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Effectiveness and cost-effectiveness of referral to a commercial open group behavioural weight management programme in adults with overweight and obesity: 5-year follow-up of the WRAP randomised controlled trial.

Background: There is evidence that commercially available behavioural weight management programmes can lead to short-term weight loss and reductions in glycaemia. Here, we aimed to provide the 5-year impact and cost-effectiveness of these interventions compared with a brief intervention. Methods: WRAP was a non-blinded, parallel-group randomised controlled trial (RCT). We recruited from primary care practices in England and randomly assigned participants to one of three interventions (brief intervention, 12-week open-group behavioural programme [WW, formerly Weight Watchers], or a 52-week open-group WW behavioural programme) in an uneven (2:5:5) allocation. Participants were followed up 5 years after randomisation using data from measurement visits at primary care practices or a research centre, review of primary care electronic medical notes, and self-report questionnaires. The primary outcome was change in weight at 5 years follow-up, assessed using analysis of covariance. We also estimated cost-effectiveness of the intervention. This study is registered at Current Controlled Trials, ISRCTN64986150. Findings: Between Oct 18, 2012, and Feb 10, 2014, we recruited 1269 eligible participants (two participants were randomly assigned but not eligible and therefore excluded) and 1040 (82%) consented to be approached about additional follow-up and to have their medical notes reviewed at 5 years. The primary outcome (weight) was ascertained for 871 (69%) of 1267 eligible participants. Mean duration of follow-up was 5·1 (SD 0·3) years. Mean weight change from baseline to 5 years was -0·46 (SD 8·31) kg in the brief intervention group, -1·95 (9·55) kg in the 12-week programme group, and -2·67 (9·81) kg in the 52-week programme. The adjusted difference in weight change was -1·76 (95% CI -3·68 to 0·17) kg between the 52-week programme and the brief intervention; -0·80 (-2·13 to 0·54) kg between the 52-week and the 12-week programme; and -0·96 (-2·90 to 0·97) kg between the 12-week programme and the brief intervention. During the trial, the 12-week programme incurred the lowest cost and produced the highest quality-adjusted life-years (QALY). Simulations beyond 5 years suggested that the 52-week programme would deliver the highest QALYs at the lowest cost and would be the most cost-effective. No participants reported adverse events related to the intervention. Interpretation: Although the difference in weight change between groups was not statistically significant, some weight loss was maintained at 5 years after an open-group behavioural weight management programme. Health economic modelling suggests that this could have important implications to reduce the incidence of weight-related disease and these interventions might be cost-saving. Funding: The UK National Institute for Health and Care Research Programme Grants for Applied Research and the Medical Research Council.

The Lancet. Public health · randomised controlled trial · 25 citationsread the source →

Baseline predictors of ninety percent or higher antiretroviral therapy adherence in a diverse urban sample: the role of patient autonomy and fatalistic religious beliefs.

The role of patient autonomy and influence of religious/spiritual beliefs on antiretroviral therapy (ART) adherence is to date not fully understood. This study assessed baseline predictors of high ART adherence (≥90%) measured by electronic drug monitors (EDM) at 12 and 24 weeks after enrollment in a randomized controlled trial testing behavioral interventions to improve ART adherence. Baseline data were collected with audio computer-assisted self interviews (ACASI) surveys among a diverse urban sample of HIV-infected participants (n = 204) recruited from community clinics in a large midwestern city. Baseline variables included a range of established ART adherence predictors as well as several less frequently studied variables related to patient autonomy and religious/spiritual beliefs. Statistically significant (p < 0.05) variables identified in univariate analyses were included in subsequent multivariate analyses predicting higher than 90% adherence at 12 and 24 weeks. Several baseline predictors retained statistical significance in multivariate analysis at 24 weeks. Baseline levels of autonomous support from friends and family, motivation to adhere, and having an active coping style were all positively associated with adherence, while the belief that God is in control of one's health was negatively associated with adherence. Results indicate that effective interventions should include a focus on promoting patients' autonomous regulation and religious/spiritual beliefs regarding ART adherence.

AIDS patient care and STDs · randomised controlled trial · 36 citationsread the source →

Subacromial balloon spacer massive rotator cuff tear treatment systematic review and meta-analysis: Patient selection and physical therapy may be keys to outcome success.

Purpose: Subacromial balloon spacer implantation (SBSI) efficacy for massive rotator cuff tear treatment was evaluated based on perceived shoulder function, active shoulder mobility, pain, complications and research study methodological quality. The purpose was to better discern the efficacy of this device from both surgical and rehabilitative perspectives to improve patient outcomes. Methods: PubMed, EMBASE and Cochrane Library databases were searched (1 January 2010 to 1 June 2024) using 'balloon spacer', 'subacromial spacer', 'subacromial balloon spacer', 'shoulder spacer' and 'inspace' terms. Pre-surgery (baseline), 12-month (12-m) and 24-month (24-m) post-SBSI mean changes were compared using one-way ANOVA and Scheffe post hoc tests, and comparative study effect sizes were calculated (p ≤ 0.05). Results: This review consists of 27 studies with 894 patients (67.8 ± 5 years of age) and 29.4 ± 17-month follow-up. Modified Coleman Methodology Scores (MCMS) revealed fair overall quality (mean = 61.4 ± 11). Constant-Murley scores improved from 34.8 ± 6 (baseline), to 64.2 ± 9 (12-m) and 67.9 ± 8 (24-m) (12-m, 24-m > baseline, p < 0.001). ASES scores improved from 35.1 ± 14 (baseline), to 83.3 ± 7 (12-m) and 81.8 ± 5 (24-m)(12-m, 24-m > baseline, p < 0.001). VAS pain scores improved from 6.6 ± 1 (baseline), to 2.6 ± 1 (12-m) and 2.0 ± 1 (24-m) (12-m, 24-m < baseline, p < 0.001). Flexion increased from 108.5 ± 25° (baseline), to 128.5 ± 30° (12-m) and 151.2 ± 14° (24-m) (24-m > 12-m, baseline, p = 0.01). Abduction increased from 97.7 ± 24° (baseline) to 116.3 ± 23° (12-m) and 142.3 ± 15° (24-m) (24-m > 12-m, baseline, p = 0.02). External rotation (ER) in adduction changed from 33.1 ± 7° (baseline) to 32.5 ± 4° (12-m) and 53.9 ± 9° (24-m)(24-m > 12-m, baseline, p = 0.01). ER at 90° abduction increased from 56.3 ± 3° (baseline) to 83.5 ± 5° (12-m) and 77.1 ± 4° (24-m) (24-m, 12-m > baseline, p = 0.01). Comparison studies, however, displayed insignificant results with small effect sizes. Conclusion: Despite overall fair MCMS scores, at 24-m post-SBSI, shoulder function improved and pain decreased. More rigorous comparative studies, however, revealed insignificant findings. Patients with the potential to re-establish the essential glenohumeral joint force couple that depresses the humeral head on the glenoid fossa and who comply with physical therapy may be more likely to achieve success following SBSI. Level of evidence: Level IV.

Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA · meta-analysis · 3 citationsread the source →

A randomized, controlled, pilot study of dialectical behavior therapy skills in a psychoeducational group for individuals with bipolar disorder.

Background: Bipolar disorder (BD) is a chronic and disabling psychiatric disorder characterized by recurrent episodes of mania/hypomania and depression. Dialectical behavior therapy (DBT) techniques have been shown to effectively treat borderline personality disorder, a condition also marked by prominent affective disturbances. The utility of DBT techniques in treating BD has been largely unexplored. The purpose of this research was to conduct a pilot study of a DBT-based psychoeducational group (BDG) in treating euthymic, depressed, or hypomanic Bipolar I or II patients. Methods: In this experiment, 26 adults with bipolar I or II were randomized to intervention or wait-list control groups and completed the Beck depression inventory II, mindfulness-based self-efficacy scale, and affective control scale at baseline and 12 weeks. The BDG intervention consisted of 12 weekly 90-min sessions which taught DBT skills, mindfulness techniques, and general BD psychoeducation. Results: Using RM-ANOVA, subjects in BDG demonstrated a trend toward reduced depressive symptoms, and significant improvement in several MSES subscales indicating greater mindful awareness, and less fear toward and more control of emotional states (ACS). These findings were supported with a larger sample of patients who completed the BDG. Furthermore, group attendees had reduced emergency room visits and mental health related admissions in the six months following BDG. Limitations: The small sample size in RCT affects power to detect between group differences. How well improvements after the12-week BDG were maintained is unknown. Conclusions: There is preliminary evidence that DBT skills reduce depressive symptoms, improve affective control, and improve mindfulness self-efficacy in BD. Its application warrants further evaluation in larger studies.

Journal of affective disorders · randomised controlled trial · 71 citationsread the source →

Efficacy and cost-effectiveness of therapist-guided internet cognitive behavioural therapy for paediatric anxiety disorders: a single-centre, single-blind, randomised controlled trial.

Background: Paediatric anxiety disorders are associated with substantial disability and long-term adverse consequences, but only a small proportion of affected children have access to evidence-based treatment. Internet-delivered cognitive behavioural therapy (ICBT) could help increase accessibility but needs further rigorous assessment. We aimed to assess the efficacy and cost-effectiveness of ICBT in the treatment of paediatric anxiety disorders. Methods: We did a single-blind randomised controlled trial in a clinical research unit within the Child and Adolescent Mental Health Services in Stockholm (Sweden). Eligible participants were children aged 8-12 years with a diagnosis of a principal anxiety disorder (seperation anxiety disorder, generalised anxiety disorder, specific phobia, social anxiety disorder, or panic disorder) of at least moderate severity. We randomly allocated participants (1:1) to ICBT or internet-delivered child-directed play, an active comparator aimed to improve parent-child relationships and increase a child's self-esteem without directly targeting anxiety. Block sizes for the randomisation varied between four and six and were generated using a computer random-number generator, and the allocation was concealed from the researchers by opaque sealed envelopes. Both treatment programmes comprised 12 modules presented over 12 weeks with weekly asynchronous online therapist support, and consisted of texts, films, illustrations, and exercises. The primary outcome was severity rating of the principal anxiety disorder 12-weeks post-treatment, via the Anxiety Disorder Interview Schedule for Diagnostic and Statistical Manual of Mental Disorders-IV (a rating of at least 4 corresponds to meeting the criteria for the principal diagnosis), assessed by clinicians masked to treatment allocation. All participants were included in the primary analysis (intention-to-treat). This trial is registered at ClinicalTrials.gov, number NCT02350257. Findings: Between March 11, 2015, and Oct 21, 2016, 131 participants were recruited and allocated to either ICBT (n=66) or internet-delivered child-directed play (n=65). The clinician-assessed severity rating of the principal anxiety disorder improved significantly after the 12-weeks treatment period for participants in both ICBT (within-group effect size 1·22, 95% CI 0·78-1·65) and the active control (0·72, 0·44-1·00) groups. However, greater improvement was seen with ICBT than with the active control (estimated mean difference 0·79, 95% CI 0·42-1·16, p=0·002; between-group effect size 0·77, 95% CI 0·40-1·15). 29 (48%) participants in the ICBT group no longer had their principal diagnosis, compared to nine (15%) in the active control group (odds ratio 5·41, 95% CI 2·26 to 12·90, p<0·0001); the number needed to treat for ICBT to gain one additional participant in remission was three (95% CI 2·85 to 3·15). ICBT resulted in an average societal-cost saving of €493·05 (95% CI 477·17 to 508·92) per participant. No severe adverse events were reported. Interpretation: ICBT is an efficacious and cost-effective treatment for paediatric anxiety disorders that should be considered for implementation in routine clinical care. Funding: The Swedish Research Council for Health, Working Life and Welfare, and Stockholm County Council.

The Lancet. Child & adolescent health · randomised controlled trial · 51 citationsread the source →

Comparing Video-Based, Telehealth-Delivered Exercise and Weight Loss Programs With Online Education on Outcomes of Knee Osteoarthritis : A Randomized Trial.

Background: Scalable knee osteoarthritis programs are needed to deliver recommended education, exercise, and weight loss interventions. Objective: To evaluate two 6-month, telehealth-delivered exercise programs, 1 with and 1 without dietary intervention. Design: 3-group, parallel randomized (5:5:2) trial. (Australian New Zealand Clinical Trials Registry: ACTRN12618000930280). Setting: Australian private health insurance members. Participants: 415 persons with symptomatic knee osteoarthritis and a body mass index between 28 and 40 kg/m2 who were aged 45 to 80 years. Intervention: All groups received access to electronic osteoarthritis information (control). The exercise program comprised 6 physiotherapist consultations via videoconference for exercise, self-management advice, and behavioral counseling, plus exercise equipment and resources. The diet and exercise program included an additional 6 dietitian consultations for a ketogenic very-low-calorie diet (2 formulated meal replacements and a low-carbohydrate meal daily) followed by a transition to healthy eating, as well as nutrition and behavioral resources. Measurements: Primary outcomes were changes in knee pain (numerical rating scale [NRS] of 0 to 10, higher indicating worse) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]; scale, 0 to 68, higher indicating worse) at 6 months (primary time point) and 12 months. Secondary outcomes were weight, physical activity, quality of life, mental health, global change, satisfaction, willingness to have surgery, orthopedic appointments, and knee surgery. Results: A total of 379 participants (91%) provided 6-month primary outcomes, and 372 (90%) provided 12-month primary outcomes. At 6 months, both programs were superior to control for pain (between-group mean difference in change on NRS: diet and exercise, -1.5 [95% CI, -2.1 to -0.8]; exercise, -0.8 [CI, -1.5 to -0.2]) and function (between-group mean difference in change on WOMAC: diet and exercise, -9.8 [CI, -12.5 to -7.0]; exercise, -7.0 [CI, -9.7 to -4.2]). The diet and exercise program was superior to exercise (pain, -0.6 [CI, -1.1 to -0.2]; function, -2.8 [CI, -4.7 to -0.8]). Findings were similar at 12 months. Limitation: Participants and clinicians were unblinded. Conclusion: Telehealth-delivered exercise and diet programs improved pain and function in people with knee osteoarthritis and overweight or obesity. A dietary intervention conferred modest additional pain and function benefits over exercise. Primary funding source: Medibank, the Medibank Better Health Foundation Research Fund, and a National Health and Medical Research Council Centre of Research Excellence.

Annals of internal medicine · randomised controlled trial · 76 citationsread the source →

Smartphone-Enhanced Symptom Management In Psychosis: Open, Randomized Controlled Trial.

Background: Improving recovery from acute symptoms and preventing relapse are two significant challenges in severe mental illness. We developed a personalized smartphone-based app to monitor symptoms in real time and validated its acceptance, reliability, and validity. Objective: To assess (i) acceptability of continuous monitoring to SMI patients and health professionals over 3 months; (ii) impact of active self-monitoring on positive psychotic symptoms assessed at 6 and 12 weeks; and (iii) the feasibility of detecting early warning signs of relapse. Methods: The active symptom monitoring smartphone app was built into an end-to-end system in two NHS Trusts to enable real-time symptom self-monitoring and detection by the clinical team of early signs of relapse in people with severe mental illness. We conducted an open randomized controlled trial of active symptom monitoring compared to usual management to assess: (i) acceptability and safety of continuous monitoring over 3 months; (ii) impact of active self-monitoring on positive psychotic symptoms assessed at 6 and 12 weeks; (iii) feasibility of detecting early warning signs of relapse communicated to the healthcare staff via an app streaming data to the electronic health record. Eligible participants with a Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnosis of schizophrenia and related disorders, and a history of relapse within the previous two years were enrolled from an early intervention team and a community mental health team. Results: Of 181 eligible patients, 81 (45%) consented and were randomized to either active symptom monitoring or management as usual. At 12 weeks, 90% (33/36) of those in the active monitoring group continued to use the system and exhibited an adherence rate (defined as responding to >33% of alerts) of 84% (30/36}. Active symptom monitoring was associated with no difference on the empowerment scale in comparison to the usual management group at 12 weeks. The pre-planned intent-to-treat analysis of the primary outcome, a positive score on the Positive and Negative Syndrome Scale (PANSS) scale, showed a significant reduction in the active symptom monitoring group over 12 weeks in the early intervention center. Alerts for personalized early warning signs of relapse were built into the workflows of both NHS Trusts, and 100% of health professional staff used the system in a new digital workflow. Qualitative analyses supported the acceptability of the system to participants and staff. Conclusions: The active smartphone monitoring system is feasible and was accepted by users in a 3-month study of people with severe mental illness, with surprisingly high levels of adherence. App use was associated with psychotic symptom improvement in recent-onset participants, but not those with longstanding illness, supporting the notion of improved self-management. When built into clinical management workflows to enable personalized alerts of symptom deterioration, the app has demonstrated utility in promoting earlier intervention for relapse. Trial registration: ISRCTN Registry ISRCTN88145142; http://www.isrctn.com/ISRCTN88145142.

Journal of medical Internet research · randomised controlled trial · 45 citationsread the source →

Preventing relapse to smoking with transcranial magnetic stimulation: Feasibility and potential efficacy.

