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Therapist guided internet based cognitive behavioural therapy for body dysmorphic disorder: single blind randomised controlled trial.

Objectives: To evaluate the efficacy of therapist guided internet based cognitive behavioural therapy (CBT) programme for body dysmorphic disorder (BDD-NET) compared with online supportive therapy. Design: A 12 week single blind parallel group randomised controlled trial. Setting: Academic medical centre. Participants: 94 self referred adult outpatients with a diagnosis of body dysmorphic disorder and a modified Yale-Brown obsessive compulsive scale (BDD-YBOCS) score of ≥ 20. Concurrent psychotropic drug treatment was permitted if the dose had been stable for at least two months before enrolment and remained unchanged during the trial. Interventions: Participants received either BDD-NET (n=47) or supportive therapy (n=47) delivered via the internet for 12 weeks. Main outcome measures: The primary outcome was the BDD-YBOCS score after treatment and follow-up (three and six months from baseline) as evaluated by a masked assessor. Responder status was defined as a ≥ 30% reduction in symptoms on the scale. Secondary outcomes were measures of depression (MADRS-S), global functioning (GAF), clinical global improvement (CGI-I), and quality of life (EQ5D). The six month follow-up time and all outcomes other than BDD-YBOCS and MADRS-S at 3 months were not pre-specified in the registration at clinicaltrials.gov because of an administrative error but were included in the original trial protocol approved by the regional ethics committee before the start of the trial. Results: BDD-NET was superior to supportive therapy and was associated with significant improvements in severity of symptoms of body dysmorphic disorder (BDD-YBOCS group difference -7.1 points, 95% confidence interval -9.8 to -4.4), depression (MADRS-S group difference -4.5 points, -7.5 to -1.4), and other secondary measures. At follow-up, 56% of those receiving BDD-NET were classed as responders, compared with 13% receiving supportive therapy. The number needed to treat was 2.34 (1.71 to 4.35). Self reported satisfaction was high. Conclusions: CBT can be delivered safely via the internet to patients with body dysmorphic disorder. BDD-NET has the potential to increase access to evidence based psychiatric care for this mental disorder, in line with NICE priority recommendations. It could be particularly useful in a stepped care approach, in which general practitioner or other mental health professionals can offer treatment to people with mild to moderate symptoms at low risk of suicide. Trial registration ClinicalTrials.gov ID: NCT02010619.

BMJ (Clinical research ed.) · randomised controlled trial · 77 citationsread the source →

Decompressive Surgery for the Treatment of Malignant Infarction of the Middle Cerebral Artery (DESTINY): a randomized, controlled trial.

Background and purpose: Decompressive surgery (hemicraniectomy) for life-threatening massive cerebral infarction represents a controversial issue in neurocritical care medicine. We report here the 30-day mortality and 6- and 12-month functional outcomes from the DESTINY trial. Methods: DESTINY (ISRCTN01258591) is a prospective, multicenter, randomized, controlled, clinical trial based on a sequential design that used mortality after 30 days as the first end point. When this end point was reached, patient enrollment was interrupted as per protocol until recalculation of the projected sample size was performed on the basis of the 6-month outcome (primary end point=modified Rankin Scale score, dichotomized to 0 to 3 versus 4 to 6). All analyses were based on intention to treat. Results: A statistically significant reduction in mortality was reached after 32 patients had been included: 15 of 17 (88%) patients randomized to hemicraniectomy versus 7 of 15 (47%) patients randomized to conservative therapy survived after 30 days (P=0.02). After 6 and 12 months, 47% of patients in the surgical arm versus 27% of patients in the conservative treatment arm had a modified Rankin Scale score of 0 to 3 (P=0.23). Conclusions: DESTINY showed that hemicraniectomy reduces mortality in large hemispheric stroke. With 32 patients included, the primary end point failed to demonstrate statistical superiority of hemicraniectomy, and the projected sample size was calculated to 188 patients. Despite this failure to meet the primary end point, the steering committee decided to terminate the trial in light of the results of the joint analysis of the 3 European hemicraniectomy trials.

Stroke · randomised controlled trial · 552 citationsread the source →

Psychosocial interventions following self-harm in adults: a systematic review and meta-analysis.

Background: Self-harm (intentional acts of non-fatal self-poisoning or self-injury) is common, particularly in young adults aged 15-35 years, often repeated, and strongly associated with suicide. Effective aftercare of individuals who self-harm is therefore important. We have undertaken a Cochrane systematic review and meta-analysis of the effectiveness of psychosocial interventions for self-harm in adults. Methods: We searched five electronic databases (CCDANCTR-Studies and References, CENTRAL, MEDLINE, Embase, and PsycINFO) between Jan 1, 1998, and April 29, 2015, for randomised controlled trials of psychosocial interventions for adults after a recent (within 6 months) episode of self-harm. Most interventions were assessed in single trials. We report results for interventions for which at least three randomised controlled trials comparing interventions with treatment as usual have been published and hence might contribute to clinical guidance. The primary outcome was repetition of self-harm at the conclusion of treatment and at 6, 12, and 24 months' follow-up analysed, when available, with the intention-to-treat method; if this was not possible, we analysed with all available case data. Findings: We identified 29 non-overlapping randomised controlled trials with three independent trials of the same intervention. Cognitive-behavioural-based psychotherapy (CBT; comprising cognitive-behavioural and problem-solving therapy) was associated with fewer participants repeating self-harm at 6 months' (odds ratio 0·54, 95% CI 0·34-0·85; 12 trials; n=1317) and at 12 months' follow-up (0·80, 0·65-0·98; ten trials; n=2232). There were also significant improvements in the secondary outcomes of depression, hopelessness, suicidal ideation, and problem solving. Patients receiving dialectical behaviour therapy (in three trials) were not less likely to repeat self-harm compared with those provided with treatment as usual at 6 months (odds ratio [OR] 0·59, 95% CI 0·16-2·15; n=267, three trials) or at 12 months (0·36, 0·05-2·47; n=172, two trials). However, the secondary endpoint of frequency of self-harm was associated with a significant reduction with use of dialectical behaviour therapy (mean difference -18·82, 95% CI -36·68 to -0·95). Four trials each of case management (OR 0·78, 95% CI 0·47-1·30; n=1608) and sending regular postcards (OR 0·87, 95% CI 0·62-1·23; n=3277) did not reduce repetition of self-harm. Interpretation: CBT seems to be effective in patients after self-harm. Dialectical behaviour therapy did not reduce the proportion of patients repeating self-harm but did reduce the frequency of self-harm. However, aside from CBT, there were few trials of other promising interventions, precluding firm conclusions as to their effectiveness. Funding: National Institute for Health Research.

The lancet. Psychiatry · meta-analysis · 141 citationsread the source →

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 →

A randomized controlled trial of the Korean version of the PEERS(®) parent-assisted social skills training program for teens with ASD.

Impaired social functioning is a hallmark feature of autism spectrum disorder (ASD), often requiring treatment throughout the life span. PEERS(®) (Program for the Education and Enrichment of Relational Skills) is a parent-assisted social skills training for teens with ASD. Although PEERS(®) has an established evidence base in improving the social skills of adolescents and young adults with ASD in North America, the efficacy of this treatment has yet to be established in cross-cultural validation trials. The objective of this study is to examine the feasibility and treatment efficacy of a Korean version of PEERS(®) for enhancing social skills through a randomized controlled trial (RCT).The English version of the PEERS(®) Treatment Manual (Laugeson & Frankel, 2010) was translated into Korean and reviewed by 21 child mental health professionals. Items identified as culturally sensitive were surveyed by 447 middle school students, and material was modified accordingly. Participants included 47 teens between 12 and 18 years of age with a diagnosis of ASD and a verbal intelligence quotient (IQ) ≥ 65. Eligible teens were randomly assigned to a treatment group (TG) or delayed treatment control group (CG). Primary outcome measures included questionnaires and direct observations quantifying social ability and problems directly related to ASD. Secondary outcome measures included scales for depressive symptoms, anxiety, and other behavioral problems. Rating scales for parental depressive symptoms and anxiety were examined to detect changes in parental psychosocial functioning throughout the PEERS(®) treatment. Independent samples t-tests revealed no significant differences at baseline across the TG and CG conditions with regard to age (14.04 ± 1.64 and 13.54 ± 1.50 years), IQ (99.39 ± 18.09 & 100.67 ± 16.97), parental education, socioeconomic status, or ASD symptoms (p < 0.05), respectively. Results for treatment outcome suggest that the TG showed significant improvement in communication and social interaction domain scores on the Autism Diagnostic Observation Schedule, interpersonal relationship and play/leisure time on the subdomain scores of the Korean version of the Vineland Adaptive Behavior Scale (p's < 0.01), social skills knowledge total scores on the Test of Adolescent Social Skills Knowledge-Revised (p < 0.01), and decreased depressive symptoms on the Child Depression Inventory following treatment (p < 0.05). Analyses of parental outcome reveal a significant decrease in maternal state anxiety in the TG after controlling for potential confounding variables (p < 0.05). Despite cultural and linguistic differences, the PEERS(®) social skills intervention appears to be efficacious for teens with ASD in Korea with modest cultural adjustment. In an RCT, participants receiving the PEERS(®) treatment showed significant improvement in social skills knowledge, interpersonal skills, and play/leisure skills, as well as a decrease in depressive symptoms and ASD symptoms. This study represents one of only a few cross-cultural validation trials of an established evidence-based treatment for adolescents with ASD.

Autism research : official journal of the International Society for Autism Research · randomised controlled trial · 96 citationsread the source →

Effectiveness of an intervention led by lay health counsellors for depressive and anxiety disorders in primary care in Goa, India (MANAS): a cluster randomised controlled trial.

Background: Depression and anxiety disorders are common mental disorders worldwide. The MANAS trial aimed to test the effectiveness of an intervention led by lay health counsellors in primary care settings to improve outcomes of people with these disorders. Methods: In this cluster randomised trial, primary care facilities in Goa, India, were assigned (1:1) by computer-generated randomised sequence to intervention or control (enhanced usual care) groups. All adults who screened positive for common mental disorders were eligible. The collaborative stepped-care intervention offered case management and psychosocial interventions, provided by a trained lay health counsellor, supplemented by antidepressant drugs by the primary care physician and supervision by a mental health specialist. The research assessor was masked. The primary outcome was recovery from common mental disorders as defined by the International Statistical Classification of Diseases and Related Health Problems-10th revision (ICD-10) at 6 months. This study is registered with ClinicalTrials.gov, number NCT00446407. Findings: 24 study clusters, with an equal proportion of public and private facilities, were randomised equally between groups. 1160 of 1360 (85%) patients in the intervention group and 1269 of 1436 (88%) in the control group completed the outcome assessment. Patients with ICD-10-confirmed common mental disorders in the intervention group were more likely to have recovered at 6 months than were those in the control group (n=620 [65·0%] vs 553 [52·9%]; risk ratio 1·22, 95% CI 1·00-1·47; risk difference=12·1%, 95% CI 1·6%-22·5%). The intervention had strong evidence of an effect in public facility attenders (369 [65·9%] vs 267 [42·5%], risk ratio 1·55, 95% CI 1·02-2·35) but no evidence for an effect in private facility attenders (251 [64·1%] vs 286 [65·9%], risk ratio 0·95, 0·74-1·22). There were three deaths and four suicide attempts in the collaborative stepped-care group and six deaths and six suicide attempts in the enhanced usual care group. None of the deaths were from suicide. Interpretation: A trained lay counsellor-led collaborative care intervention can lead to an improvement in recovery from CMD among patients attending public primary care facilities. Funding: The Wellcome Trust.

Lancet (London, England) · randomised controlled trial · 469 citationsread the source →

Stigma reduction interventions for children and adolescents in low- and middle-income countries: Systematic review of intervention strategies.

Stigmatisation and discrimination are common worldwide, and have profound negative impacts on health and quality of life. Research, albeit limited, has focused predominantly on adults. There is a paucity of literature about stigma reduction strategies concerning children and adolescents, with evidence especially sparse for low- and middle-income countries (LMIC). This systematic review synthesised child-focused stigma reduction strategies in LMIC, and compared these to adult-focused interventions. Relevant publications were systematically searched in July and August 2018 in the following databases; Cochrane, Embase, Global Health, HMIC, Medline, PsycINFO, PubMed and WorldWideScience.org, and through Google Custom Search. Included studies and identified reviews were cross-referenced. Three categories of search terms were used: (i) stigma, (ii) intervention, and (iii) LMIC settings. Data on study design, participants and intervention details including strategies and implementation factors were extracted. Within 61 unique publications describing 79 interventions, utilising 14 unique stigma reduction strategies, 14 papers discussed 21 interventions and 10 unique strategies involving children. Most studies targeted HIV/AIDS (50% for children, 38% for adults) or mental illness (14% vs 34%) stigma. Community education (47%), individual empowerment (15%) and social contact (12%) were most employed in child-focused interventions. Most interventions were implemented at one socio-ecological level; child-focused interventions mostly employed community-level strategies (88%). Intervention duration was mostly short; between half a day and a week. Printed or movie-based material was key to deliver child-focused interventions (37%), while professionals most commonly implemented adult-focused interventions (53%). Ten unique, child-focused strategies were all evaluated positively, using a diverse set of scales. Children and adolescents are under-represented in stigma reduction in LMIC. More stigma reduction interventions in LMIC, addressing a wider variety of stigmas, with children as direct and indirect target group, are needed. This systematic review is registered under International Prospective Register of Systematic Reviews PROSPERO, reference number #CRD42018094700.

Social science & medicine (1982) · systematic review · 77 citationsread the source →

Robotic radical prostatectomy in the community setting--the learning curve and beyond: initial 200 cases.

Purpose: The introduction of robotic assistance has the potential to improve surgical outcomes and reduce the steep learning curve associated with conventional laparoscopic radical prostatectomy. We report on our experience with robotic radical prostatectomy in the community setting. Materials and methods: A total of 200 patients underwent robotic radical prostatectomy during 18 months. Prospective data collection included a quality of life (Expanded Prostate Cancer Index Composite) questionnaire, basic demographics, prostate specific antigen (PSA), clinical stage and Gleason grade. Operative outcome measures included operative time, estimated blood loss and complications. Postoperative outcome measures included hospital stay, catheter time, pathology, PSA and return of continence. Results: Average operative time was 141 minutes with an estimated blood loss of 75 cc. The intraoperative complication rate was 1% with no mortality, reexploration or transfusion. Of the patients 95% were discharged home on postoperative day 1 (1 to 3) with hematocrit averaging 34.5 (range 25 to 45). The average difference in preoperative and postoperative hematocrit was 3 points (range -2 to 15). Average catheter time was 7.2 days (range 5 to 15). The positive margin rate was 10.5% for the entire series, 5.7% for T2 tumors, 28.5% (T3a), 20% (T3b) and 33% (T4a). Of the patients 95% had undetectable PSA (less than 0.1 ng/ml) at average followup of 9.7 months. Continence at 1, 3, 6, 9 and 12 months was 47%, 78%, 89%, 92% and 98%, respectively. Conclusions: Our initial experience with robotic radical prostatectomy is promising. The learning curve was approximately 20 to 25 cases. With a structured methodical approach we were able to implement robotics safely and effectively into our community practice with minimal patient morbidity, and good oncological and functional outcomes.

The Journal of urology · clinical trial · 270 citationsread the source →

Effect of COVID-19 lockdown on child protection medical assessments: a retrospective observational study in Birmingham, UK.

Objectives: To determine any change in referral patterns and outcomes in children (0-18) referred for child protection medical examination (CPME) during the COVID-19 pandemic compared with previous years. Design: Retrospective observational study, analysing routinely collected clinical data from CPME reports in a rapid response to the pandemic lockdown. Setting: Birmingham Community Healthcare NHS Trust, which provides all routine CPME for Birmingham, England, population 1.1 million including 288 000 children. Participants: Children aged under 18 years attending CPME during an 18-week period from late February to late June during the years 2018-2020. Main outcome measures: Numbers of referrals, source of disclosure and outcomes from CPME. Results: There were 78 CPME referrals in 2018, 75 in 2019 and 47 in 2020, this was a 39.7% (95% CI 12.4% to 59.0%) reduction in referrals from 2018 to 2020, and a 37.3% (95% CI 8.6% to 57.4%) reduction from 2019 to 2020. There were fewer CPME referrals initiated by school staff in 2020, 12 (26%) compared with 36 (47%) and 38 (52%) in 2018 and 2019, respectively. In all years 75.9% of children were known to social care prior to CPME, and 94% of CPME concluded that there were significant safeguarding concerns. Conclusions: School closure due to COVID-19 may have harmed children as child abuse has remained hidden. There needs to be either mandatory attendance at schools in future or viable alternatives found. There may be a significant increase in safeguarding referrals when schools fully reopen as children disclose the abuse they have experienced at home.

BMJ open · cohort or longitudinal · 42 citationsread the source →

Validation of self-reported health literacy questions among diverse English and Spanish-speaking populations.

Background: Limited health literacy (HL) contributes to poor health outcomes and disparities, and direct measurement is often time-intensive. Self-reported HL questions have not been validated among Spanish-speaking and diverse English-speaking populations. Objective: To evaluate three self-reported questions: 1 "How confident are you filling out medical forms?"; 2 "How often do you have problems learning about your medical condition because of difficulty understanding written information?"; and 3 "How often do you have someone help you read hospital materials?" Answers were based on a 5-point Likert scale. Design: This was a validation study nested within a trial of diabetes self-management support in the San Francisco Department of Public Health. Participants: English and Spanish-speaking adults with type 2 diabetes receiving primary care. Methods: Using the Test of Functional Health Literacy in Adults (s-TOFHLA) in English and Spanish as the reference, we classified HL as inadequate, marginal, or adequate. We calculated the C-index and test characteristics of the three questions and summative scale compared to the s-TOFHLA and assessed variations in performance by language, race/ethnicity, age, and education. Key results: Of 296 participants, 48% were Spanish-speaking; 9% were White, non-Hispanic; 47% had inadequate HL and 12% had marginal HL. Overall, 57% reported being confident with forms "somewhat" or less. The "confident with forms" question performed best for detecting inadequate (C-index = 0.82, (0.77-0.87)) and inadequate plus marginal HL (C index = 0.81, (0.76-0.86); p<0.01 for differences from other questions), and performed comparably to the summative scale. The "confident with forms" question and scale also performed best across language, race/ethnicity, educational attainment, and age. Conclusions: A single self-reported HL question about confidence with forms and a summative scale of three questions discriminated between Spanish and English speakers with adequate HL and those with inadequate and/or inadequate plus marginal HL. The "confident with forms" question or the summative scale may be useful for estimating HL in clinical research involving Spanish-speaking and English-speaking, chronically-ill, diverse populations.

Journal of general internal medicine · cohort or longitudinal · 243 citationsread the source →

The neighborhood social environment and physical activity: a systematic scoping review.

