SDQ) parent report (≥14). Measurements were assessed before the intervention (T0), immediately after the intervention (T1) and after a follow-up of six months (T2). SSTP takes 8 to 10 individual sessions of 40-90 minutes, provided over 10 to 12 weeks. CAU concerned any service, except SSTP. Primary outcomes were the child's psychosocial problems (SDQ parent and teacher forms and the Eyberg Child Behavior Inventory, ECBI). Secondary outcomes were parenting stress (Parenting Stress Index, PSI) and parenting skills (Alabama Parenting Questionnaire, APQ).
Results: In total 209 parents of children aged 5 to 12 with BMID were allocated blindly to either SSTP (n =111) or CAU (n =98). In the intention to treat analyses, SSTP achieved no significantly better effect than CAU for the SDQ parent report, the ECBI and the APQ on the short- and long- term. In the short term, SSTP was significantly more effective than CAU for the SDQ teacher report (B = -2.25, 95% CI -3.79 to -0.71) and the PSI (B = -7.06, 95% CI -12.11 to -2.01). For both SDQ teacher report and PSI, there was no statistically significant effect in the long term. Dropout from SSTP was considerable (49%), with the effects being solely found in the adherent SSTP subgroup.
Conclusions: SSTP had some short-term advantages over CAU, but not in the longer term.
Trial registration: Dutch Trial Register NTR2624. Registered 26 November 2010.
BMC medicine · randomised controlled trial · 21 citationsread the source →
Shoesmith A, Hall A, Wolfenden L, Shelton RC, Powell BJ, Brown H, McCrabb S, Sutherland R, Sutherland R, Yoong S, Lane C, Booth D, Nathan N. (2021)MEDLINE-indexed journal, not yet read by usImplementation science : IS · systematic review Barriers and facilitators influencing the sustainment of health behaviour interventions in schools and childcare services: a systematic review.
Background: Sustainment has been defined as the sustained use or delivery of an intervention in practice following cessation of external implementation support. This review aimed to identify and synthesise factors (barriers and facilitators) that influence the sustainment of interventions (policies, practices, or programmes) in schools and childcare services that address the leading risk factors of chronic disease.
Methods: Seven electronic databases and relevant reference lists were searched for articles, of any design, published in English, from inception to March 2020. Articles were included if they qualitatively and/or quantitatively reported on school or childcare stakeholders' (including teachers, principals, administrators, or managers) perceived barriers or facilitators to the sustainment of interventions addressing poor diet/nutrition, physical inactivity, obesity, tobacco smoking, or harmful alcohol use. Two independent reviewers screened texts, and extracted and coded data guided by the Integrated Sustainability Framework, an existing multi-level sustainability-specific framework that assesses factors of sustainment.
Results: Of the 13,158 articles identified, 31 articles met the inclusion criteria (8 quantitative, 12 qualitative, 10 mixed-methods, and 1 summary article). Overall, 29 articles were undertaken in schools (elementary n=17, middle n=3, secondary n=4, or a combination n=5) and two in childcare settings. The main health behaviours targeted included physical activity (n=9), diet (n=3), both diet and physical activity (n=15), and smoking (n=4), either independently (n=1) or combined with other health behaviours (n=3). Findings suggest that the majority of the 59 barriers and 74 facilitators identified to impact on intervention sustainment were similar across school and childcare settings. Factors predominantly relating to the 'inner contextual factors' of the organisation including: availability of facilities or equipment, continued executive or leadership support present, and team cohesion, support, or teamwork were perceived by stakeholders as influential to intervention sustainment.
Conclusions: Identifying strategies to improve the sustainment of health behaviour interventions in these settings requires a comprehensive understanding of factors that may impede or promote their ongoing delivery. This review identified multi-level factors that can be addressed by strategies to improve the sustainment of such interventions, and suggests how future research might address gaps in the evidence base.
Trial registration: This review was prospectively registered on PROSPERO: CRD42020127869 , Jan. 2020.
Implementation science : IS · systematic review · 126 citationsread the source →
Social capital and physical health: An updated review of the literature for 2007-2018.
Purpose: Social capital is frequently indicated as a determinant of population health. Despite an increase in the frequency of public health studies including such measures, our understanding of social capital's effects on health remains unclear. In 2008, a systematic review of the "first decade" of research on social capital and health was published in the textbook Social Capital and Health. Our study intends to update and expand upon this original review to account for developments in the literature over the second decade of research on social capital and health.
Methods: We employed a systematic review of empirical studies investigating the relationship between measures of social capital and physical health outcomes published between January 1, 2007 and December 31, 2018. To identify potential studies, we conducted searches of PubMed, Embase, and PsychINFO databases in January 2019 using combinations of "social capital" and "physical health" search terms.
Results: We identified 1,608 unique articles and reviewed 145 studies meeting our inclusion criteria. The most frequently examined health condition was self-reported health (57%), followed by mortality (12%), cardiovascular diseases (10%), obesity (7%), diabetes (6%), infectious diseases (5%), and cancers (3%). Of these studies, 127 (88%) reported at least partial support for a protective association between social capital and health. However, only 41 (28%) reported exclusively positive findings. The majority (59%) of results were mixed, suggesting a nuanced relationship between social capital and health. This finding could also be indicative of differences in study design, which showed substantial variation.
Conclusions: Despite limitations in the literature, our review chronicles an evolution in the field of social capital and health in terms of size and sophistication. Overall, these studies suggest that social capital may be an important protective factor for some physical health outcomes, but further research is needed to confirm and clarify these findings.
Social science & medicine (1982) · systematic review · 137 citationsread the source →
How do ageism, death anxiety and ageing anxiety among medical students and residents affect their attitude towards medical care for older patients: a systematic review.
Background: Although the number of older patients requiring medical care is increasing, caring for older patients is often seen as unattractive by medical trainees (i.e., medical students, residents, interns, and fellows). Terror Management Theory states that people have a negative attitude towards older people, because they remind people of their own mortality. We hypothesize that ageism, death anxiety, and ageing anxiety among medical trainees negatively affect their attitude towards medical care for older patients. This review aimed to examine and generate an overview of available literature on the relationship between ageism, death anxiety, and ageing anxiety among medical trainees and their attitude towards medical care for older patients.
Methods: A systematic review was performed with a review protocol based on the PRISMA Statement. PubMed, Ebsco/PsycInfo, Ebsco/ERIC and Embase were searched from inception to August 2022, using the following search terms, including their synonyms and closely related words: "medical trainees" AND "ageism" OR "death anxiety" OR "ageing anxiety" AND "(attitude AND older patient)".
Results: The search yielded 4072 different studies; 12 eligible studies (10 quantitative and 2 qualitative) were identified and synthesized using narrative synthesis. Findings suggest that a positive attitude towards older people was related to a positive attitude towards medical care for older patients among medical students. The available literature on the relationship between death anxiety and/or ageing anxiety and attitude towards medical care for older patients among medical trainees was limited and had a heterogeneity in focus, which hindered comparison of results.
Conclusion: Our findings suggest that a positive attitude towards older people in general is related to a positive attitude towards medical care for older patients among medical students. Future research should focus on further exploring underlying mechanisms affecting the attitude towards medical care for older patients among medical trainees.
BMC medical education · systematic review · 2 citationsread the source →
Organisational interventions for improving wellbeing and reducing work-related stress in teachers.
Background: The teaching profession is an occupation with a high prevalence of work-related stress. This may lead to sustained physical and mental health problems in teachers. It can also negatively affect the health, wellbeing and educational attainment of children, and impose a financial burden on the public budget in terms of teacher turnover and sickness absence. Most evaluated interventions for the wellbeing of teachers are directed at the individual level, and so do not tackle the causes of stress in the workplace. Organisational-level interventions are a potential avenue in this regard.
Objectives: To evaluate the effectiveness of organisational interventions for improving wellbeing and reducing work-related stress in teachers.
Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PsycINFO, ASSIA, AEI, BEI, BiblioMap, DARE, DER, ERIC, IBSS, SSCI, Sociological Abstracts, a number of specialist occupational health databases, and a number of trial registers and grey literature sources from the inception of each database until January 2015.
Selection criteria: Randomised controlled trials (RCTs), cluster-RCTs, and controlled before-and-after studies of organisational-level interventions for the wellbeing of teachers.
Data collection and analysis: We used standard methodological procedures expected by Cochrane.
Main results: Four studies met the inclusion criteria. They were three cluster-randomised controlled trials and one with a stepped-wedge design. Changing task characteristicsOne study with 961 teachers in eight schools compared a task-based organisational change intervention along with stress management training to no intervention. It found a small reduction at 12 months in 10 out of 14 of the subscales in the Occupational Stress Inventory, with a mean difference (MD) varying from -3.84 to 0.13, and a small increase in the Work Ability Index (MD 2.27; 95% confidence interval (CI) 1.64 to 2.90; 708 participants, low-quality evidence).Changing organisational characteristicsTwo studies compared teacher training combined with school-wide coaching support to no intervention. One study with 59 teachers in 43 schools found no significant effects on job-related anxiety (MD -0.25 95% CI -0.61 to 0.11, very low-quality evidence) or depression (MD -0.26 95% CI -0.57 to 0.05, very low-quality evidence) after 24 months. The other study with 77 teachers in 18 schools found no significant effects on the Maslach Burnout Inventory subscales (e.g. emotional exhaustion subscale: MD -0.05 95% CI -0.52 to 0.42, low-quality evidence) or the Teacher Perceived Emotional Ability subscales (e.g. regulating emotions subscale: MD 0.11 95% CI -0.11 to 0.33, low-quality evidence) after six months. Multi-component interventionOne study with 1102 teachers in 34 schools compared a multi-component intervention containing performance bonus, job promotion opportunities and mentoring support to a matched-comparison group consisting of 300 schools. It found moderately higher teacher retention rates (MD 11.50 95% CI 3.25 to 19.75 at 36 months follow-up, very low-quality evidence). However, the authors reported results only from one cohort out of four (eight schools), demonstrating a high risk of reporting bias.
Authors' conclusions: We found low-quality evidence that organisational interventions lead to improvements in teacher wellbeing and retention rates. We need further evaluation of the effects of organisational interventions for teacher wellbeing. These studies should follow a complex-interventions framework, use a cluster-randomised design and have large sample sizes.
The Cochrane database of systematic reviews · systematic review · 75 citationsread the source →
Attitudes, barriers and enablers to physical activity in pregnant women: a systematic review.
Question: What are the attitudes, barriers and enablers to physical activity perceived by pregnant women?