Many smokers attempt to quit every year, but 90% relapse within 12 months. Converging evidence suggests relapse is associated with insufficient activation of the prefrontal cortex. Delay discounting rate reflects relative activity in brain regions associated with relapse. High-frequency repetitive transcranial magnetic stimulation (rTMS) of the left dorsolateral prefrontal cortex (LDLPFC) increases cortical excitability and reduces delay discounting rates, but little is known about feasibility, tolerability, and potential efficacy for smoking cessation. We hypothesized that 8 sessions of 20Hz rTMS of the LDLPFC combined with an evidence-based self-help intervention will demonstrate feasibility, tolerability, and potential efficacy in a limited double-blind randomized control trial. Smokers (n=29), abstinent for 24h, motivated to quit, and not using cessation medications, were randomized to active 20Hz rTMS at 110% of Motor Threshold or sham stimulation that replicated the look and sound of active stimulation. Stimulation site was located using the 6cm rule and neuro-navigation. Multiple clinical, feasibility, tolerability, and efficacy measures were examined. Active rTMS decreased delay discounting of $100 (F (1, 25.3694)=4.14, p=.05) and $1000 (F (1, 25.169)=8.42, p<.01), reduced the relative risk of relapse 3-fold (RR 0.29, CI 0.10-0.76, Likelihood ratio χ2 with 1 df=6.40, p=.01), increased abstinence rates (active 50% vs. sham 15.4%, Χ2 (df=1)=3.80, p=.05), and increased uptake of the self-help intervention. Clinical, feasibility, and tolerability assessments were favorable. Combining 20Hz rTMS of the LDLPFC with an evidence-based self-help intervention is feasible, well-tolerated, and demonstrates potential efficacy.

Drug and alcohol dependence · randomised controlled trial · 62 citationsread the source →

A randomised trial comparing weight loss with aerobic exercise in overweight individuals with coronary artery disease: The CUT-IT trial.

Background: We aimed to compare the effect of aerobic interval training (AIT) versus a low energy diet (LED) on physical fitness, body composition, cardiovascular risk factors and symptoms in overweight individuals with coronary artery disease (CAD). Methods and design: Seventy non-diabetic participants with CAD, a BMI>28 kg/m(2) and aged 45 to 75 years were randomised to 12 weeks' AIT at 90% peak heart rate three times a week or LED (800-1000 kcal/day) for 8-10 weeks followed by 2-4 weeks' weight maintenance diet. Results: Twenty-six (74%) AIT and 29 (83%) LED participants completed intervention per protocol. VO2peak (mL/kg fat free mass(0.67)/min) increased by 10.4% (p = 0.002) following AIT, whereas no change was observed after LED (-3.0%, p = 0.095). The LED group lost 10.6% body weight and 26.6% body fat mass (p < 0.001) compared to 1.6% (p = 0.002) and 5.5% (p < 0.001) following AIT. Waist circumference and visceral abdominal fat were reduced by both interventions but were most pronounced following LED (between-group, p < 0.001). Total cholesterol, non-HDL-C and triglycerides decreased significantly in both groups whereas HDL-C and blood pressure were unchanged. Six participants had their antihypertensive treatment reduced following LED (between-group, p = 0.032). Canadian Cardiovascular Society (CCS), New York Heart Association (NYHA) and anxiety scores were improved, while depressive symptoms remained unchanged. Intention-to-treat analyses including 65 participants (93%) were similar to per protocol analysis. Conclusion: Both interventions were feasible and effective in achieving the desired effects. LED was superior in improving body composition and blood pressure, whereas effects on lipids and symptoms were similar in the two groups. Thus, both AIT and LED improve the cardiovascular risk profile in overweight individuals with contemporarily treated CAD.

European journal of preventive cardiology · randomised controlled trial · 30 citationsread the source →

Vitamin D Supplementation Improves Cognitive Function Through Reducing Oxidative Stress Regulated by Telomere Length in Older Adults with Mild Cognitive Impairment: A 12-Month Randomized Controlled Trial.

Background: Cognitive decline in older adults is a serious public health problem today. Association between vitamin D supplementation and cognition remains controversial. Objective: To determine whether a 12-month vitamin D supplementation improves cognitive function in elderly subjects with mild cognitive impairment (MCI), and whether it is mediated through the mechanism in which telomere length (TL) regulate oxidative stress. Methods: This was a double-blind, randomized, placebo-controlled trial in Tianjin, China. Participants were all native Chinese speakers aged 65 years and older with MCI. 183 subjects were randomized to an intervention group (vitamin D 800 IU/day, n = 93) or a placebo group (the matching starch granules, n = 90), and followed up for 12 months. Tests of cognitive function and mechanism-related biomarkers were evaluated at baseline, 6 months, and 12 months. Results: Repeated-measures ANOVA showed substantial improvements in the full scale intelligence quotient (FSIQ), information, digit span, vocabulary, block design, and picture arrangement scores in the vitamin D group over the placebo group (p < 0.001). Leukocyte TL was significantly higher, while serum 8-OXO-dG, OGG1mRNA, and P16INK4amRNA revealed greater decreases in the vitamin D group over the placebo group (p < 0.001). According to mixed-model repeated-measures ANOVA analysis, vitamin D group showed a significant enhancement in the FSIQ score for 12 months compared with the control (estimate value = 5.132, p < 0.001). Conclusion: Vitamin D supplementation for 12 months appears to improve cognitive function through reducing oxidative stress regulated by increased TL in order adults with MCI. Vitamin D may be a promising public health strategy to prevent cognitive decline.

Journal of Alzheimer's disease : JAD · randomised controlled trial · 85 citationsread the source →

A brief dyadic group based psychoeducation program improves relapse rates in recently remitted bipolar disorder: a pilot randomised controlled trial.

Background: Various adjunctive psychotherapies assist in decreasing relapse and improving outcomes for people with bipolar disorder (BD). Psychoeducation programs involving patient-only or caregiver-only groups have demonstrated some efficacy. We tested in recently remitted BD if a combined group based psychoeducation program involving patient-companion dyads decreased relapse. Method: 58 recently remitted BD out-patients were randomised to receive either treatment as usual (TAU, n=31) or 12 x 90 minute psychoeducation sessions delivered weekly in a group program to the patient and companion (SIMSEP, n=27). After 12 weeks SIMSEP patients reverted to TAU and all patients were followed until week 60 or relapse. The primary outcome measure was relapse requiring hospital or intensive community intervention. Results: 45 patients completed the study. 29 patients remained well at week 60 (SIMSEP n=17, TAU n=12), whilst 16 had relapsed (SIMSEP n=3, TAU n=13). The SIMSEP group were less likely to relapse (Fisher's exact test p=0.013; OR=0.16; 95% CI 0.04-0.70) and had an 11 week longer time to relapse compared to the TAU group (chi-square (1)=8.48, p<0.01). At study completion SIMSEP compared to TAU patients had lower Young Mania Rating Scale scores (Mann-Whitney U=255, p<0.01). Limitations: The study was limited by a small sample size. Conclusion: A brief group psychoeducation program with recently remitted BD patients and their companions resulted in a decreased relapse rate, longer time to relapse, decreased manic symptoms and improved medication adherence suggesting utility in the adjunctive psychotherapeutic treatment of BD.

Journal of affective disorders · randomised controlled trial · 44 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 →

Randomized controlled trial of maintaining quality of life during radiotherapy for advanced cancer.

Background: Psychosocial interventions often address only 1 domain of quality of life (QOL), are offered to patients with early-stage cancer, do not include the caregiver, and are delivered after cancer treatment has been completed. Methods: In the current randomized controlled trial, 131 patients with advanced cancer who received radiotherapy and their caregivers were randomly assigned to either a 6-session, structured, multidisciplinary intervention arm or a standard care arm. The average age of the patients was 58 years, the majority were male (63%), and tumor types varied (gastrointestinal [37%], brain [22%], head and neck [16%], lung [13%], and other [12%]). The six 90-minute sessions addressed the 5 domains of QOL: cognitive, physical, emotional, social, and spiritual. The in-person intervention was followed by 10 brief telephone counseling sessions that took place over the next 6 months. Results: Of the 117 patients who completed the study, overall QOL (assessed by Functional Assessment of Cancer Therapy-General [FACT-G]) at week 4 was significantly higher in the intervention group (n = 54) compared with the standard arm control group (n = 63) (75.2 vs 68.7; P = .02). The 10 brief telephone contacts did not appear to impact QOL because at week 27 the groups had identical QOL (means of 77.6 and 77.7, respectively). There was no effect of the intervention noted on caregiver QOL. Conclusions: Participating in a 6-session multidisciplinary intervention was found to be effective in maintaining the QOL of patients with advanced cancer who were actively receiving radiotherapy. The QOL and symptom burden of this population is striking, making it important to identify effective QOL strategies to implement in conjunction with cancer care.

Cancer · randomised controlled trial · 91 citationsread the source →

Yoga's impact on inflammation, mood, and fatigue in breast cancer survivors: a randomized controlled trial.

Purpose: To evaluate yoga's impact on inflammation, mood, and fatigue. Patients and methods: A randomized controlled 3-month trial was conducted with two post-treatment assessments of 200 breast cancer survivors assigned to either 12 weeks of 90-minute twice per week hatha yoga classes or a wait-list control. The main outcome measures were lipopolysaccharide-stimulated production of proinflammatory cytokines interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-α), and interleukin-1β (IL-1β), and scores on the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF), the vitality scale from the Medical Outcomes Study 36-item Short Form (SF-36), and the Center for Epidemiological Studies-Depression (CES-D) scale. Results: Immediately post-treatment, fatigue was not lower (P > .05) but vitality was higher (P = .01) in the yoga group compared with the control group. At 3 months post-treatment, fatigue was lower in the yoga group (P = .002), vitality was higher (P = .01), and IL-6 (P = .027), TNF-α (P = .027), and IL-1β (P = .037) were lower for yoga participants compared with the control group. Groups did not differ on depression at either time (P > .2). Planned secondary analyses showed that the frequency of yoga practice had stronger associations with fatigue at both post-treatment visits (P = .019; P < .001), as well as vitality (P = .016; P = .0045), but not depression (P > .05) than simple group assignment; more frequent practice produced larger changes. At 3 months post-treatment, increasing yoga practice also led to a decrease in IL-6 (P = .01) and IL-1β (P = .03) production but not in TNF-α production (P > .05). Conclusion: Chronic inflammation may fuel declines in physical function leading to frailty and disability. If yoga dampens or limits both fatigue and inflammation, then regular practice could have substantial health benefits.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · randomised controlled trial · 249 citationsread the source →

The exploration of the effectiveness of group therapy through an Internet chat as aftercare: a controlled naturalistic study.

Background: Modern communication technologies offer novel opportunities for the provision of stepped care for patients with mental disorders. This study investigated the effectiveness of group therapy delivered through an Internet chat following inpatient treatment. The main goal of the program was to reduce the risk of losing the therapeutic benefits achieved during the preceding inpatient treatment. Methods: 114 patients participated in one of two parallel groups of 8-10 patients that met with a group therapist in an Internet chat room. The groups met weekly for 12-15 weeks for 90 min. Controls were 114 patients who did not participate in the chat groups and were matched by application of propensity score methods. The main criterion was derived from comprehensive assessments of changes in health status comprising the psychological and physical condition of the patients. Assessments were conducted at admission, discharge and 12 months after discharge. Results: 12 months after discharge, chat participants showed a substantially lower risk (24.7%) for negative outcome than controls (38.5%). Furthermore, the low dropout rate and the high session attendance supported the expectation that this novel offer met patients' needs, and thus, opens a new avenue for the optimization of care for patients with mental disorders.

Psychotherapy and psychosomatics · randomised controlled trial · 42 citationsread the source →

Combining a stellate ganglion block with prolonged exposure therapy for posttraumatic stress disorder: A nonrandomized clinical trial.

Prolonged exposure therapy (PE) is an efficacious treatment for active duty service members and veterans with posttraumatic stress disorder (PTSD). However, PE is sometimes associated with high dropout rates, limited tolerability, and temporary symptom exacerbation during treatment. Stellate ganglion blocks (SGBs) are an emerging treatment that has the potential to enhance outcomes for PTSD when combined with trauma-focused psychotherapy. To date, no study of which we are aware has examined the potential additive benefits of SGB injections when administered in conjunction with trauma-focused behavioral treatment for PTSD. Thus, we conducted a nonrandomized clinical trial to evaluate the use of an SGB combined with massed PE therapy for combat-related PTSD. Participants (N = 12) were treated with 10 daily 90-min PE sessions delivered over 2 weeks and received a single SGB injection between Sessions 1 and 2. PE sessions lasted 90 min each. Participants reported a mean posttreatment PTSD symptom reduction of 32 points on the PTSD Checklist for DSM-5 (PCL-5), Hedges' gs = 1.28-2.80. Most participants (90.9%) demonstrated clinically significant change on the PCL-5 (i.e., ≥10 points) by the final treatment session and 50.0% no longer met the diagnostic criteria for PTSD per the Clinician-Administered PTSD Scale for DSM-5 at 1-month follow-up. Adverse events for the combined treatment were consistent with those previously reported for standalone SGB and PE. This combined treatment approach provides promising results for improving the tolerability of trauma-focused therapies, reducing symptom severity, and increasing PTSD remission rates.

Journal of traumatic stress · clinical trial · 10 citationsread the source →

Stress Management and Resiliency Training (SMART) program among Department of Radiology faculty: a pilot randomized clinical trial.

Objective: To test the efficacy of a Stress Management and Resiliency Training (SMART) program for decreasing stress and anxiety and improving resilience and quality of life among Department of Radiology physicians. Materials and methods: The study was approved by the institutional review board. A total of 26 Department of Radiology physicians were randomized in a single-blind trial to either the SMART program or a wait-list control arm for 12 weeks. The program involved a single 90-min group session in the SMART training with two follow-up phone calls. Primary outcomes measured at baseline and week 12 included the Perceived Stress Scale, Linear Analog Self-Assessment Scale, Mindful Attention Awareness Scale, and Connor-Davidson Resilience Scale. Results: A total of 22 physicians completed the study. A statistically significant improvement in perceived stress, anxiety, quality of life, and mindfulness at 12 weeks was observed in the study arm compared to the wait-list control arm; resilience also improved in the active arm, but the changes were not statistically significant when compared to the control arm. Conclusions: A single session to decrease stress among radiologists using the SMART program is feasible. Furthermore, the intervention afforded statistically significant and clinically meaningful improvement in anxiety, stress, quality of life, and mindful attention. Further studies including larger sample size and longer follow-up are warranted.

Explore (New York, N.Y.) · randomised controlled trial · 94 citationsread the source →

Socioeconomic gradients in the effects of universal school-based health behaviour interventions: a systematic review of intervention studies.

Background: Socioeconomic inequalities in health behaviour emerge in early life before tracking into adulthood. Many interventions to improve childhood health behaviours are delivered via schools, often targeting poorer areas. However, targeted approaches may fail to address inequalities within more affluent schools. Little is known about types of universal school-based interventions which make inequalities better or worse. Methods: Seven databases were searched using a range of natural language phrases, to identify trials and quasi-experimental evaluations of universal school-based interventions focused on smoking, alcohol, diet and/or physical activity, published from 2008-14. Articles which examined differential effects by socioeconomic status (N = 20) were synthesised using harvest plot methodology. Content analysis of 98 intervention studies examined potential reasons for attention or inattention to effects on inequality. Results: Searches identified approximately 12,000 hits. Ninety-eight evaluations were identified, including 90 completed studies, of which 20 reported effects on SES inequality. There were substantial geographical biases in reporting of inequality, with only 1 of 23 completed North American studies testing differential effects, compared to 15 out of 52 completed European studies. Studies reported a range of positive, neutral or negative SES gradients in effects. All studies with a negative gradient in effect (i.e. which widened inequality) included educational components alone or in combination with environmental change or family involvement. All studies with positive gradients in effects included environmental change components, alone or combined with education. Effects of multi-level interventions on inequality were inconsistent. Content analyses indicated that in approximately 1 in 4 studies SES inequalities were discussed in defining the problem or rationale for intervention. Other potential barriers to testing effect on inequality included assumptions that universal delivery guaranteed universal effect, or that interventions would work better for poorer groups because they had most to gain. Conclusions: Universal school-based interventions may narrow, widen or have no effect on inequality. There is a significant need for more routine testing of the effects of such interventions on inequality to enable firmer conclusions regarding types of interventions which affect inequality. Prospero registration number: CRD42014014548.

BMC public health · systematic review · 57 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 →

Video calls for reducing social isolation and loneliness in older people: a rapid review.