Background: Investigating the association of the neighborhood social environment on physical activity is complex. A systematic scoping review was performed to (1) provide an inventory of studies assessing the influence of the neighborhood social environment on physical activity since 2006; (2) describe methodologies employed; and (3) formulate recommendations for the field. Methods: Two databases were searched using terms related to 'physical activity,' 'neighborhood,' and 'social environment' in January 2017. Eligibility criteria included: 1) physical activity as an outcome; 2) neighborhood social environment as a predictor; 3) healthy population (without diagnosed clinical condition or special population); 4) observational or experimental design. Of 1352 studies identified, 181 were included. Textual data relevant to the social environment measurement and analysis were extracted from each article into qualitative software (MAXQDA) and coded to identify social environmental constructs, measurement methods, level of measurement (individual vs. aggregated to neighborhood), and whether authors explicitly recognized the construct as the social environment. The following measures were generated for each construct: number of unique measurements; % of times measured at an aggregate level; % of times authors referred to the construct as the social environment. Social environmental constructs were then grouped into larger descriptive dimensions. Results/findings: Fifty-nine social environmental constructs were identified and grouped into 9 dimensions: Crime & Safety (n = 133 studies; included in 73% of studies); Economic & Social Disadvantage (n = 55, 33%); Social Cohesion & Capital (n = 47, 26%); Social Relationships (n = 22, 12%); Social Environment (n = 16, 9%); Disorder & Incivilities (n = 15, 8%); Sense of Place/Belonging (n = 8, 4%); Discrimination/Segregation (n = 3, 2%); Civic Participation & Engagement (n = 2, 1%). Across all articles, the social environment was measured using 176 different methods, was measured at an aggregate-level 38% of the time, and referred to as the social environment 23% of the time. Conclusions: Inconsistent terminology, definitions, and measurement of the social environment and the lack of explicit language identifying constructs as the social environment make it challenging to compare results across studies and draw conclusions. Improvements are needed to increase our understanding of social environmental correlates and/or determinants of physical activity and facilitate cross-disciplinary conversations necessary to effectively intervene to promote physical activity. Trial registration: PROSPERO CRD42017059580.

The international journal of behavioral nutrition and physical activity · review · 81 citationsread the source →

Maintenance treatment with varenicline for smoking cessation in patients with schizophrenia and bipolar disorder: a randomized clinical trial.

Importance: It is estimated that more than half of those with serious mental illness smoke tobacco regularly. Standard courses of pharmacotherapeutic cessation aids improve short-term abstinence, but most who attain abstinence relapse rapidly after discontinuation of pharmacotherapy. Objective: To determine whether smokers diagnosed with schizophrenia and bipolar disease have higher rates of prolonged tobacco abstinence with maintenance pharmacotherapy than with standard treatment. Design, setting, and participants: Randomized, double-blind, placebo-controlled, parallel-group, relapse-prevention clinical trial conducted in 10 community mental-health centers. Of 247 smokers with schizophrenia or bipolar disease recruited from March 2008-April 2012, 203 received 12-weeks' open-label varenicline and cognitive behavioral therapy and 87 met abstinence criteria to enter the relapse prevention intervention. Interventions: Participants who had 2 weeks or more of continuous abstinence at week 12 of open treatment were randomly assigned to receive cognitive behavioral therapy and double-blind varenicline (1 mg, 2 per day) or placebo from weeks 12 to 52. Participants then discontinued study treatment and were followed up to week 76. Main outcomes and measures: Seven-day rate of continuous abstinence at study week 52, the end of the relapse-prevention phase, confirmed by exhaled carbon monoxide. Secondary outcomes were continuous abstinence rates for weeks 12 through 64 based on biochemically verified abstinence and weeks 12 through 76, based on self-reported smoking behavior. Results: Sixty-one participants completed the relapse-prevention phase; 26 discontinued participation (7 varenicline, 19 placebo) and were considered to have relapsed for the analyses; 18 of these had relapsed prior to dropout. At week 52, point-prevalence abstinence rates were 60% in the varenicline group (24 of 40) vs 19% (9 of 47) in the placebo group (odds ratio [OR], 6.2; 95% CI, 2.2-19.2; P < .001). From weeks 12 through 64, 45% (18 of 40) among those in the varenicline group vs 15% (7 of 47) in the placebo group were continuously abstinent (OR, 4.6; 95% CI, 1.5-15.7; P = .004), and from weeks 12 through 76, 30% (12 of 40) in the varenicline group vs 11% (5 of 47) in the placebo group were continuously abstinent (OR, 3.4; 95% CI, 1.02-13.6; P = .03). There were no significant treatment effects on psychiatric symptom ratings or psychiatric adverse events. Conclusions and relevance: Among smokers with serious mental illness who attained initial abstinence with standard treatment, maintenance pharmacotherapy with varenicline and cognitive behavioral therapy improved prolonged tobacco abstinence rates compared with cognitive behavioral therapy alone after 1 year of treatment and at 6 months after treatment discontinuation. Trial registration: clinicaltrials.gov Identifier: NCT00621777.

JAMA · randomised controlled trial · 157 citationsread the source →

One year pre-post intervention follow-up of psychological, immune, endocrine and blood pressure outcomes of mindfulness-based stress reduction (MBSR) in breast and prostate cancer outpatients.

Objectives: This study investigated the ongoing effects of participation in a mindfulness-based stress reduction (MBSR) program on quality of life (QL), symptoms of stress, mood and endocrine, immune and autonomic parameters in early stage breast and prostate cancer patients. Methods: Forty-nine patients with breast cancer and 10 with prostate cancer enrolled in an eight-week MBSR program that incorporated relaxation, meditation, gentle yoga and daily home practice. Demographic and health behaviors, QL, mood, stress symptoms, salivary cortisol levels, immune cell counts, intracellular cytokine production, blood pressure (BP) and heart rate (HR) were assessed pre- and post-intervention, and at 6- and 12-month follow-up. Results: Fifty-nine, 51, 47 and 41 patients were assessed pre- and post-intervention and at 6- and 12-month follow-up, respectively, although not all participants provided data on all outcomes at each time point. Linear mixed modeling showed significant improvements in overall symptoms of stress which were maintained over the follow-up period. Cortisol levels decreased systematically over the course of the follow-up. Immune patterns over the year supported a continued reduction in Th1 (pro-inflammatory) cytokines. Systolic blood pressure (SBP) decreased from pre- to post-intervention and HR was positively associated with self-reported symptoms of stress. Conclusions: MBSR program participation was associated with enhanced quality of life and decreased stress symptoms, altered cortisol and immune patterns consistent with less stress and mood disturbance, and decreased blood pressure. These pilot data represent a preliminary investigation of the longer-term relationships between MBSR program participation and a range of potentially important biomarkers.

Brain, behavior, and immunity · clinical trial · 346 citationsread the source →

Financial Hardships Experienced by Cancer Survivors: A Systematic Review.

Background: With rising cancer care costs, including high-priced cancer drugs, financial hardship is increasingly documented among cancer survivors in the United States; research findings have not been synthesized. Methods: We conducted a systematic review of articles published between 1990 and 2015 describing the financial hardship experienced by cancer survivors using PubMed, Embase, Scopus, and CINAHL databases. We categorized measures of financial hardship into: material conditions (eg, out-of-pocket costs, productivity loss, medical debt, or bankruptcy), psychological responses (eg, distress or worry), and coping behaviors (eg, skipped medications). We abstracted findings and conducted a qualitative synthesis. Results: Among 676 studies identified, 45 met the inclusion criteria and were incorporated in the review. The majority of the studies (82%, n = 37) reported financial hardship as a material condition measure; others reported psychological (7%, n = 3) and behavioral measures (16%, n = 7). Financial hardship measures were heterogeneous within each broad category, and the prevalence of financial hardship varied by the measure used and population studied. Mean annual productivity loss ranged from $380 to $8236, 12% to 62% of survivors reported being in debt because of their treatment, 47% to 49% of survivors reported experiencing some form of financial distress, and 4% to 45% of survivors did not adhere to recommended prescription medication because of cost. Conclusions: Financial hardship is common among cancer survivors, although we found substantial heterogeneity in its prevalence. Our findings highlight the need for consistent use of definitions, terms, and measures to determine the best intervention targets and inform intervention development in order to prevent and minimize the impact of financial hardship experienced by cancer survivors.

Journal of the National Cancer Institute · systematic review · 615 citationsread the source →

When is shame linked to constructive approach orientation? A meta-analysis.

Despite recent evidence that episodic shame can be linked to the constructive approach of failure (i.e., prosociality, self-improvement), the prevailing view is that shame is neither constructive nor approach-oriented. To integrate these opposing views, we conducted a theory-driven meta-analysis of 90 samples from the published literature (N = 12,364). As expected, shame had a positive link to constructive approach when failure (g = .47, 95% confidence interval [CI] [.37, .55]) or social image (g = .37, 95% CI [.06, .68]) was more reparable. In contrast, shame had a negative link to constructive approach when failure was less reparable (g = -.34, 95% CI [-.53, -.14]). A supplemental meta-analysis of 42 samples showed shame and guilt to have a similar positive link to constructive approach orientation when failure was more reparable (g = .44 and .43), but not when it was less reparable (g = -.08 and .27).

Journal of personality and social psychology · meta-analysis · 49 citationsread the source →

Etanercept and clinical outcomes, fatigue, and depression in psoriasis: double-blind placebo-controlled randomised phase III trial.

Background: Psoriasis has substantial psychological and emotional effects. We assessed the effect of etanercept, an effective treatment for the clinical symptoms of psoriasis, on fatigue and symptoms of depression associated with the condition. Methods: 618 patients with moderate to severe psoriasis received double-blind treatment with placebo or 50 mg twice-weekly etanercept. The primary efficacy endpoint was a 75% or greater improvement from baseline in psoriasis area and severity index score (PASI 75) at week 12. Secondary and other endpoints included the functional assessment of chronic illness therapy fatigue (FACIT-F) scale, the Hamilton rating scale for depression (Ham-D), the Beck depression inventory (BDI), and adverse events. Efficacy analyses were based on the allocated treatment. Analyses and summaries of safety data were based on the actual treatment received. This study is registered with with the identifier NCT00111449. Findings: 47% (147 of 311) of patients achieved PASI 75 at week 12, compared with 5% (15 of 306) of those receiving placebo (p<0.0001; difference 42%, 95% CI 36-48). Greater proportions of patients receiving etanercept had at least a 50% improvement in Ham-D or BDI at week 12 compared with the placebo group; patients treated with etanercept also had significant and clinically meaningful improvements in fatigue (mean FACIT-F improvement 5.0 vs 1.9; p<0.0001, difference 3.0, 95% CI 1.6-4.5). Improvements in fatigue were correlated with decreasing joint pain, whereas improvements in symptoms of depression were less correlated with objective measures of skin clearance or joint pain. Interpretation: Etanercept treatment might relieve fatigue and symptoms of depression associated with this chronic disease.

Lancet (London, England) · randomised controlled trial · 776 citationsread the source →

Muslim Americans' safety and well-being in the wake of Trump: A public health and social justice crisis.

This study examined the perceived impact of religious discrimination and Islamophobia on Muslim Americans' well-being during the 2016 United States presidential election campaign. Data were collected from a national sample of 1,130 Muslim Americans. Perceived religious discrimination (PRD) was measured using the Perceived Religious Discrimination Scale. Results of canonical correlation analysis showed that perceived Islamophobia was associated with safety (β = .45, p < .001), level of stress (β = -.25, p < .001), level of religiosity (β = -.11, p < .05), and employment (β = .11, p < .05). PRD was associated with preexposure to religious-based discrimination; β = -.12, p < .05), safety (.47, p < .001), level of stress (β = -.33, p < .001), religiosity (β = -.15, p < .010), and years in the United States (β = .16, p < .010). Results also suggest that some Muslim subgroups, such as women and older people, may face "double jeopardy" based on multiple stigmatized identities. When addressing mental health concerns in marginalized groups, it is necessary to link health with social justice and examine how social injustices may affect people's well-being. (PsycINFO Database Record

The American journal of orthopsychiatry · 7 citationsread the source →

Lifestyle changes in women with polycystic ovary syndrome.

Background: Polycystic ovary syndrome (PCOS) affects 8% to 13% of reproductive-aged women and is associated with reproductive and metabolic dysfunction. Obesity worsens the presentation of PCOS and weight management (weight loss, maintenance or prevention of excess weight gain) is proposed as an initial treatment strategy, best achieved through lifestyle changes incorporating diet, exercise and behavioural interventions. Objectives: To assess the effectiveness of lifestyle treatment in improving reproductive, anthropometric (weight and body composition), metabolic and quality of life factors in PCOS. Search methods: We searched the Cochrane Gynaecology and Fertility Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, PsycINFO, CINAHL and AMED (date of last search March 2018). We also searched controlled trials registries, conference abstracts, relevant journals, reference lists of relevant papers and reviews, and grey literature databases, with no language restrictions applied. Selection criteria: Randomised controlled trials (RCTs) comparing lifestyle treatment (diet, exercise, behavioural or combined treatments) to minimal or no treatment in women with PCOS. Data collection and analysis: Two authors independently selected trials, assessed evidence quality and risk of bias, and extracted data. Our primary outcomes were live birth, miscarriage and pregnancy. We used inverse variance and fixed-effect models in the meta-analyses. We reported dichotomous outcomes as an odds ratio and continuous outcomes as a mean difference (MD) or standardised mean difference (SMD). Main results: We included 15 studies with 498 participants. Ten studies compared physical activity to minimal dietary and behavioural intervention or no intervention. Five studies compared combined dietary, exercise and behavioural intervention to minimal intervention. One study compared behavioural intervention to minimal intervention. Risk of bias varied: eight studies had adequate sequence generation, seven had adequate clinician or outcome assessor blinding, seven had adequate allocation concealment, six had complete outcome data and six were free of selective reporting. No studies assessed the fertility primary outcomes of live birth or miscarriage. No studies reported the secondary reproductive outcome of menstrual regularity, as defined in this review. Lifestyle intervention may improve a secondary (endocrine) reproductive outcome, the free androgen index (FAI) (MD -1.11, 95% confidence interval (CI) -1.96 to -0.26, 6 RCTs, N = 204, I2 = 71%, low-quality evidence). Lifestyle intervention may reduce weight (kg) (MD -1.68 kg, 95% CI -2.66 to -0.70, 9 RCTs, N = 353, I2 = 47%, low-quality evidence). Lifestyle intervention may reduce body mass index (BMI) (kg/m2) (-0.34 kg/m2, 95% CI -0.68 to -0.01, 12 RCTs, N = 434, I2= 0%, low-quality evidence). We are uncertain of the effect of lifestyle intervention on glucose tolerance (glucose outcomes in oral glucose tolerance test) (mmol/L/minute) (SMD -0.02, 95% CI -0.38 to 0.33, 3 RCTs, N = 121, I2 = 0%, low-quality evidence). Authors' conclusions: Lifestyle intervention may improve the free androgen index (FAI), weight and BMI in women with PCOS. We are uncertain of the effect of lifestyle intervention on glucose tolerance. There were no studies that looked at the effect of lifestyle intervention on live birth, miscarriage or menstrual regularity. Most studies in this review were of low quality mainly due to high or unclear risk of bias across most domains and high heterogeneity for the FAI outcome.

The Cochrane database of systematic reviews · meta-analysis · 186 citationsread the source →

Psychological therapies for the management of chronic and recurrent pain in children and adolescents.

Background: This is an update of the original Cochrane review first published in Issue 1, 2003, and previously updated in 2009, 2012 and 2014. Chronic pain, defined as pain that recurs or persists for more than three months, is common in childhood. Chronic pain can affect nearly every aspect of daily life and is associated with disability, anxiety, and depressive symptoms. Objectives: The aim of this review was to update the published evidence on the efficacy of psychological treatments for chronic and recurrent pain in children and adolescents. The primary objective of this updated review was to determine any effect of psychological therapy on the clinical outcomes of pain intensity and disability for chronic and recurrent pain in children and adolescents compared with active treatment, waiting-list, or treatment-as-usual care. The secondary objective was to examine the impact of psychological therapies on children's depressive symptoms and anxiety symptoms, and determine adverse events. Search methods: Searches were undertaken of CENTRAL, MEDLINE, MEDLINE in Process, Embase, and PsycINFO databases. We searched for further RCTs in the references of all identified studies, meta-analyses, and reviews, and trial registry databases. The most recent search was conducted in May 2018. Selection criteria: RCTs with at least 10 participants in each arm post-treatment comparing psychological therapies with active treatment, treatment-as-usual, or waiting-list control for children or adolescents with recurrent or chronic pain were eligible for inclusion. We excluded trials conducted remotely via the Internet. Data collection and analysis: We analysed included studies and we assessed quality of outcomes. We combined all treatments into one class named 'psychological treatments'. We separated the trials by the number of participants that were included in each arm; trials with > 20 participants per arm versus trials with < 20 participants per arm. We split pain conditions into headache and mixed chronic pain conditions. We assessed the impact of both conditions on four outcomes: pain, disability, depression, and anxiety. We extracted data at two time points; post-treatment (immediately or the earliest data available following end of treatment) and at follow-up (between three and 12 months post-treatment). Main results: We identified 10 new studies (an additional 869 participants) in the updated search. The review thus included a total of 47 studies, with 2884 children and adolescents completing treatment (mean age 12.65 years, SD 2.21 years). Twenty-three studies addressed treatments for headache (including migraine); 10 for abdominal pain; two studies treated participants with either a primary diagnosis of abdominal pain or irritable bowel syndrome, two studies treated adolescents with fibromyalgia, two studies included adolescents with temporomandibular disorders, three were for the treatment of pain associated with sickle cell disease, and two studies treated adolescents with inflammatory bowel disease. Finally, three studies included adolescents with mixed pain conditions. Overall, we judged the included studies to be at unclear or high risk of bias. Children with headache painWe found that psychological therapies reduced pain frequency post-treatment for children and adolescents with headaches (risk ratio (RR) 2.35, 95% confidence interval (CI) 1.67 to 3.30, P < 0.01, number needed to treat for an additional beneficial outcome (NNTB) = 2.86), but these effects were not maintained at follow-up. We did not find a beneficial effect of psychological therapies on reducing disability in young people post-treatment (SMD -0.26, 95% CI -0.56 to 0.03), but we did find a beneficial effect in a small number of studies at follow-up (SMD -0.34, 95% CI -0.54 to -0.15). We found no beneficial effect of psychological interventions on depression or anxiety symptoms. Children with mixed pain conditionsWe found that psychological therapies reduced pain intensity post-treatment for children and adolescents with mixed pain conditions (SMD -0.43, 95% CI -0.67 to -0.19, P < 0.01), but these effects were not maintained at follow-up. We did find beneficial effects of psychological therapies on reducing disability for young people with mixed pain conditions post-treatment (SMD -0.34, 95% CI -0.54 to -0.15) and at follow-up (SMD -0.27, 95% CI -0.49 to -0.06). We found no beneficial effect of psychological interventions on depression symptoms. In contrast, we found a beneficial effect on anxiety at post-treatment in children with mixed pain conditions (SMD -0.16, 95% CI -0.29 to -0.03), but this was not maintained at follow-up. Across all pain conditions, we found that adverse events were reported in seven trials, of which two studies reported adverse events that were study-related. Quality of evidenceWe found the quality of evidence for all outcomes to be low or very low, mostly downgraded for unexplained heterogeneity, limitations in study design, imprecise and sparse data, or suspicion of publication bias. This means our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect, or we have very little confidence in the effect estimate; or the true effect is likely to be substantially different from the estimate of effect. Authors' conclusions: Psychological treatments delivered predominantly face-to-face might be effective for reducing pain outcomes for children and adolescents with headache or other chronic pain conditions post-treatment. However, there were no effects at follow-up. Psychological therapies were also beneficial for reducing disability in children with mixed chronic pain conditions at post-treatment and follow-up, and for children with headache at follow-up. We found no beneficial effect of therapies for improving depression or anxiety. The conclusions of this update replicate and add to those of a previous version of the review which found that psychological therapies were effective in reducing pain frequency/intensity for children with headache and mixed chronic pain conditions post-treatment.