Design: In a systematic literature review, eight electronic databases were searched: AMED, CINAHL, Embase, Joanna Briggs Institute, Medline, PsycInfo, SPORTDiscus (from database inception until June 2016) and PubMed (from 2011 until June 2016). Quantitative data expressed as proportions were meta-analysed. Data collected using Likert scales were synthesised descriptively. Qualitative data were analysed thematically using an inductive approach and content analysis. Findings were categorised as intrapersonal, interpersonal or environmental, based on a social-ecological framework.
Participants: Pregnant women.
Intervention: Not applicable.
Outcome measures: Attitudes and perceived barriers and enablers to physical activity during pregnancy.
Results: Forty-nine articles reporting data from 47 studies (7655 participants) were included. Data were collected using questionnaires, interviews and focus groups. Meta-analyses of proportions showed that pregnant women had positive attitudes towards physical activity, identifying it as important (0.80, 95% CI 0.52 to 0.98), beneficial (0.71, 95% CI 0.58 to 0.83) and safe (0.86, 95% CI 0.79 to 0.92). This was supported by themes emerging in 15 qualitative studies that reported on attitudes (important, 12 studies; beneficial, 10 studies). Barriers to physical activity were predominantly intrapersonal such as fatigue, lack of time and pregnancy discomforts. Frequent enablers included maternal and foetal health benefits (intrapersonal), social support (interpersonal) and pregnancy-specific programs. Few environmental factors were identified. Little information was available about attitudes, barriers and enablers of physical activity for pregnant women with gestational diabetes mellitus who are at risk from inactivity.
Conclusion: Intrapersonal themes were the most frequently reported barriers and enablers to physical activity during pregnancy. Social support also played an enabling role. Person-centred strategies using behaviour change techniques should be used to address intrapersonal and social factors to translate pregnant women's positive attitudes into increased physical activity participation.
Registration: PROSPERO CRD42016037643. [Harrison AL, Taylor NF, Shields N, Frawley HC (2018) Attitudes, barriers and enablers to physical activity in pregnant women: a systematic review. Journal of Physiotherapy 64: 24-32].
Journal of physiotherapy · systematic review · 155 citationsread the source →
Prevalence of postpartum depression among immigrant women: A systematic review and meta-analysis.
The aims of this systematic review and meta-analysis were threefold: to estimate the prevalence of postpartum depressive symptoms in immigrant women, compare this prevalence to non-immigrant women, and determine risk factors for postpartum depressive symptoms in immigrant women. Literature searches were conducted in PubMed, Embase, PsycINFO, Web of Science, Scopus, ResearchGate and Google Scholar databases from 1950 until October 2014. Twenty-four studies met the inclusion criteria of which 22 (12 cross-sectional and 10 prospective cohort) contributed data for meta-analyses. Heterogeneity and publication bias were assessed. The prevalence of postpartum depressive symptoms in immigrant women was 20% (95% confidence interval [CI] 17-23%, 18 studies, N = 13,749 women). Immigrant women were twice more likely to experience depressive symptoms in the postpartum period than non-immigrant women (pooled unadjusted odds ratio [OR] = 2.10 [95% CI 1.62-2.73, 15 studies, N = 50,519 women] and adjusted OR = 2.18 [95% CI 1.60-2.96, 7 studies, N = 35,557 women]). There was, however, evidence of publication bias with the pooled adjusted OR reduced to 1.63 (95% CI 1.22-2.17) after adjustment for bias. Risk factors associated with postpartum depressive symptoms among immigrant women included shorter length of residence in the destination country, lower levels of social support, poorer marital adjustment, and perceived insufficient household income. This study suggests that postpartum depression is a common condition among immigrant women. Moreover, immigrant women are at higher risk of postpartum depression than non-immigrant women. Further prospective studies on the risk factors of postpartum depression among immigrant women verified by a clinical diagnosis are needed.
Journal of psychiatric research · meta-analysis · 162 citationsread the source →
Technology-Assisted Parent Training Programs for Children and Adolescents With Disruptive Behaviors: A Systematic Review.
Objective: To systematically review digitally assisted parent training programs (DPTs) targeting the treatment of children and adolescents with disruptive behaviors.
Data sources: A search was conducted using PubMed, PsycINFO, and EMBASE databases for peer-reviewed studies published between January 1, 2000, and March 1, 2016. Reference lists of included and review articles were searched manually for additional references.
Study selection: Broad search terms in varying combinations for parent, training, technologies, and disruptive behavior problems were used. We included English-language articles reporting on the effectiveness of DPTs targeting child or adolescent disruptive behaviors (eg, conduct disorder, oppositional defiant disorder). DPTs designed to use digital media or software programs not to be primarily used within a therapy setting (eg, group, face-to-face) were included.
Data extraction: Study design, recruitment and sample characteristics, theoretical background, digital program features, user's engagement, and measures of child behavior were extracted.
Results: Fourteen intervention studies (n = 2,427, 58% male, 1,500 in DPT conditions, 12 randomized trials) examining 10 programs met inclusion criteria. Interventions included self-directed noninteractive (eg, podcasts; 3 studies) and interactive (eg, online software; 4 studies) DPTs, remotely administered DPTs combined with professional phone-based coaching (2 studies), and a smartphone enhancement of standard treatment. Interventions were delivered over a mean ± SD period of 8.7 ± 4.2 weeks, most (11/14; 78.6%) were remotely administered, and all recruitment procedures included an outreach for parents outside of mental health-care settings. For programs with > 5 sessions, the mean ± SD completion rate of available sessions was 68.6% ± 13.1%. In comparison to no treatment control, self-directed programs yielded significant improvements in child behavior for children (age < 9 years, Cohen d = 0.47-0.80, 4 studies) and adolescents (d = 0.17, 0.20, 2 studies). Overall, reduced professional support combined with DPT was not inferior to full-contact conditions and showed small improvement in comparison to usual care (d = 0.34). Preliminary indicators also suggested that technology enhancements may increase engagement and outcomes of standard treatment.
Conclusions: The current review indicates the efficacy of DPT across a range of therapy formats applied in real-world settings demonstrating the potential for increased accessibility of evidence-based treatment for youth with disruptive behaviors. Additional studies are needed to extend these findings and to determine moderating effects of different designs.
The Journal of clinical psychiatry · systematic review · 42 citationsread the source →
A web-based psychoeducational program for informal caregivers of patients with Alzheimer's disease: a pilot randomized controlled trial.
Background: Although several face-to-face programs are dedicated to informal caregivers of persons with dementia, they are not always accessible to overburdened or isolated caregivers. Based on a face-to-face intervention program, we adapted and designed a Web-based fully automated psychoeducational program (called Diapason) inspired by a cognitive approach.
Objective: This study aimed to evaluate through a pilot unblinded randomized controlled trial the efficacy and acceptability of a Web-based psychoeducational program for informal caregivers of persons with Alzheimer's disease (PWAD) based on a mixed methods research design.
Methods: We recruited and randomized offline 49 informal caregivers of a PWAD in a day care center in Paris, France. They either received the Web-based intervention and usual care for 3 months (experimental group, n=25) or only usual care (control group, n=24). Caregivers' perceived stress (PSS-14, primary outcome), self-efficacy, burden, perceived health status, and depression (secondary outcomes) were measured during 3 face-to-face on-site visits: at baseline, at the end of the program (month 3), and after follow-up (month 6). Additionally, semistructured interviews were conducted with experimental group caregivers at month 6 and examined with thematic analysis.
Results: Intention-to-treat analysis did not show significant differences in self-perceived stress between the experimental and control groups (P=.98). The experimental group significantly improved their knowledge of the illness (d=.79, P=.008) from baseline to month 3. Of the 25 participants allocated to the experimental group, 17 (71%) finished the protocol and entirely viewed at least 10 of 12 online sessions. On average, participants used the website 19.72 times (SD 12.88) and were connected for 262.20 minutes (SD 270.74). The results of the satisfaction questionnaire showed that most participants considered the program to be useful (95%, 19/20), clear (100%, 20/20), and comprehensive (85%, 17/20). Significant correlations were found between relationship and caregivers' program opinion (P=.01). Thus, positive opinions were provided by husbands and sons (3/3), whereas qualified opinions were primarily reported by daughters (8/11). Female spouses expressed negative (2/3) or neutral opinions (1/3). Caregivers expected more dynamic content and further interaction with staff and peers.
Conclusions: In this study, quantitative results were inconclusive owing to small sample size. Qualitative results indicated/showed little acceptance of the program and high expectations from caregivers. Caregivers did not rule out their interest in this kind of intervention provided that it met their needs. More dynamic, personalized, and social interventions are desirable. Our recruitment issues pointed out the necessity of in-depth studies about caregivers' help-seeking behaviors and readiness factors.
Trial registration: Clinicaltrials.gov NCT01430286; http://clinicaltrials.gov/ct2/show/NCT01430286 (Archived by WebCite at http://www.webcitation/6KxHaRspL).
Journal of medical Internet research · randomised controlled trial · 152 citationsread the source →
Manoogian ENC, Zadourian A, Lo HC, Gutierrez NR, Shoghi A, Rosander A, Pazargadi A, Ormiston CK, Wang X, Sui J, Hou Z, Fleischer JG, Golshan S, Taub PR, Panda S. (2022)MEDLINE-indexed journal, not yet read by usCell metabolism · randomised controlled trial Feasibility of time-restricted eating and impacts on cardiometabolic health in 24-h shift workers: The Healthy Heroes randomized control trial.
Over a quarter of the workforce in industrialized countries does shift work, which increases the risk for cardiometabolic disease. Yet shift workers are often excluded from lifestyle intervention studies to reduce this risk. In a randomized control trial with 137 firefighters who work 24-h shifts (23-59 years old, 9% female), 12 weeks of 10-h time-restricted eating (TRE) was feasible, with TRE participants decreasing their eating window (baseline, mean 14.13 h, 95% CI 13.78-14.47 h; intervention, 11.13 h, 95% CI 10.73-11.54 h, p = 3.29E-17) with no adverse effects, and improved quality of life assessed via SF-36 (ClinicalTrials.gov: NCT03533023). Compared to the standard of care (SOC) arm, TRE significantly decreased VLDL particle size. In participants with elevated cardiometabolic risks at baseline, there were significant reductions in TRE compared to SOC in glycated hemoglobin A1C and diastolic blood pressure. For individuals working a 24-h shift schedule, TRE is feasible and can improve cardiometabolic health, especially for individuals with increased risk. VIDEO ABSTRACT.
Cell metabolism · randomised controlled trial · 149 citationsread the source →
Integrated disease management interventions for patients with chronic obstructive pulmonary disease.
Background: People with chronic obstructive pulmonary disease (COPD) show considerable variation in symptoms, limitations, and well-being; this often complicates medical care. A multi-disciplinary and multi-component programme that addresses different elements of care could improve quality of life (QoL) and exercise tolerance, while reducing the number of exacerbations.
