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Effects of a cognitive-behavioral intervention targeting weight stigma: A randomized controlled trial.

Objective: To test the effects of a cognitive-behavioral intervention for weight bias internalization (WBI; i.e., self-stigma) combined with behavioral weight loss (BWL). Method: Adults with obesity and elevated WBI were randomly assigned to BWL alone or combined with the Weight Bias Internalization and Stigma Program (BWL + BIAS). Participants attended weekly group meetings for 12 weeks, followed by 2 biweekly and 2 monthly meetings (26 weeks total). Changes at Week 12 on the Weight Bias Internalization Scale (WBIS) and Weight Self-Stigma Questionnaire (WSSQ) were the principal outcomes, with changes at Week 26 assessed as secondary outcomes. Other outcomes included changes in mood, body image, eating behaviors, self-monitoring, and weight. Results: Seventy-two participants were randomized (84.7% female, 66.7% Black, mean age = 47.1 ± 11.5 years) Linear mixed models showed no significant differences between the BWL + BIAS and BWL groups in WBIS changes at Week 12 (-1.3 ± 0.2 vs. -1.0 ± 0.2) or week 26 (-1.5 ± 0.2 vs. -1.3 ± 0.2). BWL + BIAS participants had greater reductions in WSSQ total scores at Week 12 (p = .03), with greater changes on the self-devaluation subscale at Weeks 12 and 26 (p ≤ .03). BWL + BIAS participants reported significantly greater benefits on measures of eating and self-monitoring. Percent weight loss at Week 26 did not differ significantly between groups (BWL + BIAS = -4.5 ± 1.0%, BWL = -5.9 ± 1.0%, p = .28). Conclusion: A psychological intervention for WBI produced short-term reductions in some aspects of weight self-stigma in persons with obesity. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Journal of consulting and clinical psychology · randomised controlled trial · 55 citationsread the source →

Spinal manipulation, medication, or home exercise with advice for acute and subacute neck pain: a randomized trial.

Background: Mechanical neck pain is a common condition that affects an estimated 70% of persons at some point in their lives. Little research exists to guide the choice of therapy for acute and subacute neck pain. Objective: To determine the relative efficacy of spinal manipulation therapy (SMT), medication, and home exercise with advice (HEA) for acute and subacute neck pain in both the short and long term. Design: Randomized, controlled trial. (ClinicalTrials.gov registration number: NCT00029770) Setting: 1 university research center and 1 pain management clinic in Minnesota. Participants: 272 persons aged 18 to 65 years who had nonspecific neck pain for 2 to 12 weeks. Intervention: 12 weeks of SMT, medication, or HEA. Measurements: The primary outcome was participant-rated pain, measured at 2, 4, 8, 12, 26, and 52 weeks after randomization. Secondary measures were self-reported disability, global improvement, medication use, satisfaction, general health status (Short Form-36 Health Survey physical and mental health scales), and adverse events. Blinded evaluation of neck motion was performed at 4 and 12 weeks. Results: For pain, SMT had a statistically significant advantage over medication after 8, 12, 26, and 52 weeks (P ≤ 0.010), and HEA was superior to medication at 26 weeks (P = 0.02). No important differences in pain were found between SMT and HEA at any time point. Results for most of the secondary outcomes were similar to those of the primary outcome. Limitations: Participants and providers could not be blinded. No specific criteria for defining clinically important group differences were prespecified or available from the literature. Conclusion: For participants with acute and subacute neck pain, SMT was more effective than medication in both the short and long term. However, a few instructional sessions of HEA resulted in similar outcomes at most time points. Primary funding source: National Center for Complementary and Alternative Medicine, National Institutes of Health.

Annals of internal medicine · randomised controlled trial · 110 citationsread the source →

Validation of the Spanish versions of the long (26 items) and short (12 items) forms of the Self-Compassion Scale (SCS)

BACKGROUND: Self-compassion is a key psychological construct for assessing clinical outcomes in mindfulness-based interventions. The aim of this study was to validate the Spanish versions of the long (26 item) and short (12 item) forms of the Self-Compassion Scale (SCS). METHODS: The translated Spanish versions of both subscales were administered to two independent samples: Sample 1 was comprised of university students (n = 268) who were recruited to validate the long form, and Sample 2 was comprised of Aragon Health Service workers (n = 271) who were recruited to validate the short form. In addition to SCS, the Mindful Attention Awareness Scale (MAAS), the State-Trait Anxiety Inventory-Trait (STAI-T), the Beck Depression Inventory (BDI) and the Perceived Stress Questionnaire (PSQ) were administered. Construct validity, internal consistency, test-retest reliability and convergent validity were tested. RESULTS: The Confirmatory Factor Analysis (CFA) of the long and short forms of the SCS confirmed the original six-factor model in both scales, showing goodness of fit. Cronbach's α for the 26 item SCS was 0.87 (95% CI = 0.85-0.90) and ranged between 0.72 and 0.79 for the 6 subscales. Cronbach's α for the 12-item SCS was 0.85 (95% CI = 0.81-0.88) and ranged between 0.71 and 0.77 for the 6 subscales. The long (26-item) form of the SCS showed a test-retest coefficient of 0.92 (95% CI = 0.89-0.94). The Intraclass Correlation (ICC) for the 6 subscales ranged from 0.84 to 0.93. The short (12-item) form of the SCS showed a test-retest coefficient of 0.89 (95% CI: 0.87-0.93). The ICC for the 6 subscales ranged from 0.79 to 0.91. The long and short forms of the SCS exhibited a significant negative correlation with the BDI, the STAI and the PSQ, and a significant positive correlation with the MAAS. The correlation between the total score of the long and short SCS form was r = 0.92. CONCLUSION: The Spanish versions of the long (26-item) and short (12-item) forms of the SCS are valid and reliable instruments for the evaluation of self-compassion among the general population. These results substantiate the use of this scale in research and clinical practice.