The Cochrane database of systematic reviews · meta-analysis · 140 citationsread the source →

Couple therapy for depression.

Background: Couple therapy for depression has the twofold aim of modifying negative interaction patterns and increasing mutually supportive aspects of intimate relationships, changing the interpersonal context of depression. Couple therapy is included in several guidelines among the suggested treatments for depression. Objectives: 1. The main objective was to examine the effects of couple therapy compared to individual psychotherapy for depression.2. Secondary objectives were to examine the effects of couple therapy compared to drug therapy and no/minimal treatment for depression. Search methods: The Cochrane Common Mental Disorders Group Controlled Trials Register (CCMDCTR), the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid), Embase (Ovid) and PsycINFO (Ovid) were searched to 19 February 2018. Relevant journals and reference lists were checked. Selection criteria: Randomised and quasi-randomised controlled trials examining the effects of couple therapy versus individual psychotherapy, drug therapy, or no treatment/minimal treatment for depression were included in the review. Data collection and analysis: We considered as primary outcomes the depressive symptom level, the depression persistence, and the dropouts; the relationship distress level was a secondary outcome. We extracted data using a standardised spreadsheet. Where data were not included in published papers, we tried to obtain the data from the authors. We synthesised data using Review Manager software version 5.3. We pooled dichotomous data using the relative risk (RR), and continuous data calculating the standardised mean difference (SMD), together with 95% confidence intervals (CIs). We employed the random-effects model for all comparisons and also calculated a formal test for heterogeneity, the natural approximate Chi2 test. Main results: We included fourteen studies from Europe, North America, and Israel, with 651 participants. Eighty per cent of participants were Caucasian. Therefore, the findings cannot be considered as applicable to non-Western countries or to other ethnic groups in Western countries. On average, participants had moderate depression, preventing the extension of results to severely depressed patients. Almost all participants were aged between 36 and 47 years. There was no evidence of difference in effect at the end of treatment between couple therapy and individual psychotherapy, either for the continuous outcome of depressive symptoms, based on nine studies with 304 participants (SMD -0.17, 95% CI -0.44 to 0.10, low-quality evidence), or the proportion of participants remaining depressed, based on six studies with 237 participants (RR 0.94, 95% CI 0.72 to 1.22, low-quality evidence). Findings from studies with 6-month or longer follow-up confirmed the lack of difference between the two conditions. No trial gave information on harmful effects. However, we considered rates of treatment discontinuation for any reason as a proxy indicator of adverse outcomes. There was no evidence of difference for dropout rates between couple therapy and individual psychotherapy, based on eight studies with 316 participants (RR 0.85, 95% CI 0.51 to 1.41, low-quality evidence).Few data were available for the comparison with drug therapy. Data from a small study with 12 participants showed no difference for the continuous outcome of depressive symptoms at end of treatment (SMD -0.51, 95% CI -1.69 to 0.66, very low-quality evidence) and at 6-month follow-up (SMD -1.07, 95% CI -2.45 to 0.31, very low-quality evidence). Data on dropouts from two studies with 95 participants showed a clear advantage for couple therapy (RR 0.31, 95% CI 0.15 to 0.61, very low-quality evidence). However, this finding was heavily influenced by a single study, probably affected by a selection bias favouring couple therapy. The comparison between couple therapy plus drug therapy and drug therapy alone showed no difference in depressive symptom level, based on two studies with 34 participants (SMD -1.04, 95% CI -3.97 to 1.89, very low-quality evidence) and on dropouts, based on two studies with 45 participants (RR 1.03, 95% CI 0.07 to 15.52, very low-quality evidence).The comparison with no/minimal treatment showed a large significant effect favouring couple therapy both for depressive symptom level, based on three studies with 90 participants: (SMD -0.95, 95% CI -1.59 to -0.32, very low-quality evidence) and persistence of depression, based on two studies with 65 participants (RR 0.48, 95% CI 0.32 to 0.70, very low-quality evidence). No data were available for dropouts for this comparison. Concerning relationship distress, the comparison with individual psychotherapy showed that couple therapy appeared more effective in reducing distress level at the end of treatment, based on six studies with 187 participants (SMD -0.50, CI -0.97 to -0.02, very low-quality evidence) and the persistence of distress, based on two studies with 81 participants (RR 0.71, 95% CI 0.51 to 0.98, very low-quality evidence). The quality of evidence was heavily affected by substantial heterogeneity (I2 = 59%). In the analysis restricted to studies including only distressed couples, no heterogeneity was found and the effect in distress level at the end of treatment was larger (SMD -1.10, 95% CI -1.59 to -0.61). Very few data on this outcome were available for other comparisons. We assessed the certainty of the evidence using the GRADE system. The results were weakened by the low quality of evidence related to the effects on depressive symptoms, in comparison with individual psychotherapy, and by very low quality evidence for all other comparisons and for the effects on relationship distress. Most studies were affected by problems such as the small number of cases, performance bias, assessment bias due to the non-blinding outcome assessment, incomplete outcome reporting and the allegiance bias of investigators. Heterogeneity was, in particular, a problem for data about relationship distress. Authors' conclusions: Although there is suggestion that couple therapy is as effective as individual psychotherapy in improving depressive symptoms and more effective in improving relations in distressed couples, the low or very low quality of the evidence seriously limits the possibility of drawing firm conclusions. Very few data were available for comparisons with no/minimal treatment and drug therapy. Future trials of high quality should test in large samples with a long follow-up of the effects of couple therapy in comparison to other interventions in discordant couples with a depressed partner, considering the role of relationship quality as a potential effect mediator in the improvement of depression.

The Cochrane database of systematic reviews · meta-analysis · 21 citationsread the source →

Diet, physical activity, and behavioural interventions for the treatment of overweight or obesity in preschool children up to the age of 6 years.

Background: Child overweight and obesity has increased globally, and can be associated with short- and long-term health consequences. Objectives: To assess the effects of diet, physical activity, and behavioural interventions for the treatment of overweight or obesity in preschool children up to the age of 6 years. Search methods: We performed a systematic literature search in the databases Cochrane Library, MEDLINE, EMBASE, PsycINFO, CINAHL, and LILACS, as well as in the trial registers ClinicalTrials.gov and ICTRP Search Portal. We also checked references of identified trials and systematic reviews. We applied no language restrictions. The date of the last search was March 2015 for all databases. Selection criteria: We selected randomised controlled trials (RCTs) of diet, physical activity, and behavioural interventions for treating overweight or obesity in preschool children aged 0 to 6 years. Data collection and analysis: Two review authors independently assessed risk of bias, evaluated the overall quality of the evidence using the GRADE instrument, and extracted data following the Cochrane Handbook for Systematic Reviews of Interventions. We contacted trial authors for additional information. Main results: We included 7 RCTs with a total of 923 participants: 529 randomised to an intervention and 394 to a comparator. The number of participants per trial ranged from 18 to 475. Six trials were parallel RCTs, and one was a cluster RCT. Two trials were three-arm trials, each comparing two interventions with a control group. The interventions and comparators in the trials varied. We categorised the comparisons into two groups: multicomponent interventions and dietary interventions. The overall quality of the evidence was low or very low, and six trials had a high risk of bias on individual 'Risk of bias' criteria. The children in the included trials were followed up for between six months and three years. In trials comparing a multicomponent intervention with usual care, enhanced usual care, or information control, we found a greater reduction in body mass index (BMI) z score in the intervention groups at the end of the intervention (6 to 12 months): mean difference (MD) -0.3 units (95% confidence interval (CI) -0.4 to -0.2); P < 0.00001; 210 participants; 4 trials; low-quality evidence, at 12 to 18 months' follow-up: MD -0.4 units (95% CI -0.6 to -0.2); P = 0.0001; 202 participants; 4 trials; low-quality evidence, and at 2 years' follow-up: MD -0.3 units (95% CI -0.4 to -0.1); 96 participants; 1 trial; low-quality evidence. One trial stated that no adverse events were reported; the other trials did not report on adverse events. Three trials reported health-related quality of life and found improvements in some, but not all, aspects. Other outcomes, such as behaviour change and parent-child relationship, were inconsistently measured. One three-arm trial of very low-quality evidence comparing two types of diet with control found that both the dairy-rich diet (BMI z score change MD -0.1 units (95% CI -0.11 to -0.09); P < 0.0001; 59 participants) and energy-restricted diet (BMI z score change MD -0.1 units (95% CI -0.11 to -0.09); P < 0.0001; 57 participants) resulted in greater reduction in BMI than the comparator at the end of the intervention period, but only the dairy-rich diet maintained this at 36 months' follow-up (BMI z score change in MD -0.7 units (95% CI -0.71 to -0.69); P < 0.0001; 52 participants). The energy-restricted diet had a worse BMI outcome than control at this follow-up (BMI z score change MD 0.1 units (95% CI 0.09 to 0.11); P < 0.0001; 47 participants). There was no substantial difference in mean daily energy expenditure between groups. Health-related quality of life, adverse effects, participant views, and parenting were not measured. No trial reported on all-cause mortality, morbidity, or socioeconomic effects. All results should be interpreted cautiously due to their low quality and heterogeneous interventions and comparators. Authors' conclusions: Muticomponent interventions appear to be an effective treatment option for overweight or obese preschool children up to the age of 6 years. However, the current evidence is limited, and most trials had a high risk of bias. Most trials did not measure adverse events. We have identified four ongoing trials that we will include in future updates of this review. The role of dietary interventions is more equivocal, with one trial suggesting that dairy interventions may be effective in the longer term, but not energy-restricted diets. This trial also had a high risk of bias.

The Cochrane database of systematic reviews · meta-analysis · 119 citationsread the source →

Childhood maltreatment and unfavourable clinical outcomes in bipolar disorder: a systematic review and meta-analysis.

Background: Bipolar disorder affects up to one in 25 individuals and identification of early risk indicators of negative outcomes could facilitate early detection of patients with greatest clinical needs and risk. We aimed to investigate the association between childhood maltreatment and key negative outcomes in patients with bipolar disorder. Methods: For this systematic review and meta-analysis we searched MEDLINE, PsycINFO, and Embase to identify articles published before Jan 1, 2015, examining the association of maltreatment (physical, sexual, or emotional abuse, neglect, or family conflict) before age 18 years with clinical features and course of illness in bipolar disorder. Data were extracted from published reports and any missing information was requested from investigators. We did 12 independent random-effects meta-analyses to quantify the associations between childhood maltreatment and course of illness or clinical features. Findings: We initially identified 527 records and after unsuitable studies were removed, our search yielded 148 publications of which 30 were used in the meta-analysis. Patients with bipolar disorder and history of childhood maltreatment had greater mania severity (six studies, 780 participants; odds ratio [OR] 2·02, 95% CI 1·21-3·39, p=0·008), greater depression severity (eight studies, 1007 participants; 1·57, 1·25-1·99, p=0·0001), greater psychosis severity (seven studies, 1494 participants; 1·49, 1·10-2·04, p=0·011), higher risk of comorbidity with post-traumatic stress disorder (eight studies, 2494 participants; 3·60, 2·45-5·30, p<0·0001), anxiety disorders (seven studies, 5091 participants; 1·90, 1·39-2·61, p<0·0001), substance misuse disorders (11 studies, 5469 participants; 1·84, 1·41-2·39, p<0·0001), alcohol misuse disorder (eight studies, 5040 participants; 1·44, 1·13-1·83, p=0·003), earlier age of bipolar disorder onset (14 studies, 5733 participants; 1·85, 1·43-2·40, p<0·0001), higher risk of rapid cycling (eight studies, 3010 participants; 1·89, 1·45-2·48, p<0·0001), greater number of manic episodes (seven studies, 3909 participants; 1·26, 1·09-1·47, p=0·003), greater number of depressive episodes (eight studies, 4025 participants; 1·38, 1·07-1·79, p=0·013), and higher risk of suicide attempt (13 studies, 3422 participants; 2·25, 1·88-2·70, p<0·0001) compared with those with bipolar disorder without childhood maltreatment. Overall, these associations were not explained by publication bias, undue effects of individual studies, or variation in study quality. Interpretation: Childhood maltreatment predicts unfavourable clinical features and course of illness in patients with bipolar disorder. Funding: None.

The lancet. Psychiatry · meta-analysis · 278 citationsread the source →

Efficacy of 12-step mutual-help groups other than Alcoholics Anonymous: a systematic review and meta-analysis.

This paper offers a systematic review of quantitative and qualitative studies on the main twelve-step mutual-help (TSMH) groups (excluding Alcoholics Anonymous) and four meta-analyses exploring the correlation between (i) duration or involvement in TSMH groups and; (ii) severity of symptoms or quality of life. Systematic review was conducted following PRISMA guidelines. Searches of databases (MEDLINE, PsychInfo), a register (ClinicalTrials) and citations were conducted, from inception through November 01 2022. Fifty five articles were included (24 quantitative, 27 qualitative, 4 mixed-methods), corresponding to 47 distinctive studies. 68% of these studies were conducted in North America, 17% in Middle East, 11% in the European Union and 4% in Australia. The most studied TSMH group were Gamblers Anonymous (28% of the 47 studies), Narcotics Anonymous (26%), Double Trouble in Recovery (15%), Overeaters Anonymous (19%) and TSMH groups for compulsive sexual behaviors (11%). The four meta-analyses pooled data from 9 studies. Pooled mean age ranged from 36.5 to 40.5. 80-81% of participants were male. TSMH attendance and involvement were negatively correlated with severity of symptoms (high and medium levels of evidence) and positively correlated with quality of life (low levels of evidence). Twenty-one qualitative papers reported factors influencing recovery: Social (n = 15), emotional (n = 9), spiritual (n = 8), self-identification or psychological (n = 6) factors. Review provides characteristics of TSMH groups others than Alcoholics Anonymous, with implications for both research and healthcare practice. The perspective to implement TSMH groups targeting ontological addiction, at the root of all addiction, is discussed. Protocol registration: Prospero registration number: CRD42022342605.

European archives of psychiatry and clinical neuroscience · meta-analysis · 5 citationsread the source →

Early additional food and fluids for healthy breastfed full-term infants.

Background: Health organisations recommend exclusive breastfeeding for six months. However, the addition of other fluids or foods before six months is common in many countries. Recently, research has suggested that introducing solid food at around four months of age while the baby continues to breastfeed is more protective against developing food allergies compared to exclusive breastfeeding for six months. Other studies have shown that the risks associated with non-exclusive breastfeeding are dependent on the type of additional food or fluid given. Given this background we felt it was important to update the previous version of this review to incorporate the latest findings from studies examining exclusive compared to non-exclusive breastfeeding. Objectives: To assess the benefits and harms of additional food or fluid for full-term healthy breastfeeding infants and to examine the timing and type of additional food or fluid. Search methods: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (1 March 2016) and reference lists of all relevant retrieved papers. Selection criteria: Randomised or quasi-randomised controlled trials in infants under six months of age comparing exclusive breastfeeding versus breastfeeding with any additional food or fluids. Data collection and analysis: Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. Two review authors assessed the quality of the evidence using the GRADE approach. Main results: We included 11 trials (2542 randomised infants/mothers). Nine trials (2226 analysed) provided data on outcomes of interest to this review. The variation in outcome measures and time points made it difficult to pool results from trials. Data could only be combined in a meta-analysis for one primary (breastfeeding duration) and one secondary (weight change) outcome. None of the trials reported on physiological jaundice. Infant mortality was only reported in one trial. For the majority of older trials, the description of study methods was inadequate to assess the risk of bias. Most studies that we could assess showed a high risk of other biases and over half were at high risk of selection bias. Providing breastfeeding infants with artifical milk, compared to exclusive breastfeeding, did not affect rates of breastfeeding at hospital discharge (risk ratio (RR) 1.02, 95% confidence interval (CI) 0.97 to 1.08; one trial, 100 infants; low-quality evidence). At three months, breastfeeding infants who were provided with artificial milk had higher rates of any breastfeeding compared to exclusively breastfeeding infants (RR 1.21, 95% CI 1.05 to 1.41; two trials, 137 infants; low-quality evidence). Infants who were given artifical milk in the first few days after birth before breastfeeding, had less "obvious or probable symptoms" of allergy compared to exclusively breastfeeding infants (RR 0.56, 95% CI 0.35 to 0.91; one trial, 207 infants; very low-quality evidence). No difference was found in maternal confidence when comparing non-exclusive breastfeeding infants who were provided with artificial milk with exclusive breastfeeding infants (mean difference (MD) 0.10, 95% CI -0.34 to 0.54; one study, 39 infants; low-quality evidence). Rates of breastfeeding were lower in the non-exclusive breastfeeding group compared to the exclusive breastfeeding group at four, eight, 12 (RR 0.68, 95% CI 0.53 to 0.87; one trial, 170 infants; low-quality evidence), 16 and 20 weeks. The addition of glucose water resulted in fewer episodes of hypoglycaemia (below 2.2 mmol/L) compared to the exclusive breastfeeding group, reported at 12 hours (RR 0.07, 95% CI 0.00 to 1.20; one trial, 170 infants; very low-quality evidence), but no significant difference at 24 hours (RR 1.57, 95% CI 0.27 to 9.17; one trial, 170 infants; very low-quality evidence). Weight loss was lower for infants who received additional glucose water (one trial, 170 infants) at six, 12, 24 and 48 hours of life (MD -32.50 g, 95% CI -52.09 to -12.91; low-quality evidence) compared to the exclusively breastfeeding infants but no difference between groups was observed at 72 hours of life (MD 3.00 g, 95% CI -20.83 to 26.83; very low-quality evidence). In another trial with the water and glucose water arms combined (one trial, 47 infants), we found no significant difference in weight loss between the additional fluid group and the exclusively breastfeeding group on either day three or day five (MD -1.03%, 95% CI -2.24 to 0.18; very low-quality evidence) and (MD -0.20%, 95% CI -0.86 to 0.46; very low-quality evidence).Infant mortality was reported in one trial with no deaths occurring in either group (1162 infants). The early introduction of potentially allergenic foods, compared to exclusively breastfeeding, did not reduce the risk of "food allergy" to one or more of these foods between one to three years of age (RR 0.80, 95% CI 0.51 to 1.25; 1162 children), visible eczema at 12 months stratified by visible eczema at enrolment (RR 0.86, 95% CI 0.51 to 1.44; 284 children), or food protein-induced enterocolitis syndrome reactions (RR 2.00, 95% CI 0.18 to 22.04; 1303 children) (all moderate-quality evidence). Breastfeeding infants receiving additional foods from four months showed no difference in infant weight gain (g) from 16 to 26 weeks compared to exclusive breastfeeding to six months (MD -39.48, 95% CI -128.43 to 49.48; two trials, 260 children; low-quality evidence) or weight z-scores (MD -0.01, 95% CI -0.15 to 0.13; one trial, 100 children; moderate-quality evidence). Authors' conclusions: We found no evidence of benefit to newborn infants on the duration of breastfeeding from the brief use of additional water or glucose water. The quality of the evidence on formula supplementation was insufficient to suggest a change in practice away from exclusive breastfeeding. For infants at four to six months, we found no evidence of benefit from additional foods nor any risks related to morbidity or weight change. The majority of studies showed high risk of other bias and most outcomes were based on low-quality evidence which meant that we were unable to fully assess the benefits or harms of supplementation or to determine the impact from timing and type of supplementation. We found no evidence to disagree with the current international recommendation that healthy infants exclusively breastfeed for the first six months.