Objectives: To compare the effectiveness of integrated disease management (IDM) programmes versus usual care for people with chronic obstructive pulmonary disease (COPD) in terms of health-related quality of life (QoL), exercise tolerance, and exacerbation-related outcomes.
Search methods: We searched the Cochrane Airways Group Register of Trials, CENTRAL, MEDLINE, Embase, and CINAHL for potentially eligible studies. Searches were current as of September 2020.
Selection criteria: Randomised controlled trials (RCTs) that compared IDM programmes for COPD versus usual care were included. Interventions consisted of multi-disciplinary (two or more healthcare providers) and multi-treatment (two or more components) IDM programmes of at least three months' duration.
Data collection and analysis: Two review authors independently assessed trial quality and extracted data. If required, we contacted study authors to request additional data. We performed meta-analyses using random-effects modelling. We carried out sensitivity analyses for the quality of included studies and performed subgroup analyses based on setting, study design, dominant intervention components, and region.
Main results: Along with 26 studies included in the 2013 Cochrane Review, we added 26 studies for this update, resulting in 52 studies involving 21,086 participants for inclusion in the meta-analysis. Follow-up periods ranged between 3 and 48 months and were classified as short-term (up to 6 months), medium-term (6 to 15 months), and long-term (longer than 15 months) follow-up. Studies were conducted in 19 different countries. The mean age of included participants was 67 years, and 66% were male. Participants were treated in all types of healthcare settings, including primary (n =15), secondary (n = 22), and tertiary care (n = 5), and combined primary and secondary care (n = 10). Overall, the level of certainty of evidence was moderate to high. We found that IDM probably improves health-related QoL as measured by St. George's Respiratory Questionnaire (SGRQ) total score at medium-term follow-up (mean difference (MD) -3.89, 95% confidence interval (CI) -6.16 to -1.63; 18 RCTs, 4321 participants; moderate-certainty evidence). A comparable effect was observed at short-term follow-up (MD -3.78, 95% CI -6.29 to -1.28; 16 RCTs, 1788 participants). However, the common effect did not exceed the minimum clinically important difference (MCID) of 4 points. There was no significant difference between IDM and control for long-term follow-up and for generic QoL. IDM probably also leads to a large improvement in maximum and functional exercise capacity, as measured by six-minute walking distance (6MWD), at medium-term follow-up (MD 44.69, 95% CI 24.01 to 65.37; 13 studies, 2071 participants; moderate-certainty evidence). The effect exceeded the MCID of 35 metres and was even greater at short-term (MD 52.26, 95% CI 32.39 to 72.74; 17 RCTs, 1390 participants) and long-term (MD 48.83, 95% CI 16.37 to 80.49; 6 RCTs, 7288 participants) follow-up. The number of participants with respiratory-related admissions was reduced from 324 per 1000 participants in the control group to 235 per 1000 participants in the IDM group (odds ratio (OR) 0.64, 95% CI 0.50 to 0.81; 15 RCTs, median follow-up 12 months, 4207 participants; high-certainty evidence). Likewise, IDM probably results in a reduction in emergency department (ED) visits (OR 0.69, 95%CI 0.50 to 0.93; 9 RCTs, median follow-up 12 months, 8791 participants; moderate-certainty evidence), a slight reduction in all-cause hospital admissions (OR 0.75, 95%CI 0.57 to 0.98; 10 RCTs, median follow-up 12 months, 9030 participants; moderate-certainty evidence), and fewer hospital days per person admitted (MD -2.27, 95% CI -3.98 to -0.56; 14 RCTs, median follow-up 12 months, 3563 participants; moderate-certainty evidence). Statistically significant improvement was noted on the Medical Research Council (MRC) Dyspnoea Scale at short- and medium-term follow-up but not at long-term follow-up. No differences between groups were reported for mortality, courses of antibiotics/prednisolone, dyspnoea, and depression and anxiety scores. Subgroup analysis of dominant intervention components and regions of study suggested context- and intervention-specific effects. However, some subgroup analyses were marked by considerable heterogeneity or included few studies. These results should therefore be interpreted with caution.
Authors' conclusions: This review shows that IDM probably results in improvement in disease-specific QoL, exercise capacity, hospital admissions, and hospital days per person. Future research should evaluate which combination of IDM components and which intervention duration are most effective for IDM programmes, and should consider contextual determinants of implementation and treatment effect, including process-related outcomes, long-term follow-up, and cost-effectiveness analyses.
The Cochrane database of systematic reviews · meta-analysis · 48 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 →
Goodwin GM, Aaronson ST, Alvarez O, Arden PC, Baker A, Bennett JC, Bird C, Blom RE, Brennan C, Brusch D, Burke L, Campbell-Coker K, Carhart-Harris R, Cattell J, Daniel A, DeBattista C, Dunlop BW, Eisen K, Feifel D, Forbes M, Haumann HM, Hellerstein DJ, Hoppe AI, Husain MI, Jelen LA, Kamphuis J, Kawasaki J, Kelly JR, Key RE, Kishon R, Knatz Peck S, Knight G, Koolen MHB, Lean M, Licht RW, Maples-Keller JL, Mars J, Marwood L, McElhiney MC, Miller TL, Mirow A, Mistry S, Mletzko-Crowe T, Modlin LN, Nielsen RE, Nielson EM, Offerhaus SR, O'Keane V, Páleníček T, Printz D, Rademaker MC, van Reemst A, Reinholdt F, Repantis D, Rucker J, Rudow S, Ruffell S, Rush AJ, Schoevers RA, Seynaeve M, Shao S, Soares JC, Somers M, Stansfield SC, Sterling D, Strockis A, Tsai J, Visser L, Wahba M, Williams S, Young AH, Ywema P, Zisook S, Malievskaia E. (2022)MEDLINE-indexed journal, not yet read by usThe New England journal of medicine · randomised controlled trial Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression.
Background: Psilocybin is being studied for use in treatment-resistant depression.
Methods: In this phase 2 double-blind trial, we randomly assigned adults with treatment-resistant depression to receive a single dose of a proprietary, synthetic formulation of psilocybin at a dose of 25 mg, 10 mg, or 1 mg (control), along with psychological support. The primary end point was the change from baseline to week 3 in the total score on the Montgomery-Åsberg Depression Rating Scale (MADRS; range, 0 to 60, with higher scores indicating more severe depression). Secondary end points included response at week 3 (≥50% decrease from baseline in the MADRS total score), remission at week 3 (MADRS total score ≤10), and sustained response at 12 weeks (meeting response criteria at week 3 and all subsequent visits).
Results: A total of 79 participants were in the 25-mg group, 75 in the 10-mg group, and 79 in the 1-mg group. The mean MADRS total score at baseline was 32 or 33 in each group. Least-squares mean changes from baseline to week 3 in the score were -12.0 for 25 mg, -7.9 for 10 mg, and -5.4 for 1 mg; the difference between the 25-mg group and 1-mg group was -6.6 (95% confidence interval [CI], -10.2 to -2.9; P<0.001) and between the 10-mg group and 1-mg group was -2.5 (95% CI, -6.2 to 1.2; P = 0.18). In the 25-mg group, the incidences of response and remission at 3 weeks, but not sustained response at 12 weeks, were generally supportive of the primary results. Adverse events occurred in 179 of 233 participants (77%) and included headache, nausea, and dizziness. Suicidal ideation or behavior or self-injury occurred in all dose groups.
Conclusions: In this phase 2 trial involving participants with treatment-resistant depression, psilocybin at a single dose of 25 mg, but not 10 mg, reduced depression scores significantly more than a 1-mg dose over a period of 3 weeks but was associated with adverse effects. Larger and longer trials, including comparison with existing treatments, are required to determine the efficacy and safety of psilocybin for this disorder. (Funded by COMPASS Pathfinder; EudraCT number, 2017-003288-36; ClinicalTrials.gov number, NCT03775200.).
The New England journal of medicine · randomised controlled trial · 786 citationsread the source →
Maternal and child health nurse screening and care for mothers experiencing domestic violence (MOVE): a cluster randomised trial.
Background: Mothers are at risk of domestic violence (DV) and its harmful consequences postpartum. There is no evidence to date for sustainability of DV screening in primary care settings. We aimed to test whether a theory-informed, maternal and child health (MCH) nurse-designed model increased and sustained DV screening, disclosure, safety planning and referrals compared with usual care.
Methods: Cluster randomised controlled trial of 12 month MCH DV screening and care intervention with 24 month follow-up. The study was set in community-based MCH nurse teams (91 centres, 163 nurses) in north-west Melbourne, Australia. Eight eligible teams were recruited. Team randomisation occurred at a public meeting using opaque envelopes. Teams were unable to be blinded. The intervention was informed by Normalisation Process Theory, the nurse-designed good practice model incorporated nurse mentors, strengthened relationships with DV services, nurse safety, a self-completion maternal health screening checklist at three or four month consultations and DV clinical guidelines. Usual care involved government mandated face-to-face DV screening at four weeks postpartum and follow-up as required. Primary outcomes were MCH team screening, disclosure, safety planning and referral rates from routine government data and a postal survey sent to 10,472 women with babies ≤ 12 months in study areas. Secondary outcomes included DV prevalence (Composite Abuse Scale, CAS) and harm measures (postal survey).
Results: No significant differences were found in routine screening at four months (IG 2,330/6,381 consultations (36.5 %) versus CG 1,792/7,638 consultations (23.5 %), RR = 1.56 CI 0.96-2.52) but data from maternal health checklists (n = 2,771) at three month IG consultations showed average screening rates of 63.1 %. Two years post-intervention, IG safety planning rates had increased from three (RR 2.95, CI 1.11-7.82) to four times those of CG (RR 4.22 CI 1.64-10.9). Referrals remained low in both intervention groups (IGs) and comparison groups (CGs) (<1 %). 2,621/10,472 mothers (25 %) returned surveys. No difference was found between arms in preference or comfort with being asked about DV or feelings about self.
Conclusion: A nurse-designed screening and care model did not increase routine screening or referrals, but achieved significantly increased safety planning over 36 months among postpartum women. Self-completion DV screening was welcomed by nurses and women and contributed to sustainability.
Trial registration: Australian New Zealand Clinical Trials Registry, ACTRN12609000424202, 10/03/2009.
BMC medicine · randomised controlled trial · 58 citationsread the source →
Nonsuicidal Self-Injury and Perfectionism: A Systematic Review.