Background: The current COVID-19 pandemic has been identified as a possible trigger for increases in loneliness and social isolation among older people due to the restrictions on movement that many countries have put in place. Loneliness and social isolation are consistently identified as risk factors for poor mental and physical health in older people. Video calls may help older people stay connected during the current crisis by widening the participant's social circle or by increasing the frequency of contact with existing acquaintances. Objectives: The primary objective of this rapid review is to assess the effectiveness of video calls for reducing social isolation and loneliness in older adults. The review also sought to address the effectiveness of video calls on reducing symptoms of depression and improving quality of life. Search methods: We searched CENTRAL, MEDLINE, PsycINFO and CINAHL from 1 January 2004 to 7 April 2020. We also searched the references of relevant systematic reviews. Selection criteria: Randomised controlled trials (RCTs) and quasi-RCTs (including cluster designs) were eligible for inclusion. We excluded all other study designs. The samples in included studies needed to have a mean age of at least 65 years. We included studies that included participants whether or not they were experiencing symptoms of loneliness or social isolation at baseline. Any intervention in which a core component involved the use of the internet to facilitate video calls or video conferencing through computers, smartphones or tablets with the intention of reducing loneliness or social isolation, or both, in older adults was eligible for inclusion. We included studies in the review if they reported self-report measures of loneliness, social isolation, symptoms of depression or quality of life.  Two review authors screened 25% of abstracts; a third review author resolved conflicts. A single review author screened the remaining abstracts. The second review author screened all excluded abstracts and we resolved conflicts by consensus or by involving a third review author. We followed the same process for full-text articles. Data collection and analysis: One review author extracted data, which another review author checked. The primary outcomes were loneliness and social isolation and the secondary outcomes were symptoms of depression and quality of life. One review author rated the certainty of evidence for the primary outcomes according to the GRADE approach and another review author checked the ratings. We conducted fixed-effect meta-analyses for the primary outcome, loneliness, and the secondary outcome, symptoms of depression. Main results: We identified three cluster quasi-randomised trials, which together included 201 participants. The included studies compared video call interventions to usual care in nursing homes. None of these studies were conducted during the COVID-19 pandemic.  Each study measured loneliness using the UCLA Loneliness Scale. Total scores range from 20 (least lonely) to 80 (most lonely). The evidence was very uncertain and suggests that video calls may result in little to no difference in scores on the UCLA Loneliness Scale compared to usual care at three months (mean difference (MD) -0.44, 95% confidence interval (CI) -3.28 to 2.41; 3 studies; 201 participants), at six months (MD -0.34, 95% CI -3.41 to 2.72; 2 studies; 152 participants) and at 12 months (MD -2.40, 95% CI -7.20 to 2.40; 1 study; 90 participants). We downgraded the certainty of this evidence by three levels for study limitations, imprecision and indirectness. None of the included studies reported social isolation as an outcome. Each study measured symptoms of depression using the Geriatric Depression Scale. Total scores range from 0 (better) to 30 (worse). The evidence was very uncertain and suggests that video calls may result in little to no difference in scores on the Geriatric Depression Scale compared to usual care at three months' follow-up (MD 0.41, 95% CI -0.90 to 1.72; 3 studies; 201 participants) or six months' follow-up (MD -0.83, 95% CI -2.43 to 0.76; 2 studies, 152 participants). The evidence suggests that video calls may have a small effect on symptoms of depression at one-year follow-up, though this finding is imprecise (MD -2.04, 95% CI -3.98 to -0.10; 1 study; 90 participants). We downgraded the certainty of this evidence by three levels for study limitations, imprecision and indirectness. Only one study, with 62 participants, reported quality of life. The study measured quality of life using a Taiwanese adaptation of the Short-Form 36-question health survey (SF-36), which consists of eight subscales that measure different aspects of quality of life: physical function; physical role; emotional role; social function; pain: vitality; mental health; and physical health. Each subscale is scored from 0 (poor health) to 100 (good health). The evidence is very uncertain and suggests that there may be little to no difference between people allocated to usual care and those allocated to video calls in three-month scores in physical function (MD 2.88, 95% CI -5.01 to 10.77), physical role (MD -7.66, 95% CI -24.08 to 8.76), emotional role (MD -7.18, 95% CI -16.23 to 1.87), social function (MD 2.77, 95% CI -8.87 to 14.41), pain scores (MD -3.25, 95% CI -15.11 to 8.61), vitality scores (MD -3.60, 95% CI -9.01 to 1.81), mental health (MD 9.19, 95% CI 0.36 to 18.02) and physical health (MD 5.16, 95% CI -2.48 to 12.80). We downgraded the certainty of this evidence by three levels for study limitations, imprecision and indirectness. Authors' conclusions: Based on this review there is currently very uncertain evidence on the effectiveness of video call interventions to reduce loneliness in older adults. The review did not include any studies that reported evidence of the effectiveness of video call interventions to address social isolation in older adults. The evidence regarding the effectiveness of video calls for outcomes of symptoms of depression was very uncertain. Future research in this area needs to use more rigorous methods and more diverse and representative participants. Specifically, future studies should target older adults, who are demonstrably lonely or socially isolated, or both, across a range of settings to determine whether video call interventions are effective in a population in which these outcomes are in need of improvement.

The Cochrane database of systematic reviews · meta-analysis · 128 citationsread the source →

Recruitment and retention rates in randomised controlled trials of exercise therapy in people with multimorbidity: a systematic review and meta-analysis.

Aim: To quantify recruitment, retention and differential retention rates and associated trial, participant and intervention characteristics in randomised controlled trials (RCTs) evaluating the effect of exercise therapy in people with multimorbidity. Data sources: MEDLINE, EMBASE, CINAHL and CENTRAL from 1990 to April 20, 2020. Study selection: RCTs including people with multimorbidity comparing exercise therapy with a non-exposed comparator group reporting at least one of the following outcomes: physical function, health-related quality of life, depression symptoms, or anxiety symptoms. Data extraction and synthesis: Recruitment rates (proportion of people randomised/proportion of people eligible), retention rates (proportion of people providing the outcomes of interest/proportion randomised) and differential retention rates (difference in proportion of people providing the outcomes in the intervention group and comparator group) were calculated. Meta-analysis using a random-effects model was used to estimate pooled proportions. Methodological quality was assessed using Cochrane ´Risk of Bias tool 2.0´ for individual studies, and the GRADE approach was used to assess the overall quality of the evidence. Results: Twenty-three RCTs with 3363 people were included. The pooled prevalence for recruitment rate was 75% (95%CI 66 to 84%). The pooled prevalence for retention rate was 90% (95%CI 86 to 94%) at the end of the intervention (12 weeks; interquartile range (IQR) (12 to 12)). Meta-regression analyses showed that increasing age and including a higher proportion of people with hypertension was associated with lower retention rates. Retention rates did not differ between the intervention and comparator groups. The overall quality of the evidence was deemed very low. Conclusion: Three in four eligible people with multimorbidity were randomised to RCTs using exercise therapy, of which nine out of 10 provided end of treatment outcomes with no difference seen between the intervention and comparison groups. However, the results must be interpreted with caution due to large differences between the included studies. Trial registration: ClinicalTrials.gov CRD42020161329 . Registered on 28 April 2020.

Trials · meta-analysis · 38 citationsread the source →

Effects of a parenting intervention to address maternal psychological wellbeing and child development and growth in rural Uganda: a community-based, cluster randomised trial.

Background: Parenting interventions have been implemented to improve the compromised developmental potential among 39% of children younger than 5 years living in low-income and middle-income countries. Maternal wellbeing is important for child development, especially in children younger than 3 years who are vulnerable and dependent on their mothers for nutrition and stimulation. We assessed an integrated, community-based parenting intervention that targeted both child development and maternal wellbeing in rural Uganda. Methods: In this community-based, cluster randomised trial, we assessed the effectiveness of a manualised, parenting intervention in Lira, Uganda. We selected and randomly assigned 12 parishes (1:1) to either parenting intervention or control (inclusion on a waitlist with a brief message on nutrition) groups using a computer-generated list of random numbers. Within each parish, we selected two to three eligible communities that had a parish office or a primary school in which a preschool could be established, more than 75 households with children younger than 6 years, and at least 15 socially disadvantaged families (ie, maternal education of primary school level or lower) with at least one child younger than 36 months. Participants within communities were mother-child dyads, where the child was 12-36 months of age at enrollment, and the mother had low maternal education. In the parenting intervention group, participants attended 12 fortnightly peer-led group sessions focusing on child care and maternal wellbeing. The primary outcomes were cognitive and receptive language development, as measured with the Bayley Scales of Infant Development, 3rd edn. Secondary outcomes included self-reported maternal depressive symptoms, using the Center for Epidemiologic Studies Depression Scale, and child growth. Theoretically-relevant parenting practices, including the Home Observation for Measurement of the Environment inventory, and mother-care variables, such as perceived spousal support, were also assessed as potential mediators. Baseline assessments were done in January, 2013, and endline assessments were done in November, 2013, 3 months after completion of the programme. Ethics approval was received from Mbarara and McGill universities. This trial is registered with ClinicalTrials.gov, NCT01906606. Findings: Between December, 2012, and January, 2013, 13 communities (194 dyads) were randomly assigned to receive intervention, and 12 communities (154 dyads) were assigned to a waitlist control. 319 dyads completed baseline measures (171 in the intervention group and 148 in the control group), and 291 dyads completed endline measures (160 in the intervention group and 131 in the control group). At endline, children in the intervention group had significantly higher cognitive scores (58·90 vs 55·65, effect size 0·36, 95% CI 0·12-0·59) and receptive language scores (23·86 vs 22·40, 0·27, 0·03-0·50) than did children in the control group. Mothers in the intervention group reported significantly fewer depressive symptoms (15·36 vs 18·61, -0·391, 95% CI -0·62 to -0·16) than did mothers in the control group. However, no differences were found in child growth between groups. Interpretation: The 12 session integrated parenting intervention delivered by non-professional community members improved child development and maternal wellbeing in rural Uganda. Because this intervention was largely managed and implemented by a local organisation, using local community members and minimal resources, such a programme has the potential to be replicated and scaled up in other low-resource, village-based settings. Funding: Plan Uganda via Plan Finland (Ministry of Foreign Affairs) and Plan Australia (Australian Aid).

The Lancet. Global health · randomised controlled trial · 208 citationsread the source →

Dialectical behaviour therapy v. mentalisation-based therapy for borderline personality disorder.

Background: Dialectical behaviour therapy (DBT) and mentalisation-based therapy (MBT) are both widely used evidence-based treatments for borderline personality disorder (BPD), yet a head-to-head comparison of outcomes has never been conducted. The present study therefore aimed to compare the clinical outcomes of DBT v. MBT in patients with BPD. Methods: A non-randomised comparison of clinical outcomes in N = 90 patients with BPD receiving either DBT or MBT over a 12-month period. Results: After adjusting for potentially confounding differences between participants, participants receiving DBT reported a significantly steeper decline over time in incidents of self-harm (adjusted IRR = 0.93, 95% CI 0.87-0.99, p = 0.02) and in emotional dysregulation (adjusted β = -1.94, 95% CI -3.37 to -0.51, p < 0.01) than participants receiving MBT. Differences in treatment dropout and use of crisis services were no longer significant after adjusting for confounding, and there were no significant differences in BPD symptoms or interpersonal problems. Conclusions: Within this sample of people using specialist personality disorder treatment services, reductions in self-harm and improvements in emotional regulation at 12 months were greater amongst those receiving DBT than amongst those receiving MBT. Experimental studies assessing outcomes beyond 12 months are needed to examine whether these findings represent differences in the clinical effectiveness of these therapies.

Psychological medicine · randomised controlled trial · 28 citationsread the source →

A co-designed mHealth programme to support healthy lifestyles in Māori and Pasifika peoples in New Zealand (OL@-OR@): a cluster-randomised controlled trial.

Background: The OL@-OR@ mobile health programme was co-designed with Māori and Pasifika communities in New Zealand, to support healthy lifestyle behaviours. We aimed to determine whether use of the programme improved adherence to health-related guidelines among Māori and Pasifika communities in New Zealand compared with a control group on a waiting list for the programme. Methods: The OL@-OR@ trial was a 12-week, two-arm, cluster-randomised controlled trial. A cluster was defined as any distinct location or setting in New Zealand where people with shared interests or contexts congregated, such as churches, sports clubs, and community groups. Members of a cluster were eligible to participate if they were aged 18 years or older, had regular access to a mobile device or computer, and had regular internet access. Clusters of Māori and of Pasifika (separately) were randomly assigned (1:1) to either the intervention or control condition. The intervention group received the OL@-OR@ mHealth programme (smartphone app and website). The control group received a control version of the app that only collected baseline and outcome data. The primary outcome was self-reported adherence to health-related guidelines, which were measured with a composite health behaviour score (of physical activity, smoking, alcohol intake, and fruit and vegetable intake) at 12 weeks. The secondary outcomes were self-reported adherence to health-related behaviour guidelines at 4 weeks; self-reported bodyweight at 12 weeks; and holistic health and wellbeing status at 12 weeks, in all enrolled individuals in eligible clusters; and user engagement with the app, in individuals allocated to the intervention. Adverse events were not collected. This study is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12617001484336. Findings: Between Jan 24 and Aug 14, 2018, we enrolled 337 Māori participants from 19 clusters and 389 Pasifika participants from 18 clusters (n=726 participants) in the intervention group and 320 Māori participants from 15 clusters and 405 Pasifika participants from 17 clusters (n=725 participants) in the control group. Of these participants, 227 (67%) Māori participants and 347 (89%) Pasifika participants (n=574 participants) in the intervention group and 281 (88%) Māori participants and 369 (91%) Pasifika participants (n=650 participants) in the control group completed the 12-week follow-up and were included in the final analysis. Relative to baseline, adherence to health-related behaviour guidelines increased at 12 weeks in both groups (315 [43%] of 726 participants at baseline to 329 [57%] of 574 participants in the intervention group; 331 [46%] of 725 participants to 369 [57%] of 650 participants in the control group); however, there was no significant difference between intervention and control groups in adherence at 12 weeks (odds ratio [OR] 1·13; 95% CI 0·84-1·52; p=0·42). Furthermore, the proportion of participants adhering to guidelines on physical activity (351 [61%] of 574 intervention group participants vs 407 [63%] of 650 control group participants; OR 1·03, 95% CI 0·73-1·45; p=0·88), smoking (434 [76%] participants vs 501 [77%] participants; 1·12, 0·67-1·87; p=0·66), alcohol consumption (518 [90%] participants vs 596 [92%] participants; 0·73, 0·37-1·44; p=0·36), and fruit and vegetable intake (194 [34%] participants vs 196 [30%] participants; 1·08, 0·79-1·49; p=0·64) did not differ between groups. We found no significant differences between the intervention and control groups in any secondary outcome. 147 (26%) intervention group participants engaged with the OL@-OR@ programme (ie, set at least one behaviour change goal online). Interpretation: The OL@-OR@ mobile health programme did not improve adherence to health-related behaviour guidelines amongst Māori and Pasifika individuals. Funding: Healthier Lives He Oranga Hauora National Science Challenge.

The Lancet. Digital health · randomised controlled trial · 45 citationsread the source →

Noninvasive Transcutaneous Vagus Nerve Stimulation Decreases Whole Blood Culture-Derived Cytokines and Chemokines: A Randomized, Blinded, Healthy Control Pilot Trial.

Objectives: The purpose of this study was to test the transcutaneous noninvasive vagus nerve stimulator (nVNS) (gammaCore©) device to determine if it modulates the peripheral immune system, as has been previously published for implanted vagus nerve stimulators. Materials and methods: A total of 20 healthy males and females were randomized to receive either nVNS or sham stimulation (SST). All subjects underwent an initial blood draw at 8:00 am, followed by stimulation with nVNS or SST at 8:30 am. Stimulation was repeated at 12:00 pm and 6:00 pm. Additional blood samples were withdrawn 90 min and 24 hour after the first stimulation session. After samples were cultured using the Myriad RBM TruCulture (Austin, TX) system (WBCx), levels of cytokines and chemokines were measured by the Luminex assay and statistical analyses within and between groups were performed using the Wilcoxon Signed Ranks Test and Mann-Whitney U with the statistical program R. Results: A significant percent decrease in the levels of the cytokine interleukin [IL]-1β, tumor necrosis factor [TNF] levels, and chemokine, interleukin [IL]-8 IL-8, macrophage inflammatory protein [MIP]-1α, and monocyte chemoattractant protein [MCP]-1 levels was observed in the nVNS group non-lipopolysaccharide (LPS)-stimulated whole blood culture (n-WBCx) at the 24-hour time point (p < 0.05). In SST group, there was a significant percent increase in IL-8 at 90 min post-stimulation (p < 0.05). At 90 min, the nVNS group had a greater percent decrease in IL-8 concentration (p < 0.05) compared to SST group. The nVNS group had a greater percent decrease in cytokines (TNF, IL-1β) and chemokines (MCP-1 and IL-8) at 24 hour (p < 0.05) in comparison to SST. LPS-stimulated whole blood cultures (L-WBCx) did not show a significant decrease in cytokine levels in either the nVNS or SST group across any time points. The nVNS group showed a significant percent increase in LPS-stimulated IL-10 levels at the 24-hour time point in comparison to SST. Conclusions: nVNS downregulates inflammatory cytokine release suggesting that nVNS may be an effective anti-inflammatory treatment.

Neuromodulation : journal of the International Neuromodulation Society · randomised controlled trial · 128 citationsread the source →

A Physical Activity and Diet Program Delivered by Artificially Intelligent Virtual Health Coach: Proof-of-Concept Study.