The Cochrane database of systematic reviews · meta-analysis · 47 citationsread the source →

Efficacy of school-based interventions aimed at decreasing sugar-sweetened beverage consumption among adolescents: a systematic review.

Objective: To verify the efficacy of school-based interventions aimed at reducing sugar-sweetened beverage (SSB) consumption among adolescents in order to develop or improve public health interventions. Design: Systematic review of interventions targeting adolescents and/or the school environment. Setting: The following databases were investigated: MEDLINE/PubMed, PsycINFO, CINAHL and EMBASE. Proquest Dissertations and Theses was also investigated for unpublished trials. Subjects: Adolescents were defined as individuals between the ages of 12 and 17 years. Results: A total of thirty-six studies detailing thirty-six different interventions tested among independent samples (n 152 001) were included in the review. Twenty interventions were classified as educational/behavioural and ten were classified as legislative/environmental interventions. Only six interventions targeted both individuals and their environment. Over 70 % of all interventions, regardless of whether they targeted individuals, their environment or both, were effective in decreasing SSB consumption. Legislative/environmental studies had the highest success rate (90·0 %). Educational/behavioural interventions only and interventions that combined educational/behavioural and legislative/environmental approaches were almost equally effective in reducing SSB consumption with success rates of 65·0 and 66·7 %, respectively. Among the interventions that had an educational/behavioural component, 61·5 % were theory-based. The behaviour change techniques most frequently used in interventions were providing information about the health consequences of performing the behaviour (72·2 %), restructuring the physical environment (47·2 %), behavioural goal setting (36·1 %), self-monitoring of behaviour (33·3 %), threat to health (30·6 %) and providing general social support (30·6 %). Conclusions: School-based interventions show promising results to reduce SSB consumption among adolescents. A number of recommendations are made to improve future studies.

Public health nutrition · meta-analysis · 69 citationsread the source →

Vitamin A supplementation for preventing morbidity and mortality in children from six months to five years of age.

Background: Vitamin A deficiency (VAD) is a major public health problem in low- and middle-income countries, affecting 190 million children under five years of age and leading to many adverse health consequences, including death. Based on prior evidence and a previous version of this review, the World Health Organization has continued to recommend vitamin A supplementation for children aged 6 to 59 months. There are new data available from recently published randomised trials since the previous publication of this review in 2010, and this update incorporates this information and reviews the evidence. Objectives: To assess the effects of vitamin A supplementation (VAS) for preventing morbidity and mortality in children aged six months to five years. Search methods: In March 2016 we searched CENTRAL, Ovid MEDLINE, Embase, six other databases, and two trials registers. We also checked reference lists and contacted relevant organisations and researchers to identify additional studies. Selection criteria: Randomised controlled trials (RCTs) and cluster-RCTs evaluating the effect of synthetic VAS in children aged six months to five years living in the community. We excluded studies involving children in hospital and children with disease or infection. We also excluded studies evaluating the effects of food fortification, consumption of vitamin A rich foods, or beta-carotene supplementation. Data collection and analysis: For this update, two reviewers independently assessed studies for inclusion and abstracted data, resolving discrepancies by discussion. We performed meta-analyses for outcomes, including all-cause and cause-specific mortality, disease, vision, and side effects. We used the GRADE approach to assess the quality of the evidence. Main results: We identified 47 studies (4 of which are new to this review), involving approximately 1,223,856 children. Studies took place in 19 countries: 30 (63%) in Asia, 16 of these in India; 8 (17%) in Africa; 7 (15%) in Latin America, and 2 (4%) in Australia. About one-third of the studies were in urban/periurban settings, and half were in rural settings; the remaining studies did not clearly report settings. Most of the studies included equal numbers of girls and boys and lasted about a year. The included studies were at variable overall risk of bias; however, evidence for the primary outcome was at low risk of bias. A meta-analysis for all-cause mortality included 19 trials (1,202,382 children). At longest follow-up, there was a 12% observed reduction in the risk of all-cause mortality for vitamin A compared with control using a fixed-effect model (risk ratio (RR) 0.88, 95% confidence interval (CI) 0.83 to 0.93; high-quality evidence). This result was sensitive to choice of model, and a random-effects meta-analysis showed a different summary estimate (24% reduction: RR 0.76, 95% CI 0.66 to 0.88); however, the confidence intervals overlapped with that of the fixed-effect model. Nine trials reported mortality due to diarrhoea and showed a 12% overall reduction for VAS (RR 0.88, 95% CI 0.79 to 0.98; 1,098,538 participants; high-quality evidence). There was no significant effect for VAS on mortality due to measles, respiratory disease, and meningitis. VAS reduced incidence of diarrhoea (RR 0.85, 95% CI 0.82 to 0.87; 15 studies; 77,946 participants; low-quality evidence) and measles (RR 0.50, 95% CI 0.37 to 0.67; 6 studies; 19,566 participants; moderate-quality evidence). However, there was no significant effect on incidence of respiratory disease or hospitalisations due to diarrhoea or pneumonia. There was an increased risk of vomiting within the first 48 hours of VAS (RR 1.97, 95% CI 1.44 to 2.69; 4 studies; 10,541 participants; moderate-quality evidence). Authors' conclusions: Vitamin A supplementation is associated with a clinically meaningful reduction in morbidity and mortality in children. Therefore, we suggest maintaining the policy of universal supplementation for children under five years of age in populations at risk of VAD. Further placebo-controlled trials of VAS in children between six months and five years of age would not change the conclusions of this review, although studies that compare different doses and delivery mechanisms are needed. In populations with documented vitamin A deficiency, it would be unethical to conduct placebo-controlled trials.

The Cochrane database of systematic reviews · meta-analysis · 175 citationsread the source →

Effects of depression, anxiety and screen use on adolescent substance use.

The current study examined relations between depression risk, anxiety risk, screen time and substance use among adolescents receiving SBIRT services. Between October 2018 and June 2020, 1701 youth ages 12 to 17 received SBIRT services (47% male, 24.2% non-white). SBIRT screening included the completion of the Patient Health Questionnaire for depression risk, Generalized Anxiety Disorder-7 item scale, a question on average amount of screen time daily, and the S2BI for substance use. Analyses included t-tests and chi-squares to examine demographic differences across variables, bivariate correlations among independent variables to assess for use within regression analyses, and stepwise linear regressions to examine relations between depression risk, anxiety risk, screen time and substance use. Analyses were examined using the full sample as well as those who scored positive for mild mental health symptoms. Median screen time was 3 to 4 h daily, 29% met criteria for mental health problems or risky substance use with high comorbidity of depression and anxiety risk. Findings demonstrated a significant risk of increased substance use associated with depression risk, severe anxiety risk, and screen time. Anxiety risk alone was not related to substance use risk when accounting for depression risk. Routine screening for depression, other mental health concerns, screen time and substance use is critical in supporting adolescent health and development, especially given comorbidity and their relative contributions. Interventions aimed at decreasing screen time, and identifying mental health problems may aid in decreasing substance use risk in adolescents.

Preventive medicine reports · 19 citationsread the source →

Exercise-based cardiac rehabilitation for coronary heart disease.

Background: Coronary heart disease (CHD) is the most common cause of death globally. However, with falling CHD mortality rates, an increasing number of people living with CHD may need support to manage their symptoms and prognosis. Exercise-based cardiac rehabilitation (CR) aims to improve the health and outcomes of people with CHD. This is an update of a Cochrane Review previously published in 2016. Objectives: To assess the clinical effectiveness and cost-effectiveness of exercise-based CR (exercise training alone or in combination with psychosocial or educational interventions) compared with 'no exercise' control, on mortality, morbidity and health-related quality of life (HRQoL) in people with CHD. Search methods: We updated searches from the previous Cochrane Review, by searching CENTRAL, MEDLINE, Embase, and two other databases in September 2020. We also searched two clinical trials registers in June 2021. Selection criteria: We included randomised controlled trials (RCTs) of exercise-based interventions with at least six months' follow-up, compared with 'no exercise' control. The study population comprised adult men and women who have had a myocardial infarction (MI), coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI), or have angina pectoris, or coronary artery disease. Data collection and analysis: We screened all identified references, extracted data and assessed risk of bias according to Cochrane methods. We stratified meta-analysis by duration of follow-up: short-term (6 to 12 months); medium-term (> 12 to 36 months); and long-term ( > 3 years), and used meta-regression to explore potential treatment effect modifiers. We used GRADE for primary outcomes at 6 to 12 months (the most common follow-up time point).  MAIN RESULTS: This review included 85 trials which randomised 23,430 people with CHD. This latest update identified 22 new trials (7795 participants). The population included predominantly post-MI and post-revascularisation patients, with a mean age ranging from 47 to 77 years. In the last decade, the median percentage of women with CHD has increased from 11% to 17%, but females still account for a similarly small percentage of participants recruited overall ( < 15%). Twenty-one of the included trials were performed in low- and middle-income countries (LMICs). Overall trial reporting was poor, although there was evidence of an improvement in quality over the last decade. The median longest follow-up time was 12 months (range 6 months to 19 years). At short-term follow-up (6 to 12 months), exercise-based CR likely results in a slight reduction in all-cause mortality (risk ratio (RR) 0.87, 95% confidence interval (CI) 0.73 to 1.04; 25 trials; moderate certainty evidence), a large reduction in MI (RR 0.72, 95% CI 0.55 to 0.93; 22 trials; number needed to treat for an additional beneficial outcome (NNTB) 75, 95% CI 47 to 298; high certainty evidence), and a large reduction in all-cause hospitalisation (RR 0.58, 95% CI 0.43 to 0.77; 14 trials;  NNTB 12, 95% CI 9 to 21; moderate certainty evidence). Exercise-based CR likely results in little to no difference in risk of cardiovascular mortality (RR 0.88, 95% CI 0.68 to 1.14; 15 trials; moderate certainty evidence), CABG (RR 0.99, 95% CI 0.78 to 1.27; 20 trials; high certainty evidence), and PCI (RR 0.86, 95% CI 0.63 to 1.19; 13 trials; moderate certainty evidence) up to 12 months' follow-up. We are uncertain about the effects of exercise-based CR on cardiovascular hospitalisation, with a wide confidence interval including considerable benefit as well as harm (RR 0.80, 95% CI 0.41 to 1.59; low certainty evidence). There was evidence of substantial heterogeneity across trials for cardiovascular hospitalisations (I2 = 53%), and of small study bias for all-cause hospitalisation, but not for all other outcomes. At medium-term follow-up, although there may be little to no difference in all-cause mortality (RR 0.90, 95% CI 0.80 to 1.02; 15 trials), MI (RR 1.07, 95% CI 0.91 to 1.27; 12 trials), PCI (RR 0.96, 95% CI 0.69 to 1.35; 6 trials), CABG (RR 0.97, 95% CI 0.77 to 1.23; 9 trials), and all-cause hospitalisation (RR 0.92, 95% CI 0.82 to 1.03; 9 trials), a large reduction in cardiovascular mortality was found (RR 0.77, 95% CI 0.63 to 0.93; 5 trials). Evidence is uncertain for difference in risk of cardiovascular hospitalisation (RR 0.92, 95% CI 0.76 to 1.12; 3 trials). At long-term follow-up, although there may be little to no difference in all-cause mortality (RR 0.91, 95% CI 0.75 to 1.10), exercise-based CR may result in a large reduction in cardiovascular mortality (RR 0.58, 95% CI 0.43 to 0.78; 8 trials) and MI (RR 0.67, 95% CI 0.50 to 0.90; 10 trials). Evidence is uncertain for CABG (RR 0.66, 95% CI 0.34 to 1.27; 4 trials), and PCI (RR 0.76, 95% CI 0.48 to 1.20; 3 trials). Meta-regression showed benefits in outcomes were independent of CHD case mix, type of CR, exercise dose, follow-up length, publication year, CR setting, study location, sample size or risk of bias. There was evidence that exercise-based CR may slightly increase HRQoL across several subscales (SF-36 mental component, physical functioning, physical performance, general health, vitality, social functioning and mental health scores) up to 12 months' follow-up; however, these may not be clinically important differences. The eight trial-based economic evaluation studies showed exercise-based CR to be a potentially cost-effective use of resources in terms of gain in quality-adjusted life years (QALYs). Authors' conclusions: This updated Cochrane Review supports the conclusions of the previous version, that exercise-based CR provides important benefits to people with CHD, including reduced risk of MI, a likely small reduction in all-cause mortality, and a large reduction in all-cause hospitalisation, along with associated healthcare costs, and improved HRQoL up to 12 months' follow-up. Over longer-term follow-up, benefits may include reductions in cardiovascular mortality and MI. In the last decade, trials were more likely to include females, and be undertaken in LMICs, increasing the generalisability of findings. Well-designed, adequately-reported RCTs of CR in people with CHD more representative of usual clinical practice are still needed. Trials should explicitly report clinical outcomes, including mortality and hospital admissions, and include validated HRQoL outcome measures, especially over longer-term follow-up, and assess costs and cost-effectiveness.

The Cochrane database of systematic reviews · systematic review · 330 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 and treatment of mental disorders in Lebanon: a national epidemiological survey.

Background: Mental disorders are believed to account for a large portion of disease burden worldwide. However, no national studies have been undertaken to assess this assumption in the Arab world. Methods: As part of the WHO World Mental Health (WMH) Survey Initiative, a nationally representative psychiatric epidemiological survey of 2857 adults (aged 18 years) was done in Lebanon between September, 2002, and September, 2003, through a study called LEBANON (Lebanese Evaluation of the Burden of Ailments and Needs Of the Nation). 12-month prevalence and severity of DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, fourth edition) disorders, and treatment were assessed with the WHO Composite International Diagnostic Interview (CIDI, version 3.0). Information was also obtained for sociodemographics and exposure to traumatic events in the Lebanon wars. Findings: 308 (17.0%) of respondents met criteria for at least one 12-month DSM-IV/CIDI disorder, 108 (27.0%) of whom were classified serious and an additional 112 (36.0%) moderate. Nearly half of respondents had a history of exposure to war-related traumatic events. Significantly elevated odds ratios (OR) of mood, anxiety, and impulse-control disorders were associated with two (OR 2.0-3.6) or more (2.2-9.1) war-related traumatic events, resulting in substantially higher proportions of moderate and severe 12-month mental disorders in respondents exposed to multiple war-related traumata (16.8-20.4%) compared with other respondents (3.3-3.5%). Only 47 (10.9%) respondents with 12-month disorders obtained treatment. 85% of people were treated in the general medical sector and the mental-health-care system, and the rest by religious or spiritual advisers, counsellors, herbalists, or fortune-tellers. Interpretation: Mental disorders are common in Lebanon, with a prevalence equivalent to that in Western Europe. However, the number of individuals with mental disorders who are not receiving treatment is considerably higher in Lebanon than in Western countries.

Lancet (London, England) · 182 citationsread the source →

Efficacy and Feasibility of a Therapist-Guided Internet-Based Intervention for Older Persons with Childhood Traumatization: A Randomized Controlled Trial.

Objective: Although cognitive-behavioral treatment approaches for post-traumatic stress disorder (PTSD) exist, only a small proportion of older adults seeks psychological treatment. Alternative treatment approaches are thus needed to fill the gap between provision and use of psychological interventions. This study aimed to investigate the efficacy and feasibility of an Internet-based, therapist-guided cognitive-behavioral therapy (Internet-based CBT) for older individuals with PTSD symptoms. Methods: Patients with clinically meaningful (i.e., subsyndromal or greater) PTSD symptoms were randomly assigned to a 6-week treatment group of therapist-guided Internet-based CBT (N = 47; treatment group) or a wait-list group (N = 47; WL). The treatment group was assessed pre- and post-treatment as well as at 3-, 6- and 12-month follow-ups. Results: Linear mixed-effects analyses showed a significant interaction between group (treatment versus WL) and time (pre versus post) for PTSD symptoms with a moderate between-group effect size in favor of the treatment group (d = 0.42). Effects in the treatment group were maintained up to the 12-month follow-up. Findings indicate a significant interaction (group × time) for quality of life (d = 0.39) and self-efficacy (d = 0.38). With regard to the feasibility, attrition rate was very low in both groups (treatment group: 12.8%, WL: 6.4%) and working alliance was very high. Conclusions: Results suggest that therapist-guided Internet-based CBT is associated with a substantial reduction in PTSD symptoms, and increase in resource-related variables in older adults with (subsyndromal) PTSD. This Internet-based intervention may offer a promising option in a stepped-care approach for older trauma-affected persons who may otherwise not pursue mental health treatment.

The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry · randomised controlled trial · 45 citationsread the source →

Outcomes of an early childhood obesity prevention program in a low-income community: a pilot, randomized trial.