Health and Quality of Life Outcomes · 307 citationsread the source →

Populations and Interventions for Palliative and End-of-Life Care: A Systematic Review.

Importance: Evidence supports palliative care effectiveness. Given workforce constraints and the costs of new services, payers and providers need help to prioritize their investments. They need to know which patients to target, which personnel to hire, and which services best improve outcomes. Objective: To inform how payers and providers should identify patients with "advanced illness" and the specific interventions they should implement, we reviewed the evidence to identify (1) individuals appropriate for palliative care and (2) elements of health service interventions (personnel involved, use of multidisciplinary teams, and settings of care) effective in achieving better outcomes for patients, caregivers, and the healthcare system. Evidence review: Systematic searches of MEDLINE, EMBASE, PsycINFO, Web of Science, and Cochrane Database of Systematic Reviews databases (1/1/2001-1/8/2015). Results: Randomized controlled trials (124) met inclusion criteria. The majority of studies in cancer (49%, 38 of 77 studies) demonstrated statistically significant patient or caregiver outcomes (e.g., p < 0.05), as did those in congestive heart failure (CHF) (62%, 13 of 21), chronic obstructive pulmonary disease (COPD; 58%, 11 of 19), and dementia (60%, 15 of 25). Most prognostic criteria used clinicians' judgment (73%, 22 of 30). Most interventions included a nurse (70%, 69 of 98), and many were nurse-only (39%, 27 of 69). Social workers were well represented, and home-based approaches were common (56%, 70 of 124). Home interventions with visits were more effective than those without (64%, 28 of 44; vs. 46%, 12 of 26). Interventions improved communication and care planning (70%, 12 of 18), psychosocial health (36%, 12 of 33, for depressive symptoms; 41%, 9 of 22, for anxiety), and patient (40%, 8 of 20) and caregiver experiences (63%, 5 of 8). Many interventions reduced hospital use (65%, 11 of 17), but most other economic outcomes, including costs, were poorly characterized. Palliative care teams did not reliably lower healthcare costs (20%, 2 of 10). Conclusions: Palliative care improves cancer, CHF, COPD, and dementia outcomes. Effective models include nurses, social workers, and home-based components, and a focus on communication, psychosocial support, and the patient or caregiver experience. High-quality research on intervention costs and cost outcomes in palliative care is limited.

Journal of palliative medicine · systematic review · 135 citationsread the source →

Waitlist-controlled trial of cognitive behavior therapy for hoarding disorder.

Objective: This study investigated a multicomponent cognitive behavioral treatment (CBT) for hoarding based on a model proposed by Frost and colleagues and manualized in Steketee and Frost (2007). Method: Participants with clinically significant hoarding were recruited from the community and a university-based anxiety clinic. Of the 46 patients randomly assigned to CBT or waitlist (WL), 40 completed the 12-week assessment and 36 completed 26 sessions. Treatment included education and case formulation, motivational interviewing, skills training for organizing and problem solving, direct exposure to nonacquiring and discarding, and cognitive therapy. Measures included the Saving Inventory-Revised (self-report), Hoarding Rating Scale-Interview, and measures of clinical global improvement. Between group repeated measures analyses using general linear modeling examined the effect of CBT versus WL on hoarding symptoms and moodstate after 12 weeks. Within group analyses examined pre-post effects for all CBT participants combined after 26 sessions. Results: After 12 weeks, CBT participants benefited significantly more than WL patients on hoarding severity and mood with moderate effect sizes. After 26 sessions of CBT, participants showed significant reductions in hoarding symptoms with large effect sizes for most measures. At session 26, 71% of patients were considered improved on therapist clinical global improvement ratings and 81% of patients rated themselves improved; 41% of completers were clinically significantly improved. Conclusions: Multicomponent CBT was effective in treating hoarding. However, treatment refusal and compliance remain a concern, and further research with independent assessors is needed to establish treatment benefits and durability of gains.

Depression and anxiety · randomised controlled trial · 112 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 →

Exercise therapy for chronic fatigue syndrome.