Background: Poor diet and physical inactivity are leading modifiable causes of death and disease. Advances in artificial intelligence technology present tantalizing opportunities for creating virtual health coaches capable of providing personalized support at scale. Objective: This proof of concept study aimed to test the feasibility (recruitment and retention) and preliminary efficacy of physical activity and Mediterranean-style dietary intervention (MedLiPal) delivered via artificially intelligent virtual health coach. Methods: This 12-week single-arm pre-post study took place in Adelaide, Australia, from March to August 2019. Participants were inactive community-dwelling adults aged 45 to 75 years, recruited through news stories, social media posts, and flyers. The program included access to an artificially intelligent chatbot, Paola, who guided participants through a computer-based individualized introductory session, weekly check-ins, and goal setting, and was available 24/7 to answer questions. Participants used a Garmin Vivofit4 tracker to monitor daily steps, a website with educational materials and recipes, and a printed diet and activity log sheet. Primary outcomes included feasibility (based on recruitment and retention) and preliminary efficacy for changing physical activity and diet. Secondary outcomes were body composition (based on height, weight, and waist circumference) and blood pressure. Results: Over 4 weeks, 99 potential participants registered expressions of interest, with 81 of those screened meeting eligibility criteria. Participants completed a mean of 109.8 (95% CI 1.9-217.7) more minutes of physical activity at week 12 compared with baseline. Mediterranean diet scores increased from a mean of 3.8 out of 14 at baseline, to 9.6 at 12 weeks (mean improvement 5.7 points, 95% CI 4.2-7.3). After 12 weeks, participants lost an average 1.3 kg (95% CI -0.1 to -2.5 kg) and 2.1 cm from their waist circumference (95% CI -3.5 to -0.7 cm). There were no significant changes in blood pressure. Feasibility was excellent in terms of recruitment, retention (90% at 12 weeks), and safety (no adverse events). Conclusions: An artificially intelligent virtual assistant-led lifestyle-modification intervention was feasible and achieved measurable improvements in physical activity, diet, and body composition at 12 weeks. Future research examining artificially intelligent interventions at scale, and for other health purposes, is warranted.

JMIR mHealth and uHealth · 86 citationsread the source →

In Vivo Feedback Predicts Parent Behavior Change in the Attachment and Biobehavioral Catch-up Intervention.

Understanding mechanisms and active ingredients of intervention is critical to training clinicians, particularly when interventions are transported from laboratories to communities. One promising active ingredient of parenting programs is clinicians' in vivo feedback regarding parent-child interactions. The present study examined whether a form of in vivo feedback, in the moment commenting, predicted treatment retention and parent behavior change when the Attachment and Biobehavioral Catch-up (ABC) intervention was implemented in a community setting. Observational data were collected from 78 parent-child dyads (96% mothers; M age = 29 years; 81% minority; infants' M age = 12 months; 90% minority) across 640 sessions conducted by 9 clinicians (100% female, M age = 39; 67% minority) in Hawaii. Parental behavior was assessed with a semistructured play task before and after intervention. Clinicians' in-the-moment feedback to parents was assessed from intervention session videos. Clinicians' frequency and quality of in-the-moment feedback predicted change in parental intrusiveness and sensitivity at posttreatment. Frequency of in-the-moment feedback also predicted likelihood of retention. Hierarchical linear modeling demonstrated strong support for these associations at the between-clinician level, and limited additional support at the within-clinician (i.e., between-case) level. Thus, a hypothesized active ingredient of treatment, in-the-moment feedback, predicted community-based ABC outcomes. The results complement lab-based evidence to suggest that in vivo feedback may be a mechanism of change in parenting interventions. Helping clinicians to provide frequent, high-quality in vivo feedback may improve parenting program outcomes in community settings.

Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53 · 51 citationsread the source →

Effects of multicomponent exercise on cognitive function in older adults with amnestic mild cognitive impairment: a randomized controlled trial.

Unlabelled: Background: To examine the effects of a multicomponent exercise program on the cognitive function of older adults with amnestic mild cognitive impairment (aMCI). Methods: Design: Twelve months, randomized controlled trial; Setting: Community center in Japan; Participants: Fifty older adults (27 men) with aMCI ranging in age from 65 to 93 years (mean age, 75 years); Intervention: Subjects were randomized into either a multicomponent exercise (n = 25) or an education control group (n = 25). Subjects in the multicomponent exercise group exercised under the supervision of physiotherapists for 90 min/d, 2 d/wk, for a total of 80 times over 12 months. The exercises included aerobic exercises, muscle strength training, and postural balance retraining, and were conducted using multiple conditions to stimulate cognitive functions. Subjects in the control group attended three education classes regarding health during the 12-month period. MEASUREMENTS were administered before, after the 6-month, and after the 12-month intervention period; Measurements: The performance measures included the mini-mental state examination, logical memory subtest of the Wechsler memory scale-revised, digit symbol coding test, letter and categorical verbal fluency test, and the Stroop color word test. Results: The mean adherence to the exercise program was 79.2%. Improvements of cognitive function following multicomponent exercise were superior at treatment end (group × time interactions for the mini-mental state examination (P = 0.04), logical memory of immediate recall (P = 0.03), and letter verbal fluency test (P = 0.02)). The logical memory of delayed recall, digit symbol coding, and Stroop color word test showed main effects of time, although there were no group × time interactions. Conclusions: This study indicates that exercise improves or supports, at least partly, cognitive performance in older adults with aMCI.

BMC neurology · randomised controlled trial · 175 citationsread the source →

Cognitive behavioural therapy as an adjunct to pharmacotherapy for primary care based patients with treatment resistant depression: results of the CoBalT randomised controlled trial.

Background: Only a third of patients with depression respond fully to antidepressant medication but little evidence exists regarding the best next-step treatment for those whose symptoms are treatment resistant. The CoBalT trial aimed to examine the effectiveness of cognitive behavioural therapy (CBT) as an adjunct to usual care (including pharmacotherapy) for primary care patients with treatment resistant depression compared with usual care alone. Methods: This two parallel-group multicentre randomised controlled trial recruited 469 patients aged 18-75 years with treatment resistant depression (on antidepressants for ≥6 weeks, Beck depression inventory [BDI] score ≥14 and international classification of diseases [ICD]-10 criteria for depression) from 73 UK general practices. Participants were randomised, with a computer generated code (stratified by centre and minimised according to baseline BDI score, whether the general practice had a counsellor, previous treatment with antidepressants, and duration of present episode of depression) to one of two groups: usual care or CBT in addition to usual care, and were followed up for 12 months. Because of the nature of the intervention it was not possible to mask participants, general practitioners, CBT therapists, or researchers to the treatment allocation. Analyses were by intention to treat. The primary outcome was response, defined as at least 50% reduction in depressive symptoms (BDI score) at 6 months compared with baseline. This trial is registered, ISRCTN38231611. Findings: Between Nov 4, 2008, and Sept 30, 2010, we assigned 235 patients to usual care, and 234 to CBT plus usual care. 422 participants (90%) were followed up at 6 months and 396 (84%) at 12 months, finishing on Oct 31, 2011. 95 participants (46%) in the intervention group met criteria for response at 6 months compared with 46 (22%) in the usual care group (odds ratio 3·26, 95% CI 2·10-5·06, p<0·001). Interpretation: Before this study, no evidence from large-scale randomised controlled trials was available for the effectiveness of augmentation of antidepressant medication with CBT as a next-step for patients whose depression has not responded to pharmacotherapy. Our study has provided robust evidence that CBT as an adjunct to usual care that includes antidepressants is an effective treatment, reducing depressive symptoms in this population. Funding: National Institute for Health Research Health Technology Assessment.

Lancet (London, England) · randomised controlled trial · 215 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 →

Comparative effectiveness of cognitive behavioural therapy, modafinil, and their combination for treating fatigue in multiple sclerosis (COMBO-MS): a randomised, statistician-blinded, parallel-arm trial.

Background: Fatigue is one of the most disabling symptoms reported by people with multiple sclerosis. Although behavioural and pharmacological interventions might be partly beneficial, their combined effects have not been evaluated for multiple sclerosis fatigue, or examined with sufficient consideration of characteristics that might affect treatment response. In this comparative effectiveness research trial, we compared the effectiveness of cognitive behavioural therapy (CBT), modafinil, and their combination for treating multiple sclerosis fatigue. Methods: This randomised, analyst-blinded, parallel-arm, comparative effectiveness trial was done at two universities in the USA. Adults (aged ≥18 years) with multiple sclerosis and problematic fatigue (Fatigue Severity Scale [FSS] score ≥4) were randomly assigned (1:1:1), using a web-based treatment assignment system with minimisation, to receive CBT, modafinil, or both for 12 weeks. Statisticians were masked to group assignment, but participants, study neurologists, CBT interventionalists, and coordinators were not masked to treatment assignment. The primary outcome was the change in Modified Fatigue Impact Scale (MFIS) from baseline to 12 weeks, assessed using multiple linear regression, adjusted for age, sex, study site, anxiety, pain, baselines MFIS score, and physical activity. Analyses were done by intent to treat. The trial was registered with clinicaltrials.gov, NCT03621761, and is completed. Findings: Between Nov 15, 2018, and June 2, 2021, 336 participants were randomly assigned treatment (114 assigned to CBT, 114 assigned to modafinil, and 108 assigned to combination therapy). At 12 weeks, CBT (n=103), modafinil (n=107), and combination therapy (n=102) were associated with clinically meaningful within-group MFIS reductions of 15·20 (SD 11·90), 16·90 (15·90), and 17·30 (16·20) points, respectively. Change in MFIS scores from baseline to 12 weeks did not differ between groups: relative to combination therapy, the adjusted total mean difference in MFIS change score was 1·88 (95% CI -2·21 to 5·96) for CBT and 1·20 (-2·83 to 5·23) for modafinil. Most common adverse events for modafinil-containing treatment groups included insomnia (eight [7%] for modafinil and eight [7%] for combination therapy) and anxiety (three [3%] for modafinil and nine [8%] for combination therapy). Interpretation: Modafinil, CBT, and combination therapy were associated with similar reductions in the effects of multiple sclerosis fatigue at 12 weeks. Combination therapy was not associated with augmented improvement compared with the individual interventions. Further research is needed to determine whether effects of these interventions on multiple sclerosis-related fatigue is influenced by sleep hygiene and sleepiness. No serious adverse events related to the study drug were encountered. Funding: Patient-Centered Outcomes Research Institute and National Multiple Sclerosis Society.

The Lancet. Neurology · randomised controlled trial · 6 citationsread the source →

Subjective cognitive dysfunction in breast cancer patients: a systematic review.

Objective: Results from studies examining subjective cognitive dysfunctioning (SCD) in breast cancer (BC) patients are unclear. Therefore, this review examined (i) the prevalence of SCD, (ii) the differences between (treatment) groups in SCD, (iii) the course of SCD, (iv) the relationship of SCD with psychological factors, and (v) the relationship between SCD and objective cognitive dysfunctioning (OCD). Methods: Through a systematic literature search, we identified 27 studies concerning SCD in BC patients. The methodological quality of these studies was examined according to predefined criteria. The methodological limitations and heterogeneity across studies were taken into account. Results: Eight studies were graded of high, 12 of moderate, and seven of low quality. Twenty-one to 90% of the patients reported SCD. The comparison between different (treatment) groups, at different time points of the cancer trajectory, rendered inconclusive evidence regarding the relation of SCD to the cancer itself, chemotherapy, and hormonal therapy. SCD and OCD were unrelated, but SCD was associated with psychological distress, fatigue, and health status. Conclusions: SCD does exist in BC patients, but it remains unclear if this is more commonly found in BC patients than in the general population. It is inconclusive if SCD is developed post-treatment or already exists pretreatment. Since there is a relationship between SCD and anxiety and depression, SCD may be more indicative of emotional distress instead of OCD. Attention toward SCD in future research is warranted in order to draw valid conclusions regarding SCD in BC patients.

Psycho-oncology · systematic review · 204 citationsread the source →

Development of a comprehensive flourishing intervention to promote mental health using an e-Delphi technique.

Background: Although observational studies have already shown promising results of flourishing, a broader concept of health based on positive psychology, there is still a gap in the literature regarding studies that combine different topics of flourishing in a single intervention. Objectives: To develop a comprehensive and integrate intervention based on positive psychology gathering different topics of flourishing to improve mental health outcomes in individuals with depressive symptoms. Methods: The following steps were performed: (1) a comprehensive literature review; (2) the designing of a 12-session group intervention based on the values, virtues, and topics of flourishing; (3) assessment of the rationale, coherence, and feasibility by a panel of healthcare professionals answering semi-structured questions, and (4) application of an e-Delphi technique including mental health experts to reach a consensus of at least 80% for each item of the protocol. Results: A total of 25 experts participated in the study, 8 in the panel with semi-structured questions and 17 in the e-Delphi technique. A three-round e-Delphi technique was required to reach a consensus for all items. In the first round, a consensus was reached for 86.2% of the items. The remaining items (13.8%) were either excluded or reformulated. In the second round, a consensus was not obtained on one item, which was reformulated and approved in the third round. Qualitative analyses of the open questions were performed and suggestions for the protocol were considered. The final version of the intervention was composed of 12 weekly group sessions with 90-min each. The topics included in the intervention were physical and mental health, virtues and character strengths, love, gratitude, kindness, volunteering, happiness, social support, family, friends and community, forgiveness, compassion, resilience, spirituality, purpose and meaning of life, imagining the "best possible future," and flourishing. Conclusion: The flourishing intervention was successfully developed using an e-Delphi technique. The intervention is ready to be tested in an experimental study to verify its feasibility and effectiveness.

Frontiers in psychiatry · 2 citationsread the source →

Repetitive transcranial magnetic stimulation for generalised anxiety disorder: a pilot randomised, double-blind, sham-controlled trial.

Background: Repetitive transcranial magnetic stimulation (rTMS) holds promise for treating generalised anxiety disorder (GAD) but has only been studied in uncontrolled research. Aims: This is the first randomised controlled trial (clinicaltrials.gov: NCT01659736) to investigate the efficacy and neural correlates of rTMS in GAD. Method: Twenty five participants (active n = 13; sham, n = 12) enrolled. rTMS was targeted at the right dorsolateral prefrontal cortex (DLPFC, 1 Hz, 90% resting motor threshold). Results: Response and remission rates were higher in the active v. sham groups and there were significant group × time interactions for anxiety, worry and depressive symptoms, favouring active v. sham. In addition, right DLPFC activation during a decision-making gambling task increased at post-treatment for active rTMS only, and changes in neuroactivation correlated significantly with changes in worry symptoms. Conclusions: Findings provide preliminary evidence that rTMS may improve GAD symptoms in association with modifying neural activity in the stimulation site.

The British journal of psychiatry : the journal of mental science · randomised controlled trial · 79 citationsread the source →

Prevalence of post-traumatic stress disorder symptoms in adult critical care survivors: a systematic review and meta-analysis.

Background: As more patients are surviving intensive care, mental health concerns in survivors have become a research priority. Among these, post-traumatic stress disorder (PTSD) can have an important impact on the quality of life of critical care survivors. However, data on its burden are conflicting. Therefore, this systematic review and meta-analysis aimed to evaluate the prevalence of PTSD symptoms in adult critical care patients after intensive care unit (ICU) discharge. Methods: We searched MEDLINE, EMBASE, LILACS, Web of Science, PsycNET, and Scopus databases from inception to September 2018. We included observational studies assessing the prevalence of PTSD symptoms in adult critical care survivors. Two reviewers independently screened studies and extracted data. Studies were meta-analyzed using a random-effects model to estimate PTSD symptom prevalence at different time points, also estimating confidence and prediction intervals. Subgroup and meta-regression analyses were performed to explore heterogeneity. Risk of bias was assessed using the Joanna Briggs Institute tool and the GRADE approach. Results: Of 13,267 studies retrieved, 48 were included in this review. Overall prevalence of PTSD symptoms was 19.83% (95% confidence interval [CI], 16.72-23.13; I2 = 90%, low quality of evidence). Prevalence varied widely across studies, with a wide range of expected prevalence (from 3.70 to 43.73% in 95% of settings). Point prevalence estimates were 15.93% (95% CI, 11.15-21.35; I2 = 90%; 17 studies), 16.80% (95% CI, 13.74-20.09; I2 = 66%; 13 studies), 18.96% (95% CI, 14.28-24.12; I2 = 92%; 13 studies), and 20.21% (95% CI, 13.79-27.44; I2 = 58%; 7 studies) at 3, 6, 12, and > 12 months after discharge, respectively. Conclusion: PTSD symptoms may affect 1 in every 5 adult critical care survivors, with a high expected prevalence 12 months after discharge. ICU survivors should be screened for PTSD symptoms and cared for accordingly, given the potential negative impact of PTSD on quality of life. In addition, action should be taken to further explore the causal relationship between ICU stay and PTSD, as well as to propose early measures to prevent PTSD in this population. Trial registration: PROSPERO, CRD42017075124 , Registered 6 December 2017.

Critical care (London, England) · meta-analysis · 208 citationsread the source →

Gender differences in depression in representative national samples: Meta-analyses of diagnoses and symptoms.