Background: Obesity is a major and worldwide health problem in children. Objectives: The Early Childhood Obesity Prevention Program is a multi-component, randomized, controlled trial of a pilot community-focused obesity prevention program for mother/newborn dyads. Methods: Underserved, mother/newborn dyads were recruited to receive a standard home visitation program (Nurturing Families Network, NFN) or an enhanced program (NFN+) that incorporated behavioural change strategies (e.g., goal-setting, problem-solving) and focused on six obesity-associated behaviours (breastfeeding, juice/sugar-sweetened beverages, solids, infant sleep, TV/screen time and soothability) with linkages to community resources. Weight-for-length (WFL) z-score and maternal diet were secondary outcomes. Results: Fifty-seven dyads were recruited and 47 fully eligible dyads were enrolled (NFN = 21, NFN+ = 26). Forty-one (87.2%) were assessed at 6 months and 34 (72.3%) at 12 months. Retention at 12 months was higher for NFN+ dyads (84.6% vs. 56.1%, p = 0.04). NFN+ mothers were more likely to continue breastfeeding at 6 and 12 months vs. NFN mothers (p = 0.03 and 0.003, respectively), and at 12 months, NFN+ infants had fewer nocturnal awakenings (p = 0.04). There were no differences in other primary outcome measures or in WFL z-score at 6 or 12 months. Conclusions: A multi-component behavioural intervention increased breastfeeding duration and decreased nocturnal awakenings in infants of low-income families.

Pediatric obesity · randomised controlled trial · 21 citationsread the source →

The EMPOWER blended digital intervention for relapse prevention in schizophrenia: a feasibility cluster randomised controlled trial in Scotland and Australia.

Background: Early warning signs monitoring by service users with schizophrenia has shown promise in preventing relapse but the quality of evidence is low. We aimed to establish the feasibility of undertaking a definitive randomised controlled trial to determine the effectiveness of a blended digital intervention for relapse prevention in schizophrenia. Methods: This multicentre, feasibility, cluster randomised controlled trial aimed to compare Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) with treatment as usual in community mental health services (CMHS) in Glasgow and Melbourne. CMHS were the unit of randomisation, selected on the basis of those that probably had five or more care coordinators willing to participate. Participants were eligible if they were older than 16 years, had a schizophrenia or related diagnosis confirmed via case records, were able to provide informed consent, had contact with CMHS, and had had a relapse within the previous 2 years. Participants were randomised within stratified clusters to EMPOWER or to continue their usual approach to care. EMPOWER blended a smartphone for active monitoring of early warning signs with peer support to promote self-management and clinical triage to promote access to relapse prevention. Main outcomes were feasibility, acceptability, usability, and safety, which was assessed through face-to-face interviews. App usage was assessed via the smartphone and self-report. Primary end point was 12 months. Participants, research assistants and other team members involved in delivering the intervention were not masked to treatment conditions. Assessment of relapse was done by an independent adjudication panel masked to randomisation group. The study is registered at ISRCTN (99559262). Findings: We identified and randomised eight CMHS (six in Glasgow and two in Melbourne) comprising 47 care coordinators. We recruited 86 service users between Jan 19 and Aug 8, 2018; 73 were randomised (42 [58%] to EMPOWER and 31 [42%] to treatment as usual). There were 37 (51%) men and 36 (49%) women. At 12 months, main outcomes were collected for 32 (76%) of service users in the EMPOWER group and 30 (97%) of service users in the treatment as usual group. Of those randomised to EMPOWER, 30 (71%) met our a priori criterion of more than 33% adherence to daily monitoring that assumed feasibility. Median time to discontinuation of these participants was 31·5 weeks (SD 14·5). There were 29 adverse events in the EMPOWER group and 25 adverse events in the treatment as usual group. There were 13 app-related adverse events, affecting 11 people, one of which was serious. Fear of relapse was lower in the EMPOWER group than in the treatment as usual group at 12 months (mean difference -7·53 (95% CI -14·45 to 0·60; Cohen's d -0·53). Interpretation: A trial of digital technology to monitor early warning signs blended with peer support and clinical triage to detect and prevent relapse appears to be feasible, safe, and acceptable. A further main trial is merited. Funding: UK National Institute for Health Research Health Technology Assessment programme and the Australian National Health and Medical Research Council.

The lancet. Psychiatry · randomised controlled trial · 50 citationsread the source →

Cognitive behavioural therapy for adults with dissociative seizures (CODES): a pragmatic, multicentre, randomised controlled trial.

Background: Dissociative seizures are paroxysmal events resembling epilepsy or syncope with characteristic features that allow them to be distinguished from other medical conditions. We aimed to compare the effectiveness of cognitive behavioural therapy (CBT) plus standardised medical care with standardised medical care alone for the reduction of dissociative seizure frequency. Methods: In this pragmatic, parallel-arm, multicentre randomised controlled trial, we initially recruited participants at 27 neurology or epilepsy services in England, Scotland, and Wales. Adults (≥18 years) who had dissociative seizures in the previous 8 weeks and no epileptic seizures in the previous 12 months were subsequently randomly assigned (1:1) from 17 liaison or neuropsychiatry services following psychiatric assessment, to receive standardised medical care or CBT plus standardised medical care, using a web-based system. Randomisation was stratified by neuropsychiatry or liaison psychiatry recruitment site. The trial manager, chief investigator, all treating clinicians, and patients were aware of treatment allocation, but outcome data collectors and trial statisticians were unaware of treatment allocation. Patients were followed up 6 months and 12 months after randomisation. The primary outcome was monthly dissociative seizure frequency (ie, frequency in the previous 4 weeks) assessed at 12 months. Secondary outcomes assessed at 12 months were: seizure severity (intensity) and bothersomeness; longest period of seizure freedom in the previous 6 months; complete seizure freedom in the previous 3 months; a greater than 50% reduction in seizure frequency relative to baseline; changes in dissociative seizures (rated by others); health-related quality of life; psychosocial functioning; psychiatric symptoms, psychological distress, and somatic symptom burden; and clinical impression of improvement and satisfaction. p values and statistical significance for outcomes were reported without correction for multiple comparisons as per our protocol. Primary and secondary outcomes were assessed in the intention-to-treat population with multiple imputation for missing observations. This trial is registered with the International Standard Randomised Controlled Trial registry, ISRCTN05681227, and ClinicalTrials.gov, NCT02325544. Findings: Between Jan 16, 2015, and May 31, 2017, we randomly assigned 368 patients to receive CBT plus standardised medical care (n=186) or standardised medical care alone (n=182); of whom 313 had primary outcome data at 12 months (156 [84%] of 186 patients in the CBT plus standardised medical care group and 157 [86%] of 182 patients in the standardised medical care group). At 12 months, no significant difference in monthly dissociative seizure frequency was identified between the groups (median 4 seizures [IQR 0-20] in the CBT plus standardised medical care group vs 7 seizures [1-35] in the standardised medical care group; estimated incidence rate ratio [IRR] 0·78 [95% CI 0·56-1·09]; p=0·144). Dissociative seizures were rated as less bothersome in the CBT plus standardised medical care group than the standardised medical care group (estimated mean difference -0·53 [95% CI -0·97 to -0·08]; p=0·020). The CBT plus standardised medical care group had a longer period of dissociative seizure freedom in the previous 6 months (estimated IRR 1·64 [95% CI 1·22 to 2·20]; p=0·001), reported better health-related quality of life on the EuroQoL-5 Dimensions-5 Level Health Today visual analogue scale (estimated mean difference 6·16 [95% CI 1·48 to 10·84]; p=0·010), less impairment in psychosocial functioning on the Work and Social Adjustment Scale (estimated mean difference -4·12 [95% CI -6·35 to -1·89]; p<0·001), less overall psychological distress than the standardised medical care group on the Clinical Outcomes in Routine Evaluation-10 scale (estimated mean difference -1·65 [95% CI -2·96 to -0·35]; p=0·013), and fewer somatic symptoms on the modified Patient Health Questionnaire-15 scale (estimated mean difference -1·67 [95% CI -2·90 to -0·44]; p=0·008). Clinical improvement at 12 months was greater in the CBT plus standardised medical care group than the standardised medical care alone group as reported by patients (estimated mean difference 0·66 [95% CI 0·26 to 1·04]; p=0·001) and by clinicians (estimated mean difference 0·47 [95% CI 0·21 to 0·73]; p<0·001), and the CBT plus standardised medical care group had greater satisfaction with treatment than did the standardised medical care group (estimated mean difference 0·90 [95% CI 0·48 to 1·31]; p<0·001). No significant differences in patient-reported seizure severity (estimated mean difference -0·11 [95% CI -0·50 to 0·29]; p=0·593) or seizure freedom in the last 3 months of the study (estimated odds ratio [OR] 1·77 [95% CI 0·93 to 3·37]; p=0·083) were identified between the groups. Furthermore, no significant differences were identified in the proportion of patients who had a more than 50% reduction in dissociative seizure frequency compared with baseline (OR 1·27 [95% CI 0·80 to 2·02]; p=0·313). Additionally, the 12-item Short Form survey-version 2 scores (estimated mean difference for the Physical Component Summary score 1·78 [95% CI -0·37 to 3·92]; p=0·105; estimated mean difference for the Mental Component Summary score 2·22 [95% CI -0·30 to 4·75]; p=0·084), the Generalised Anxiety Disorder-7 scale score (estimated mean difference -1·09 [95% CI -2·27 to 0·09]; p=0·069), and the Patient Health Questionnaire-9 scale depression score (estimated mean difference -1·10 [95% CI -2·41 to 0·21]; p=0·099) did not differ significantly between groups. Changes in dissociative seizures (rated by others) could not be assessed due to insufficient data. During the 12-month period, the number of adverse events was similar between the groups: 57 (31%) of 186 participants in the CBT plus standardised medical care group reported 97 adverse events and 53 (29%) of 182 participants in the standardised medical care group reported 79 adverse events. Interpretation: CBT plus standardised medical care had no statistically significant advantage compared with standardised medical care alone for the reduction of monthly seizures. However, improvements were observed in a number of clinically relevant secondary outcomes following CBT plus standardised medical care when compared with standardised medical care alone. Thus, adults with dissociative seizures might benefit from the addition of dissociative seizure-specific CBT to specialist care from neurologists and psychiatrists. Future work is needed to identify patients who would benefit most from a dissociative seizure-specific CBT approach. Funding: National Institute for Health Research, Health Technology Assessment programme.

The lancet. Psychiatry · randomised controlled trial · 192 citationsread the source →

Laparoscopic ileocaecal resection versus infliximab for terminal ileitis in Crohn's disease: a randomised controlled, open-label, multicentre trial.

Background: Treatment of patients with ileocaecal Crohn's disease who have not responded to conventional therapy is commonly scaled up to biological agents, but surgery can also offer excellent short-term and long-term results. We compared laparoscopic ileocaecal resection with infliximab to assess how they affect health-related quality of life. Methods: In this randomised controlled, open-label trial, in 29 teaching hospitals and tertiary care centres in the Netherlands and the UK, adults with non-stricturing, ileocaecal Crohn's disease, in whom conventional therapy has failed were randomly allocated (1:1) by an internet randomisation module with biased-coin minimisation for participating centres and perianal fistula to receive laparoscopic ileocaecal resection or infliximab. Eligible patients were aged 18-80 years, had active Crohn's disease of the terminal ileum, and had not responded to at least 3 months of conventional therapy with glucocorticosteroids, thiopurines, or methotrexate. Patients with diseased terminal ileum longer than 40 cm or abdominal abscesses were excluded. The primary outcome was quality of life on the Inflammatory Bowel Disease Questionnaire (IBDQ) at 12 months. Secondary outcomes were general quality of life, measured by the Short Form-36 (SF-36) health survey and its physical and mental component subscales, days unable to participate in social life, days on sick leave, morbidity (additional procedures and hospital admissions), and body image and cosmesis. Analyses of the primary outcome were done in the intention-to-treat population, and safety analyses were done in the per-protocol population. This trial is registered at the Dutch Trial Registry (NTR1150). Findings: Between May 2, 2008, and October 14, 2015, 73 patients were allocated to have resection and 70 to receive infliximab. Corrected for baseline differences, the mean IBDQ score at 12 months was 178·1 (95% CI 171·1-185·0) in the resection group versus 172·0 (164·3-179·6) in the infliximab group (mean difference 6·1 points, 95% CI -4·2 to 16·4; p=0·25). At 12 months, the mean SF-36 total score was 112·1 (95% CI 108·0-116·2) in the resection group versus 106·5 (102·1-110·9) in the infliximab group (mean difference 5·6, 95% CI -0·4 to 11·6), the mean physical component score was 47·7 (45·7-49·7) versus 44·6 (42·5-46·8; mean difference 3·1, 4·2 to 6·0), and the mean mental component score was 49·5 (47·0-52·1) versus 46·1 (43·3-48·9; mean difference 3·5, -0·3 to 7·3). Mean numbers of days of sick leave were 3·4 days (SD 7·1) in the resection group versus 1·4 days (4·7) in the infliximab group (p<0·0001), days not able to take part in social life were 1·8 days (6·3) versus 1·1 days (4·5; p=0·20), days of scheduled hospital admission were 6·5 days (3·8) versus 6·8 days (3·2; p=0·84), and the number of patients who had unscheduled hospital admissions were 13 (18%) of 73 versus 15 (21%) of 70 (p=0·68). Body-image scale mean scores in the patients who had resection were 16·0 (95% CI 15·2-16·8) at baseline versus 17·8 (17·1-18·4) at 12 months, and cosmetic scale mean scores were 17·6 (16·6-18·6) versus 18·6 (17·6-19·6). Surgical intervention-related complications classified as IIIa or worse on the Clavien-Dindo scale occurred in four patients in the resection group. Treatment-related serious adverse events occurred in two patients in the infliximab group. During a median follow-up of 4 years (IQR 2-6), 26 (37%) of 70 patients in the infliximab group had resection, and 19 (26%) of 73 patients in the resection group received anti-TNF. Interpretation: Laparoscopic resection in patients with limited (diseased terminal ileum <40 cm), non-stricturing, ileocaecal Crohn's disease in whom conventional therapy has failed could be considered a reasonable alternative to infliximab therapy. Funding: Netherlands Organisation for Health Research and Development.

The lancet. Gastroenterology & hepatology · randomised controlled trial · 228 citationsread the source →

Effect of an early perinatal depression intervention on long-term child development outcomes: follow-up of the Thinking Healthy Programme randomised controlled trial.

Background: Perinatal depression has been linked with deleterious child development outcomes, yet maternal depression interventions have not been shown to have lasting effects on child development, and evidence is not available from countries of low or middle income. In the Thinking Healthy Programme cluster-randomised controlled trial, a perinatal depression intervention was assessed in Pakistan in 2006-07. The intervention significantly reduced depression levels 12 months post partum compared with a control. We aimed to assess the effect of this same intervention on the cognitive, socioemotional, and physical development of children at around age 7 years. Methods: Mother-child dyads who participated in the Thinking Healthy Programme cluster-randomised controlled trial were interviewed when the index child was about 7 years old. A reference group of 300 mothers who did not have prenatal depression and, therefore, did not receive the original intervention, was enrolled with their children at the same time. The primary cognitive outcome was the score on the Wechsler Preschool and Primary Scale of Intelligence (WPPSI-IV); primary socioemotional outcomes included scores on the Strengths and Difficulties Questionnaire (SDQ) and the Spence Children's Anxiety Scale (SCAS); and primary physical outcomes were height-for-age, weight-for-age, and body-mass index (BMI)-for-age Z scores. Generalised linear modelling with random effects to account for clustering was the main method of analysis. Analyses were by intention to treat. The Thinking Healthy Programme cluster-randomised trial was registered at ISRCTN.com, number ISRCTN65316374. Findings: Of 705 participating mother-child dyads interviewed at the end of the Thinking Healthy Programme randomised controlled trial, 584 (83%) dyads were enrolled. 289 mothers had received the intervention and 295 had received a control consisting of enhanced usual care. The mean age of the children was 7·6 years (SD 0·1). Overall, cognitive, socioemotional, or physical development outcomes did not differ between children in the intervention or control groups whose mothers had prenatal depression. When compared with the reference group of children whose mothers did not have prenatal depression, the Thinking Healthy Programme trial children had worse socioemotional outcomes; mean scores were significantly higher on the SDQ for total difficulty (11·34 vs 10·35; mean difference 0·78, 95% CI 0·09-1·47; p=0·03) and on the SCAS for anxiety (21·33 vs 17·57; mean difference 2·93, 1·15-4·71; p=0·0013). Cognitive and physical outcomes did not differ. Interpretation: Our findings show that cognitive, socioemotional, and physical developmental outcomes of children at age 7 years whose mother had prenatal depression did not differ between those who received the Thinking Healthy Programme intervention and those who received the control. Further investigation is needed to understand what types of complex interventions or approaches are needed for long-term gains in maternal and child wellbeing. Prolonged, detailed, and frequent follow-up is warranted for all interventions. Funding: Grand Challenges Canada (Government of Canada), Saving Brains programme.

The lancet. Psychiatry · randomised controlled trial · 76 citationsread the source →

Insecurity, distress and mental health: experimental and randomized controlled trials of a psychosocial intervention for youth affected by the Syrian crisis.

Background: Strengthening the evidence base for humanitarian interventions that provide psychosocial support to war-affected youth is a key priority. We tested the impacts of an 8-week programme of structured activities informed by a profound stress attunement (PSA) framework (Advancing Adolescents), delivered in group-format to 12-18 year-olds in communities heavily affected by the Syrian crisis. We included both Syrian refugee and Jordanian youth. Methods: We followed an experimental design, comparing treatment youth and wait-list controls over two programme implementation cycles, randomizing to study arm in cycle 2 (ClinicalTrials.gov ID: NCT03012451). We measured insecurity, distress, mental health difficulties, prosocial behaviour and post-traumatic stress symptoms at three time-points: baseline (n = 817 youth; 55% Syrian, 43% female), postintervention (n = 463; 54% Syrian, 47% female), and follow-up (n = 212, 58% Syrian, 43% female). Regression models assessed: prospective intervention impacts, adjusting for baseline scores, trauma exposure, age, and gender; differential impacts across levels of trauma exposure and activity-based modality; and sustained recovery 1 year later. We analysed cycle-specific and cycle-pooled data for youth exclusively engaged in Advancing Adolescents and for the intent-to-treat sample. Results: We found medium to small effect sizes for all psychosocial outcomes, namely Human Insecurity (β = -7.04 (95% CI: -10.90, -3.17), Cohen's d = -0.4), Human Distress (β = -5.78 (-9.02, -2.54), d = -0.3), and Perceived Stress (β = -1.92 (-3.05, -0.79), d = -0.3); and two secondary mental health outcomes (AYMH: β = -3.35 (-4.68, -2.02), d = -0.4; SDQ: β = -1.46 (-2.42, -0.50), d = -0.2). We found no programme impacts for prosocial behaviour or post-traumatic stress reactions. Beneficial impacts were stronger for youth with exposure to four trauma events or more. While symptoms alleviated for both intervention and control groups over time, there were sustained effects of the intervention on Human Insecurity. Conclusions: Findings strengthen the evidence base for mental health and psychosocial programming for a generation affected by conflict and forced displacement. We discuss implications for programme implementation and evaluation research.