Background: Chronic fatigue syndrome (CFS) is characterised by persistent, medically unexplained fatigue, as well as symptoms such as musculoskeletal pain, sleep disturbance, headaches and impaired concentration and short-term memory. CFS presents as a common, debilitating and serious health problem. Treatment may include physical interventions, such as exercise therapy, which was last reviewed in 2004. Objectives: The objective of this review was to determine the effects of exercise therapy (ET) for patients with CFS as compared with any other intervention or control.• Exercise therapy versus 'passive control' (e.g. treatment as usual, waiting-list control, relaxation, flexibility).• Exercise therapy versus other active treatment (e.g. cognitive-behavioural therapy (CBT), cognitive treatment, supportive therapy, pacing, pharmacological therapy such as antidepressants).• Exercise therapy in combination with other specified treatment strategies versus other specified treatment strategies (e.g. exercise combined with pharmacological treatment vs pharmacological treatment alone). Search methods: We searched The Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register (CCDANCTR), the Cochrane Central Register of Controlled Trials (CENTRAL) and SPORTDiscus up to May 2014 using a comprehensive list of free-text terms for CFS and exercise. We located unpublished or ongoing trials through the World Health Organization (WHO) International Clinical Trials Registry Platform (to May 2014). We screened reference lists of retrieved articles and contacted experts in the field for additional studies SELECTION CRITERIA: Randomised controlled trials involving adults with a primary diagnosis of CFS who were able to participate in exercise therapy. Studies had to compare exercise therapy with passive control, psychological therapies, adaptive pacing therapy or pharmacological therapy. Data collection and analysis: Two review authors independently performed study selection, risk of bias assessments and data extraction. We combined continuous measures of outcomes using mean differences (MDs) and standardised mean differences (SMDs). We combined serious adverse reactions and drop-outs using risk ratios (RRs). We calculated an overall effect size with 95% confidence intervals (CIs) for each outcome. Main results: We have included eight randomised controlled studies and have reported data from 1518 participants in this review. Three studies diagnosed individuals with CFS using the 1994 criteria of the Centers for Disease Control and Prevention (CDC); five used the Oxford criteria. Exercise therapy lasted from 12 to 26 weeks. Seven studies used variations of aerobic exercise therapy such as walking, swimming, cycling or dancing provided at mixed levels in terms of intensity of the aerobic exercise from very low to quite rigorous, whilst one study used anaerobic exercise. Control groups consisted of passive control (eight studies; e.g. treatment as usual, relaxation, flexibility) or CBT (two studies), cognitive therapy (one study), supportive listening (one study), pacing (one study), pharmacological treatment (one study) and combination treatment (one study). Risk of bias varied across studies, but within each study, little variation was found in the risk of bias across our primary and secondary outcome measures. Investigators compared exercise therapy with 'passive' control in eight trials, which enrolled 971 participants. Seven studies consistently showed a reduction in fatigue following exercise therapy at end of treatment, even though the fatigue scales used different scoring systems: an 11-item scale with a scoring system of 0 to 11 points (MD -6.06, 95% CI -6.95 to -5.17; one study, 148 participants; low-quality evidence); the same 11-item scale with a scoring system of 0 to 33 points (MD -2.82, 95% CI -4.07 to -1.57; three studies, 540 participants; moderate-quality evidence); and a 14-item scale with a scoring system of 0 to 42 points (MD -6.80, 95% CI -10.31 to -3.28; three studies, 152 participants; moderate-quality evidence). Serious adverse reactions were rare in both groups (RR 0.99, 95% CI 0.14 to 6.97; one study, 319 participants; moderate-quality evidence), but sparse data made it impossible for review authors to draw conclusions. Study authors reported a positive effect of exercise therapy at end of treatment with respect to sleep (MD -1.49, 95% CI -2.95 to -0.02; two studies, 323 participants), physical functioning (MD 13.10, 95% CI 1.98 to 24.22; five studies, 725 participants) and self-perceived changes in overall health (RR 1.83, 95% CI 1.39 to 2.40; four studies, 489 participants). It was not possible for review authors to draw conclusions regarding the remaining outcomes. Investigators compared exercise therapy with CBT in two trials (351 participants). One trial (298 participants) reported little or no difference in fatigue at end of treatment between the two groups using an 11-item scale with a scoring system of 0 to 33 points (MD 0.20, 95% CI -1.49 to 1.89). Both studies measured differences in fatigue at follow-up, but neither found differences between the two groups using an 11-item fatigue scale with a scoring system of 0 to 33 points (MD 0.30, 95% CI -1.45 to 2.05) and a nine-item Fatigue Severity Scale with a scoring system of 1 to 7 points (MD 0.40, 95% CI -0.34 to 1.14). Serious adverse reactions were rare in both groups (RR 0.67, 95% CI 0.11 to 3.96). We observed little or no difference in physical functioning, depression, anxiety and sleep, and we were not able to draw any conclusions with regard to pain, self-perceived changes in overall health, use of health service resources and drop-out rate. With regard to other comparisons, one study (320 participants) suggested a general benefit of exercise over adaptive pacing, and another study (183 participants) a benefit of exercise over supportive listening. The available evidence was too sparse to draw conclusions about the effect of pharmaceutical interventions. Authors' conclusions: Patients with CFS may generally benefit and feel less fatigued following exercise therapy, and no evidence suggests that exercise therapy may worsen outcomes. A positive effect with respect to sleep, physical function and self-perceived general health has been observed, but no conclusions for the outcomes of pain, quality of life, anxiety, depression, drop-out rate and health service resources were possible. The effectiveness of exercise therapy seems greater than that of pacing but similar to that of CBT. Randomised trials with low risk of bias are needed to investigate the type, duration and intensity of the most beneficial exercise intervention.

The Cochrane database of systematic reviews · meta-analysis · 80 citationsread the source →

Interventions to prevent obesity in children aged 5 to 11 years old.