Background: Nonsuicidal self-injury (NSSI) and perfectionism mean a huge concern related to mental health and psychopathology. Recently, there has been a growing interest in research on the exploration of the association of perfectionism and NSSI, but till today there is no systematic review has been prepared in this topic. Aims: Therefore, we performed a systematic literature review of published studies that investigated the association between NSSI and perfectionism. Methods: The systematic search was made on PubMed, OVID Medline, PsychInfo, Scopus, and Web of Science. The search terms were ("nonsuicidal self-injury" OR "nonsuicidal self-injury" OR NSSI OR "self-injury" OR "self-injurious behavior" OR SIB OR "self-harm" OR "deliberate self-harm" OR DSH) AND (perfectionism). The inclusion criteria were as follows: written in English; reported empirical data; used validated self-report measures; investigated the association of nonsuicidal self-injury and perfectionism. There were no restrictions on participants regarding age, gender, race or ethnicity. Exclusion criteria: not written in English; was a review/meta-analysis; measured suicide behavior; measured self-injury irrespective of motivation or suicidal intent; was not about the association between nonsuicidal self-injury and perfectionism. Results: After the screening process, 15 studies were included in our systematic review. The majority of studies (12) were published in the last 10 years. Nine (60%) recruited participants from community samples, four (26.7%) from clinical populations, and two (13.3%) both from community and clinical participants. Fourteen (93.3%) of the studies were cross-sectional studies, and one study contained a longitudinal investigation. The majority of studies included only or mainly female participants (62.3-87.2%) and two studies contained a balanced male-female ratio population. Fourteen (93.3%) studies from the 15 studies found a significant positive association between NSSI and perfectionism. Limitations: The heterogeneity of used instruments makes it difficult to compare the results of involved studies. Only two studies investigated populations with balanced gender ratios. Only two studies examined both clinical and community populations. Clinical investigations enrolled mainly eating-disordered (ED) patients. Conclusions: The results of the current systematic review highlight the role of perfectionism in NSSI engagement. This systematic review may help the development of effective prevention initiatives and treatment strategies.
Frontiers in psychiatry · systematic review · 16 citationsread the source →
Antenatal anxiety disorder as a predictor of postnatal depression: a longitudinal study.
Previous research has implicated high levels of antenatal anxiety as a predictor of postnatal depression, but there is a paucity of evidence on the relationship between the various forms of anxiety and postnatal depression. A longitudinal study of 246 mothers (56 with antenatal generalised anxiety disorder (GAD), 68 with antenatal generalised social phobia, 28 with both disorders in the antenatal period, and 94 with no antenatal GAD or social phobia) allowed us to explore whether antenatal social phobia and GAD predict high Edinburgh Postnatal Depression Scale (EPDS) scores (probable depression >12) at 10-14 days, 10-12 weeks, 10 months, 14 months, and 24 months postnatally. We found that, after accounting for the presence of other antenatal anxiety disorders, antenatal depression, maternal age at child's birth, socio-economic status and ethnicity in the models, antenatal GAD independently predicted depression at all time points after delivery. A less robust relationship was found for antenatal social phobia, which predicted postnatal depression at only 10 months after birth. One possibility consistent with our findings is that there may be differences in the timing of postnatal depression with different forms of antenatal anxiety disorders.
Journal of affective disorders · 68 citationsread the source →
Benefits and Harms of Sodium-Glucose Co-Transporter 2 Inhibitors in Patients with Type 2 Diabetes: A Systematic Review and Meta-Analysis.
Objective: Sodium-glucose co-transporter 2 inhibitors (SGLT2-i) are a novel drug class for the treatment of diabetes. We aimed at describing the maximal benefits and risks associated with SGLT2-i for patients with type 2 diabetes.
Design: Systematic review and meta-analysis.
Data sources and study selection: We included double-blinded, randomised controlled trials (RCTs) evaluating SGLT2-i administered in the highest approved therapeutic doses (canagliflozin 300 mg/day, dapagliflozin 10 mg/day, and empagliflozin 25 mg/day) for ≥12 weeks. Comparison groups could receive placebo or oral antidiabetic drugs (OAD) including metformin, sulphonylureas (SU), or dipeptidyl peptidase 4 inhibitors (DPP-4-i). Trials were identified through electronic databases and extensive manual searches. Primary outcomes were glycated haemoglobin A1c (HbA1c) levels, serious adverse events, death, severe hypoglycaemia, ketoacidosis and CVD. Secondary outcomes were fasting plasma glucose, body weight, blood pressure, heart rate, lipids, liver function tests, creatinine and adverse events including infections. The quality of the evidence was assessed using GRADE.
Results: Meta-analysis of 34 RCTs with 9,154 patients showed that SGLT2-i reduced HbA1c compared with placebo (mean difference -0.69%, 95% confidence interval -0.75 to -0.62%). We downgraded the evidence to 'low quality' due to variability and evidence of publication bias (P = 0.015). Canagliflozin was associated with the largest reduction in HbA1c (-0.85%, -0.99% to -0.71%). There were no differences between SGLT2-i and placebo for serious adverse events. SGLT2-i increased the risk of urinary and genital tract infections and increased serum creatinine, and exerted beneficial effects on bodyweight, blood pressure, lipids and alanine aminotransferase (moderate to low quality evidence). Analysis of 12 RCTs found a beneficial effect of SGLT2-i on HbA1c compared with OAD (-0.20%, -0.28 to -0.13%; moderate quality evidence).
Conclusion: This review includes a large number of patients with type 2 diabetes and found that SGLT2-i reduces HbA1c with a notable increased risk in non-serious adverse events. The analyses may overestimate the intervention benefit due bias.
PloS one · meta-analysis · 174 citationsread the source →
Omega-3 supplementation lowers inflammation in healthy middle-aged and older adults: a randomized controlled trial.
Observational studies have linked lower levels of omega-3 (n-3) polyunsaturated fatty acids (PUFAs) with inflammation and depression. This study was designed to determine whether n-3 supplementation would decrease serum cytokine production and depressive symptoms in 138 healthy middle-aged and older adults (average age=51.04, SD=7.76) who were sedentary and overweight (average BMI=30.59, SD=4.50). This three-arm randomized, placebo-controlled, double-blind 4-month trial compared responses to (1) 2.5 g/d n-3 PUFAs, or (2) 1.25 g/d n-3 PUFAs, or (3) placebo capsules that mirrored the proportions of fatty acids in the typical American diet. Serum interleukin-6 decreased by 10% and 12% in our low and high dose n-3 groups, respectively, compared to a 36% increase in the placebo group. Similarly, low and high dose n-3 groups showed modest 0.2% and -2.3% changes in serum tumor necrosis factor alpha, compared to a 12% increase in the control group. Depressive symptoms were quite low at baseline and did not change significantly in response to supplementation. Our data suggest that n-3 PUFAs can reduce inflammation in overweight, sedentary middle-aged and older adults, and thus could have broad health benefits. These data provide a window into the ways in which the n-3 PUFAs may impact disease initiation, progression, and resolution. ClinicalTrials.gov identifier: NCT00385723.
Brain, behavior, and immunity · randomised controlled trial · 173 citationsread the source →
Leyland-Jones B, Semiglazov V, Pawlicki M, Pienkowski T, Tjulandin S, Manikhas G, Makhson A, Roth A, Dodwell D, Baselga J, Biakhov M, Valuckas K, Voznyi E, Liu X, Vercammen E. (2005)MEDLINE-indexed journal, not yet read by usJournal of clinical oncology : official journal of the American Society of Clinical Oncology · randomised controlled trial Maintaining normal hemoglobin levels with epoetin alfa in mainly nonanemic patients with metastatic breast cancer receiving first-line chemotherapy: a survival study.
Purpose: To evaluate the effect on survival and quality of life of maintaining hemoglobin (Hb) in the range of 12 to 14 g/dL with epoetin alfa versus placebo in women with metastatic breast cancer (MBC) receiving first-line chemotherapy.
Patients and methods: Eligible patients were randomly assigned to receive epoetin alfa 40,000 U once weekly or placebo for 12 months. Study drug was initiated if baseline Hb was < or = 13 g/dL or when Hb decreased to < or = 13g/dL during the study. The primary end point was 12-month overall survival (OS).
Results: The study drug administration was stopped early in accordance with a recommendation from the Independent Data Monitoring Committee because of higher mortality in the group treated with epoetin alfa. Enrollment had been completed, with 939 patients enrolled (epoetin alfa, n = 469; placebo, n = 470). Most patients had Hb more than 12 g/dL at baseline (median Hb, 12.8 g/dL) or during the study. From the final analysis, 12-month OS was 70% for epoetin alfa recipients and 76% for placebo recipients (P = .01). Optimal tumor response and time to disease progression were similar between groups. The reason for the difference in mortality between groups could not be determined from additional subsequent analyses involving both study data and chart review.
Conclusion: In this trial, the use of epoetin alfa to maintain high Hb targets in women with MBC, most of whom did not have anemia at the start of treatment, was associated with decreased survival. Additional research is required to clarify the potential impact of erythropoietic agents on survival when the Hb target range is 10 to 12 g/dL.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology · randomised controlled trial · 475 citationsread the source →
Enhancing oral health via sense of coherence: a cluster-randomized trial.
Sense of coherence (SOC) has been related to oral health behaviors and oral-health-related quality of life (OHRQoL) in observational studies. This cluster-randomized trial aimed to test the effect of an intervention to enhance SOC on OHRQoL in children. Twelve primary schools were randomly allocated to intervention and control groups. The intervention was comprised of 7 sessions over 2 mos, focusing on child participation and empowerment. The first 4 sessions were classroom activities, and the last 3 involved working on healthy school projects. Trained teachers who received a one-day course delivered the intervention. Socio-demographic and clinical data, together with self-reported measures of OHRQoL, SOC, and oral health beliefs, were obtained from 261 total 10- to 12-year-olds (133 in the intervention and 128 in the control groups). Data were collected at baseline, 2 wks after the intervention, and at three-month follow-up. Mixed-effects models indicated that the intervention increased SOC and improved OHRQoL, together with oral health beliefs and gingival health. The findings offer experimental evidence that OHRQoL can be influenced by SOC. SOC may also provide an avenue for oral health promotion (Australian New Zealand Clinical Trials Registry ACTRN12612000547842).
Journal of dental research · randomised controlled trial · 52 citationsread the source →
Raskind MA, Peskind ER, Chow B, Harris C, Davis-Karim A, Holmes HA, Hart KL, McFall M, Mellman TA, Reist C, Romesser J, Rosenheck R, Shih MC, Stein MB, Swift R, Gleason T, Lu Y, Huang GD. (2018)MEDLINE-indexed journal, not yet read by usThe New England journal of medicine · randomised controlled trial Trial of Prazosin for Post-Traumatic Stress Disorder in Military Veterans.
Background: In randomized trials, prazosin, an α1-adrenoreceptor antagonist, has been effective in alleviating nightmares associated with post-traumatic stress disorder (PTSD) in military veterans.