Journal of child psychology and psychiatry, and allied disciplines · randomised controlled trial · 60 citationsread the source →

“As du Coeur” study: a randomized controlled trial on physical activity maintenance in cardiovascular patients

BACKGROUND: The benefits of supervised physical activity programs in cardiac rehabilitation have been amply demonstrated, but the quantity of physical activity often declines quickly once supervision ends. This trial assesses the effectiveness of an experimental intervention drawing on habit formation theory to maintain physical activity. METHODS: Cardiovascular patients (N = 47) were randomly assigned to one of two groups. The first group participated in two supervised physical activity (SPA) sessions per week for 20 weeks. The second group was offered a progressively autonomous physical activity (PAPA) program as follows: the same supervised program as the SPA group for 10 weeks and then a further 10 weeks with one supervised session replaced by a strategy to build and sustain the habit of autonomous physical activity. The International Physical Activity Questionnaire (IPAQ; Craig et al. Med Sci Sports Exerc 35(8):1381-1395, 2003) was used to measure the quantity of physical activity, which was the primary outcome. The number of participants was limited, and we thus took multiple IPAQ measurements (at 0, 5, 7, 9 and 12 months after the start of the intervention) and used a mixed model for analysis. Physical condition, automaticity of the physical activity behavior, motivation, and quality of life were examined for changes. RESULTS: No significant between-group differences were noted for physical activity behaviors after the program, physical condition, motivation, or behavioral automaticity. The PAPA group nevertheless completed more PA sessions during the intervention, and their quality of life was significantly higher than that of the SPA group at 12 months. CONCLUSION: Although the number of supervised sessions was lower, the progressively autonomous PA program resulted in the same or even higher positive outcomes than the fully supervised PA program. TRIAL REGISTRATION: Current Controlled Trials ISRCTN77313697 , retrospectively registered on 20 November 2015.

BMC Cardiovascular Disorders · randomised controlled trial · 17 citationsread the source →

Padeliporfin vascular-targeted photodynamic therapy versus active surveillance in men with low-risk prostate cancer (CLIN1001 PCM301): an open-label, phase 3, randomised controlled trial.

Background: Vascular-targeted photodynamic therapy, a novel tissue-preserving treatment for low-risk prostate cancer, has shown favourable safety and efficacy results in single-arm phase 1 and 2 studies. We compared this treatment with the standard of care, active surveillance, in men with low-risk prostate cancer in a phase 3 trial. Methods: This randomised controlled trial was done in 47 European university centres and community hospitals. Men with low-risk, localised prostate cancer (Gleason pattern 3) who had received no previous treatment were randomly assigned (1:1) to vascular-targeted photodynamic therapy (4 mg/kg padeliporfin intravenously over 10 min and optical fibres inserted into the prostate to cover the desired treatment zone and subsequent activation by laser light 753 nm with a fixed power of 150 mW/cm for 22 min 15 s) or active surveillance. Randomisation was done by a web-based allocation system stratified by centre with balanced blocks of two or four patients. Best practice for active surveillance at the time of study design was followed (ie, biopsy at 12-month intervals and prostate-specific antigen measurement and digital rectal examination at 3-month intervals). The co-primary endpoints were treatment failure (histological progression of cancer from low to moderate or high risk or death during 24 months' follow-up) and absence of definite cancer (absence of any histology result definitely positive for cancer at month 24). Analysis was by intention to treat. Treatment was open-label, but investigators assessing primary efficacy outcomes were masked to treatment allocation. This trial is registered with ClinicalTrials.gov, number NCT01310894. Findings: Between March 8, 2011, and April 30, 2013, we randomly assigned 206 patients to vascular-targeted photodynamic therapy and 207 patients to active surveillance. Median follow-up was 24 months (IQR 24-25). The proportion of participants who had disease progression at month 24 was 58 (28%) of 206 in the vascular-targeted photodynamic therapy group compared with 120 (58%) of 207 in the active surveillance group (adjusted hazard ratio 0·34, 95% CI 0·24-0·46; p<0·0001). 101 (49%) men in the vascular-targeted photodynamic therapy group had a negative prostate biopsy result at 24 months post treatment compared with 28 (14%) men in the active surveillance group (adjusted risk ratio 3·67, 95% CI 2·53-5·33; p<0·0001). Vascular-targeted photodynamic therapy was well tolerated. The most common grade 3-4 adverse events were prostatitis (three [2%] in the vascular-targeted photodynamic therapy group vs one [<1%] in the active surveillance group), acute urinary retention (three [2%] vs one [<1%]) and erectile dysfunction (two [1%] vs three [1%]). The most common serious adverse event in the vascular-targeted photodynamic therapy group was retention of urine (15 patients; severe in three); this event resolved within 2 months in all patients. The most common serious adverse event in the active surveillance group was myocardial infarction (three patients). Interpretation: Padeliporfin vascular-targeted photodynamic therapy is a safe, effective treatment for low-risk, localised prostate cancer. This treatment might allow more men to consider a tissue-preserving approach and defer or avoid radical therapy. Funding: Steba Biotech.

The Lancet. Oncology · randomised controlled trial · 236 citationsread the source →

A therapist-supported internet-based intervention for bereaved siblings: A randomized controlled trial

Background: The loss of a sibling can have a long-term impact on the mental and physical health of the surviving sibling throughout adolescence and later adulthood. Even though bereaved siblings can be identified as a high-risk group, evidence-based interventions for this bereavement group are still missing. Aim: To evaluate the treatment effects of an internet-based writing intervention for bereaved siblings aged 16–65 years. Design: A two-armed randomized controlled trial (DRKS00011514) compared the intervention to a waiting list control group. The 6-week intervention consisted of six structured writing assignments that were based on cognitive behavioral therapy, focusing on the specific situation of bereaved siblings. Setting/participants: Eighty-six bereaved siblings (loss >1 month ago, no severe psychiatric symptoms) were randomly allocated to the intervention group ( n = 47) or the waiting list control group ( n = 39). Primary outcomes were symptoms of prolonged grief disorder and depression; secondary outcomes were posttraumatic stress symptoms and survivor guilt. Results: Symptoms of depression and prolonged grief disorder improved significantly in the intention-to-treat analyses from pre-to post-measurement compared with the control group ( g Depression = −0.62, g Grief = 0.33). In the intervention group, all primary and secondary outcomes decreased significantly from baseline to 12-month follow-up ( gs = −0.38 to −1.04). A significant clinical change could be found for depression (34%) compared to the waitlist control group (10%). Conclusions: Bereaved siblings profited from this brief internet-based writing intervention in the short- and long-term. However, future research, such as dismantling studies, may help to further optimize the benefits of an intervention aimed at bereaved siblings.

Palliative Medicine · randomised controlled trial · 20 citationsread the source →

Acceptance and commitment therapy for symptom interference in metastatic breast cancer patients: a pilot randomized trial.

Purpose: Breast cancer is the leading cause of cancer mortality in women worldwide. With medical advances, metastatic breast cancer (MBC) patients often live for years with many symptoms that interfere with activities. However, there is a paucity of efficacious interventions to address symptom-related suffering and functional interference. Thus, this study examined the feasibility and preliminary efficacy of telephone-based acceptance and commitment therapy (ACT) for symptom interference with functioning in MBC patients. Methods: Symptomatic MBC patients (N = 47) were randomly assigned to six telephone sessions of ACT or six telephone sessions of education/support. Patients completed measures of symptom interference and measures assessing the severity of pain, fatigue, sleep disturbance, depressive symptoms, and anxiety. Results: The eligibility screening rate (64%) and high retention (83% at 8 weeks post-baseline) demonstrated feasibility. When examining within-group change, ACT participants showed decreases in symptom interference (i.e., fatigue interference and sleep-related impairment; Cohen's d range = - 0.23 to - 0.31) at 8 and 12 weeks post-baseline, whereas education/support participants showed minimal change in these outcomes (d range = - 0.03 to 0.07). Additionally, at 12 weeks post-baseline, ACT participants showed moderate decreases in fatigue and sleep disturbance (both ds = - 0.43), whereas education/support participants showed small decreases in these outcomes (ds = - 0.24 and - 0.18 for fatigue and sleep disturbance, respectively). Both the ACT and education/support groups showed reductions in depressive symptoms (ds = - 0.27 and - 0.28) at 12 weeks post-baseline. Group differences in all outcomes were not statistically significant. Conclusions: ACT shows feasibility and promise in improving fatigue and sleep-related outcomes in MBC patients and warrants further investigation.

Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · randomised controlled trial · 62 citationsread the source →

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 →

Vagus nerve stimulation paired with rehabilitation for upper limb motor function after ischaemic stroke (VNS-REHAB): a randomised, blinded, pivotal, device trial.

Background: Long-term loss of arm function after ischaemic stroke is common and might be improved by vagus nerve stimulation paired with rehabilitation. We aimed to determine whether this strategy is a safe and effective treatment for improving arm function after stroke. Methods: In this pivotal, randomised, triple-blind, sham-controlled trial, done in 19 stroke rehabilitation services in the UK and the USA, participants with moderate-to-severe arm weakness, at least 9 months after ischaemic stroke, were randomly assigned (1:1) to either rehabilitation paired with active vagus nerve stimulation (VNS group) or rehabilitation paired with sham stimulation (control group). Randomisation was done by ResearchPoint Global (Austin, TX, USA) using SAS PROC PLAN (SAS Institute Software, Cary, NC, USA), with stratification by region (USA vs UK), age (≤30 years vs >30 years), and baseline Fugl-Meyer Assessment-Upper Extremity (FMA-UE) score (20-35 vs 36-50). Participants, outcomes assessors, and treating therapists were masked to group assignment. All participants were implanted with a vagus nerve stimulation device. The VNS group received 0·8 mA, 100 μs, 30 Hz stimulation pulses, lasting 0·5 s. The control group received 0 mA pulses. Participants received 6 weeks of in-clinic therapy (three times per week; total of 18 sessions) followed by a home exercise programme. The primary outcome was the change in impairment measured by the FMA-UE score on the first day after completion of in-clinic therapy. FMA-UE response rates were also assessed at 90 days after in-clinic therapy (secondary endpoint). All analyses were by intention to treat. This trial is registered at ClinicalTrials.gov, NCT03131960. Findings: Between Oct 2, 2017, and Sept 12, 2019, 108 participants were randomly assigned to treatment (53 to the VNS group and 55 to the control group). 106 completed the study (one patient for each group did not complete the study). On the first day after completion of in-clinic therapy, the mean FMA-UE score increased by 5·0 points (SD 4·4) in the VNS group and by 2·4 points (3·8) in the control group (between group difference 2·6, 95% CI 1·0-4·2, p=0·0014). 90 days after in-clinic therapy, a clinically meaningful response on the FMA-UE score was achieved in 23 (47%) of 53 patients in the VNS group versus 13 (24%) of 55 patients in the control group (between group difference 24%, 6-41; p=0·0098). There was one serious adverse event related to surgery (vocal cord paresis) in the control group. Interpretation: Vagus nerve stimulation paired with rehabilitation is a novel potential treatment option for people with long-term moderate-to-severe arm impairment after ischaemic stroke. Funding: MicroTransponder.

Lancet (London, England) · randomised controlled trial · 397 citationsread the source →

Reducing violence and increasing condom use in the intimate partnerships of female sex workers: study protocol for Samvedana Plus, a cluster randomised controlled trial in Karnataka state, south India.

Background: Female sex workers (FSWs) are at increased risk of HIV and STIs compared to women in the general population, and frequently experience violence in their working and domestic lives from a variety of perpetrators, which can enhance this risk. While progress has been made in addressing violence by police and clients, little work has been done to understand and prevent violence by intimate partners (IPs) among FSW populations. Methods: Samvedana Plus is a multi-level intervention programme that works with FSWs, their IPs, the sex worker community, and the general population, and aims to reduce violence and increase consistent condom use within these 'intimate' relationships. The programme involves shifting norms around the acceptability of beating as a form of discipline, challenging gender roles that give men authority over women, and working with men and women to encourage new relationship models based on gender equity and respect. The programme will aim to cover 800 FSWs and their IPs living in 47 villages in Bagalkot district, northern Karnataka. The study is designed to assess two primary outcomes: the proportion of FSWs who report: (i) physical or sexual partner violence; and (ii) consistent condom use in their intimate relationship, within the past 6 months. The evaluation will employ a cluster-randomised controlled trial design, with 50 % of the village clusters (n = 24) randomly selected to receive the intervention for the first 24 months and the remaining 50 % (n = 23) receiving the intervention thereafter. Statisticians will be blinded to treatment arm allocation. The evaluation will use an adjusted, cluster-level intention to treat analysis, comparing outcomes in intervention and control villages at midline (12 months) and endline (24 months). The evaluation design will involve quantitative and qualitative assessments with (i) all FSWs who report an IP (ii) IPs; and process/ implementation monitoring. Baseline data collection was completed in April 2015, and endline data collection is anticipated in May 2017. Conclusions: This is an innovative intervention programme that aims to address violence by IPs as part of HIV prevention programming with FSWs. Reducing violence is expected to reduce vulnerability to HIV acquisition, and help women to work and live without fear of violence. Trial registration: Clinical Trials NCT02807259 Jun 24 2016 (retrospectively registered).

BMC public health · randomised controlled trial · 20 citationsread the source →

Uptake of antiretroviral therapy and male circumcision after community-based HIV testing and strategies for linkage to care versus standard clinic referral: a multisite, open-label, randomised controlled trial in South Africa and Uganda.

Background: Male circumcision decreases HIV acquisition by 60%, and antiretroviral therapy (ART) almost eliminates HIV transmission from HIV-positive people who are virally suppressed; however, coverage of these interventions has lagged behind targets. We aimed to assess whether community-based HIV testing with counsellor support and point-of-care CD4 cell count testing would increase uptake of ART and male circumcision. Methods: We did this multisite, open-label, randomised controlled trial in six research-naive communities in rural South Africa and Uganda. Eligible HIV-positive participants (aged ≥16 years) were randomly assigned (1:1:1) in a factorial design to receive lay counsellor clinic linkage facilitation, lay counsellor follow-up home visits, or standard-of-care clinic referral, and then (1:1) either point-of-care CD4 cell count testing or referral for CD4 testing. HIV-negative uncircumcised men (aged 16-49 years) who could receive secure mobile phone text messages were randomly assigned (1:1:1) to receive text message reminders, lay counsellor visits, or standard clinic referral. The study biostatistician generated the randomisation schedule via a computer-generated random number program with varying block sizes (multiples of six or three) stratified by country. Primary outcomes for HIV-positive people were obtaining a CD4 cell count, linkage to an HIV clinic, ART initiation, and viral suppression at 9 months, and for HIV-negative uncircumcised men were visiting a circumcision facility and uptake of male circumcision at 3 months. We assessed social harms as a safety outcome throughout the study. We did the primary analyses by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT02038582. Findings: Between June 6, 2013, and March 11, 2015, 15 332 participants were tested. 2339 (15%) participants tested HIV positive, of whom 1325 (57%) were randomly assigned to receive lay counsellor clinic linkage facilitation (n=437), lay counsellor follow-up home visits (n=449), or standard clinic referral (n=439), and then point-of-care CD4 cell testing (n=206, n=220, and n=213, respectively) or referral for CD4 testing (n=231, n=229, and n=226, respectively). 12 993 (85%) participants tested HIV negative, of whom 750 (6%) uncircumcised men were randomly assigned to receive clinic referral (n=230), text message reminders (n=288), or lay counsellor follow-up visits (n=232). 1218 (93%) of 1303 HIV-positive participants were linked to care, but only 488 (37%) participants initiated ART. Overall, 635 (50%) of 1272 HIV-positive individuals achieved viral suppression at 9 months: 219 (52%) of 419 participants in the clinic facilitation group, 202 (47%) of 431 participants in the lay counsellor follow-up group, and 214 (51%) of 422 participants in the clinic referral group, with no significant differences between groups (p=0·668 for clinic facilitation and p=0·273 for lay counsellor follow-up vs clinic referral). 523 (72%) of 734 HIV-negative men visited a circumcision facility, with no difference between groups. 62 (28%) of 224 men were circumcised in the male circumcision clinic referral group compared with 137 (48%) of 284 men in the text message reminder group (relative risk 1·72, 95% CI 1·36-2·17; p<0·0001) and 106 (47%) of 226 men in the lay counsellor follow-up group (1·67, 1·29-2·14; p=0·0001). No cases of study-related social harm were reported, including probing about partnership separation, unintended disclosure, gender-based violence, and stigma. Interpretation: All the community-based strategies achieved high rates of linkage of HIV-positive people to HIV clinics, roughly a third of whom initiated ART, and of those more than 80% were virally suppressed at 9 months. Uptake of male circumcision was almost two-times higher in men who received text message reminders or lay counsellor visits than in those who received standard-of-care clinic referral. Clinic barriers to ART initiation should be addressed in future strategies to increase the proportion of HIV-positive people accessing treatment and achieving viral suppression. Funding: National Institute of Allergy and Infectious Diseases, National Institutes of Health.

The lancet. HIV · randomised controlled trial · 65 citationsread the source →

Telephone-Based Cognitive Behavioral Therapy for Insomnia in Perimenopausal and Postmenopausal Women With Vasomotor Symptoms: A MsFLASH Randomized Clinical Trial.

Importance: Effective, practical, nonpharmacologic therapies are needed to treat menopause-related insomnia symptoms in primary and women's specialty care settings. Objective: To evaluate the efficacy of telephone-based cognitive behavioral therapy for insomnia (CBT-I) vs menopause education control (MEC). Design, setting, and participants: A single-site, randomized clinical trial was conducted from September 1, 2013, to August 31, 2015, in western Washington State among 106 perimenopausal or postmenopausal women aged 40 to 65 years with moderate insomnia symptoms (Insomnia Severity Index [ISI] score, ≥12) and 2 or more daily hot flashes. Blinded assessments were conducted at baseline, 8, and 24 weeks postrandomization. An intent-to-treat analysis was conducted. Interventions: Six CBT-I or MEC telephone sessions in 8 weeks. Participants submitted weekly electronic sleep diaries and received group-specific written educational materials. The CBT-I sessions included sleep restriction, stimulus control, sleep hygiene education, cognitive restructuring, and behavioral homework; MEC sessions provided information about menopause and women's health. Main outcomes and measures: Primary outcome was scores on the ISI (score range, 0-28; scores ≥15 indicate moderate to severe insomnia). Secondary outcome was scores on the Pittsburgh Sleep Quality Index (score range, 0-21; higher scores indicate worse sleep quality). Additional outcomes included sleep and hot flash diary variables and hot flash interference. Results: At 8 weeks, ISI scores had decreased 9.9 points among 53 women receiving CBT-I (mean [SD] age, 55.0 [3.5] years) and 4.7 points among 53 women receiving MEC (age, 54.7 [4.7] years), a mean between-group difference of 5.2 points (95% CI, -6.1 to -3.3; P < .001). Pittsburgh Sleep Quality Index scores decreased 4.0 points in women receiving CBT-I and 1.4 points in women receiving MEC, a mean between-group difference of 2.7 points (95% CI, -3.9 to -1.5; P < .001). Significant group differences were sustained at 24 weeks. At 8 and 24 weeks, 33 of 47 women (70%) and 37 of 44 (84%) in the CBT-I group, respectively, had ISI scores in the no-insomnia range compared with 10 of 41 (24%) and 16 of 37 (43%) in the MEC group, respectively. The CBT-I group also had greater improvements in diary-reported sleep latency, wake time, and sleep efficiency. There were no between-group differences in frequency of daily hot flashes, but hot flash interference was significantly decreased at 8 weeks for the CBT-I group (-15.7; 95% CI, -20.4 to -11.0) compared with the MEC group (-7.1; 95% CI, -14.6 to 0.4) (P = .03), differences that were maintained at 24 weeks for the CBT-I group (-22.8; 95% CI, -28.6 to -16.9) and MEC group (-11.6; 95% CI, -19.4 to -3.8) (P = .003). Conclusions and relevance: Telephone-based CBT-I improved sleep in perimenopausal and postmenopausal women with insomnia and hot flashes. Results support further development and testing of centralized CBT-I programs for treating menopausal insomnia. Trial registration: clinicaltrials.gov Identifier: NCT01936441.