Background: Prevention of obesity in children is an international public health priority given the prevalence of the condition (and its significant impact on health, development and well-being). Interventions that aim to prevent obesity involve behavioural change strategies that promote healthy eating or 'activity' levels (physical activity, sedentary behaviour and/or sleep) or both, and work by reducing energy intake and/or increasing energy expenditure, respectively. There is uncertainty over which approaches are more effective and numerous new studies have been published over the last five years, since the previous version of this Cochrane review. Objectives: To assess the effects of interventions that aim to prevent obesity in children by modifying dietary intake or 'activity' levels, or a combination of both, on changes in BMI, zBMI score and serious adverse events. Search methods: We used standard, extensive Cochrane search methods. The latest search date was February 2023. Selection criteria: Randomised controlled trials in children (mean age 5 years and above but less than 12 years), comparing diet or 'activity' interventions (or both) to prevent obesity with no intervention, usual care, or with another eligible intervention, in any setting. Studies had to measure outcomes at a minimum of 12 weeks post baseline. We excluded interventions designed primarily to improve sporting performance. Data collection and analysis: We used standard Cochrane methods. Our outcomes were body mass index (BMI), zBMI score and serious adverse events, assessed at short- (12 weeks to < 9 months from baseline), medium- (9 months to < 15 months) and long-term (≥ 15 months) follow-up. We used GRADE to assess the certainty of the evidence for each outcome. Main results: This review includes 172 studies (189,707 participants); 149 studies (160,267 participants) were included in meta-analyses. One hundred forty-six studies were based in high-income countries. The main setting for intervention delivery was schools (111 studies), followed by the community (15 studies), the home (eight studies) and a clinical setting (seven studies); one intervention was conducted by telehealth and 31 studies were conducted in more than one setting. Eighty-six interventions were implemented for less than nine months; the shortest was conducted over one visit and the longest over four years. Non-industry funding was declared by 132 studies; 24 studies were funded in part or wholly by industry. Dietary interventions versus control Dietary interventions, compared with control, may have little to no effect on BMI at short-term follow-up (mean difference (MD) 0, 95% confidence interval (CI) -0.10 to 0.10; 5 studies, 2107 participants; low-certainty evidence) and at medium-term follow-up (MD -0.01, 95% CI -0.15 to 0.12; 9 studies, 6815 participants; low-certainty evidence) or zBMI at long-term follow-up (MD -0.05, 95% CI -0.10 to 0.01; 7 studies, 5285 participants; low-certainty evidence). Dietary interventions, compared with control, probably have little to no effect on BMI at long-term follow-up (MD -0.17, 95% CI -0.48 to 0.13; 2 studies, 945 participants; moderate-certainty evidence) and zBMI at short- or medium-term follow-up (MD -0.06, 95% CI -0.13 to 0.01; 8 studies, 3695 participants; MD -0.04, 95% CI -0.10 to 0.02; 9 studies, 7048 participants; moderate-certainty evidence). Five studies (1913 participants; very low-certainty evidence) reported data on serious adverse events: one reported serious adverse events (e.g. allergy, behavioural problems and abdominal discomfort) that may have occurred as a result of the intervention; four reported no effect. Activity interventions versus control Activity interventions, compared with control, may have little to no effect on BMI and zBMI at short-term or long-term follow-up (BMI short-term: MD -0.02, 95% CI -0.17 to 0.13; 14 studies, 4069 participants; zBMI short-term: MD -0.02, 95% CI -0.07 to 0.02; 6 studies, 3580 participants; low-certainty evidence; BMI long-term: MD -0.07, 95% CI -0.24 to 0.10; 8 studies, 8302 participants; zBMI long-term: MD -0.02, 95% CI -0.09 to 0.04; 6 studies, 6940 participants; low-certainty evidence). Activity interventions likely result in a slight reduction of BMI and zBMI at medium-term follow-up (BMI: MD -0.11, 95% CI -0.18 to -0.05; 16 studies, 21,286 participants; zBMI: MD -0.05, 95% CI -0.09 to -0.02; 13 studies, 20,600 participants; moderate-certainty evidence). Eleven studies (21,278 participants; low-certainty evidence) reported data on serious adverse events; one study reported two minor ankle sprains and one study reported the incident rate of adverse events (e.g. musculoskeletal injuries) that may have occurred as a result of the intervention; nine studies reported no effect. Dietary and activity interventions versus control Dietary and activity interventions, compared with control, may result in a slight reduction in BMI and zBMI at short-term follow-up (BMI: MD -0.11, 95% CI -0.21 to -0.01; 27 studies, 16,066 participants; zBMI: MD -0.03, 95% CI -0.06 to 0.00; 26 studies, 12,784 participants; low-certainty evidence) and likely result in a reduction of BMI and zBMI at medium-term follow-up (BMI: MD -0.11, 95% CI -0.21 to 0.00; 21 studies, 17,547 participants; zBMI: MD -0.05, 95% CI -0.07 to -0.02; 24 studies, 20,998 participants; moderate-certainty evidence). Dietary and activity interventions compared with control may result in little to no difference in BMI and zBMI at long-term follow-up (BMI: MD 0.03, 95% CI -0.11 to 0.16; 16 studies, 22,098 participants; zBMI: MD -0.02, 95% CI -0.06 to 0.01; 22 studies, 23,594 participants; low-certainty evidence). Nineteen studies (27,882 participants; low-certainty evidence) reported data on serious adverse events: four studies reported occurrence of serious adverse events (e.g. injuries, low levels of extreme dieting behaviour); 15 studies reported no effect. Heterogeneity was apparent in the results for all outcomes at the three follow-up times, which could not be explained by the main setting of the interventions (school, home, school and home, other), country income status (high-income versus non-high-income), participants' socioeconomic status (low versus mixed) and duration of the intervention. Most studies excluded children with a mental or physical disability. Authors' conclusions: The body of evidence in this review demonstrates that a range of school-based 'activity' interventions, alone or in combination with dietary interventions, may have a modest beneficial effect on obesity in childhood at short- and medium-term, but not at long-term follow-up. Dietary interventions alone may result in little to no difference. Limited evidence of low quality was identified on the effect of dietary and/or activity interventions on severe adverse events and health inequalities; exploratory analyses of these data suggest no meaningful impact. We identified a dearth of evidence for home and community-based settings (e.g. delivered through local youth groups), for children living with disabilities and indicators of health inequities.