Methods: We recruited veterans from 13 Department of Veterans Affairs medical centers who had chronic PTSD and reported frequent nightmares. Participants were randomly assigned to receive prazosin or placebo for 26 weeks; the drug or placebo was administered in escalating divided doses over the course of 5 weeks to a daily maximum of 20 mg in men and 12 mg in women. After week 10, participants continued to receive prazosin or placebo in a double-blind fashion for an additional 16 weeks. The three primary outcome measures were the change in score from baseline to 10 weeks on the Clinician-Administered PTSD Scale (CAPS) item B2 ("recurrent distressing dreams"; scores range from 0 to 8, with higher scores indicating more frequent and more distressing dreams); the change in score from baseline to 10 weeks on the Pittsburgh Sleep Quality Index (PSQI; scores range from 0 to 21, with higher scores indicating worse sleep quality); and the Clinical Global Impression of Change (CGIC) score at 10 weeks (scores range from 1 to 7, with lower scores indicating greater improvement and a score of 4 indicating no change).
Results: A total of 304 participants underwent randomization; 152 were assigned to prazosin, and 152 to placebo. At 10 weeks, there were no significant differences between the prazosin group and the placebo group in the mean change from baseline in the CAPS item B2 score (between-group difference, 0.2; 95% confidence interval [CI], -0.3 to 0.8; P=0.38), in the mean change in PSQI score (between-group difference, 0.1; 95% CI, -0.9 to 1.1; P=0.80), or in the CGIC score (between-group difference, 0; 95% CI, -0.3 to 0.3; P=0.96). There were no significant differences in these measures at 26 weeks (a secondary outcome) or in other secondary outcomes. At 10 weeks, the mean difference between the prazosin group and the placebo group in the change from baseline in supine systolic blood pressure was a decrease of 6.7 mm Hg. The adverse event of new or worsening suicidal ideation occurred in 8% of the participants assigned to prazosin versus 15% of those assigned to placebo.
Conclusions: In this trial involving military veterans who had chronic PTSD, prazosin did not alleviate distressing dreams or improve sleep quality. (Funded by the Department of Veterans Affairs Cooperative Studies Program; PACT ClinicalTrials.gov number, NCT00532493 .).
The New England journal of medicine · randomised controlled trial · 203 citationsread the source →
The impact of olive oil polyphenol supplementation on metabolic syndrome parameters The OleoMetS study: A randomized, controlled clinical trial.
Background & aims: Olive oil aldehydic phenols (OOPs), including oleocanthal, oleacein, oleuropein aglycone, and ligstroside aglycone, are highly bioactive secoiridoids with unique health-protective properties. Preclinical investigations have demonstrated that OOPs possess anti-inflammatory and antioxidant attributes. The aim of the study was to assess the direct health properties of OOPs as a food supplement in humans diagnosed with metabolic syndrome. Fasting Blood Glucose (FBG) and Hemoglobin A1c (HbA1c) were chosen as primary endpoints because they are key indicators of glucose control, a core aspect of metabolic syndrome. Their combined assessment offers a comprehensive view of both short-term and long-term glucose regulation, making them highly relevant for evaluating interventions.
Methods: This double-blind, randomized, controlled clinical trial screened 110 individuals for eligibility between September 16, 2024, and January 27, 2025. Eight did not meet the inclusion criteria for metabolic syndrome, and 102 eligible participants were randomly assigned to the OOPs supplement or placebo group using a computer-generated randomization sequence to receive either the OOPs supplement or placebo. The 12-week intervention provided either a 10 mg/day polyphenol-rich olive oil extract food supplement (80 % oleocanthal/oleacein, 18 % oleuropein aglycon/ligstroside aglycon) or a placebo. No changes to lifestyle were recommended, and diet and physical activity were assessed at week 6. Fasting blood glucose (FBG) and hemoglobin A1C (HbA1c) were the primary outcomes. Secondary outcomes included lipid profile, C-reactive protein (CRP), body mass index (BMI), blood pressure, waist circumference, liver function tests (LFTs), estimated glomerular filtration rate (eGFR), uric acid, and fatigue scores. Repeated measures ANOVA/Linear Mixed Models were used to compare the mean changes (12 weeks-baseline) in fasting blood glucose levels between the intervention group and the placebo arm. Similar analysis (changes since baseline) was conducted for the continuous secondary outcomes. For categorical outcomes, changes since baseline were compared using chi-square methods. Bonferroni adjustments were made for multiple comparisons as appropriate.
Results: All 102 randomized participants completed the 12-week intervention and were included in the final analysis. The intervention group demonstrated significant improvements across various metabolic and physiological markers compared to the placebo group. Notable reductions were observed in FBG (mean difference: -7.06 mg/dL, p < 0.0001) and HbA1c (-0.29 %, p < 0.0001). Additionally, the intervention led to significant decreases in BMI (-1.15, p < 0.0001), systolic blood pressure (-7.66 mmHg, p = 0.004), triglycerides (-8.57, p = 0.0003), oxidized LDL (-5.01, p < 0.0001), uric acid (-1.04, p < 0.0001), ALT (-4.92, p = 0.0002), and fatigue scores (-16.88, p < 0.0001). A significant increase in eGFR was also noted (+3.38, p = 0.0002).
Conclusion: Supplementation with OOPs shows promise in improving key metabolic markers in patients with MetS. The intervention was well-tolerated, with no serious adverse events reported. Further studies with longer intervention periods, follow-ups, and even higher OOPs dosages are needed to assess the long-term durability and magnitude of the effect.
Trial registration: ClinicalTrials.gov Identifier: NCT07144488.
Clinical nutrition ESPEN · randomised controlled trialread the source →
Gooding P, Pratt D, Edwards D, Awenat Y, Drake RJ, Emsley R, Jones S, Kapur N, Lobban F, Peters S, Boardman B, Harris K, Huggett C, Haddock G. (2025)MEDLINE-indexed journal, not yet read by usThe lancet. Psychiatry · randomised controlled trial Underlying mechanisms and efficacy of a suicide-focused psychological intervention for psychosis, the Cognitive Approaches to Combatting Suicidality (CARMS): a multicentre, assessor-masked, randomised controlled trial in the UK.
Background: There is a need for theoretically grounded and testable suicide-focused psychological therapies, especially in people with severe mental health problems, specifically non-affective psychosis. We aimed to test both the underlying mechanisms and efficacy of a suicide-focused therapy, cognitive behavioural suicide prevention for psychosis (CBSPp).
Methods: We did a multicentre, assessor-masked, randomised controlled trial conducted at four UK National Health Service (NHS) sites. Participants were eligible for enrolment if they were 18 years or older; met ICD-10 criteria for non-affective psychosis (F20-F29); had self-reported suicidal experiences in the 3 months before recruitment; were under the care of an NHS mental health services team; were not receiving a psychological therapy as part of a similar trial; had sufficient competency in the English language not to need an interpreter to participate; and were able to give informed consent. After screening for eligibility and completion of baseline assessments, participants were randomly allocated in a 1:1 ratio to either the treatment as usual group (control) or CBSPp therapy plus standard treatment group (treatment), with stratification by use of antidepressant medication and NHS site. Randomisation took place using an online Sealed Envelope randomisation procedure conducted and overseen by the Manchester Academic Health Sciences Centre Clinical Trials Unit (MCTU). This system was accessed only by specially allocated staff (eg, the CARMS Trial Manager or the MCTU Trial manager). When the system randomly allocated a participant, an unmasked email confirmation was sent to the unmasked coprincipal investigator and the CARMS Trial Manager (also unmasked). Assessors, the trial statistician, and one coprincipal investigator were masked to allocation group. Participants were informed of their randomised allocation group by an unmasked CARMS staff member. Experts-by-experience were involved in all stages of the research. For those in the treatment group, approximately 24 one-to-one therapy sessions were offered, usually weekly, for around 50 min per session. Assessments were conducted at baseline, month 6, and month 12. The primary outcome was suicide ideation severity measured by the 25-item Adult Suicide Ideation Questionnaire (ASIQ), assessed at month 6 relative to baseline. Outcome analyses used mixed models in the intention-to-treat population. Planned mediation indirect linear regression models examined appraisals of poor social support, emotional difficulties, interpersonal problem-solving difficulties, defeat, entrapment, and hopelessness as mediators at 6 months with allocation condition (treatment vs control) as the predictor variable and suicidal ideation severity (ASIQ) at 6 months as the outcome variable, whilst controlling for baseline levels of the mediator and outcome variables. The trial was registered before recruitment at ClinicalTrials.gov (NCT03114917) and ISRCTN (ISRCTN17776666) and is complete.
Findings: We recruited participants from four NHS sites from June 21, 2017, to Nov 25, 2020, with the final 12-month assessment completed on Jan 10, 2022. 479 participants were screened for eligibility, and of these 329 (69%) provided consent and were enrolled. After 69 participants were lost to follow-up, 292 participants were randomly allocated to the treatment and control groups (149 [51%] and 143 [49%], respectively). At baseline, 161 (55%) participants were male and 130 (45%) were female; one participant (<1%) in the treatment group was missing gender data. Mean age was 35·1 years (SD 13·2; range 18-69), and 247 (85%) were White or Caucasian. Severity of suicidal ideation was not statistically different between the treatment (n=136) and the control groups (n=116) at 6 months (p=0·07; Cohen's d -0·20 [95% CI -0·42 to 0·02]). A significant indirect mediation effect (-2·85, -7·00 to -0·23) showed that therapy strengthened social support appraisals which, in turn, reduced suicidal ideation severity at 6 months more in the treatment group than in the control group. Suicide attempts were the most frequent severe adverse event (132 attempts in 26 participants in the treatment group vs 91 attempts in 30 participants in the control group). There were four deaths in the CARMS study, none of which were by suicide or considered related to treatment.
Interpretation: CBSPp had no effect on suicidal ideation at 6 months, but it did have a significant indirect effect via improving appraisals of social support. It is important to explore how suicide-focused therapies can be developed and implemented in mental health services so that they maximally enhance appraisals of social support and social connection in ways that endure.
Funding: Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health and Care Research partnership (reference number: 13/161/25).