JAMA internal medicine · randomised controlled trial · 114 citationsread the source →

Interventions for treating femoral shaft fractures in children and adolescents.

Background: Fractures of the femoral shaft in children are relatively uncommon but serious injuries that disrupt the lives of children and their carers and can result in significant long-term disability. Treatment involves either surgical fixation, such as intramedullary nailing or external fixation, or conservative treatment involving prolonged immobilisation, often in hospital. Objectives: To assess the effects (benefits and harms) of interventions for treating femoral shaft fractures in children and adolescents. Search methods: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (accessed 16 August 2013), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2013 Issue 7), MEDLINE (1946 to August Week 1 2013), EMBASE (1980 to 2012 week 9), CINAHL (16 August 2013), clinical trials registries, conference proceedings and reference lists; and contacted trial authors and experts in the field. Selection criteria: Randomised and quasi-randomised controlled trials comparing conservative and surgical interventions for diaphyseal fractures of the femur in children under 18 years of age. Our primary outcomes were functional outcome measures, unacceptable malunion, and serious adverse events. Data collection and analysis: Two authors independently screened and selected trials, assessed risk of bias and extracted data. We assessed the overall quality of the evidence for each outcome for each comparison using the GRADE approach. We pooled data using a fixed-effect model. Main results: We included 10 trials (six randomised and four quasi-randomised) involving a total of 527 children (531 fractures). All trials were at some risk of bias, including performance bias as care provider blinding was not practical, but to a differing extent. Just one trial was at low risk of selection bias. Reflecting both the risk of bias and the imprecision of findings, we judged the quality of evidence to be 'low' for most outcomes, meaning that we are unsure about the estimates of effect. Most trials failed to report on self-assessed function or when children resumed their usual activities. The trials evaluated 10 different comparisons, belonging to three main categories. Surgical versus conservative treatment Four trials presenting data for 264 children aged 4 to 12 years made this comparison. Low quality evidence (one trial, 101 children) showed children had very similar function assessed using the RAND health status score at two years after surgery (external fixation) compared with conservative treatment (spica cast): mean 69 versus 68. The other three trials did not report on function. There was moderate quality evidence (four trials, 264 children, aged 4 to 12 years, followed up 3 to 24 months) that surgery reduced the risk of malunion (risk ratio (RR) 0.29, 95% confidence interval (CI) 0.15 to 0.59, 4 trials). Assuming an illustrative baseline risk of 115 malunions per 1000 in children treated conservatively, these data equate to 81 fewer (95% CI 47 to 97 fewer) malunions per 1000 in surgically-treated children. Conversely, low quality evidence indicated that there were more serious adverse events such as infections after surgery (RR 2.39, 95% CI 1.10 to 5.17, 4 trials). Assuming an illustrative baseline risk of 40 serious adverse events per 1000 for conservative treatment, these data equate to 56 more (95% CI 4 to 167 more) serious adverse events per 1000 children treated surgically. There was low quality evidence (one trial, 101 children) of similar satisfaction levels in children and parents with surgery involving external fixation and plaster cast only. However, there was low quality evidence (one trial, 46 children) that more parents were satisfied with intramedullary nailing than with traction followed by a cast, and that surgery reduced the time taken off from school. Comparisons of different methods of conservative treatmentThe three trials in this category made three different comparisons. We are very unsure if unacceptable malunion rates differ between immediate hip spica versus skeletal traction followed by spica in children aged 3 to 10 years followed up for six to eight weeks (RR 4.0, 95% CI 0.5 to 32.9; one trial, 42 children; very low quality evidence). Malunion rates at 5 to 10 years may not differ between traction followed by functional orthosis versus traction followed by spica cast in children aged 5 to 13 years (RR 0.98, 95% CI 0.46 to 2.12; one trial, 43 children; low quality evidence). We are very unsure (very low quality evidence) if either function or serious adverse events (zero events reported) differ between single-leg versus double-leg spica casts (one trial, 52 young children aged two to seven years). Low quality evidence on the same comparison indicates that single-leg casts are less awkward to manage by parents, more comfortable for the child and may require less time off work by the caregiver. Comparisons of different methods of surgical treatmentThe three trials in this category made three different comparisons. Very low quality evidence means that we are very unsure if the rates of malunion, serious adverse events, time to return to school or parental satisfaction actually differ in children whose fractures were fixed using elastic stable intramedullary nailing or external fixation (one trial, 19 children). The same applies to the rates of serious adverse events and time to resume full weight-bearing in children treated with dynamic versus static external fixation (one trial, 52 children). Very low quality evidence (one trial, 47 children) means that we do not know if malunion, serious adverse events and time to resume weight-bearing actually differ between intramedullary nailing versus submuscular plating. However, there could be more difficulties in plate removal subsequently. Authors' conclusions: There is insufficient evidence to determine if long-term function differs between surgical and conservative treatment. Surgery results in lower rates of malunion in children aged 4 to 12 years, but may increase the risk of serious adverse events. Elastic stable intramedullary nailing may reduce recovery time. There is insufficient evidence from comparisons of different methods of conservative treatment or of different methods of surgical treatment to draw conclusions on the relative effects of the treatments compared in the included trials.

The Cochrane database of systematic reviews · meta-analysis · 23 citationsread the source →

Early intervention for psychosis.

Background: Proponents of early intervention have argued that outcomes might be improved if more therapeutic efforts were focused on the early stages of schizophrenia or on people with prodromal symptoms. Early intervention in schizophrenia has two elements that are distinct from standard care: early detection, and phase-specific treatment (phase-specific treatment is a psychological, social or physical treatment developed, or modified, specifically for use with people at an early stage of the illness).Early detection and phase-specific treatment may both be offered as supplements to standard care, or may be provided through a specialised early intervention team. Early intervention is now well established as a therapeutic approach in America, Europe and Australasia. Objectives: To evaluate the effects of: (a) early detection; (b) phase-specific treatments; and (c) specialised early intervention teams in the treatment of people with prodromal symptoms or first-episode psychosis. Search strategy: We searched the Cochrane Schizophrenia Group Trials Register (March 2009), inspected reference lists of all identified trials and reviews and contacted experts in the field. Selection criteria: We included all randomised controlled trials (RCTs) designed to prevent progression to psychosis in people showing prodromal symptoms, or to improve outcome for people with first-episode psychosis. Eligible interventions, alone and in combination, included: early detection, phase-specific treatments, and care from specialised early intervention teams. We accepted cluster-randomised trials but excluded non-randomised trials. Data collection and analysis: We reliably selected studies, quality rated them and extracted data. For dichotomous data, we estimated relative risks (RR), with the 95% confidence intervals (CI). Where possible, we calculated the number needed to treat/harm statistic (NNT/H) and used intention-to-treat analysis (ITT). Main results: Studies were diverse, mostly small, undertaken by pioneering researchers and with many methodological limitations (18 RCTs, total n=1808). Mostly, meta-analyses were inappropriate. For the six studies addressing prevention of psychosis for people with prodromal symptoms, olanzapine seemed of little benefit (n=60, 1 RCT, RR conversion to psychosis 0.58 CI 0.3 to 1.2), and cognitive behavioural therapy (CBT) equally so (n=60, 1 RCT, RR conversion to psychosis 0.50 CI 0.2 to 1.7). A risperidone plus CBT plus specialised team did have benefit over specialist team alone at six months (n=59, 1 RCT, RR conversion to psychosis 0.27 CI 0.1 to 0.9, NNT 4 CI 2 to 20), but this was not seen by 12 months (n=59, 1 RCT, RR 0.54 CI 0.2 to 1.3). Omega 3 fatty acids (EPA) had advantage over placebo (n=76, 1 RCT, RR transition to psychosis 0.13 CI 0.02 to 1.0, NNT 6 CI 5 to 96). We know of no replications of this finding. The remaining trials aimed to improve outcome in first-episode psychosis. Phase-specific CBT for suicidality seemed to have little effect, but the single study was small (n=56, 1 RCT, RR suicide 0.81 CI 0.05 to 12.26). Family therapy plus a specialised team in the Netherlands did not clearly affect relapse (n=76, RR 1.05 CI 0.4 to 3.0), but without the specialised team in China it may (n=83, 1 RCT, RR admitted to hospital 0.28 CI 0.1 to 0.6, NNT 3 CI 2 to 6). The largest and highest quality study compared specialised team with standard care. Leaving the study early was reduced (n=547, 1 RCT, RR 0.59 CI 0.4 to 0.8, NNT 9 CI 6 to 18) and compliance with treatment improved (n=507, RR stopped treatment 0.20 CI 0.1 to 0.4, NNT 9 CI 8 to 12). The mean number of days spent in hospital at one year were not significantly different (n=507, WMD, -1.39 CI -2.8 to 0.1), neither were data for 'Not hospitalised' by five years (n=547, RR 1.05 CI 0.90 to 1.2). There were no significant differences in numbers 'not living independently' by one year (n=507, RR 0.55 CI 0.3 to 1.2). At five years significantly fewer participants in the treatment group were 'not living independently' (n=547, RR 0.42 CI 0.21 to 0.8, NNT 19 CI 14 to 62). When phase-specific treatment (CBT) was compared with befriending no significant differences emerged in the number of participants being hospitalised over the 12 months (n=62, 1 RCT, RR 1.08 CI 0.59 to 1.99).Phase-specific treatment E-EPA oils suggested no benefit (n=80, 1 RCT, RR no response 0.90 CI 0.6 to 1.4) as did phase-specific treatment brief intervention (n=106, 1 RCT, RR admission 0.86 CI 0.4 to 1.7). Phase-specific ACE found no benefit but participants given vocational intervention were more likely to be employed (n=41, 1 RCT, RR 0.39 CI 0.21 to 0.7, NNT 2 CI 2 to 4). Phase-specific cannabis and psychosis therapy did not show benefit (n=47, RR cannabis use 1.30 CI 0.8 to 2.2) and crisis assessment did not reduce hospitalisation (n=98, RR 0.85 CI 0.6 to 1.3). Weight was unaffected by early behavioural intervention. Authors' conclusions: There is emerging, but as yet inconclusive evidence, to suggest that people in the prodrome of psychosis can be helped by some interventions. There is some support for specialised early intervention services, but further trials would be desirable, and there is a question of whether gains are maintained. There is some support for phase-specific treatment focused on employment and family therapy, but again, this needs replicating with larger and longer trials.

The Cochrane database of systematic reviews · meta-analysis · 133 citationsread the source →

The association of patient relationship style and outcomes in collaborative care treatment for depression in patients with diabetes.

Purpose: We sought to determine whether relationship style in patients with diabetes receiving depression treatment is associated with differential quality of care and depression outcomes. Methods: From 9 health maintenance organization clinics, 324 primary care patients with diabetes and comorbid major depression and/or dysthymia participated in the Pathways randomized controlled trial of collaborative care for depression (n = 160) versus usual care (n = 164). The intervention provided outreach, enhanced support of antidepressant medication use, and problem-solving treatment delivered by nurse case managers. Using attachment theory principles, we categorized patients as having an independent (n = 190) or interactive (n = 134) relationship style. We assessed whether patient relationship style moderated treatment group differences in quality of care and depression outcomes. Results: Among independent relationship style patients, the intervention resulted in significantly greater satisfaction with depression care in the first 6 months and 47 more depression-free days (P < 0.0003) based on the Hopkins Symptom Checklist at 12 months, compared with usual care. There were no significant treatment group differences in satisfaction with care or depression outcomes among patients with interactive relationship style. Among patients receiving the intervention, those with an independent relationship style received significantly more problem-solving treatment sessions as compared with patients with an interactive relationship style. Conclusion: Among depressed patients with diabetes, the Pathways collaborative care intervention improved quality of care for depression compared with usual care in both relationship style groups but was associated with significantly better depressive outcomes and greater satisfaction with care compared with usual care in patients with independent but not interactive relationship style.

Medical care · randomised controlled trial · 47 citationsread the source →

Treating anxiety disorders in children with high functioning autism spectrum disorders: a controlled trial.

A family-based, cognitive behavioural treatment for anxiety in 47 children with comorbid anxiety disorders and High Functioning Autism Spectrum Disorder (HFA) was evaluated. Treatment involved 12 weekly group sessions and was compared with a waiting list condition. Changes between pre- and post-treatment were examined using clinical interviews as well as child-, parent- and teacher-report measures. Following treatment, 71.4% of the treated participants no longer fulfilled diagnostic criteria for an anxiety disorder. Comparisons between the two conditions indicated significant reductions in anxiety symptoms as measured by self-report, parent report and teacher report. Discussion focuses on the implications for the use of cognitive behaviour therapy with HFA children, for theory of mind research and for further research on the treatment components.

Journal of autism and developmental disorders · randomised controlled trial · 177 citationsread the source →

Fewer emergency readmissions and better quality of life for older adults at risk of hospital readmission: a randomized controlled trial to determine the effectiveness of a 24-week exercise and telephone follow-up program.

Objectives: To evaluate the effect of an exercise-based model of hospital and in-home follow-up care for older people at risk of hospital readmission on emergency health service utilization and quality of life. Design: Randomized controlled trial. Setting: Tertiary metropolitan hospital in Australia. Participants: One hundred twenty-eight patients (64 intervention, 64 control) with an acute medical admission, aged 65 and older and with at least one risk factor for readmission (multiple comorbidities, impaired functionality, aged >or=75, recent multiple admissions, poor social support, history of depression). Intervention: Comprehensive nursing and physiotherapy assessment and individualized program of exercise strategies and nurse-conducted home visit and telephone follow-up commencing in the hospital and continuing for 24 weeks after discharge. Measurements: Emergency health service utilization (emergency hospital readmissions and visits to emergency department, general practitioner (GP), or allied health professional) and health-related quality of life (Medical Outcomes Study 12-item Short Form Survey (SF-12v2) collected at baseline and 4, 12, and 24 weeks after discharge. Results: The intervention group required significantly fewer emergency hospital readmissions (22% of intervention group, 47% of control group, P=.007) and emergency GP visits (25% of intervention group, 67% of control group, P<.001). The intervention group also reported significantly greater improvements in quality of life than the control group as measured using SF-12v2 Physical Component Summary scores (F (3, 279)=30.43, P<.001) and Mental Component Summary scores (F (3, 279)=7.20, P<.001). Conclusion: Early introduction of an individualized exercise program and long-term telephone follow-up may reduce emergency health service utilization and improve quality of life of older adults at risk of hospital readmission.

Journal of the American Geriatrics Society · randomised controlled trial · 161 citationsread the source →

Weight loss on the web: A pilot study comparing a structured behavioral intervention to a commercial program.

Objective: Internet weight loss programs have become widely available as alternatives to standard treatment, but few data are available on their efficacy. This study aimed to investigate the effectiveness of a structured behavioral weight loss website (VTrim) vs. a commercial weight loss website (eDiets.com). Research methods and procedures: A randomized, controlled trial was conducted from February 2003 to March 2005, in 124 overweight and obese subjects ages 18 years and older with a BMI of 25 to 39.9 kg/m2 (mean age, 47 +/- 9 years; BMI, 32 +/- 3 kg/m2; 20% men). Analyses were performed for the 88 subjects who had complete follow-up data. Participants were randomly assigned to 12-month VTrim (n = 62) or eDiets.com (n = 62) intervention. VTrim participants had access to a therapist-led structured behavioral weight loss program delivered on-line. eDiets.com subjects had access to a self-help commercial on-line weight loss program. Body weight, social support, and use of website components were measured at 0, 6, and 12 months. Results: Repeated-measures analyses showed that the VTrim group lost significantly more weight than the eDiets.com group at 6 months (8.3 +/- 7.9 kg vs. 4.1 +/- 6.2 kg; p = 0.004) and maintained a greater loss at 12 months (7.8 +/- 7.5 kg vs. 3.4 +/- 5.8 kg; p = 0.002). More participants in the VTrim group maintained a 5% weight loss goal (65% vs. 37.5%; p = 0.01) at 12 months. Discussion: An on-line, therapist-led structured behavioral weight loss website produced greater weight loss than a self-help commercial website. Because commercial sites have great potential public health impact, future research should investigate the feasibility of incorporating a more structured behavioral program into a commercial application.

Obesity (Silver Spring, Md.) · randomised controlled trial · 146 citationsread the source →

Percutaneous mitral valve repair for mitral regurgitation in high-risk patients: results of the EVEREST II study.

Background: The EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy) High-Risk registry and REALISM Continued Access Study High-Risk Arm are prospective registries of patients who received the MitraClip device (Abbott Vascular, Santa Clara, California) for mitral regurgitation (MR) in the United States. Objectives: The purpose of this study was to report 12-month outcomes in high-risk patients treated with the percutaneous mitral valve edge-to-edge repair. Methods: Patients with grades 3 to 4+ MR and a surgical mortality risk of ≥12%, based on the Society of Thoracic Surgeons risk calculator or the estimate of a surgeon coinvestigator following pre-specified protocol criteria, were enrolled. Results: In the studies, 327 of 351 patients completed 12 months of follow-up. Patients were elderly (76 ± 11 years of age), with 70% having functional MR and 60% having prior cardiac surgery. The mitral valve device reduced MR to ≤2+ in 86% of patients at discharge (n = 325; p < 0.0001). Major adverse events at 30 days included death in 4.8%, myocardial infarction in 1.1%, and stroke in 2.6%. At 12 months, MR was ≤2+ in 84% of patients (n = 225; p < 0.0001). From baseline to 12 months, left ventricular (LV) end-diastolic volume improved from 161 ± 56 ml to 143 ± 53 ml (n = 203; p < 0.0001) and LV end-systolic volume improved from 87 ± 47 ml to 79 ± 44 ml (n = 202; p < 0.0001). New York Heart Association functional class improved from 82% in class III/IV at baseline to 83% in class I/II at 12 months (n = 234; p < 0.0001). The 36-item Short Form Health Survey physical and mental quality-of-life scores improved from baseline to 12 months (n = 191; p < 0.0001). Annual hospitalization rate for heart failure fell from 0.79% pre-procedure to 0.41% post-procedure (n = 338; p < 0.0001). Kaplan-Meier survival estimate at 12 months was 77.2%. Conclusions: The percutaneous mitral valve device significantly reduced MR, improved clinical symptoms, and decreased LV dimensions at 12 months in this high-surgical-risk cohort. (Endovascular Valve Edge-to-Edge REpair STudy [EVERESTIIRCT]; NCT00209274).