The Cochrane database of systematic reviews · meta-analysis · 40 citationsread the source →

Health impacts of parental migration on left-behind children and adolescents: a systematic review and meta-analysis.

Background: Globally, a growing number of children and adolescents are left behind when parents migrate. We investigated the effect of parental migration on the health of left behind-children and adolescents in low-income and middle-income countries (LMICs). Methods: For this systematic review and meta-analysis we searched MEDLINE, Embase, CINAHL, the Cochrane Library, Web of Science, PsychINFO, Global Index Medicus, Scopus, and Popline from inception to April 27, 2017, without language restrictions, for observational studies investigating the effects of parental migration on nutrition, mental health, unintentional injuries, infectious disease, substance use, unprotected sex, early pregnancy, and abuse in left-behind children (aged 0-19 years) in LMICs. We excluded studies in which less than 50% of participants were aged 0-19 years, the mean or median age of participants was more than 19 years, fewer than 50% of parents had migrated for more than 6 months, or the mean or median duration of migration was less than 6 months. We screened studies using systematic review software and extracted summary estimates from published reports independently. The main outcomes were risk and prevalence of health outcomes, including nutrition (stunting, wasting, underweight, overweight and obesity, low birthweight, and anaemia), mental health (depressive disorder, anxiety disorder, conduct disorders, self-harm, and suicide), unintentional injuries, substance use, abuse, and infectious disease. We calculated pooled risk ratios (RRs) and standardised mean differences (SMDs) using random-effects models. This study is registered with PROSPERO, number CRD42017064871. Findings: Our search identified 10 284 records, of which 111 studies were included for analysis, including a total of 264 967 children (n=106 167 left-behind children and adolescents; n=158 800 children and adolescents of non-migrant parents). 91 studies were done in China and focused on effects of internal labour migration. Compared with children of non-migrants, left-behind children had increased risk of depression and higher depression scores (RR 1·52 [95% CI 1·27-1·82]; SMD 0·16 [0·10-0·21]), anxiety (RR 1·85 [1·36-2·53]; SMD 0·18 [0·11-0·26]), suicidal ideation (RR 1·70 [1·28-2·26]), conduct disorder (SMD 0·16 [0·04-0·28]), substance use (RR 1·24 [1·00-1·52]), wasting (RR 1·13 [1·02-1·24]) and stunting (RR 1·12 [1·00-1·26]). No differences were identified between left-behind children and children of non-migrants for other nutrition outcomes, unintentional injury, abuse, or diarrhoea. No studies reported outcomes for other infectious diseases, self-harm, unprotected sex, or early pregnancy. Study quality varied across the included studies, with 43% of studies at high or unclear risk of bias across five or more domains. Interpretation: Parental migration is detrimental to the health of left-behind children and adolescents, with no evidence of any benefit. Policy makers and health-care professionals need to take action to improve the health of these young people. Funding: Wellcome Trust.

Lancet (London, England) · meta-analysis · 330 citationsread the source →

A systematic review on the therapeutic effectiveness of non-invasive brain stimulation for the treatment of anxiety disorders.

The interest in the use of non-invasive brain stimulation for enhancing neural functions and reducing symptoms in anxiety disorders is growing. Based on the DSM-V classification for anxiety disorders, we examined all available research using repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS) for the treatment of specific phobias, social anxiety disorder, panic disorder, agoraphobia, and generalized anxiety disorder. A systematic literature search conducted in PubMed and Google Scholar databases provided 26 results: 12 sham-controlled studies and 15 not sham-controlled studies. With regard to the latter sub-group of studies, 9 were case reports, and 6 open label studies. Overall, our work provides preliminary evidence that both, excitatory stimulation of the left prefrontal cortex and inhibitory stimulation of the right prefrontal cortex can reduce symptom severity in anxiety disorders. The current results are discussed in the light of a model for the treatment for anxiety disorders via non-invasive brain stimulation, which is based on up-/downregulation mechanisms and might serve as guide for future systematic investigations in the field.

Neuroscience and biobehavioral reviews · systematic review · 126 citationsread the source →

Systematic review of burnout among healthcare providers in sub-Saharan Africa.