In 2 meta-analyses on gender differences in depression in nationally representative samples, we advance previous work by including studies of depression diagnoses and symptoms to (a) estimate the magnitude of the gender difference in depression across a wide array of nations and ages; (b) use a developmental perspective to elucidate patterns of gender differences across the life span; and (c) incorporate additional theory-driven moderators (e.g., gender equity). For major depression diagnoses and depression symptoms, respectively, we meta-analyzed data from 65 and 95 articles and their corresponding national data sets, representing data from 1,716,195 and 1,922,064 people in over 90 different nations. Overall, odds ratio (OR) = 1.95, 95% confidence interval (CI) [1.88, 2.03], and d = 0.27 [0.26, 0.29]. Age was the strongest predictor of effect size. The gender difference for diagnoses emerged earlier than previously thought, with OR = 2.37 at age 12. For both meta-analyses, the gender difference peaked in adolescence (OR = 3.02 for ages 13-15, and d = 0.47 for age 16) but then declined and remained stable in adulthood. Cross-national analyses indicated that larger gender differences were found in nations with greater gender equity, for major depression, but not depression symptoms. The gender difference in depression represents a health disparity, especially in adolescence, yet the magnitude of the difference indicates that depression in men should not be overlooked. (PsycINFO Database Record

Psychological bulletin · meta-analysis · 1630 citationsread the source →

The effectiveness of third wave cognitive behavioural therapies for children and adolescents: A systematic review and meta-analysis.

Objectives: Third wave cognitive behavioural therapies are increasingly used with children and adolescents. This meta-analysis aimed to determine the effectiveness of four third-wave interventions (acceptance and commitment therapy, compassion focused therapy, mindfulness-based cognitive therapy, and metacognitive therapy) for youth. Methods: Four electronic databases were used to identify randomized controlled trials, which tested effects related to health, well-being and functioning. Sensitivity analyses considering study quality were conducted and moderators were explored. Results: The results based on 50 RCTs meeting inclusion criteria indicated emotional symptoms/internalizing problems (g = -.68, 95% CI -.98 to -.37, k = 43, N = 3265), behavioural difficulties/externalizing problems (g = -.62, 95% CI -1.01 to -.22, k = 23, N = 1659), interference from difficulties (g = -.46, 95% CI -.87 to -.05, k = 21, N = 1786), third wave processes (g = .39, 95% CI .17 to .62, k = 22, N = 1900), wellbeing/flourishing (g = .76, 95% CI .35 to 1.17, k = 21, N = 1303) and physical health/pain (g = .72, 95% CI .01 to 1.44, k = 9, N = 1171) yielded significant effects. Effect for quality of life (g = .62, 95% CI -.08 to 1.31, k = 12, N = 1271) was non-significant. When analysing only those studies rated moderate-high quality, third wave interventions yielded significant superiority effects compared to controls for emotional symptoms/internalizing problems (g = -.55, 95% CI -.82 to -.27, k = 28, N = 2110), interference from difficulties (g = -.48, 95% CI -.90 to -.05, k = 21, N = 1605), third wave processes (g = .27, 95% CI .11 to .43, k = 18, N = 1692), well-being/flourishing (g = .50, 95% CI .18 to .81, k = 16, N = 1063), and quality of life (g = .32, 95% CI .04 to .60, k = 10, N = 1212). Behavioural difficulties/externalizing problems (g = -.38, 95% CI -.86 to .10, k = 15, N = 1351) and physical health/pain (g = .52, 95% CI -.14 to 1.17, k = 8, N = 1139) ceased to be significant. Widespread heterogeneity raised concerns about generalizability and follow-up data was relatively sparse. Conclusions: This meta-analysis finds promising results for use of third wave CBT with youth, though the review has limitations.

The British journal of clinical psychology · meta-analysis · 19 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 →

Psychological interventions for antisocial personality disorder.

Background: Antisocial personality disorder (AsPD) is associated with poor mental health, criminality, substance use and relationship difficulties. This review updates Gibbon 2010 (previous version of the review). Objectives: To evaluate the potential benefits and adverse effects of psychological interventions for adults with AsPD. Search methods: We searched CENTRAL, MEDLINE, Embase, 13 other databases and two trials registers up to 5 September 2019. We also searched reference lists and contacted study authors to identify studies. Selection criteria: Randomised controlled trials of adults, where participants with an AsPD or dissocial personality disorder diagnosis comprised at least 75% of the sample randomly allocated to receive a psychological intervention, treatment-as-usual (TAU), waiting list or no treatment. The primary outcomes were aggression, reconviction, global state/functioning, social functioning and adverse events. Data collection and analysis: We used standard methodological procedures expected by Cochrane. Main results: This review includes 19 studies (eight new to this update), comparing a psychological intervention against TAU (also called 'standard Maintenance'(SM) in some studies). Eight of the 18 psychological interventions reported data on our primary outcomes. Four studies focussed exclusively on participants with AsPD, and 15 on subgroups of participants with AsPD. Data were available from only 10 studies involving 605 participants. Eight studies were conducted in the UK and North America, and one each in Iran, Denmark and the Netherlands. Study duration ranged from 4 to 156 weeks (median = 26 weeks). Most participants (75%) were male; the mean age was 35.5 years. Eleven studies (58%) were funded by research councils. Risk of bias was high for 13% of criteria, unclear for 54% and low for 33%. Cognitive behaviour therapy (CBT) + TAU versus TAU One study (52 participants) found no evidence of a difference between CBT + TAU and TAU for physical aggression (odds ratio (OR) 0.92, 95% CI 0.28 to 3.07; low-certainty evidence) for outpatients at 12 months post-intervention. One study (39 participants) found no evidence of a difference between CBT + TAU and TAU for social functioning (mean difference (MD) -1.60 points, 95% CI -5.21 to 2.01; very low-certainty evidence), measured by the Social Functioning Questionnaire (SFQ; range = 0-24), for outpatients at 12 months post-intervention. Impulsive lifestyle counselling (ILC) + TAU versus TAU One study (118 participants) found no evidence of a difference between ILC + TAU and TAU for trait aggression (assessed with Buss-Perry Aggression Questionnaire-Short Form) for outpatients at nine months (MD 0.07, CI -0.35 to 0.49; very low-certainty evidence). One study (142 participants) found no evidence of a difference between ILC + TAU and TAU alone for the adverse event of death (OR 0.40, 95% CI 0.04 to 4.54; very low-certainty evidence) or incarceration (OR 0.70, 95% CI 0.27 to 1.86; very low-certainty evidence) for outpatients between three and nine months follow-up. Contingency management (CM) + SM versus SM One study (83 participants) found evidence that, compared to SM alone, CM + SM may improve social functioning measured by family/social scores on the Addiction Severity Index (ASI; range = 0 (no problems) to 1 (severe problems); MD -0.08, 95% CI -0.14 to -0.02; low-certainty evidence) for outpatients at six months. 'Driving whilst intoxicated' programme (DWI) + incarceration versus incarceration One study (52 participants) found no evidence of a difference between DWI + incarceration and incarceration alone on reconviction rates (hazard ratio 0.56, CI -0.19 to 1.31; very low-certainty evidence) for prisoner participants at 24 months. Schema therapy (ST) versus TAU One study (30 participants in a secure psychiatric hospital, 87% had AsPD diagnosis) found no evidence of a difference between ST and TAU for the number of participants who were reconvicted (OR 2.81, 95% CI 0.11 to 74.56, P = 0.54) at three years. The same study found that ST may be more likely to improve social functioning (assessed by the mean number of days until patients gain unsupervised leave (MD -137.33, 95% CI -271.31 to -3.35) compared to TAU, and no evidence of a difference between the groups for overall adverse events, classified as the number of people experiencing a global negative outcome over a three-year period (OR 0.42, 95% CI 0.08 to 2.19). The certainty of the evidence for all outcomes was very low. Social problem-solving (SPS) + psychoeducation (PE) versus TAU One study (17 participants) found no evidence of a difference between SPS + PE and TAU for participants' level of social functioning (MD -1.60 points, 95% CI -5.43 to 2.23; very low-certainty evidence) assessed with the SFQ at six months post-intervention. Dialectical behaviour therapy versus TAU One study (skewed data, 14 participants) provided very low-certainty, narrative evidence that DBT may reduce the number of self-harm days for outpatients at two months post-intervention compared to TAU. Psychosocial risk management (PSRM; 'Resettle') versus TAU One study (skewed data, 35 participants) found no evidence of a difference between PSRM and TAU for a number of officially recorded offences at one year after release from prison. It also found no evidence of difference between the PSRM and TAU for the adverse event of death during the study period (OR 0.89, 95% CI 0.05 to 14.83, P = 0.94, 72 participants (90% had AsPD), 1 study, very low-certainty evidence). Authors' conclusions: There is very limited evidence available on psychological interventions for adults with AsPD. Few interventions addressed the primary outcomes of this review and, of the eight that did, only three (CM + SM, ST and DBT) showed evidence that the intervention may be more effective than the control condition. No intervention reported compelling evidence of change in antisocial behaviour. Overall, the certainty of the evidence was low or very low, meaning that we have little confidence in the effect estimates reported. The conclusions of this update have not changed from those of the original review, despite the addition of eight new studies. This highlights the ongoing need for further methodologically rigorous studies to yield further data to guide the development and application of psychological interventions for AsPD and may suggest that a new approach is required.

The Cochrane database of systematic reviews · meta-analysis · 32 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 →

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 →

Hepatitis B immunoglobulin during pregnancy for prevention of mother-to-child transmission of hepatitis B virus.

Background: Hepatitis is a viral infection of the liver. It is mainly transmitted between people through contact with infected blood, frequently from mother to baby in-utero. Hepatitis B poses significant risk to the fetus and up to 85% of infants infected by their mothers at birth develop chronic hepatitis B virus (HBV) infection. Hepatitis B immunoglobulin (HBIG) is a purified solution of human immunoglobulin that could be administered to the mother, newborn, or both. HBIG offers protection against HBV infection when administered to pregnant women who test positive for hepatitis B envelope antigen (HBeAg) or hepatitis B surface antigen (HBsAg), or both. When HBIG is administered to pregnant women, the antibodies passively diffuse across the placenta to the child. This materno-fetal diffusion is maximal during the third trimester of pregnancy. Up to 1% to 9% infants born to HBV-carrying mothers still have HBV infection despite the newborn receiving HBIG plus active HBV vaccine in the immediate neonatal period. This suggests that additional intervention such as HBIG administration to the mother during the antenatal period could be beneficial to reduce the transmission rate in utero. Objectives: To determine the benefits and harms of hepatitis B immunoglobulin (HBIG) administration to pregnant women during their third trimester of pregnancy for the prevention of mother-to-child transmission of hepatitis B virus infection. Search methods: We searched the The Cochrane Hepato-Biliary Group Controlled Trials Register, CENTRAL, MEDLINE Ovid, Embase Ovid, Science Citation Index Expanded (Web of Science), SCOPUS, African Journals OnLine, and INDEX MEDICUS up to June 2016. We searched ClinicalTrials.gov and portal of the WHO International Clinical Trials Registry Platform (ICTRP) in December 2016. Selection criteria: We included randomised clinical trials comparing HBIG versus placebo or no intervention in pregnant women with HBV. Data collection and analysis: Two authors extracted data independently. We analysed dichotomous outcome data using risk ratio (RR) and continuous outcome data using mean difference (MD) with 95% confidence intervals (CI). For meta-analyses, we used a fixed-effect model and a random-effects model, along with an assessment of heterogeneity. If there were statistically significant discrepancies in the results, we reported the more conservative point estimate. If the two estimates were equal, we used the estimate with the widest CI as our main result. We assessed bias control using the Cochrane Hepato-Biliary Group suggested bias risk domains and risk of random errors using Trial Sequential Analysis (TSA). We assessed the quality of the evidence using GRADE. Main results: All 36 included trials originated from China and were at overall high risk of bias. The trials included 6044 pregnant women who were HBsAg, HBeAg, or hepatitis B virus DNA (HBV-DNA) positive. Only seven trials reported inclusion of HBeAg-positive mothers. All 36 trials compared HBIG versus no intervention. None of the trials used placebo. Most of the trials assessed HBIG 100 IU (two trials) and HBIG 200 IU (31 trials). The timing of administration of HBIG varied; 30 trials administered three doses of HBIG 200 IU at 28, 32, and 36 weeks of pregnancy. None of the trials reported all-cause mortality or other serious adverse events in the mothers or babies. Serological signs of hepatitis B infection of the newborns were reported as HBsAg, HBeAg, and HBV-DNA positive results at end of follow-up. Twenty-nine trials reported HBsAg status in newborns (median 1.2 months of follow-up after birth; range 0 to 12 months); seven trials reported HBeAg status (median 1.1 months of follow-up after birth; range 0 to 12 months); and 16 trials reported HBV-DNA status (median 1.2 months of follow-up; range 0 to 12 months). HBIG reduced mother-to-child transmission (MTCT) of HBsAg when compared with no intervention (179/2769 (6%) with HBIG versus 537/2541 (21%) with no intervention; RR 0.30, TSA-adjusted CI 0.20 to 0.52; I2 = 36%; 29 trials; 5310 participants; very low quality evidence). HBV-DNA reduced MTCT of HBsAg (104/1112 (9%) with HBV-DNA versus 382/1018 (38%) with no intervention; RR 0.25, TSA-adjusted CI 0.22 to 0.27; I2 = 84%; 16 trials; 2130 participants; low quality evidence). TSA supported both results. Meta-analysis showed that maternal HBIG did not decrease HBeAg in newborns compared with no intervention (184/889 (21%) with HBIG versus 232/875 (27%) with no intervention; RR 0.68, TSA-adjusted CI 0.04 to 6.37; I2 = 90%; 7 trials; 1764 participants; very low quality evidence). TSA could neither support nor refute this observation as data were too sparse. None of the trials reported adverse events of the immunoglobulins on the newborns, presence of local and systemic adverse events on the mothers, or cost-effectiveness of treatment. Authors' conclusions: Due to very low to low quality evidence found in this review, we are uncertain of the effect of benefit of antenatal HBIG administration to the HBV-infected mothers on newborn outcomes, such as HBsAg, HBV-DNA, and HBeAg compared with no intervention. The results of the effects of HBIG on HBsAg and HBeAg are surrogate outcomes (raising risk of indirectness), and we need to be critical while interpreting the findings. We found no data on newborn mortality or maternal mortality or both, or other serious adverse events. Well-designed randomised clinical trials are needed to determine the benefits and harms of HBIG versus placebo in prevention of MTCT of HBV.

The Cochrane database of systematic reviews · meta-analysis · 42 citationsread the source →

Cohort Profile: The National Longitudinal Study of Adolescent to Adult Health (Add Health)