Journal of the American College of Cardiology · randomised controlled trial · 321 citationsread the source →

Long-term quality-of-life outcomes after radical prostatectomy or watchful waiting: the Scandinavian Prostate Cancer Group-4 randomised trial.

Background: For men with localised prostate cancer, surgery provides a survival benefit compared with watchful waiting. Treatments are associated with morbidity. Results for functional outcome and quality of life are rarely reported beyond 10 years and are lacking from randomised settings. We report results for quality of life for men in the Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4) after a median follow-up of more than 12 years. Methods: All living Swedish and Finnish men (400 of 695) randomly assigned to radical prostatectomy or watchful waiting in SPCG-4 from 1989 to 1999 were included in our analysis. An additional 281 men were included in a population-based control group matched for region and age. Physical symptoms, symptom-induced stress, and self-assessed quality of life were evaluated with a study-specific questionnaire. Longitudinal data were available for 166 Swedish men who had answered quality-of-life questionnaires at an earlier timepoint. Findings: 182 (88%) of 208 men in the radical prostatectomy group, 167 (87%) of 192 men in the watchful-waiting group, and 214 (76%) of 281 men in the population-based control group answered the questionnaire. Men in SPCG-4 had a median follow-up of 12·2 years (range 7-17) and a median age of 77·0 years (range 61-88). High self-assessed quality of life was reported by 62 (35%) of 179 men allocated radical prostatectomy, 55 (34%) of 160 men assigned to watchful waiting, and 93 (45%) of 208 men in the control group. Anxiety was higher in the SPCG-4 groups (77 [43%] of 178 and 69 [43%] of 161 men) than in the control group (68 [33%] of 208 men; relative risk 1·42, 95% CI 1·07-1·88). Prevalence of erectile dysfunction was 84% (146 of 173 men) in the radical prostatectomy group, 80% (122 of 153) in the watchful-waiting group, and 46% (95 of 208) in the control group and prevalence of urinary leakage was 41% (71 of 173), 11% (18 of 164), and 3% (six of 209), respectively. Distress caused by these symptoms was reported significantly more often by men allocated radical prostatectomy than by men assigned to watchful waiting. In a longitudinal analysis of men in SPCG-4 who provided information at two follow-up points 9 years apart, 38 (45%) of 85 men allocated radical prostatectomy and 48 (60%) of 80 men allocated watchful waiting reported an increase in number of physical symptoms; 50 (61%) of 82 and 47 (64%) of 74 men, respectively, reported a reduction in quality of life. Interpretation: For men in SPCG-4, negative side-effects were common and added more stress than was reported in the control population. In the radical prostatectomy group, erectile dysfunction and urinary leakage were often consequences of surgery. In the watchful-waiting group, side-effects can be caused by tumour progression. The number and severity of side-effects changes over time at a higher rate than is caused by normal ageing and a loss of sexual ability is a persistent psychological problem for both interventions. An understanding of the patterns of side-effects and time dimension of their occurrence for each treatment is important for full patient information. Funding: US National Institutes of Health; Swedish Cancer Society; Foundation in Memory of Johanna Hagstrand and Sigfrid Linnér.

The Lancet. Oncology · randomised controlled trial · 277 citationsread the source →

Stepped Care for Affective Disorders and Musculoskeletal Pain (SCAMP) study: design and practical implications of an intervention for comorbid pain and depression.

Objective: Depression and pain are common comorbid conditions that have reciprocal adverse effects on disability and treatment outcomes. The objective of this article is to describe a study that tests the effectiveness of a stepped-care approach using a combined medication-behavioral intervention. Method: Stepped Care for Affective Disorders and Musculoskeletal Pain (SCAMP) is an NIMH-sponsored randomized clinical trial nested within a prospective cohort study. A total of 250 patients with clinically significant depression (PHQ-9 scores > or =10) and musculoskeletal pain of the lower back or legs (hip or knee) and 250 nondepressed patients with similar pain are enrolled, with baseline and serial follow-up assessments to be conducted over 12 months. The depressed patients are randomized to either a stepped-care intervention group or a usual-care control group. Stepped-care patients receive 12 weeks of optimized antidepressant management (Step 1) followed by six sessions of a pain self-management (PSM) program over the next 12 weeks (Step 2), all delivered by a nurse care manager who is supervised by a physician specialist. Approximately two thirds of the care manager contacts are by telephone. Results: The target sample of 500 subjects has been successfully enrolled, and randomization of the depressed patients has resulted in balanced groups of patients with moderately severe pain and depression. Mean SCL-20 depression severity in the clinical trial group is 1.9, with most meeting DSM-IV criteria for major depression (76.3%) and the rest having dysthymia only (18.4%) or minor depression (5.3%). Pain is about equally distributed between lower back (53%) and hip or knee (47%). A rational algorithmic approach to antidepressant selection and dosing, as well as an overview of the PSM program, is provided. Conclusions: When completed, SCAMP will test whether optimized antidepressant management improves outcomes in patients with comorbid depression and pain and whether PSM produces additional benefits. The findings will be important for both primary care and mental health clinicians confronted by the prevalent depression-pain dyad.

General hospital psychiatry · randomised controlled trial · 79 citationsread the source →

A randomised controlled multicentre trial of treatments for adolescent anorexia nervosa including assessment of cost-effectiveness and patient acceptability - the TOuCAN trial.

Objective: To evaluate the clinical effectiveness and cost-effectiveness of inpatient compared with outpatient treatment and general (routine) treatment in Child and Adolescent Mental Health Services (CAMHS) against specialist treatment for young people with anorexia nervosa. In addition, to determine young people's and their carers' satisfaction with these treatments. Design: A population-based, pragmatic randomised controlled trial (RCT) was carried out on young people age 12 to 18 presenting to community CAMHS with anorexia nervosa. Setting: Thirty-five English CAMHS in the north-west of England co-ordinated through specialist centres in Manchester and Liverpool. Participants: Two hundred and fifteen young people (199 female) were identified, of whom 167 (mean age 14 years 11 months) were randomised and 48 were followed up as a preference group. Interventions: Randomised patients were allocated to either inpatient treatment in one of four units with considerable experience in the treatment of anorexia nervosa, a specialist outpatient programme delivered in one of two centres, or treatment as usual in general community CAMHS. The outpatient programmes spanned 6 months of treatment. The length of inpatient treatment was determined on a case-by-case basis on clinical need with outpatient follow-up to a minimum of 6 months. Main outcome measures: Follow-up assessments were carried out at 1, 2 and 5 years. The primary outcome measure was the Morgan-Russell Average Outcome Scale (MRAOS) and associated categorical outcomes. Secondary outcome measures included physical measures of weight, height, body mass index (BMI) and % weight for height. Research ratings included the Health of the National Outcome Scale for Children and Adolescents (HoNOSCA). Self report measures comprised the user version of HoNOSCA (HoNOSCA-SR), the Eating Disorder Inventory 2 (EDI-2), the Family Assessment Device (FAD) and the recent Mood and Feelings Questionnaire (MFQ). Information on resource use was collected in interview at 1, 2 and 5 years using the Child and Adolescent Service Use Schedule (CA-SUS). Satisfaction was measured quantitatively using a questionnaire designed for the study and qualitative (free) responses on it. The questionnaire data were supplemented by qualitative analysis of user and carer focus groups. Results: Of the 167 patients randomised, 65% adhered to the allocated treatment. Adherence was lower for inpatient treatment (49%) than for general CAMHS (71%) or specialist outpatient treatment (77%) (p = 0.013). Every subject was traced at both 1 and 2 years, with the main outcome measure completed (through contact with the subject, family members or clinicians), by 94% at 1 year, 93% at 2 years, but only 47% at 5 years. A validated outcome category was assigned for 98% at 1 year, 96% at 2 years and 60% at 5 years. There was significant improvement in all groups at each time point, with the number achieving a good outcome being 19% at 1 year, 33% at 2 years and 64% (of those followed up) at 5 years. Analysis demonstrated no difference in treatment effectiveness of randomisation to inpatient compared with outpatient treatment, or, specialist over generalist treatment at any time point, when baseline characteristics were taken into account. Generalist CAMHS treatment was slightly more expensive over the first 2 years of the study, largely because greater numbers were subsequently admitted to hospital after the initial treatment phase. The specialist outpatient programme was the dominant treatment in terms of incremental cost-effectiveness. Specialist treatments had a higher probability of being more cost-effective than generalist treatments and outpatient treatment had a higher probability of being more cost-effective than inpatient care. Parental satisfaction with treatment was generally good, though better with specialist than generalist treatment. Young people's satisfaction was much more mixed, but again better with specialist treatment, including inpatient care. Conclusion: Poor adherence to randomisation (despite initial consent to it), limits the assessment of the treatment effect of inpatient care. However, this study provides little support for lengthy inpatient psychiatric treatment on clinical or health economic grounds. These findings are broadly consistent with existing guidelines on the treatment of anorexia nervosa, which suggest that outpatient treatments should be offered to the majority, with inpatient treatment offered in rare cases, though our findings lend little support to a stepped-care approach in which inpatient care is offered to outpatient non-responders. Outpatient care, supported by brief (medical) inpatient management for correction of acute complications may be a preferable approach. The health economic analysis and user views both support NICE guidelines, which suggest that anorexia nervosa should be managed in specialist services that have experience and expertise in its management. Comprehensive general CAMHS might, however, be well placed to manage milder cases. Further research should focus on the specific components of outpatient psychological therapies. Although family-based treatments are well established, trials have not established their effectiveness compared with good-quality individual psychological therapies and the combination of individual and family approaches is untested. Further research is needed to establish which patients (if any) might respond to inpatient psychiatric treatment when unresponsive to outpatient care, the positive and negative components of it and the optimum length of stay. Trial registration: NRR number (National Research Register) N0484056615; Current Controlled Trials ISRCTN39345394.

Health technology assessment (Winchester, England) · randomised controlled trial · 56 citationsread the source →

Comparison of the effect of ranibizumab and verteporfin for polypoidal choroidal vasculopathy: 12-month LAPTOP study results.

Purpose: To compare the effect of photodynamic therapy (PDT) and intravitreal ranibizumab in patients with polypoidal choroidal vasculopathy (PCV). Design: Randomized clinical trial. Methods: Setting: Multicenter. Study population: Total of 93 patients with treatment-naïve PCV. Intervention: Patients were randomized to 2 arms. Patients in the PDT arm underwent a single session of PDT with verteporfin, and patients in the ranibizumab arm received 3 monthly ranibizumab injections at baseline. Additional treatment was performed as needed in each arm. Main outcome measures: Primary outcome measurement was the proportion of patients gaining or losing more than 0.2 logarithm of minimal angle of resolution (logMAR) units from baseline. Mean change of logMAR and central retinal thickness (CRT) were also evaluated. Results: In the PDT arm (n = 47), 17.0% achieved visual acuity gain, 55.3% had no change, and 27.7% experienced visual acuity loss. The results were 30.4%, 60.9%, and 8.7%, respectively, in the ranibizumab arm (n = 46), significantly better than the PDT arm (P = .039). In the PDT arm, mean CRT improved (366.8 ± 113.6 μm to 289.1 ± 202.3 μm, P < .001), but logMAR was unchanged (0.57 ± 0.31 to 0.62 ± 0.40). The ranibizumab arm demonstrated improvement in both CRT (418.9 ± 168.6 μm to 311.2 ± 146.9 μm, P < .001) and logMAR (0.48 ± 0.27 to 0.39 ± 0.26, P = .003). Mean change of logMAR was also greater in the ranibizumab arm (P = .011). Conclusion: Intravitreal injection of ranibizumab is more effective than PDT for treatment-naïve PCV.

American journal of ophthalmology · randomised controlled trial · 119 citationsread the source →

Cognitive behavioural treatment for women who have menopausal symptoms after breast cancer treatment (MENOS 1): a randomised controlled trial.

Background: Hot flushes and night sweats (HFNS) affect 65-85% of women after breast cancer treatment; they are distressing, causing sleep problems and decreased quality of life. Hormone replacement therapy is often either undesirable or contraindicated. Safe, effective non-hormonal treatments are needed. We investigated whether cognitive behavioural therapy (CBT) can help breast cancer survivors to effectively manage HFNS. Methods: In this randomised controlled trial, we recruited women from breast clinics in London, UK, who had problematic HFNS (minimum ten problematic episodes a week) after breast-cancer treatment. Participants were randomly allocated to receive either usual care or usual care plus group CBT (1:1). Randomisation was done in blocks of 12-20 participants, stratifying by age (younger than 50 years, 50 years or older), and was done with a computer-generated sequence. The trial statistician and researchers collecting outcome measures were masked to group allocation. Group CBT comprised one 90 min session a week for 6 weeks, and included psycho-education, paced breathing, and cognitive and behavioural strategies to manage HFNS. Assessments were done at baseline, 9 weeks, and 26 weeks after randomisation. The primary outcome was the adjusted mean difference in HFNS problem rating (1-10) between CBT and usual care groups at 9 weeks after randomisation. Analysis of the primary endpoint was done by modified intention to treat. The trial is registered, ISRCTN13771934, and was closed March 15, 2011. Findings: Between May 5, 2009, and Aug 27, 2010, 96 women were randomly allocated to group CBT (n=47) or usual care (n=49). Group CBT significantly reduced HFNS problem rating at 9 weeks after randomisation compared with usual care (mean difference -1·67, 95% CI -2·43 to -0·91; p<0·0001) and improvements were maintained at 26 weeks (mean difference -1·76, -2·54 to -0·99; p<0·0001). We recorded no CBT-related adverse events. Interpretation: Group CBT seems to be a safe and effective treatment for women who have problematic HFNS after breast cancer treatment with additional benefits to mood, sleep, and quality of life. The treatment could be incorporated into breast cancer survivorship programmes and delivered by trained breast cancer nurses. Funding: Cancer Research UK.

The Lancet. Oncology · randomised controlled trial · 190 citationsread the source →

The effectiveness of SPARX, a computerised self help intervention for adolescents seeking help for depression: randomised controlled non-inferiority trial.

Objective: To evaluate whether a new computerised cognitive behavioural therapy intervention (SPARX, Smart, Positive, Active, Realistic, X-factor thoughts) could reduce depressive symptoms in help seeking adolescents as much or more than treatment as usual. Design: Multicentre randomised controlled non-inferiority trial. Setting: 24 primary healthcare sites in New Zealand (youth clinics, general practices, and school based counselling services). Participants: 187 adolescents aged 12-19, seeking help for depressive symptoms, with no major risk of self harm and deemed in need of treatment by their primary healthcare clinicians: 94 were allocated to SPARX and 93 to treatment as usual. Interventions: Computerised cognitive behavioural therapy (SPARX) comprising seven modules delivered over a period of between four and seven weeks, versus treatment as usual comprising primarily face to face counselling delivered by trained counsellors and clinical psychologists. Outcomes: The primary outcome was the change in score on the children's depression rating scale-revised. Secondary outcomes included response and remission on the children's depression rating scale-revised, change scores on the Reynolds adolescent depression scale-second edition, the mood and feelings questionnaire, the Kazdin hopelessness scale for children, the Spence children's anxiety scale, the paediatric quality of life enjoyment and satisfaction questionnaire, and overall satisfaction with treatment ratings. Results: 94 participants were allocated to SPARX (mean age 15.6 years, 62.8% female) and 93 to treatment as usual (mean age 15.6 years, 68.8% female). 170 adolescents (91%, SPARX n = 85, treatment as usual n = 85) were assessed after intervention and 168 (90%, SPARX n = 83, treatment as usual n = 85) were assessed at the three month follow-up point. Per protocol analyses (n = 143) showed that SPARX was not inferior to treatment as usual. Post-intervention, there was a mean reduction of 10.32 in SPARX and 7.59 in treatment as usual in raw scores on the children's depression rating scale-revised (between group difference 2.73, 95% confidence interval -0.31 to 5.77; P=0.079). Remission rates were significantly higher in the SPARX arm (n = 31, 43.7%) than in the treatment as usual arm (n = 19, 26.4%) (difference 17.3%, 95% confidence interval 1.6% to 31.8%; P = 0.030) and response rates did not differ significantly between the SPARX arm (66.2%, n = 47) and treatment as usual arm (58.3%, n = 42) (difference 7.9%, -7.9% to 24%; P = 0.332). All secondary measures supported non-inferiority. Intention to treat analyses confirmed these findings. Improvements were maintained at follow-up. The frequency of adverse events classified as "possibly" or "probably" related to the intervention did not differ between groups (SPARX n = 11; treatment as usual n = 11). Conclusions: SPARX is a potential alternative to usual care for adolescents presenting with depressive symptoms in primary care settings and could be used to address some of the unmet demand for treatment. Trial registration: Australian New Zealand Clinical Trials ACTRN12609000249257.

BMJ (Clinical research ed.) · randomised controlled trial · 316 citationsread the source →

A study of early complementary feeding determinants in the Republic of Ireland based on a cross-sectional analysis of the Growing Up in Ireland infant cohort.

Objective: Early complementary feeding has been shown to increase the risk of overweight, obesity and chronic diseases later in life. Poor compliance with current guidelines on complementary feeding has been reported by Irish studies. The aim of the present paper is to identify predictors of early complementary feeding in order to help health professionals target population groups in greater need of dietary intervention as well as to provide effective advice. Design: Cross-sectional analysis of the national, longitudinal Growing Up in Ireland study. Setting: Data were derived from the first wave (2007-2008) of the Growing Up in Ireland infant cohort. Subjects: A cohort of mothers (n 11 134) from the Republic of Ireland, interviewed when their infants were 9 months of age. Results: Of the infants, 1469 (13·5 %) had been regularly taking solids in the period between 12 and 16 weeks; this percentage increased to 47·0 % of the sample in the period between 16 and 20 weeks. Timing of formula feeding commencement, high maternal BMI and choosing a relative as the infant's minder were strongly associated with early introduction of solids both in bivariate and multivariate analysis. Those infants who started formula feeding at >4 months were 88·4% less likely to be introduced to solids early compared with those who started at <2 months (OR = 0·116; 95% CI 0·072, 0·186; P < 0·001). Conclusions: The results demonstrate that biological, social and behavioural aspects exert an important role in infant feeding practices. These findings are relevant to the design of policies and intervention programmes aimed at educating parents.

Public health nutrition · 19 citationsread the source →