Background: Burnout is characterized by physical and emotional exhaustion from long-term exposure to emotionally demanding work. Burnout affects interpersonal skills, job performance, career satisfaction, and psychological health. However, little is known about the burden of burnout among healthcare providers in sub-Saharan Africa. Methods: Relevant articles were identified through a systematic review of PubMed, Web of Science (Thomson Reuters), and PsycINFO (EBSCO). Studies were selected for inclusion if they examined a quantitative measure of burnout among healthcare providers in sub-Saharan Africa. Results: A total of 65 articles met our inclusion criteria for this systematic review. Previous studies have examined burnout in sub-Saharan Africa among physicians (N = 12 articles), nurses (N = 26), combined populations of healthcare providers (N = 18), midwives (N = 2), and medical or nursing students (N = 7). The majority of studies assessed burnout using the Maslach Burnout Inventory. The highest levels of burnout were reported among nurses, although all healthcare providers showed high burnout. Burnout among healthcare providers is associated with their work environments, interpersonal and professional conflicts, emotional distress, and low social support. Conclusions: Available studies on this topic are limited by several methodological challenges. More rigorously designed epidemiologic studies of burnout among healthcare providers are warranted. Health infrastructure improvements will eventually be essential, though difficult to achieve, in under-resourced settings. Programs aimed at raising awareness and coping with burnout symptoms through stress management and resilience enhancement trainings are also needed.

BMC public health · systematic review · 187 citationsread the source →

Vitamin D levels and perinatal depressive symptoms in women at risk: a secondary analysis of the mothers, omega-3, and mental health study.

Background: Vitamin D insufficiency may be associated with depressive symptoms in non-pregnant adults. We performed this study to evaluate whether low maternal vitamin D levels are associated with depressive symptoms in pregnancy. Methods: This study was a secondary analysis of a randomized trial designed to assess whether prenatal omega-3 fatty acid supplementation would prevent depressive symptoms. Pregnant women from Michigan who were at risk for depression based on Edinburgh Postnatal Depression Scale Score or history of depression were enrolled. Participants completed the Beck Depression Inventory (BDI) and Mini International Neuropsychiatric Interview at 12-20 weeks, 26-28 weeks, 34-36 weeks, and 6-8 weeks postpartum. Vitamin D levels were measured at 12-20 weeks (N = 117) and 34-36 weeks (N = 112). Complete datasets were available on 105 subjects. Using regression analyses, we evaluated the relationship between vitamin D levels with BDI scores as well as with MINI diagnoses of major depressive disorder and generalized anxiety disorder. Our primary outcome measure was the association of maternal vitamin D levels with BDI scores during early and late pregnancy and postpartum. Results: We found that vitamin D levels at 12-20 weeks were inversely associated with BDI scores both at 12-20 and at 34-36 weeks' gestation (P < 0.05, both). For every one unit increase in vitamin D in early pregnancy, the average decrease in the mean BDI score was .14 units. Vitamin D levels were not associated with diagnoses of major depressive disorder or generalized anxiety disorder. Conclusions: In women at risk for depression, early pregnancy low vitamin D levels are associated with higher depressive symptom scores in early and late pregnancy. Future investigations should study whether vitamin D supplementation in early pregnancy may prevent perinatal depressive symptoms. Trial registration: https://clinicaltrials.gov/ Registration number: NCT00711971.

BMC pregnancy and childbirth · randomised controlled trial · 30 citationsread the source →

Effects of Fecal Microbiome Transfer in Adolescents With Obesity: The Gut Bugs Randomized Controlled Trial.

Importance: Treatment of pediatric obesity is challenging. Preclinical studies in mice indicated that weight and metabolism can be altered by gut microbiome manipulation. Objective: To assess efficacy of fecal microbiome transfer (FMT) to treat adolescent obesity and improve metabolism. Design, setting, and participants: This randomized, double-masked, placebo-controlled trial (October 2017-March 2019) with a 26-week follow-up was conducted among adolescents aged 14 to 18 years with a body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) of 30 or more in Auckland, New Zealand. A total of 87 individuals took part-565 individuals responded to advertisements, 328 were ineligible, and 150 declined participation. Clinical data were analyzed from September 2019 to May 2020. Interventions: Single course of oral encapsulated fecal microbiome from 4 healthy lean donors of the same sex or saline placebo. Main outcomes and measures: Primary outcome was BMI standard deviation score at 6 weeks using intention-to-treat analysis. Secondary outcomes included body composition, cardiometabolic parameters, well-being, and gut microbiome composition. Results: Eighty-seven participants (59% female adolescents, mean [SD] age 17.2 [1.4] years) were randomized 1:1, in groups stratified by sex, to FMT (42 participants) or placebo (45 participants). There was no effect of FMT on BMI standard deviation score at 6 weeks (adjusted mean difference [aMD] -0.026; 95% CI -0.074, 0.022). Reductions in android-to-gynoid-fat ratio in the FMT vs placebo group were observed at 6, 12, and 26 weeks, with aMDs of -0.021 (95% CI, -0.041 to -0.001), -0.023 (95% CI, -0.043 to -0.003), and -0.029 (95% CI, -0.049 to -0.008), respectively. There were no observed effects on insulin sensitivity, liver function, lipid profile, inflammatory markers, blood pressure, total body fat percentage, gut health, and health-related quality of life. Gut microbiome profiling revealed a shift in community composition among the FMT group, maintained up to 12 weeks. In post-hoc exploratory analyses among participants with metabolic syndrome at baseline, FMT led to greater resolution of this condition (18 to 4) compared with placebo (13 to 10) by 26 weeks (adjusted odds ratio, 0.06; 95% CI, 0.01-0.45; P = .007). There were no serious adverse events recorded throughout the trial. Conclusions and relevance: In this randomized clinical trial of adolescents with obesite, there was no effect of FMT on weight loss in adolescents with obesity, although a reduction in abdominal adiposity was observed. Post-hoc analyses indicated a resolution of undiagnosed metabolic syndrome with FMT among those with this condition. Further trials are needed to confirm these results and identify organisms and mechanisms responsible for mediating the observed benefits. Trial registration: Australian New Zealand Clinical Trials Registry Identifier: ACTRN12615001351505.