The National Longitudinal Study of Adolescent Health (Add Health) was developed in the 1990s in response to a mandate from the United States Congress to fund a study of adolescent health, and was designed by a team of multidisciplinary investigators from the social, behavioural and biomedical sciences. The original purpose of Add Health was to understand the causes of adolescent health and health behaviour, with special emphasis on the multiple contexts of adolescent life. To achieve this scientific goal, Add Health sampled the school and family environments in which young people live their lives, which included data on peer relationship dyads, parents, siblings, neighbourhoods and communities, and provides independent and direct measurement of these complex environments over time. As the cohort transitioned into adulthood, research objectives turned to understanding how adolescent experiences, behaviours and contexts are linked to health and achievement outcomes in adulthood, and the name of the study was officially changed to The National Longitudinal Study of Adolescent to Adult Health in 2014. Add Health is housed at the Carolina Population Center at the University of North Carolina (UNC) and has been led by two principal investigators and project directors: J Richard Udry from 1994–2004; and Kathleen Mullan Harris from 2004 to the present. Add Health is a nationally representative cohort study of more than 20 000 adolescents in grades 7–12 (aged 12–19) in the USA in 1994–95, who have been followed through adolescence and into adulthood with five in-home interviews in 1995 (Wave I), 1996 (Wave II), 2001–02 (Wave III), 2008–09 (Wave IV) and 2016–18 (Wave V).1Figure 1 displays the sampling design for selecting the original cohort. A school-based design selected 80 high schools and a paired feeder school from a list of all high schools in the USA in 1994. An in-school questionnaire was administered to more than 90 000 students in grades 7–12, who attended these schools during the 1994–95 school year, and school administrators also filled out a questionnaire about the school. Sampling structure. School rosters from the 1993–94 school year provided the sampling frame for a second level of sampling for a 90-min in-home interview with an adolescent and a 30-min interview with one parent. A grade- and gender-stratified core sample was selected from each school pair, representing a self-weighting nationally representative sample of 12 105 American adolescents in grades 7–12 in 1995. Based on responses to the in-school survey, specific subpopulations were oversampled for purposes of providing sufficient numbers for research on vulnerable and otherwise rare populations, including ethnic (Cuban, Puerto Rican and Chinese), genetic relatedness to siblings (identical/fraternal twins, full/half siblings and unrelated adolescents living in the same household), adoption status and disability samples. Black adolescents with highly educated parents were also oversampled. For two large schools and fourteen small schools, interviews with all enrolled students were attempted to create a special saturation sample. The core sample plus the special samples yield a total of 20 745 adolescents. This Wave I in-home sample represents the national cohort of adolescents in grades 7–12 in the USA in 1995, which is followed prospectively. Because school rosters from the year preceding sample selection were used as the sampling frame for the prospective cohort, high school dropouts over 2 years (e.g. 1993–94; 1994–95) were eligible for sample selection, resulting in little bias due to high school dropouts.2 For more details on design, see Harris 2010 and Harris et al., 2013.3,4 Figure 2 shows the longitudinal design of Add Health. The Wave I in-home adolescent cohort has been followed up with four subsequent waves spanning 20+ years. In 1996, all adolescents in grades 7 through 11 in Wave I (plus 12th graders who were part of the genetic and adopted sample) were re-interviewed for Wave II (n = 14 738); the decision not to follow up the seniors who were in grade 12 at Wave I was design-based. The Wave II sample were in grades 8 through 12. A follow-up school administrator interview measured change in school context from 1995 to 1996. Longitudinal design. The original cohort was followed through their transition to early adulthood with a Wave III in-home interview in 2001–02 when the sample was aged 18–26 years (n = 15 197). A sample of 1507 partners were randomly selected during the in-home interview and interviewed, filling quota samples of about 500 married, 500 cohabiting and 500 dating partners. Wave IV re-interviewed the original cohort as they settled into young adulthood in 2008–09 when the cohort was aged 24–32 years (n = 15 701). Wave V followed the cohort to the end of young adulthood when they were aged 32–42, with continuous interviewing using a mixed-mode protocol during 2016–18. Finally, the Add Health Parent Study completed a 20-year follow-up of a subset of the parents of Add Health respondents during 2015–17 (n = 3006). Add Health uses state-of-the-art methods and techniques for panel maintenance and tracing to locate and schedule an interview with all living eligible respondents, including those who may have been non-responsive in a preceding wave. Table 1 presents response rates for the eligible sample at each completed wave of interviews. Response rates have been quite high, highest when the interval between interview waves is short but remarkably high even when the interval is over 5 years at Waves III and IV. The transition from adolescence to early adulthood and the young adult period is an especially transient phase of the life course and it is difficult to track and locate young people. Add Health has done exceptionally well, with response rates of 77.4% and 80.3% at Waves III and IV. Response rates in Add Health for the eligible sample at each wave of in-home interviews By design, respondents who were in the 12th grade at Wave I and who were not part of the genetic sample were not interviewed at Wave II. Response rate at Wave III is based on 15 170 respondents who had data at Wave I. An additional 27 respondents without Wave I data were included at Wave III as part of the genetic subsample. Wave V response rates are not provided because data collection is ongoing, and only a subset of Wave V respondents completed in-home interviews. Response rates in Add Health for the eligible sample at each wave of in-home interviews By design, respondents who were in the 12th grade at Wave I and who were not part of the genetic sample were not interviewed at Wave II. Response rate at Wave III is based on 15 170 respondents who had data at Wave I. An additional 27 respondents without Wave I data were included at Wave III as part of the genetic subsample. Wave V response rates are not provided because data collection is ongoing, and only a subset of Wave V respondents completed in-home interviews. There has been differential attrition by gender, age, socioeconomic status, urban residence, immigrant status and race across time, with higher response rates for female, younger, higher socioeconomic status, urban, native-born and White respondents at Waves III and IV. These attrition patterns are consistent with most longitudinal cohort studies. Add Health response rates exceed other national studies with multiple year intervals between waves (e.g. National Survey of Families and Households 2001–03 wave had a 55% response rate; Midlife in the United States 2004–06 interview had a 75% retention rate).5,6 At each wave, Add Health analysed whether patterns of attrition pose any bias to estimates of survey outcomes.7–10 In general, non-response analyses compare respondents and non-respondents on a range of demographic, health, behavioural and attitudinal indicators measured at baseline, and estimate the extent to which differences between respondents and non-respondents introduce bias in study results. Results indicated that total and relative biases, remaining after study estimates were adjusted with final sampling weights, were minimal and that the sample at each wave adequately represented the same population as the Wave I sample. Analysis of bias due to attrition at Wave IV indicated low rates of bias that rarely exceeded 1%, which is small relative to the 20% to 80% prevalence rates for most of the baseline indicators. Despite common patterns of attrition over time, the design strategy to re-interview the original Wave I cohort at each follow-up wave minimizes non-response bias and continues to adequately represent the original cohort of 7-12th graders in US schools in 1995. Add Health contains unprecedented environmental, behavioural, psychosocial, biological and genetic data from early adolescence into adulthood on a large, nationally representative sample with extensive racial, ethnic, socioeconomic and geographical diversity.4 Longitudinal survey data on respondents’ social, economic, psychological and physical well-being is combined with contextual data on family, neighbourhood, community, school, friendships, peer groups and romantic relationships, providing unique opportunities to study how psychological characteristics, social environments and behaviours beginning in early adolescence are linked to health and well-being in adulthood. Extensive longitudinal life histories of health-related behaviour are available, including physical activity, risk behaviour, substance use, sexual behaviour, civic engagement, education and multiple longitudinal indicators of health status, such as general health, chronic illness, overweight status and obesity, mental health, disability, health promotion and sleep. Objective measures of health were collected across all waves, including anthropometrics, sexually transmitted infection (STI) test results [including human immunodeficiency virus (HIV)], DNA and an expanded set of biomarkers in adulthood (Waves IV and V) (including blood pressure and pulse, measures of glucose homeostasis, lipid metabolism, inflammation, immune and renal function and a medications inventory). Below we describe the innovative multilevel data that have provided unprecedented research opportunities for a multidisciplinary scientific community. The clustered design of Add Health makes possible unique contextual levels of measurement, shown in Table 2. School-context data come from school administrator reports on school policies, health services and other school characteristics and from the in-school interviews of students whose aggregated responses represent school census measures. From respondent reports of colleges attended, college context data have been linked to individual records. Family-context data come from parent questionnaires, adolescent in-school and in-home questionnaires and interviews with siblings and additional adolescents living in the same household. Contextual levels of measurement in Add Health W1 = adolescent in- school and in-home, parent and school administrator surveys, geocodes. W2 = adolescent in-home, school administrator and geocodes. W3 = young adult in-home and partner sample surveys, geocodes, biomarkers. W4 = young adult in-home, biomarkers, geocodes. W5 = adult survey, biomarkers, geocodes. Additional variables from administrative datasets (e.g. US Census, Centers for Disease Control and Prevention, National Center for Health Statistics, Federal Bureau of Investigation, National Council of Churches, Common Core of Data, Private School Survey). , variable available; o, planned variable construction. Contextual levels of measurement in Add Health W1 = adolescent in- school and in-home, parent and school administrator surveys, geocodes. W2 = adolescent in-home, school administrator and geocodes. W3 = young adult in-home and partner sample surveys, geocodes, biomarkers. W4 = young adult in-home, biomarkers, geocodes. W5 = adult survey, biomarkers, geocodes. Additional variables from administrative datasets (e.g. US Census, Centers for Disease Control and Prevention, National Center for Health Statistics, Federal Bureau of Investigation, National Council of Churches, Common Core of Data, Private School Survey). , variable available; o, planned variable construction. Adolescents were asked to nominate friends and sexual and romantic partners from the school rosters in the in-school and in-home surveys at Waves I and II. Peer networks characteristics can be constructed by linking friends’ data and constructing variables based on friends’ responses, and similar measures can be constructed for linked romantic and sexual partners. These peer- and dyad-context measures constitute the social network data, including information on friendship networks, sexual networks and friendship and relationship dyads. Respondents’ home residences have been geocoded at each interview wave, and contextual data on the neighbourhood, community and state have been merged to all individual records. Nearly 12 000 environmental data elements at multiple geographical levels are available across waves. This includes such information as race, ethnic, foreign-born and religious denomination composition, poverty rates, crime statistics, STI prevalence, divorce and child support laws, welfare policies, cigarette taxes, the proximity and number of parks, sidewalks, recreation centres, fast food restaurants, alcohol outlets and other physical and social characteristics of the environments in which young people live. Table 3 shows the array of survey and biological data in Add Health. The top panel lists the domains covered by the survey instruments at each wave, including individual-level data on household and family structure, personality, religiosity and spirituality, relationships, sexual behaviour, contraception, pregnancy, children and parenting, sleep patterns, physical activity, diet, substance use/abuse, violence, delinquency, involvement with the criminal justice system, education history, work experiences, military service, chronic and disabling conditions, injury, mental health, suicide and health service access and use. Even though respondents were first interviewed in early adolescence, there are data on infancy (birthweight) and childhood (e.g. maltreatment, chronic conditions, attention deficit hyperactivity disorder) and complete data on fertility outcomes (there were more than 14 500 births to Add Health respondents by Wave IV). Survey and biomarker domains across Waves I-V in Add Health Survey and biomarker domains across Waves I-V in Add Health The bottom panel of Table 3 shows the biological measures available across waves. The original study design included important features for understanding biological processes in health and developmental trajectories across the life course, including an embedded genetic sample with more than 3000 pairs of adolescents with varying biological resemblance (see Figure 1) and measurement of height and weight to track the obesity epidemic. At Wave III, urine and saliva samples were collected to test for STI and HIV,11,12 and buccal cell saliva was collected from twins and full siblings in the genetic subsample for DNA extraction.13 An expanded set of biological measures were collected at Wave IV, including biomarkers of cardiovascular health (blood pressure, pulse), metabolic processes (waist circumference, glycosylated haemoglobin, blood glucose, lipids), immune function (Epstein-Barr virus), inflammation (C-reactive protein) and a medications inventory. Repeat biomarker measures were collected at Wave V, including new markers of renal disease. Saliva DNA was collected from the full sample at Wave IV. Candidate loci in the dopamine and serotonin pathways have been genotyped and disseminated to the scientific community.14 Genome-wide genotyping was completed on 10 974 Wave IV respondents who consented to archive their specimens for further testing, and genome-wide association study (GWAS) data are available from the database of Genotypes and Phenotypes (dbGaP). Add Health maintains a biospecimen archive available for ancillary studies. Add Health has a large and multidisciplinary user base of more than 50 000 researchers around the world, who have published over 3500 peer-reviewed articles in more than 750 different disciplinary journals, and has been the data source for more than 800 master’s theses and dissertations. Publications are listed at [https://www.cpc.unc.edu/projects/addhealth/publications]. Early publications focused on the role of social context in the development of adolescent health, behaviour, expectations and attainment, finding important influences of family and school connectedness,15 peer influence,16–18 romantic relationships,19 and neighbourhoods.20–22 For example, adolescents with a greater number and higher quality of connections to their school and family had better physical and mental health and higher attainment than youth with Adolescents whose friendship networks included friends with highly parents were than those whose friends had parents to studies that romantic in adolescence can adolescent and is with higher rates of obesity and weight in publications an of chronic young including a prevalence of and prevalence of the longitudinal data, researchers have the developmental and health pathways to young adult Add Health data support longitudinal studies of partner substance and health during the early life course from adolescence into young Add Health has the obesity and outcomes for adolescents. In adolescence of the sample were in 2001–02 when the cohort was aged the to in of the cohort at 24–32 was on these longitudinal data, The and the of obesity early in that adolescents were more to obesity in young adulthood with overweight by a risk of to individual obesity trajectories from adolescence at Wave II to young adulthood at Wave III into not who were who during the transition to young adulthood, and who were adolescence and young adulthood, As shown in Figure greater to obesity during adolescence and young adulthood is with a higher of high and sleep in adulthood. from adolescence to young adulthood with multiple health outcomes in adulthood (n The unique design and of the sample possible health research on special including the adopted youth living with parents sexual and adopted adolescents are more to suicide than their adolescents are at higher health risk on a range of indicators with adolescents who only one and more and than There is a large and of research that the genetic data with the longitudinal environmental data to the of and in health and behavioural of genetic research articles have these on a range of including risk substance sexual and friendship and Genome-wide association study (GWAS) data were for the pairs and Wave IV archive the of a large number of These the new differences in the education and of school environments in the education association with and family and education role in social and cohort differences in the genetic relationship between education and In innovative new research is providing human of genetic in which the of individual behaviour, for and Figure for social genetic of and friends on attainment, and The the of school and of for attainment in the top in the second panel and height in the The is the baseline of on outcomes in a with other and the represent the adjusted for individual-level The results that the of an and friends the attainment, an height is with the height of Add Health has in for new including attainment, height and alcohol genetic Add Health research uses biomarker data to social and behavioural with measures of research has the between a childhood and STI social status and and and life course of social and life for The role of social and social context in pathways was for the first young the for in the early in life and biological are to family and urban young from social is with mental health but physical health for young with The of Add Health from contextual and national design. The adolescent social context and peer network data, in are unique because they not on to an of an national of people who live in all 50 and come from race, ethnic, geographical and socioeconomic and ethnic with sufficient numbers to of Puerto and and and vulnerable including with children and adopted and sexual genetic sample of over 3000 pairs of with varying biological and longitudinal data from respondents and their longitudinal social, behavioural and biological data beginning in early adolescence and into extensive longitudinal multilevel data beginning in early adolescence on life and social and physical including family, school, neighbourhood, community and social measures of health including blood pressure, glucose, virus circumference, and and DNA on 000 and genome-wide genotyping on the full sample at Wave and collection of DNA on twins and full data be available in the including and data (see Table a of the of survey data measurement of specific and a for survey and biomarker measures. are available to researchers in representing a subset of and high which are only to which can only be used in a data to Add Health data to other and high school data, which are available in data access the and of respondents data access to a range of including data access study and can be at data can be Add Health is an longitudinal study of a nationally representative US cohort of 20 745 adolescents in grades (aged in includes four in-home interviews in 1996, 2016–18. attrition has been with response rates from to across follow-up waves, and attrition bias has been The study unprecedented environmental, behavioural, psychosocial, biological and genetic data from early adolescence into adulthood with extensive racial, ethnic, socioeconomic and geographical Add Health has a large, multidisciplinary user base of over 50 000 researchers around the world, who have published over 3500 research the Add Health cohort at the of the obesity with for health and social genetic of and on health and Add Health datasets are to a data to the of information and in of the see Add Health is by the National of Health and with from other and The full list of can be at This research uses data from Add a project by Kathleen Mullan Harris and designed by J Richard and Kathleen Mullan at the University of North Carolina at and by from the National of Health and with from other and is due to and for in the original design. also to data from National of Health and to Kathleen Mullan Harris and to Kathleen Mullan and of

International Journal of Epidemiology · 531 citationsread the source →

Correlates of bullying perpetration among Lebanese adolescents: a national study.

Background: Presently, 1 in 4 Lebanese adolescents is involved in bullying, with 12% being perpetrators. In Lebanon, around 90% of bullying incidents occur in schools. Given the lack of studies tackling bullying perpetration in Lebanon, this study aims to identify and target risk factors of bullying perpetration among Lebanese adolescents, which would serve future prevention and intervention programs. Methods: This cross-sectional study took place between January and May 2019 in a proportionate random sample of schools from all Lebanese districts. A total of 1810 (90.5%) out of 2000 students accepted to participate. Results: Results showed that 831 (49.1%, CI: 0.46-0.51) participants had bullied other people. A stepwise linear regression, using as the dependent variable the bullying perpetration score, showed that higher psychological (β = 0.12; 95% CI 0.083-0.176), sexual (β = 0.26; 95% CI 0.128-0.411), neglect (β = 0.08; 95% CI 0.051-0.120), physical abuse (β = 0.13; 95% CI 0.036-0.235), higher internet addiction (β = 0.07; 95% CI 0.057-0.097), higher social fear (β = 0.10; 95% CI 0.075-0.140), and having separated parents (β = 1.60; 95% CI 0.561-2.650) were significantly associated with more bullying perpetration. Higher social avoidance (β = - 0.03; 95% CI -0.062- -0.003) was significantly associated with less bullying perpetration. Conclusion: The results revealed that bullying perpetration is significantly associated with parental status, child abuse, internet addiction, and social fear. Educational and relevant governmental institutions could use our findings to develop and implement efficient bullying prevention and intervention programs for all involved parties.

BMC pediatrics · 14 citationsread the source →

Dismantling, optimising, and personalising internet cognitive behavioural therapy for depression: a systematic review and component network meta-analysis using individual participant data.

Background: Internet cognitive behavioural therapy (iCBT) is a viable delivery format of CBT for depression. However, iCBT programmes include training in a wide array of cognitive and behavioural skills via different delivery methods, and it remains unclear which of these components are more efficacious and for whom. Methods: We did a systematic review and individual participant data component network meta-analysis (cNMA) of iCBT trials for depression. We searched PubMed, PsycINFO, Embase, and the Cochrane Library for randomised controlled trials (RCTs) published from database inception to Jan 1, 2019, that compared any form of iCBT against another or a control condition in the acute treatment of adults (aged ≥18 years) with depression. Studies with inpatients or patients with bipolar depression were excluded. We sought individual participant data from the original authors. When these data were unavailable, we used aggregate data. Two independent researchers identified the included components. The primary outcome was depression severity, expressed as incremental mean difference (iMD) in the Patient Health Questionnaire-9 (PHQ-9) scores when a component is added to a treatment. We developed a web app that estimates relative efficacies between any two combinations of components, given baseline patient characteristics. This study is registered in PROSPERO, CRD42018104683. Findings: We identified 76 RCTs, including 48 trials contributing individual participant data (11 704 participants) and 28 trials with aggregate data (6474 participants). The participants' weighted mean age was 42·0 years and 12 406 (71%) of 17 521 reported were women. There was suggestive evidence that behavioural activation might be beneficial (iMD -1·83 [95% credible interval (CrI) -2·90 to -0·80]) and that relaxation might be harmful (1·20 [95% CrI 0·17 to 2·27]). Baseline severity emerged as the strongest prognostic factor for endpoint depression. Combining human and automated encouragement reduced dropouts from treatment (incremental odds ratio, 0·32 [95% CrI 0·13 to 0·93]). The risk of bias was low for the randomisation process, missing outcome data, or selection of reported results in most of the included studies, uncertain for deviation from intended interventions, and high for measurement of outcomes. There was moderate to high heterogeneity among the studies and their components. Interpretation: The individual patient data cNMA revealed potentially helpful, less helpful, or harmful components and delivery formats for iCBT packages. iCBT packages aiming to be effective and efficient might choose to include beneficial components and exclude ones that are potentially detrimental. Our web app can facilitate shared decision making by therapist and patient in choosing their preferred iCBT package. Funding: Japan Society for the Promotion of Science.