The lancet. Psychiatry · randomised controlled trial · 4 citationsread the source →
A pilot randomised controlled trial of metacognitive therapy for prolonged grief
OBJECTIVES: Prolonged grief disorder is associated with significant distress and impairment and thus efforts to improve treatments are essential. The present pilot study tested the efficacy and feasibility of group Metacognitive Grief Therapy (MCGT) designed specifically for prolonged grief symptomatology to reduce the psychological distress and impaired function resulting from bereavement. DESIGN/PARTICIPANTS: Twenty-two bereaved adult participants with prolonged grief symptomatology were randomised to a wait-list control (n=10) or an intervention condition (n=12) with a 3-month and 6-month follow-up. The wait-list control group was offered treatment after the post-test assessment. INTERVENTION: Participants attended six group MCGT sessions that ran for 2 hours per week. OUTCOME MEASURES: A primary outcome measure of prolonged grief symptomatology and secondary outcome measures of depression, anxiety, rumination, metacognitive beliefs and quality of life were taken pretreatment and post-treatment for both groups and at the 3-month and 6-month follow-up for the intervention group. A Generalised Linear Mixed Model was used to assess treatment efficacy. RESULTS: Post-treatment intent-to-treat analyses showed MCGT reduced prolonged grief symptomatology (Cohen's d=1.7), depression (d=1.3), anxiety (d=0.8), stress (d=1.0), rumination (d=0.9) and increased quality of life (d=0.6), and these effects were maintained at the 3-month and 6-month follow-ups. No prepost between-group differences were found in metacognitive beliefs. However, a large significant effect was identified at the 3-month and 6-month follow-ups (d=1.0). CONCLUSION: The results show promise for the utility of group MCGT for reducing psychological distress and promoting quality of life. Additionally, the results underscore the need for a full randomised controlled trial of group MCGT, which may be an important addition to the treatment armamentarium available to support people with prolonged grief. TRIAL REGISTRATION NUMBER: 2015;5:e007221. doi:10.1136/bmjopen-2014-007221.
BMJ Open · randomised controlled trial · 35 citationsread the source →
Peterson AL, Straud CL, Young-McCaughan S, McCallin JP, Hoch M, Roux NP, Koch L, Lara-Ruiz J, Roache JD, Hein JM, Blount TH, STRONG STAR Consortium. (2022)MEDLINE-indexed journal, not yet read by usJournal of traumatic stress · clinical trial Combining a stellate ganglion block with prolonged exposure therapy for posttraumatic stress disorder: A nonrandomized clinical trial.
Prolonged exposure therapy (PE) is an efficacious treatment for active duty service members and veterans with posttraumatic stress disorder (PTSD). However, PE is sometimes associated with high dropout rates, limited tolerability, and temporary symptom exacerbation during treatment. Stellate ganglion blocks (SGBs) are an emerging treatment that has the potential to enhance outcomes for PTSD when combined with trauma-focused psychotherapy. To date, no study of which we are aware has examined the potential additive benefits of SGB injections when administered in conjunction with trauma-focused behavioral treatment for PTSD. Thus, we conducted a nonrandomized clinical trial to evaluate the use of an SGB combined with massed PE therapy for combat-related PTSD. Participants (N = 12) were treated with 10 daily 90-min PE sessions delivered over 2 weeks and received a single SGB injection between Sessions 1 and 2. PE sessions lasted 90 min each. Participants reported a mean posttreatment PTSD symptom reduction of 32 points on the PTSD Checklist for DSM-5 (PCL-5), Hedges' gs = 1.28-2.80. Most participants (90.9%) demonstrated clinically significant change on the PCL-5 (i.e., ≥10 points) by the final treatment session and 50.0% no longer met the diagnostic criteria for PTSD per the Clinician-Administered PTSD Scale for DSM-5 at 1-month follow-up. Adverse events for the combined treatment were consistent with those previously reported for standalone SGB and PE. This combined treatment approach provides promising results for improving the tolerability of trauma-focused therapies, reducing symptom severity, and increasing PTSD remission rates.
Journal of traumatic stress · clinical trial · 10 citationsread the source →
Early response to psychotherapy and long-term change in worry symptoms in older adults with generalized anxiety disorder.
Objectives: To determine the association of early and long-term reductions in worry symptoms after cognitive behavior therapy (CBT) for generalized anxiety disorder (GAD) in older adults.
Design: Substudy of larger randomized controlled trial.
Setting: Family medicine clinic and large multispecialty health organization in Houston, TX, between March 2004 and August 2006.
Participants: Patients (N = 76) aged 60 years or older with a principal or coprincipal diagnosis of GAD, excluding those with significant cognitive impairment, bipolar disorder, psychosis, or active substance abuse.
Intervention: CBT, up to 10 sessions for 12 weeks, or enhanced usual care (regular, brief telephone calls, and referrals to primary care provider as needed).
Measurements: Penn State Worry Questionnaire (PSWQ) administered by telephone at baseline, 1 month (mid treatment), 3 months (posttreatment), and at 3-month intervals through 15 months (1-year follow-up). The authors used binary logistic regression analysis to determine the association between early (1 month) response and treatment responder status (reduction of more than 8.5 points on the PSWQ) at 3 and 15 months. The authors also used hierarchical linear modeling to determine the relationship of early response to the trajectory of score change after posttreatment.
Results: Reduction in PSWQ scores after the first month predicted treatment response at posttreatment and follow-up, controlling for treatment arm and baseline PSWQ score. The magnitude of early reduction also predicted the slope of score change from posttreatment through the 15-month assessment.
Conclusion: Early symptom reduction is associated with long-term outcomes after psychotherapy in older adults with GAD.
The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry · randomised controlled trial · 25 citationsread the source →
Mottillo S, Filion KB, Bélisle P, Joseph L, Gervais A, O'Loughlin J, Paradis G, Pihl R, Pilote L, Rinfret S, Tremblay M, Eisenberg MJ. (2009)MEDLINE-indexed journal, not yet read by usEuropean heart journal · meta-analysis Behavioural interventions for smoking cessation: a meta-analysis of randomized controlled trials.
Aims: Widely varying estimates of treatment effects have been reported in randomized controlled trials (RCTs) investigating the efficacy of behavioural interventions for smoking cessation. Previous meta-analyses investigating behavioural interventions have important limitations and do not include recently published RCTs. We undertook a meta-analysis of RCTs to synthesize the treatment effects of four behavioural interventions, including minimal clinical intervention (brief advice from a healthcare worker), and intensive interventions, including individual, group, and telephone counselling.
Methods and results: We searched the CDC Tobacco Information and Prevention, Cochrane Library, EMBASE, Medline, and PsycINFO databases. We included only RCTs that reported biochemically validated smoking cessation outcomes at 6 and/or 12 months after the target quit date. Outcomes were aggregated using hierarchical Bayesian random-effects models. We identified 50 RCTs, which randomized n = 26 927 patients (minimal clinical intervention: 9 RCTs, n = 6456; individual counselling: 23 RCTs, n = 8646; group counselling: 12 RCTs, n = 3600; telephone counselling: 10 RCTs, n = 8225). The estimated mean treatment effects were minimal clinical intervention [odds ratio (OR) 1.50, 95% credible interval (CrI) 0.84-2.78], individual counselling (OR 1.49, 95% CrI 1.08-2.07), group counselling (OR 1.76, 95% CrI 1.11-2.93), and telephone counselling (OR 1.58, 95% CrI 1.15-2.29).
Conclusion: Intensive behavioural interventions result in substantial increases in smoking abstinence compared with control. Although minimal clinical intervention may increase smoking abstinence, there is insufficient evidence to draw strong conclusions regarding its efficacy.
European heart journal · meta-analysis · 102 citationsread the source →
Very early poststroke aphasia therapy: a pilot randomized controlled efficacy trial.
Background and purpose: Early stroke rehabilitation has shown benefits over spontaneous recovery. Insufficient evidence exists to determine the benefits of early aphasia intervention. We hypothesized that daily aphasia therapy would show better communication outcomes than usual care (UC) in early poststroke recovery.
Method: This prospective, randomized, single-blinded, controlled trial was conducted in three acute-care hospitals in Perth, Australia, each with over 200 stroke admissions annually. Patients with acute stroke causing moderate to severe aphasia were recruited at a median of three-days (range: 0-10 days) to receive daily aphasia therapy or usual care therapy. Individually tailored, impairment-based intervention was provided for the acute hospital stay or intervention phase (median: 19 days; range: 5-76). Primary outcome measures were the aphasia quotient and functional communication profile at acute hospital discharge or four-weeks poststroke, whichever came first. A random-number generator and sealed envelopes were used to randomize participants. Assessments were completed by a blinded assessor.
Results: Fifty-nine participants were recruited, with six withdrawals (10%) and seven deaths (12%) at six-months. Ninety percent had ischemic strokes, with 56·5% experiencing a total anterior circulation stroke. The group mean (± SD) age was 69·1 (± 13·9) years. Six participants (18·75%) in the daily aphasia therapy group did not complete the minimum (150 min) therapy required for this study. The daily aphasia therapy intervention phase mean therapy session time was 45 min (range: 30-80) and the total mean amount of therapy for the daily aphasia therapy participants was 331 min (range: 30-1415). Four (15%) participants in the usual care group received therapy. The collective total therapy provided to these participants was 295 min over seven sessions. Usual care participants received an average of 10·5 min of therapy per week during the intervention phase. At the primary end point, a generalized estimating equations model demonstrated that after controlling for initial aphasia severity, participants receiving daily aphasia therapy scored 15·1 more points (P = 0·010) on the aphasia quotient and 11·3 more points (P = 0·004) on the functional communication profile than those receiving usual care therapy.
Conclusions: Daily aphasia therapy in very early stroke recovery improved communication outcomes in people with moderate to severe aphasia.
International journal of stroke : official journal of the International Stroke Society · randomised controlled trial · 60 citationsread the source →
Effectiveness of behaviour change techniques in physiotherapy interventions to promote physical activity adherence in lower limb osteoarthritis patients: A systematic review.
Background: Lower limb osteoarthritis (OA) causes high levels of individual pain and disability and is an increasing socio-economic burden to global healthcare systems. Physical Activity interventions are commonly provided by physiotherapists to help patients with lower limb OA manage their clinical symptoms.
Objective: To identify and evaluate the effectiveness of behavioural change techniques (BCTs) within physiotherapy interventions to increase physical activity (PA) adherence in patients with lower limb OA.
Design: A systematic review was conducted, following Cochrane guidelines according to a published and registered protocol (CRD42016039932). Two independent researchers conducted searches, determined eligibility, assessed risk of bias (Cochrane tool), intervention fidelity (NIHBCC checklist), and coded randomised controlled trials (RCTs) for BCTs (V1 taxonomy). BCT effectiveness ratios were calculated and RCT risk of bias and intervention fidelity were summarised narratively.
Data sources: A highly sensitive search strategy was conducted on Medline, Embase, PsycINFO, CENTRAL, CINAHL and PEDro and grey literature databases from inception to January 2nd, 2018. Reference lists of included RCTs and relevant articles were reviewed, and a citation search was conducted using Web of Science.
Eligibility criteria for selecting studies: RCTs that evaluated the effectiveness of a physiotherapy intervention that incorporated ≥1 BCT that promoted home or community-based PA adherence in patients with lower limb osteoarthritis.