JAMA network open · randomised controlled trial · 120 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 →

Efficacy of Personalized Diabetes Self-care Using an Electronic Medical Record-Integrated Mobile App in Patients With Type 2 Diabetes: 6-Month Randomized Controlled Trial.

Background: A system that combines technology and web-based coaching can help treat chronic conditions such as diabetes. However, the effectiveness of apps in mobile health (mHealth) interventions is inconclusive and unclear due to heterogeneous interventions and varying follow-up durations. In addition, randomized controlled trial data are limited, and long-term follow-up is lacking, especially for apps integrated into electronic medical records. Objective: We aimed to assess the effect of an electronic medical record-integrated mobile app for personalized diabetes self-care, focusing on the self-monitoring of blood glucose and lifestyle modifications, on glycemic control in patients with type 2 diabetes mellitus. Methods: In a 26-week, 3-arm, randomized, controlled, open-label, parallel group trial, patients with type 2 diabetes mellitus and a hemoglobin A1c (HbA1c) level of ≥7.5% were recruited. The mHealth intervention consisted of self-monitoring of blood glucose with the automatic transfer of glucose, diet, and physical activity counseling data (iCareD system). Participants were randomly assigned to the following three groups: usual care (UC), mobile diabetes self-care (MC), and MC with personalized, bidirectional feedback from physicians (MPC). The primary outcome was the change in HbA1c levels at 26 weeks. In addition, diabetes-related self-efficacy, self-care activities, and satisfaction with the iCareD system were assessed after the intervention. Results: A total of 269 participants were enrolled, and 234 patients (86.9%) remained in the study at 26 weeks. At 12 weeks after the intervention, the mean decline in HbA1c levels was significantly different among the 3 groups (UC vs MC vs MPC: -0.49% vs -0.86% vs -1.04%; P=.02). The HbA1c level decreased in all groups; however, it did not differ among groups after 26 weeks. In a subgroup analysis, HbA1c levels showed a statistically significant decrease after the intervention in the MPC group compared with the change in the UC or MC group, especially in patients aged <65 years (P=.02), patients with a diabetes duration of ≥10 years (P=.02), patients with a BMI of ≥25.0 kg/m2 (P=.004), patients with a C-peptide level of ≥0.6 ng/mL (P=.008), and patients who did not undergo treatment with insulin (P=.004) at 12 weeks. A total of 87.2% (137/157) of the participants were satisfied with the iCareD system. Conclusions: The mHealth intervention for diabetes self-care showed short-term efficacy in glycemic control, and the effect decreased over time. The participants were comfortable with using the iCareD system and exhibited high adherence. Trial registration: Clinical Research Information Service, Republic of Korea KCT0004128; https://tinyurl.com/bdd6pa9m.

Journal of medical Internet research · randomised controlled trial · 48 citationsread the source →

Single blind randomised controlled trial of GAME (Goals - Activity - Motor Enrichment) in infants at high risk of cerebral palsy.

Background: Cerebral palsy (CP) is caused by a lesion in the developing infant brain. Recent neuroplasticity literature suggests that intensive, task-specific intervention ought to commence early, during the critical period of neural development. Aims: To determine whether "GAME" (Goals - Activity - Motor Enrichment), a motor learning, environmental enrichment intervention, is effective for improving motor skills in infants at high risk of CP. Methods and procedures: Single blind randomised controlled trial of GAME versus standard care. Primary outcome was motor skills on the Peabody Developmental Motor Scales-2 (PDMS-2). Secondary outcomes included Canadian Occupational Performance Measure (COPM), Bayley Scales of Infant and Toddler Development (BSID-III) and Gross Motor Function Measure-66 (GMFM-66). Outcome assessors were masked to group allocation and data analyzed with multiple regression. Outcomes and results: All n=30 infants enrolled received the assigned intervention until 16 weeks post enrolment. At 12 months of age, n=26 completed assessments. Significant between group differences were found in raw scores on the PDMS-2 in favour of GAME (B=20.71, 95%CI 1.66-39.76, p=0. 03) and at 12 months on the total motor quotient (B=8.29, 95%CI 0.13-16.45,p =0.05). Significant between group differences favored GAME participants at 12 months on the cognitive scale of the BSID-III and satisfaction scores on the COPM. Conclusion: GAME intervention resulted in advanced motor and cognitive outcomes when compared with standard care.

Research in developmental disabilities · randomised controlled trial · 147 citationsread the source →

Effects of a Multi-Disciplinary Lifestyle Intervention on Cardiometabolic Risk Factors in Young Women with Abdominal Obesity: A Randomised Controlled Trial.