The lancet. Psychiatry · systematic review · 158 citationsread the source →

Acupuncture for Managing Cancer-Related Insomnia: A Systematic Review of Randomized Clinical Trials.

Background: Insomnia is a prominent complaint of cancer patients that can significantly affect their quality of life and symptoms related to sleep quality. Conventional drug approaches have a low rate of success in alleviating those suffering insomnia. The aim of this systematic review was to assess the efficacy of acupuncture in the management of cancer-related insomnia. Methods: A total of 12 databases were searched from their inception through January 2016 without language restriction. Randomized controlled trials (RCTs) and quasi-RCTs were included if acupuncture was used as the sole intervention or as an adjunct to another standard treatment for any cancer-related insomnia. The data extraction and the risk of bias assessments were performed by 2 independent reviewers. Results: Of the 90 studies screened, 6 RCTs were included. The risk of bias was generally unclear or low. Three RCTs showed equivalent effects on the Pittsburgh Sleep Quality Index and 2 RCTs showed the similar effects on response rate to those of conventional drugs at the end of treatment. The other RCT showed acupuncture was better than hormone therapy in the numbers of hours slept each night and number of times woken up each night. The 3 weeks of follow-up in 2 RCTs showed superior effects of acupuncture compared with conventional drugs, and a meta-analysis showed significant effects of acupuncture. Two RCTs tested the effects of acupuncture on cancer-related insomnia compared with sham acupuncture. One RCT showed favourable effects, while the other trial failed to do so. Conclusion: There is a low level of evidence that acupuncture may be superior to sham acupuncture, drugs or hormones therapy. However, the number of studies and effect size are small for clinical significance. Further clinical trials are warranted.

Integrative cancer therapies · systematic review · 59 citationsread the source →

Guided graded exercise self-help plus specialist medical care versus specialist medical care alone for chronic fatigue syndrome (GETSET): a pragmatic randomised controlled trial.

Background: Graded exercise therapy is an effective and safe treatment for chronic fatigue syndrome, but it is therapist intensive and availability is limited. We aimed to test the efficacy and safety of graded exercise delivered as guided self-help. Methods: In this pragmatic randomised controlled trial, we recruited adult patients (18 years and older) who met the UK National Institute for Health and Care Excellence criteria for chronic fatigue syndrome from two secondary-care clinics in the UK. Patients were randomly assigned to receive specialist medical care (SMC) alone (control group) or SMC with additional guided graded exercise self-help (GES). Block randomisation (randomly varying block sizes) was done at the level of the individual with a computer-generated sequence and was stratified by centre, depression score, and severity of physical disability. Patients and physiotherapists were necessarily unmasked from intervention assignment; the statistician was masked from intervention assignment. SMC was delivered by specialist doctors but was not standardised; GES consisted of a self-help booklet describing a six-step graded exercise programme that would take roughly 12 weeks to complete, and up to four guidance sessions with a physiotherapist over 8 weeks (maximum 90 min in total). Primary outcomes were fatigue (measured by the Chalder Fatigue Questionnaire) and physical function (assessed by the Short Form-36 physical function subscale); both were self-rated by patients at 12 weeks after randomisation and analysed in all randomised patients with outcome data at follow-up (ie, by modified intention to treat). We recorded adverse events, including serious adverse reactions to trial interventions. We used multiple linear regression analysis to compare SMC with GES, adjusting for baseline and stratification factors. This trial is registered at ISRCTN, number ISRCTN22975026. Findings: Between May 15, 2012, and Dec 24, 2014, we recruited 211 eligible patients, of whom 107 were assigned to the GES group and 104 to the control group. At 12 weeks, compared with the control group, mean fatigue score was 19·1 (SD 7·6) in the GES group and 22·9 (6·9) in the control group (adjusted difference -4·2 points, 95% CI -6·1 to -2·3, p<0·0001; effect size 0·53) and mean physical function score was 55·7 (23·3) in the GES group and 50·8 (25·3) in the control group (adjusted difference 6·3 points, 1·8 to 10·8, p=0·006; 0·20). No serious adverse reactions were recorded and other safety measures did not differ between the groups, after allowing for missing data. Interpretation: GES is a safe intervention that might reduce fatigue and, to a lesser extent, physical disability for patients with chronic fatigue syndrome. These findings need confirmation and extension to other health-care settings. Funding: UK National Institute for Health Research Research for Patient Benefit Programme and the Sue Estermann Fund.

Lancet (London, England) · randomised controlled trial · 44 citationsread the source →

Effect of a Multicomponent Behavioral Intervention in Adults Impaired by Psychological Distress in a Conflict-Affected Area of Pakistan

Importance: The mental health consequences of conflict and violence are wide-ranging and pervasive. Scalable interventions to address a range of mental health problems are needed. Objective: To test the effectiveness of a multicomponent behavioral intervention delivered by lay health workers to adults with psychological distress in primary care settings. Design, Setting, and Participants: A randomized clinical trial was conducted from November 1, 2014, through January 28, 2016, in 3 primary care centers in Peshawar, Pakistan, that included 346 adult primary care attendees with high levels of both psychological distress and functional impairment according to the 12-item General Health Questionnaire and the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). Interventions: Lay health workers administered 5 weekly 90-minute individual sessions that included empirically supported strategies of problem solving, behavioral activation, strengthening social support, and stress management. The control was enhanced usual care. Main Outcomes and Measures: Primary outcomes, anxiety and depression symptoms, were independently measured at 3 months with the Hospital Anxiety and Depression Scale (HADS). Secondary outcomes were posttraumatic stress symptoms (Posttraumatic Stress Disorder Checklist for DSM-5), functional impairment (WHODAS 2.0), progress on problems for which the person sought help (Psychological Outcome Profiles), and symptoms of depressive disorder (9-item Patient Health Questionnaire). Results: Among 346 patients (mean [SD] age, 33.0 [11.8] years; 78.9% women), 172 were randomly assigned to the intervention and 174 to enhanced usual care; among them, 146 and 160 completed the study, respectively. At baseline, the intervention and control groups had similar mean (SD) HADS scores on symptoms of anxiety (14.16 [3.17] vs 13.64 [3.20]; adjusted mean difference [AMD], 0.52; 95% CI, -0.22 to 1.27) and depression (12.67 [3.27] vs 12.49 [3.34]; AMD, 0.17, 95% CI, -0.54 to 0.89). After 3 months of treatment, the intervention group had significantly lower mean (SD) HADS scores than the control group for anxiety (7.25 [3.63] vs 10.03 [3.87]; AMD, -2.77; 95% CI, -3.56 to -1.98) and depression (6.30 [3.40] vs 9.27 [3.56]; AMD, -2.98; 95% CI, -3.74 to -2.22). At 3 months, there were also significant differences in scores of posttraumatic stress (AMD, -5.86; 95% CI, -8.53 to -3.19), functional impairment (AMD, -4.17; 95% CI, -5.84 to -2.51), problems for which the person sought help (AMD, -1.58; 95% CI, -2.40 to -0.77), and symptoms of depressive disorder (AMD, -3.41; 95% CI, -4.49 to -2.34). Conclusions and Relevance: Among adults impaired by psychological distress in a conflict-affected area, lay health worker administration of a brief multicomponent intervention based on established behavioral strategies, compared with enhanced usual care, resulted in clinically significant reductions in anxiety and depressive symptoms at 3 months. Trial Registration: anzctr.org.au Identifier: ANZCTR12614001235695.

JAMA · randomised controlled trial · 306 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 →

A randomized controlled trial of in-patient treatment for anorexia nervosa in medically unstable adolescents.

Background: Anorexia nervosa (AN) is a serious disorder incurring high costs due to hospitalization. International treatments vary, with prolonged hospitalizations in Europe and shorter hospitalizations in the USA. Uncontrolled studies suggest that longer initial hospitalizations that normalize weight produce better outcomes and fewer admissions than shorter hospitalizations with lower discharge weights. This study aimed to compare the effectiveness of hospitalization for weight restoration (WR) to medical stabilization (MS) in adolescent AN. Method: We performed a randomized controlled trial (RCT) with 82 adolescents, aged 12-18 years, with a DSM-IV diagnosis of AN and medical instability, admitted to two pediatric units in Australia. Participants were randomized to shorter hospitalization for MS or longer hospitalization for WR to 90% expected body weight (EBW) for gender, age and height, both followed by 20 sessions of out-patient, manualized family-based treatment (FBT). Results: The primary outcome was the number of hospital days, following initial admission, at the 12-month follow-up. Secondary outcomes were the total number of hospital days used up to 12 months and full remission, defined as healthy weight (>95% EBW) and a global Eating Disorder Examination (EDE) score within 1 standard deviation (s.d.) of published means. There was no significant difference between groups in hospital days following initial admission. There were significantly more total hospital days used and post-protocol FBT sessions in the WR group. There were no moderators of primary outcome but participants with higher eating psychopathology and compulsive features reported better clinical outcomes in the MS group. Conclusions: Outcomes are similar with hospitalizations for MS or WR when combined with FBT. Cost savings would result from combining shorter hospitalization with FBT.

Psychological medicine · randomised controlled trial · 131 citationsread the source →

The effect of a behavioral activation treatment for substance use on post-treatment abstinence: a randomized controlled trial.

Aims: To compare outcomes for a behavioral activation group treatment for substance use [life enhancement treatment for substance use (LETS ACT)] versus a time and group size-matched control condition delivered in a residential treatment setting. Design: Single-site two-arm parallel-group randomized clinical trial with follow-up assessment at 3, 6 and 12 months post-treatment. Setting: Residential substance use treatment facility in the United States. Participants: Participants were 263 adults [mean age 42.7 (11.8); 29.5% female; 95.4% African American; 73.2% court mandated] whose insurance dictated 30-day (65.9%) or 90-day (34.1%) treatment duration. Intervention and comparator: LETS ACT (n = 142) is a treatment developed originally for depression and modified for substance use. It teaches participants to increase positively reinforcing value-driven activities in order to counter depression and relapse. The control group [supportive counseling (SC); n = 121] received time and group size-matched supportive counseling. Treatment was delivered in five or eight 1-hour sessions depending on patient length of stay. Measurements: Percentage abstinent at follow-up, percentage of substance use days among those reporting use, depressive symptoms [Beck Depression Inventory (BDI)] and adverse consequences of drug use [Short Inventory of Problems-Alcohol and Drug (SIP-AD)]. Findings: LETS ACT had significantly higher abstinence rates at 3 months [odds ratio (OR) = 2.2, 95% confidence interval (CI) = 1.3-3.7], 6 months (OR = 2.6, 95% CI= 1.3-5.0) and 12 months (OR = 2.9, 95% CI = 1.3-6.1) post-treatment compared with SC. LETS ACT participants reported significantly fewer adverse consequences from substance use at 12 months post-treatment [B = 4.50, standard error (SE) = 2.17, 95% CI = 0.22-8.78]. Treatment condition had no effect on percentage substance use days among those who resumed use or on change in depressive symptoms; the latter decreased over time only in those who remained abstinent after residential treatment irrespective of condition (B = 0.43, SE = 0.11, 95% confidence interval = 0.22-0.65). Conclusions: A behavioral activation group treatment for substance use (LETS ACT) appears to increase the likelihood of abstinence and reduce adverse consequences from substance use up to 12 months post-treatment.

Addiction (Abingdon, England) · randomised controlled trial · 105 citationsread the source →

Online yoga to reduce post traumatic stress in women who have experienced stillbirth: a randomized control feasibility trial.

Background: About 1 in every 150 pregnancies end in stillbirth. Consequences include symptoms of post traumatic stress disorder (PTSD), depression, and anxiety. Yoga has been used to treat PTSD in other populations and may improve health outcomes for stillbirth mothers. The purpose of this study was to determine: (a) feasibility of a 12-week home-based, online yoga intervention with varying doses; (b) acceptability of a "stretch and tone" control group; and (c) preliminary efficacy of the intervention on reducing symptoms of PTSD, anxiety, depression, perinatal grief, self-compassion, emotional regulation, mindfulness, sleep quality, and subjective health. Methods: Participants (N = 90) were recruited nationally and randomized into one of three groups for yoga or exercise (low dose (LD), 60 min per week; moderate dose (MD), 150 min per week; and stretch-and-tone control group (STC)). Baseline and post-intervention surveys measured main outcomes (listed above). Frequency analyses were used to determine feasibility. Repeated measures ANCOVA were used to determine preliminary efficacy. Multiple regression analyses were used to determine a dose-response relationship between minutes of yoga and each outcome variable. Results: Over half of participants completed the intervention (n = 48/90). Benchmarks (≥70% reported > 75% satisfaction) were met in each group for satisfaction and enjoyment. Participants meeting benchmarks (completing > 90% of prescribed minutes 9/12 weeks) for LD and MD groups were 44% (n = 8/18) and 6% (n = 1/16), respectively. LD and MD groups averaged 44.0 and 77.3 min per week of yoga, respectively. The MD group reported that 150 prescribed minutes per week of yoga was too much. There were significant decreases in PTSD and depression, and improvements in self-rated health at post-intervention for both intervention groups. There was a significant difference in depression scores (p = .036) and grief intensity (p = .009) between the MD and STC groups. PTSD showed non-significant decreases of 43% and 56% at post-intervention in LD and MD groups, respectively (22% decrease in control). Conclusions: This was the first study to determine the feasibility and preliminary efficacy of an online yoga intervention for women after stillbirth. Future research warrants a randomized controlled trial. Trial registration: ClinicalTrials.gov. NCT02925481. Registered 10-04-16.

BMC complementary medicine and therapies · randomised controlled trial · 53 citationsread the source →

The impact of a virtual mind-body program on resilience factors among international English-speaking adults with neurofibromatoses: secondary analysis of a randomized clinical trial.

Purpose: To test the effects of the Relaxation Response Resiliency Program - Neurofibromatosis (3RP-NF), a mind-body resilience program for people with NF, on resilience factors from baseline to post-treatment and 6- and 12-month follow-up. Methods: This is a secondary analysis of a fully powered randomized clinical trial (RCT) of 3RP-NF and health education control (HEP-NF). We recruited adults with NF1, NF2, or schwannomatosis who reported stress or difficulty coping with NF symptoms. Both conditions received 8 weekly 90-minute group sessions; 3RP-NF focused on building resilience skills. We measured resilience factors via the Measure of Current Status-A (adaptive coping), Cognitive and Affective Mindfulness Scale-Revised (mindfulness), Gratitude Questionnaire-6 (gratitude), Life Orientation Test Optimism Scale (optimism), and Medical Outcomes Study Social Support Survey (perceived social support) at baseline, post-intervention, and 6- and 12-month follow-up. We used linear mixed models with completely unstructured covariance across up to four repeated measurements (baseline, post-treatment, and 6- and 12-month follow-up) to investigate treatment effects on resilience factors. Results: We enrolled 228 individuals (Mage=42.7, SD = 14.6; 74.5% female; 87.7% White; 72.8% NF1, 14.0% NF2, 13.2% schwannomatosis). Within groups, both 3RP-NF and HEP-NF showed statistically significant improvements in all outcomes across timepoints. 3RP-NF showed significantly greater improvement in adaptive coping compared to HEP-NF from baseline to post-intervention and baseline to 6 months (Mdifference= 0.29; 95% CI 0.13-0.46; p < 0.001; Mdifference= 0.25; 95% CI 0.07-0.33; p = 0.005); there were no other between-group differences amongst the remaining resilience factors. Conclusion: 3RP-NF showed promise in sustainably improving coping abilities amongst people with NF. Trial registration information: ClinicalTrials.gov Identifier: NCT03406208. Registration submitted December 6, 2017, first patient enrolled October 2017.

Journal of neuro-oncology · randomised controlled trial · 6 citationsread the source →

Clinical and cost-effectiveness of nurse-delivered sleep restriction therapy for insomnia in primary care (HABIT): a pragmatic, superiority, open-label, randomised controlled trial.