Results: Twenty-four RCTs (n = 2366 participants) of variable risk of bias (RoB) (5 low; 7 moderate; 12 high) and poor intervention reporting from 10 countries were included. Heterogeneity of intervention BCTs and PA adherence outcome measures precluded meta-analysis. Thirty-one distinct BCTs were identified in 31 interventions across RCTs. In general, BCTs demonstrated higher effectiveness ratios for short-term and long-term PA adherence compared with medium-term outcomes. The BCTs 'behavioural contract', 'non-specific reward', 'patient-led goal setting' (behaviour), 'self-monitoring of behaviour', and 'social support (unspecified) demonstrated the highest effectiveness ratios across time points to promote PA adherence.
Conclusions: BCTs demonstrate higher short and long-term than medium-term effectiveness ratios. Further research involving low RoB RCTs incorporating transparently reported interventions with pre-specified BCTs aimed at optimising lower limb OA patient PA adherence is required.
PloS one · systematic review · 81 citationsread the source →
Randomized controlled trial of a web-based computer-tailored smoking cessation program as a supplement to nicotine patch therapy.
Aim: To assess the efficacy of World Wide Web-based tailored behavioral smoking cessation materials among nicotine patch users.
Design: Two-group randomized controlled trial.
Setting: World Wide Web in England and Republic of Ireland.
Participants: A total of 3971 subjects who purchased a particular brand of nicotine patch and logged-on to use a free web-based behavioral support program.
Intervention: Web-based tailored behavioral smoking cessation materials or web-based non-tailored materials.
Measurements: Twenty-eight-day continuous abstinence rates were assessed by internet-based survey at 6-week follow-up and 10-week continuous rates at 12-week follow-up.
Findings: Using three approaches to the analyses of 6- and 12-week outcomes, participants in the tailored condition reported clinically and statistically significantly higher continuous abstinence rates than participants in the non-tailored condition. In our primary analyses using as a denominator all subjects who logged-on to the treatment site at least once, continuous abstinence rates at 6 weeks were 29.0% in the tailored condition versus 23.9% in the non-tailored condition (OR = 1.30; P = 0.0006); at 12 weeks continuous abstinence rates were 22.8% versus 18.1%, respectively (OR = 1.34; P = 0.0006). Moreover, satisfaction with the program was significantly higher in the tailored than in the non-tailored condition.
Conclusions: The results of this study demonstrate a benefit of the web-based tailored behavioral support materials used in conjunction with nicotine replacement therapy. A web-based program that collects relevant information from users and tailors the intervention to their specific needs had significant advantages over a web-based non-tailored cessation program.
Addiction (Abingdon, England) · randomised controlled trial · 191 citationsread the source →
A longitudinal analysis of emotional impact, coping strategies and post-traumatic psychological growth following spinal cord injury: a 10-year review.
Objectives: To review emotional impact, psychological growth and coping strategies in a sample of traumatic spinal cord injured people from 12 weeks post-injury to 10 years post-hospital discharge.
Design: Longitudinal, multiple wave panel design.
Methods: Eighty-seven people with traumatically acquired spinal cord injuries were assessed at 12 weeks post-injury and followed up 10 years later (43% of the original sample responded). The Beck Depression Inventory, the State Anxiety Inventory, the COPE Scale, the Functional Independence Measure and the Social Support Inventory were completed on both occasions.
Results: Rates of anxiety and depression had changed little over the 10-year period. Two-thirds of the sample showed no signs or symptoms of depression. Coping strategies remained relatively stable over time, statistically significant regression models (coping strategies at week 12 post-injury) predicted one-third of the variance in depression at year 10. Rates of post-traumatic psychological growth were associated with higher levels of psychological distress.
Conclusions: These results suggest that many people living with spinal cord injury manage the consequences of their disability without significant levels of psychopathology. However, the coping strategies they employ remain critical in accounting for this adjustment. The relationship between post-traumatic growth and psychological well-being was found to be complex, raising many questions for future research.
British journal of health psychology · review · 155 citationsread the source →
Cost-effectiveness of a national exercise referral programme for primary care patients in Wales: results of a randomised controlled trial.
Background: A recent HTA review concluded that there was a need for RCTs of exercise referral schemes (ERS) for people with a medical diagnosis who might benefit from exercise. Overall, there is still uncertainty as to the cost-effectiveness of ERS. Evaluation of public health interventions places challenges on conventional health economics approaches. This economic evaluation of a national public health intervention addresses this issue of where ERS may be most cost effective through subgroup analysis, particularly important at a time of financial constraint.
Method: This economic analysis included 798 individuals aged 16 and over (55% of the randomised controlled trial (RCT) sample) with coronary heart disease risk factors and/or mild to moderate anxiety, depression or stress. Individuals were referred by health professionals in a primary care setting to a 16 week national exercise referral scheme (NERS) delivered by qualified exercise professionals in local leisure centres in Wales, UK. Health-related quality of life, health care services use, costs per participant in NERS, and willingness to pay for NERS were measured at 6 and 12 months.
Results: The base case analysis assumed a participation cost of £385 per person per year, with a mean difference in QALYs between the two groups of 0.027. The incremental cost-effectiveness ratio was £12,111 per QALY gained. Probabilistic sensitivity analysis demonstrated an 89% probability of NERS being cost-effective at a payer threshold of £30,000 per QALY. When participant payments of £1 and £2 per session were considered, the cost per QALY fell from £12,111 (base case) to £10,926 and £9,741, respectively. Participants with a mental health risk factor alone or in combination with a risk of chronic heart disease generated a lower ICER (£10,276) compared to participants at risk of chronic heart disease only (£13,060).
Conclusions: Results of cost-effectiveness analyses suggest that NERS is cost saving in fully adherent participants. Though full adherence to NERS (62%) was higher for the economics sample than the main sample (44%), results still suggest that NERS can be cost-effective in Wales with respect to existing payer thresholds particularly for participants with mental health and CHD risk factors.
Trial registration: Current Controlled Trials ISRCTN47680448.
BMC public health · randomised controlled trial · 31 citationsread the source →
Intermittent Fasting with or without Exercise Prevents Weight Gain and Improves Lipids in Diet-Induced Obese Mice.
Intermittent fasting (IF) and high intensity interval training (HIIT) are effective lifestyle interventions for improving body composition and overall health. However, the long-term effects of IF and potential synergistic effects of combining IF with exercise are unclear. The purpose of the study was to investigate the long-term effects of IF, with or without HIIT, on body composition and markers of metabolic health in diet-induced obese mice. In a randosmised, controlled design, 8-week-old C57BL/6 mice (males (n = 39) and females (n = 49)) were fed a high fat (HF) and sugar (S) water diet (30% (w/v)) for 24-weeks but were separated into five groups at 12-weeks: (1) 'obese' baseline control (OBC); (2) no intervention (CON); (3) intermittent fasting (IF); (4) high intensity intermittent exercise (HIIT) and (5) combination of dietary and exercise intervention (IF + HIIT). Body composition, strength and blood variables were measured at 0, 10 and/or 12-weeks. Intermittent fasting with or without HIIT resulted in significantly less weight gain, fat mass accumulation and reduced serum low density lipoproteins (LDL) levels compared to HIIT and CON male mice (p < 0.05). The results suggest that IF, with or without HIIT, can be an effective strategy for weight gain prevention despite concurrently consuming a high fat and sugar diet.
Nutrients · cohort or longitudinal · 35 citationsread the source →
Young adult mental health and functional outcomes among individuals with remitted, persistent and late-onset ADHD.
Background: Attention-deficit hyperactivity disorder (ADHD) is associated with mental health problems and functional impairment across many domains. However, how the longitudinal course of ADHD affects later functioning remains unclear. AimsWe aimed to disentangle how ADHD developmental patterns are associated with young adult functioning.
Method: The Environmental Risk (E-Risk) Longitudinal Twin Study is a population-based cohort of 2232 twins born in England and Wales in 1994-1995. We assessed ADHD in childhood at ages 5, 7, 10 and 12 years and in young adulthood at age 18 years. We examined three developmental patterns of ADHD from childhood to young adulthood - remitted, persistent and late-onset ADHD - and compared these groups with one another and with non-ADHD controls on functioning at age 18 years. We additionally tested whether group differences were attributable to childhood IQ, childhood conduct disorder or familial factors shared between twins.
Results: Compared with individuals without ADHD, those with remitted ADHD showed poorer physical health and socioeconomic outcomes in young adulthood. Individuals with persistent or late-onset ADHD showed poorer functioning across all domains, including mental health, substance misuse, psychosocial, physical health and socioeconomic outcomes. Overall, these associations were not explained by childhood IQ, childhood conduct disorder or shared familial factors.
Conclusions: Long-term associations of childhood ADHD with adverse physical health and socioeconomic outcomes underscore the need for early intervention. Young adult ADHD showed stronger associations with poorer mental health, substance misuse and psychosocial outcomes, emphasising the importance of identifying and treating adults with ADHD.Declaration of interestNone.
The British journal of psychiatry : the journal of mental science · cohort or longitudinal · 50 citationsread the source →
Nonsuicidal self-injury in adolescence: longitudinal course, trajectories, and intrapersonal predictors.
Although prevalence rates of nonsuicidal self-injury (NSSI) has been established throughout adolescence, little is known about the progression of NSSI, and consequently, about the risk factors for youth NSSI engagement. This study aimed to describe the overall longitudinal course of NSSI and the latent trajectory classes of NSSI in a population-based sample of adolescents using multi-wave data. Moreover, this study examined whether sex, lifetime history of depression, rumination, and negative attributional style predicted the longitudinal course of NSSI and trajectory group membership. Participants were 617 Chinese adolescents in Grades 10 through 12 (51.4 % girls). NSSI was assessed across eight waves of data. History of depression, rumination, and negative attributional style were assessed at baseline. Latent growth curve modeling revealed that only lifetime depression predicted the longitudinal course of NSSI from Grades 10 to 12, with depressed adolescents showing greater and more stable NSSI engagement over time than non-depressed adolescents. Group-based trajectory modeling yielded three distinct trajectory classes of NSSI engagement: low (69.2 %), moderate (26.1 %), and chronic (4.7 %). Negative attributional style distinguished adolescents in the chronic vs. low and moderate NSSI trajectory classes. Sex, rumination, and lifetime depression predicted membership in the chronic and/or moderate vs. low NSSI trajectory class. NSSI trajectory classes, based on frequency of NSSI, exist and are differentiated by sex, depression history, rumination, and negative attributional style. This study suggests that during this period of adolescence NSSI may be a relatively stable behavior, especially for some adolescents. Negative attributional style may be a salient risk factor for chronic NSSI engagement.
Journal of abnormal child psychology · 119 citationsread the source →
Happy Family Kitchen II: a cluster randomized controlled trial of a community-based positive psychology family intervention for subjective happiness and health-related quality of life in Hong Kong.