Background: Insomnia is prevalent and distressing but access to the first-line treatment, cognitive behavioural therapy (CBT), is extremely limited. We aimed to assess the clinical and cost-effectiveness of sleep restriction therapy, a key component of CBT, which has the potential to be widely implemented. Methods: We did a pragmatic, superiority, open-label, randomised controlled trial of sleep restriction therapy versus sleep hygiene. Adults with insomnia disorder were recruited from 35 general practices across England and randomly assigned (1:1) using a web-based randomisation programme to either four sessions of nurse-delivered sleep restriction therapy plus a sleep hygiene booklet or a sleep hygiene booklet only. There was no restriction on usual care for either group. Outcomes were assessed at 3 months, 6 months, and 12 months. The primary endpoint was self-reported insomnia severity at 6 months measured with the insomnia severity index (ISI). The primary analysis included participants according to their allocated group and who contributed at least one outcome measurement. Cost-effectiveness was evaluated from the UK National Health Service and personal social services perspective and expressed in terms of incremental cost per quality-adjusted life year (QALY) gained. The trial was prospectively registered (ISRCTN42499563). Findings: Between Aug 29, 2018, and March 23, 2020 we randomly assigned 642 participants to sleep restriction therapy (n=321) or sleep hygiene (n=321). Mean age was 55·4 years (range 19-88), with 489 (76·2%) participants being female and 153 (23·8%) being male. 580 (90·3%) participants provided data for at least one outcome measurement. At 6 months, mean ISI score was 10·9 (SD 5·5) for sleep restriction therapy and 13·9 (5·2) for sleep hygiene (adjusted mean difference -3·05, 95% CI -3·83 to -2·28; p<0·0001; Cohen's d -0·74), indicating that participants in the sleep restriction therapy group reported lower insomnia severity than the sleep hygiene group. The incremental cost per QALY gained was £2076, giving a 95·3% probability that treatment was cost-effective at a cost-effectiveness threshold of £20 000. Eight participants in each group had serious adverse events, none of which were judged to be related to intervention. Interpretation: Brief nurse-delivered sleep restriction therapy in primary care reduces insomnia symptoms, is likely to be cost-effective, and has the potential to be widely implemented as a first-line treatment for insomnia disorder. Funding: The National Institute for Health and Care Research Health Technology Assessment Programme.

Lancet (London, England) · randomised controlled trial · 59 citationsread the source →

The Spear and Shield intervention to increase the availability and acceptability of voluntary medical male circumcision in Zambia: a cluster randomised controlled trial.

Background: Widespread voluntary medical male circumcision in Africa could avert an estimated 3·436 million HIV infections and 300,000 deaths over the next 10 years. Most Zambian men have expressed little interest in the procedure. We tested the effect of the Spear and Shield intervention designed to increase demand for voluntary medical male circumcision among these hard-to-reach men. Methods: This cluster randomised controlled trial was done between Feb 1, 2012, and Oct 31, 2014, in Lusaka, Zambia, where HIV prevalence is 20·8%. 13 community health centres were stratified by HIV voluntary counselling and testing rates and patient census, and randomly assigned (5:5:3) to experimental (the intervention), control, or observation-only conditions. Community health centre health-care providers at all 13 sites received training in voluntary medical male circumcision. Eligible participants were aged at least 18 years, HIV-negative, uncircumcised, and had not proactively requested or planned for voluntary medical male circumcision at the time of enrolment. Trial statisticians did not participate in randomisation. After voluntary counselling and HIV testing, participants were recruited; female partners were invited to participate. The primary outcomes at the individual level were the likelihood of voluntary medical male circumcision by 12 months post-intervention, and condom use after voluntary medical male circumcision among participants receiving the intervention. The trial is registered with ClinicalTrials.gov, number NCT01688167. Findings: 800 uncircumcised HIV-negative men (400 in the experimental group, 400 in the control group) were enrolled. 161 participants in the experimental group and 96 in the control group had voluntary medical male circumcision (adjusted odds ratio 2·45, 95% CI 1·24-4·90; p=0·02). Condom use was examined in participants who had voluntary medical male circumcision and reported sexual activity within 1 month of a post-circumcision assessment (88 in the experimental group and 64 in the control group). Condom use over time increased in the experimental group (p=0·03) but not in the control group (p=0·2). One patient died in each group; no adverse events related to study participation were reported. Interpretation: Comprehensive HIV prevention programmes can increase the demand for and uptake of voluntary medical male circumcision services. Funding: US National Institutes of Health/National Institute of Mental Health (R01MH095539).

The lancet. HIV · randomised controlled trial · 42 citationsread the source →

Actissist: Proof-of-Concept Trial of a Theory-Driven Digital Intervention for Psychosis.

Background: Timely access to intervention for psychosis is crucial yet problematic. As such, health care providers are forming digital strategies for addressing mental health challenges. A theory-driven digital intervention that monitors distressing experiences and provides real-time active management strategies could improve the speed and quality of recovery in psychosis, over and above conventional treatments. This study assesses the feasibility and acceptability of Actissist, a digital health intervention grounded in the cognitive model of psychosis that targets key early psychosis domains. Methods: A proof-of-concept, single, blind, randomized controlled trial of Actissist, compared to a symptom-monitoring control. Thirty-six early psychosis patients were randomized on a 2:1 ratio to each arm of the trial. Actissist was delivered via a smartphone app over 12-weeks; clinical and functional assessment time-points were baseline, post-treatment and 22-weeks. Assessors' blind to treatment condition conducted the assessments. Acceptability was examined using qualitative methods. Results: Actissist was feasible (75% participants used Actissist at least once/day; uptake was high, 97% participants remained in the trial; high follow-up rates), acceptable (90% participants recommend Actissist), and safe (0 serious adverse events), with high levels of user satisfaction. Treatment effects were large on negative symptoms, general psychotic symptoms and mood. The addition of Actissist conferred benefit at post-treatment assessment over routine symptom-monitoring and treatment as usual. Conclusions: This is the first controlled proof-of-concept trial of a theory-driven digital health intervention for early psychosis. Actissist is feasible and acceptable to early psychosis patients, with a strong signal for treatment efficacy. Trial Registration: ISRCTN: 34966555.

Schizophrenia bulletin · randomised controlled trial · 143 citationsread the source →

Using a Mobile Application in the Treatment of Dysregulated Anger Among Veterans.

Objective: Anger is a symptom of post-traumatic stress disorder (PTSD) associated with a range of clinical and functional impairments, and may be especially prevalent among veterans with PTSD. Effective anger management therapies exist but may be undermined by poor engagement or lack of treatment availability. Finding ways to engage veterans in anger management therapy or to improve access can be helpful in improving clinical outcomes. This randomized controlled trial compared anger management treatment (AMT) with AMT augmented by a mobile application (app) system, Remote Exercises for Learning Anger and Excitation Management (RELAX). Methods: Participants were 58 veterans enrolled in 12 sessions of either AMT alone or AMT with the RELAX system (AMT + RELAX). The RELAX system includes the RELAX app, a wearable heart rate monitor, a remote server, and a web-based therapist interface. RELAX allows the user to practice skills, monitor symptoms, and record physiological data. The server collects data on app use. A web-based interface allows the therapist to access data on between-session practice, and skills use. Measures administered at baseline, post-treatment, and 3-and 6-month follow-up include state and trait anger, dimensions of anger, PTSD, depression, interpersonal functioning, and satisfaction. We used multilevel modeling to account for the nesting of time points within participants and participants within treatment groups. Predictors were Treatment Condition (AMT + RELAX and AMT), Linear Time (baseline, post-treatment, 3-and 6-month follow-up), and Quadratic Time and Treatment Condition × Linear Time interaction. All analyses were conducted using SPSS 21 (Armonk, New York). Approval was obtained from the institutional review board. Results: Across groups, the treatment dropout rate was 13.8%; of those who remained in treatment, 90% received an adequate dose of treatment (10 or more sessions). There were no significant differences between groups on attendance or treatment completion. Participants in both treatments demonstrated statistically significant and clinically meaningful reductions in anger severity and significant post-treatment reductions in PTSD. Veterans did not report significant changes in depression or interpersonal functioning. Veterans in the AMT + RELAX group reported spending significantly less time on homework assignments, and they rated the AMT + RELAX app as helpful and easy to use, with these ratings improving over time. Conclusion: Findings suggest that AMT + RELAX was beneficial in reducing anger symptoms and promoting efficient use of the between-session practice; however, AMT + RELAX did not outperform AMT. This study is an important contribution as it is one of the first randomized controlled trials to study the efficacy of a technology-enhanced, evidence-based psychotherapy for anger management. Findings are limited because of small sample size and modifications to the technology during the trial. However, the results highlight the possible benefits of mobile app-supported treatment, including increasing the accessibility of treatment, lowering therapist workload, reducing costs of treatment, reducing practice time, and enabling new activities and types of treatments. This study presents preliminary evidence that mobile apps can be a valuable addition to treatment for patients with anger difficulties. Future research should evaluate how much therapist involvement is needed to support anger management.

Military medicine · randomised controlled trial · 21 citationsread the source →

Psychotherapy for depression in older veterans via telemedicine: a randomised, open-label, non-inferiority trial.

Background: Many older adults with major depression, particularly veterans, do not have access to evidence-based psychotherapy. Telemedicine could increase access to best-practice care for older adults facing barriers of mobility, stigma, and geographical isolation. We aimed to establish non-inferiority of behavioural activation therapy for major depression delivered via telemedicine to same-room care in largely male, older adult veterans. Methods: In this randomised, controlled, open-label, non-inferiority trial, we recruited veterans (aged ≥58 years) meeting DSM-IV criteria for major depressive disorder from the Ralph H Johnson Veterans Affairs Medical Center and four associated community outpatient-based clinics in the USA. We excluded actively psychotic or demented people, those with both suicidal ideation and clear intent, and those with substance dependence. The study coordinator randomly assigned participants (1:1; block size 2-6; stratified by race; computer-generated randomisation sequence by RGK) to eight sessions of behavioural activation for depression either via telemedicine or in the same room. The primary outcome was treatment response according to the Geriatric Depression Scale (GDS) and Beck Depression Inventory (BDI; defined as a 50% reduction in symptoms from baseline at 12 months), and Structured Clinical Interview for DSM-IV, clinician version (defined as no longer being diagnosed with major depressive disorder at 12 months follow-up), in the per-protocol population (those who completed at least four treatment sessions and for whom all outcome measurements were done). Those assessing outcomes were masked. The non-inferiority margin was 15%. This trial is registered with ClinicalTrials.gov, number NCT00324701. Findings: Between April 1, 2007, and July 31, 2011, we screened 780 patients, and the study coordinator randomly assigned participants to either telemedicine (120 [50%]) or same-room treatment (121 [50%]). We included 100 (83%) patients in the per-protocol analysis in the telemedicine group and 104 (86%) in the same-room group. Treatment response according to GDS did not differ significantly between the telemedicine (22 [22·45%, 90% CI 15·52-29·38] patients) and same-room (21 [20·39%, 90% CI 13·86-26·92]) groups, with an absolute difference of 2·06% (90% CI -7·46 to 11·58). Response according to BDI also did not differ significantly (telemedicine 19 [24·05%, 90% CI 16·14-31·96] patients; same room 19 [23·17%, 90% CI 15·51-30·83]), with an absolute difference of 0·88% (90% CI -10·13 to 11·89). Response on the Structured Clinical Interview for DSM-IV, clinician version, also did not differ significantly (39 [43·33%, 90% CI 34·74-51·93] patients in the telemedicine group and 46 [48·42%, 90% CI 39·99-56·85] in the same-room group), with a difference of -5·09% (-17·13 to 6·95; p=0·487). Results from the intention-to-treat population were similar. MEM analyses showed that no significant differences existed between treatment trajectories over time for BDI and GDS. The criteria for non-inferiority were met. We did not note any adverse events. Interpretation: Telemedicine-delivered psychotherapy for older adults with major depression is not inferior to same-room treatment. This finding shows that evidence-based psychotherapy can be delivered, without modification, via home-based telemedicine, and that this method can be used to overcome barriers to care associated with distance from and difficulty with attendance at in-person sessions in older adults. Funding: US Department of Veterans Affairs.

The lancet. Psychiatry · randomised controlled trial · 123 citationsread the source →

The effectiveness of lifestyle triple P in the Netherlands: a randomized controlled trial.

Introduction: Lifestyle Triple P is a general parenting intervention which focuses on preventing further excessive weight gain in overweight and obese children. The objective of the current study was to assess the effectiveness of the Lifestyle Triple P intervention in the Netherlands. Method: We used a parallel randomized controlled design to test the effectiveness of the intervention. In total, 86 child-parent triads (children 4-8 years old, overweight or obese) were recruited and randomly assigned (allocation ratio 1:1) to the Lifestyle Triple P intervention or the control condition. Parents in the intervention condition received a 14-week intervention consisting of ten 90-minute group sessions and four individual telephone sessions. Primary outcome measure was the children's body composition (BMI z-scores, waist circumference and skinfolds). The research assistant who performed the measurements was blinded for group assignment. Secondary outcome measures were the children's dietary behavior and physical activity level, parenting practices, parental feeding style, parenting style, and parental self-efficacy. Outcome measures were assessed at baseline and 4 months (short-term) and 12 months (long-term) after baseline. Multilevel multiple regression analyses were conducted to determine the effect of the intervention on primary and secondary outcome measures. Results: No intervention effects were found on children's body composition. Analyses of secondary outcomes showed positive short-term intervention effects on children's soft-drink consumption and parental responsibility regarding physical activity, encouragement to eat, psychological control, and efficacy and satisfaction with parenting. Longer-term intervention effects were found on parent's report of children's time spent on sedentary behavior and playing outside, parental monitoring food intake, and responsibility regarding nutrition. Conclusion: Although the Lifestyle Triple P intervention showed positive effects on some parent reported child behaviors and parenting measures, no effects were visible on children's body composition or objectively measured physical activity. Several adjustments of the intervention content are recommended, for example including a booster session. Trial registration: Nederlands Trial Register NTR 2555.

PloS one · randomised controlled trial · 44 citationsread the source →

Efficacy and Safety of Oral Janus Kinase 1 Inhibitor Abrocitinib for Patients With Atopic Dermatitis: A Phase 2 Randomized Clinical Trial.

Importance: Atopic dermatitis is associated with substantial patient and caregiver burden. Currently available treatments for atopic dermatitis are inadequate or contraindicated for some patients. Abrocitinib (PF-04965842) is an oral Janus kinase 1 selective inhibitor under investigation for the treatment of atopic dermatitis. Objective: To investigate the efficacy and safety of abrocitinib for patients with moderate to severe atopic dermatitis. Design, setting, and participants: A phase 2b, randomized, double-blinded, placebo-controlled, parallel-group trial was conducted from April 15, 2016, to April 4, 2017, at 58 centers in Australia, Canada, Germany, Hungary, and the United States among 267 patients 18 to 75 years of age with a clinical diagnosis of moderate to severe atopic dermatitis for 1 year or more and inadequate response or contraindication to topical medications for 4 weeks or more within 12 months. Efficacy was assessed in the full analysis set, which was a modified intention-to-treat population that included all patients who received 1 dose or more of the study drug except for 4 patients from 1 site. Interventions: Participants were randomly assigned 1:1:1:1:1 to receive abrocitinib (200 mg, 100 mg, 30 mg, or 10 mg) or placebo once daily for 12 weeks. Main outcomes and measures: The primary outcome was the proportion of patients achieving an Investigator's Global Assessment of clear (0) or almost clear (1) with an improvement from baseline of 2 grades or more at week 12. The secondary outcome was the percentage change from baseline in the Eczema Area and Severity Index at week 12. Results: Of the 267 participants, 144 were women (mean [SD] age, 40.8 [16.1] years). At week 12, 21 of 48 patients receiving 200 mg of abrocitinib (43.8%; P < .001, 2-sided), 16 of 54 patients receiving 100 mg of abrocitinib (29.6%; P < .001), and 3 of 52 patients receiving placebo (5.8%) achieved grades of clear or almost clear on the Investigator's Global Assessment scale with improvement of 2 grades or more; these rates correspond to maximum effect model-based estimates of 44.5% (95% CI, 26.7%-62.3%) for those receiving 200 mg of abrocitinib, 27.8% (95% CI, 14.8%-40.9%) for those receiving 100 mg of abrocitinib, and 6.3% (95% CI, -0.2% to 12.9%) for those receiving placebo. Reductions in the Eczema Area and Severity Index were 82.6% (90% CI, 72.4%-92.8%; P < .001) for those receiving 200 mg of abrocitinib, 59.0% (90% CI, 48.8%-69.3%; P = .009) for those receiving 100 mg of abrocitinib, and 35.2% (90% CI, 24.4%-46.1%) for those receiving placebo. Adverse events were observed in 184 of 267 patients (68.9%); the most frequently reported adverse events (in ≥3 patients in any group) were dermatitis atopic, upper respiratory tract infection, headache, nausea, and diarrhea. Dose-dependent decreases in platelet count were observed but trended upward toward baseline levels after week 4. Conclusions and relevance: Once-daily oral abrocitinib was effective and well tolerated for short-term use in adults with moderate to severe atopic dermatitis. Additional trials are necessary to evaluate long-term efficacy and safety. Trial registration: ClinicalTrials.gov identifier: NCT02780167.

JAMA dermatology · randomised controlled trial · 197 citationsread the source →