Background: Most positive psychology interventions conducted in the West have been focused on the individual. Family relationships are highly valued in the Chinese collectivist culture, and it is of interest to know whether family-focused interventions can improve the well-being of Chinese people. We have previously reported the effectiveness of a positive psychology family intervention in terms of family well-being. Based on the data derived from the Happy Family Kitchen II project, this paper examines the effectiveness of a community-based positive psychology family intervention on subjective happiness and health-related quality of life.
Methods: Thirty-one social service units and schools organized intervention programs for 2070 participants in Hong Kong. In a cluster randomized controlled trial, participants were randomly assigned on the basis of computer-generated numbers into the intervention group or the control group. The intervention programs emphasized one of five positive psychology themes: joy, gratitude, flow, savoring, and listening. The control group engaged in activities unrelated to the intervention, such as arts and crafts workshops. Subjective happiness and mental and physical quality of life were assessed at baseline and at 4 weeks and 12 weeks postintervention.
Results: Data of 1261 participants were analyzed. The results showed that the intervention was more effective than the control condition in improving subjective happiness, with a small effect size, at 12 weeks postintervention (β = .15, p = .020, Cohen's d = .16). However, there were no improvements in mental and physical quality of life in the intervention group compared with the control group at 4 weeks (β = .39, p = .494, d = .05; β = -.10, p = 1.000, d = -.01, respectively) and 12 weeks postintervention (β = .71, p = .233, d = .08; β = -.05, p = 1.000, d = -.01, respectively). Furthermore, the booster session was no more effective than the tea gathering session in improving subjective happiness (β = .00, p = .990, d = .00) or mental (β = 1.20, p = 1.000, d = -.04) and physical quality of life (β = .15, p = 1.000, d = -.01).
Conclusions: The analyses extend previous findings of salutary effects on family well-being by showing that positive psychology family interventions can improve subjective happiness. Suggestions for future research are proposed.
Trial registration: ClinicalTrials.gov NCT01796275 . Retrospectively registered 19 February 2013.
Trials · randomised controlled trial · 9 citationsread the source →
Gooderham MJ, Forman SB, Bissonnette R, Beebe JS, Zhang W, Banfield C, Zhu L, Papacharalambous J, Vincent MS, Peeva E. (2019)MEDLINE-indexed journal, not yet read by usJAMA dermatology · randomised controlled trial Efficacy and Safety of Oral Janus Kinase 1 Inhibitor Abrocitinib for Patients With Atopic Dermatitis: A Phase 2 Randomized Clinical Trial.
Importance: Atopic dermatitis is associated with substantial patient and caregiver burden. Currently available treatments for atopic dermatitis are inadequate or contraindicated for some patients. Abrocitinib (PF-04965842) is an oral Janus kinase 1 selective inhibitor under investigation for the treatment of atopic dermatitis.
Objective: To investigate the efficacy and safety of abrocitinib for patients with moderate to severe atopic dermatitis.
Design, setting, and participants: A phase 2b, randomized, double-blinded, placebo-controlled, parallel-group trial was conducted from April 15, 2016, to April 4, 2017, at 58 centers in Australia, Canada, Germany, Hungary, and the United States among 267 patients 18 to 75 years of age with a clinical diagnosis of moderate to severe atopic dermatitis for 1 year or more and inadequate response or contraindication to topical medications for 4 weeks or more within 12 months. Efficacy was assessed in the full analysis set, which was a modified intention-to-treat population that included all patients who received 1 dose or more of the study drug except for 4 patients from 1 site.
Interventions: Participants were randomly assigned 1:1:1:1:1 to receive abrocitinib (200 mg, 100 mg, 30 mg, or 10 mg) or placebo once daily for 12 weeks.
Main outcomes and measures: The primary outcome was the proportion of patients achieving an Investigator's Global Assessment of clear (0) or almost clear (1) with an improvement from baseline of 2 grades or more at week 12. The secondary outcome was the percentage change from baseline in the Eczema Area and Severity Index at week 12.
Results: Of the 267 participants, 144 were women (mean [SD] age, 40.8 [16.1] years). At week 12, 21 of 48 patients receiving 200 mg of abrocitinib (43.8%; P < .001, 2-sided), 16 of 54 patients receiving 100 mg of abrocitinib (29.6%; P < .001), and 3 of 52 patients receiving placebo (5.8%) achieved grades of clear or almost clear on the Investigator's Global Assessment scale with improvement of 2 grades or more; these rates correspond to maximum effect model-based estimates of 44.5% (95% CI, 26.7%-62.3%) for those receiving 200 mg of abrocitinib, 27.8% (95% CI, 14.8%-40.9%) for those receiving 100 mg of abrocitinib, and 6.3% (95% CI, -0.2% to 12.9%) for those receiving placebo. Reductions in the Eczema Area and Severity Index were 82.6% (90% CI, 72.4%-92.8%; P < .001) for those receiving 200 mg of abrocitinib, 59.0% (90% CI, 48.8%-69.3%; P = .009) for those receiving 100 mg of abrocitinib, and 35.2% (90% CI, 24.4%-46.1%) for those receiving placebo. Adverse events were observed in 184 of 267 patients (68.9%); the most frequently reported adverse events (in ≥3 patients in any group) were dermatitis atopic, upper respiratory tract infection, headache, nausea, and diarrhea. Dose-dependent decreases in platelet count were observed but trended upward toward baseline levels after week 4.
Conclusions and relevance: Once-daily oral abrocitinib was effective and well tolerated for short-term use in adults with moderate to severe atopic dermatitis. Additional trials are necessary to evaluate long-term efficacy and safety.
Trial registration: ClinicalTrials.gov identifier: NCT02780167.
JAMA dermatology · randomised controlled trial · 197 citationsread the source →
Partnering faith leaders with community health workers increases utilization of antenatal care and facility delivery services in Ethiopia: A cluster randomized trial.
Background: Ethiopia and other countries continue to experience high rates of maternal mortality and neonatal deaths. Interventions are needed to increase utilization of antenatal care (ANC) and facility delivery services to improve outcomes.
Methods: A cluster-randomized trial was conducted in the Amhara Region of Ethiopia, with 6 communities randomly assigned to receive the intervention and 12 communities monitored as controls. Intervention teams provided outreach to pregnant women and their families. Registry data were used to measure utilization of services provided at health centers in intervention and control communities. The intervention consisted of trained pairs of community health workers and Ethiopian Orthodox priests who worked together to promote health messages around safe delivery. The pairs visited pregnant women and their families in their homes to provide counseling, discuss concerns, and answer questions about ANC and facility deliveries. Intervention impact was measured using facility-level data on monthly number of ANC visits and facility deliveries at the health centers that served the intervention and control communities. Intervention effect was measured using difference-in-difference analyses estimated by generalized estimating equation models.
Results: During the 12-month intervention period, intervention facilities (n = 6) recorded 14% more ANC1 visits (relative risk RR = 1.14; 95% confidence interval (CI) = 1.09-1.19; P < 0.001) and 26% more ANC4 visits (RR = 1.26; 95%CI = 1.18, 1.34; P < 0.001) compared to control health centers (n = 12). The intervention health centers experienced a 10% increase in facility deliveries over what would have been expected had the intervention not occurred (RR = 1.10; 95% CI = 1.05-1.16; P < 0.001).
Conclusions: Promotion of safe delivery through home visits by community health workers paired with Ethiopian Orthodox priests increased utilization of ANC and facility delivery services. This approach could leverage the influential role of faith leaders and increase the impact of community health workers in Ethiopia.
Trial registration: NCT04039932.
Journal of global health · randomised controlled trial · 8 citationsread the source →
A novel cognitive-behavioral stress management method for multiple sclerosis. A brief report of an observational study.
Objectives: Psychological stress is an important risk factor for multiple sclerosis (MS) onset, relapse, neurological symptoms and psychosocial adjustment to the disease. Mounting evidence suggests that stress management could halt the disease progression and improve patients' wellbeing. The aim of this study was to investigate the effectiveness of a novel cognitive-behavioral stress management technique (called Pythagorean Self-Awareness Intervention - PSAI) routinely used in our clinics in patients with MS.
Methods: In this observational study, 148 MS patients receiving PSAI for 8-weeks were compared patients who followed only usual care. Measurements included cognitive function, psychological distress and physical fatigue. Propensity score (PS) methods (given the observational design) and linear mixed models were employed to address study's endpoints.
Results: A total of 128 (86.5%) of MS patients fulfilled the PS criteria for analyses (72 in the PSAI group and 56 in the control group). Patients of tertiary education, longer disease duration, higher cognitive score and psychological distress were more likely to choose to participate in the PSAI group. PSAI patients were found with statistical significant beneficial changes in cognitive speed processing, verbal memory, stress, anxiety, depression and fatigue. Based on the numbers-needed-to-treat of the weighted data, PSAI was particularly effective in improving cognitive speed processing (NNT = 10) and stress (NNT = 12).
Discussion: PSAI can benefit cognitive function and psychological distress in MS patients. Future studies should expand these results in randomized trials and by using longer follow-up and MS activity-related endpoints.
Abbreviations: BICAMS: Brief International Cognitive Assessment for Multiple Sclerosis BVMT-R: Brief Visuospatial Memory Test Revised CVLT: California Verbal Learning Test DASS: Depression Anxiety Stress Scale EDSS: Expanded Disability Status Scale MS: Multiple Sclerosis NNT: Numbers Needed to Treat PS: Propensity Score PSAI: Pythagorean Self-Awareness Intervention RR: Relapsing Remitting SDMT: Symbol Digits Modalities Test VAS-PF: Visual Analogue Scale Physical Fatigue.
Neurological research · cohort or longitudinal · 10 citationsread the source →
A pilot randomized trial of metacognitive therapy vs applied relaxation in the treatment of adults with generalized anxiety disorder.
Metacognitive Therapy (MCT) and Applied Relaxation (AR) were compared in a pilot treatment trial of generalized anxiety disorder (GAD). Twenty outpatients meeting criteria for DSM-IV-TR GAD were assessed before treatment, after treatment and at 6 m and 12 m follow-up. The patients were randomized and treated individually for 8-12 weekly sessions. There was no drop-out from MCT and 10% at 6 m follow-up from AR. At post-treatment and at both follow-up points MCT was superior to AR. Standardized recovery rates for MCT at post-treatment were 80% on measures of worry and trait-anxiety compared with 10% following AR. At 6 m follow-up recovery rates for MCT were 70% on both measures compared with 10% and 20% for AR. At 12 m follow-up recovery rates for MCT were 80% (worry) and 60% (trait-anxiety) compared with 10% and 20% following AR. The recovery rates for MCT are similar to those obtained in an earlier uncontrolled trial (Wells & King, 2006). The effect sizes and standardized recovery rates for MCT suggest that it is a highly effective treatment.
Behaviour research and therapy · randomised controlled trial · 79 citationsread the source →