Background: Young women are under-represented in cardiovascular disease research, with obesity and cardiometabolic risk factor interventions generally targeting older adults. Furthermore, appropriate study designs for young women remain uncertain. This study aimed to assess the impact of a 12 week multi-disciplinary lifestyle intervention on cardiometabolic risk factors in premenopausal women with abdominal obesity. Methods: Women aged 18-30 y with abdominal obesity [waist circumference (WC) ≥ 80 cm] were randomised to a 12 week lifestyle intervention (n = 26) of physical activity, nutrition education and cognitive behavioural therapy, or a wait-list control group (n = 17). Both groups completed anthropometric, biochemical, nutrition and fitness testing, at pre (0 weeks) and post (12 weeks), with intervention participants completed follow-up testing at 24 weeks. Results: Results from a linear mixed model showed no between-group differences, other than increased physical activity in the intervention group, at post. In the intervention group alone, positive within-group changes were observed in WC, waist-hip-ratio (WHR), waist-height-ratio (WHtR), resting heart rate, blood pressure, predicted VO2max, and total energy intake. Most changes were maintained at 24 weeks post-intervention. Similar within-group improvements were observed in control participants in WC, WHR, WHtR, and systolic blood pressure but no changes were detected in physical activity and nutrition. Conclusions: Cardiometabolic risk factors were decreased as a result of a lifestyle intervention in young women with abdominal obesity. It is difficult to describe observations in the control group without greater understanding of the behaviour of wait-list participants. Trial registration: Australian New Zealand Clinical Trials Registry ACTRN12612001017819.

PloS one · randomised controlled trial · 20 citationsread the source →

Exit Interviews Examining Changes to Mood and Work/Productivity Impacts Related to Vasomotor Symptoms: Perspectives of Postmenopausal Women Receiving Elinzanetant in Phase III Clinical Trials.

Background: Vasomotor symptoms (VMS; hot flashes) significantly impact women's health-related quality of life during the menopausal transition. Two phase III trials (OASIS 1 and 2) were conducted to investigate the efficacy and safety of elinzanetant for the treatment of moderate-to-severe VMS associated with menopause. This exit interview study explored the impact of VMS on women's mood and work/productivity before and since treatment. Methods: A total of 40 postmenopausal women from the USA who participated in OASIS 1 and 2 (receiving elinzanetant for 26 weeks or placebo for 12 weeks followed by elinzanetant for 14 weeks) took part in a 60-min exit interview. Interviews were conducted via telephone by trained qualitative interviewers using a semi-structured interview guide; concept-elicitation techniques, followed by focused questioning, were used to explore concepts of interest. Interview transcripts were analyzed using thematic analysis methods in Atlas.ti. Saturation analysis was conducted to determine the appropriateness of the sample size. Results: Twelve mood concepts and seven work/productivity concepts were reported to be associated with VMS before taking the study medication. Most commonly reported mood concepts included reduced happiness (60.0%), embarrassment (50.0%), and mood swings (45.0%). Most commonly reported work/productivity concepts included reduced concentration (77.5%) and reduced productivity (67.5%). Most participants reported improvements since taking the study medication (mood: ≥ 82.4%; work/productivity: ≥ 80.0%), which contributed to other positive changes (e.g., in social wellbeing). Improvements were considered meaningful (≥ 72.2%) and highly satisfying (≥ 71.4%). Conclusion: This study provides novel insights into women's experiences of VMS-associated impacts on mood and work/productivity, highlighting the emotional and economic burdens of VMS. Data support and contextualize the treatment benefits of elinzanetant on mood and work/productivity that are meaningful to women.

The patient · randomised controlled trial · 2 citationsread the source →

Mobile phone-based interventions for smoking cessation.

Background: Access to mobile phones continues to increase exponentially globally, outstripping access to fixed telephone lines, fixed computers and the Internet. Mobile phones are an appropriate and effective option for the delivery of smoking cessation support in some contexts. This review updates the evidence on the effectiveness of mobile phone-based smoking cessation interventions. Objectives: To determine whether mobile phone-based smoking cessation interventions increase smoking cessation in people who smoke and want to quit. Search methods: For the most recent update, we searched the Cochrane Tobacco Addiction Group Specialised Register in April 2015. We also searched the UK Clinical Research Network Portfolio for current projects in the UK, and the ClinicalTrials.gov register for ongoing or recently completed studies. We searched through the reference lists of identified studies and attempted to contact the authors of ongoing studies. We applied no restrictions on language or publication date. Selection criteria: We included randomised or quasi-randomised trials. Participants were smokers of any age who wanted to quit. Studies were those examining any type of mobile phone-based intervention for smoking cessation. This included any intervention aimed at mobile phone users, based around delivery via mobile phone, and using any functions or applications that can be used or sent via a mobile phone. Data collection and analysis: Review authors extracted information on risk of bias and methodological details using a standardised form. We considered participants who dropped out of the trials or were lost to follow-up to be smoking. We calculated risk ratios (RR) and 95% confidence intervals (CI) for each included study. Meta-analysis of the included studies used the Mantel-Haenszel fixed-effect method. Where meta-analysis was not possible, we presented a narrative summary and descriptive statistics. Main results: This updated search identified 12 studies with six-month smoking cessation outcomes, including seven studies completed since the previous review. The interventions were predominantly text messaging-based, although several paired text messaging with in-person visits or initial assessments. Two studies gave pre-paid mobile phones to low-income human immunodeficiency virus (HIV)-positive populations - one solely for phone counselling, the other also included text messaging. One study used text messages to link to video messages. Control programmes varied widely. Studies were pooled according to outcomes - some providing measures of continuous abstinence or repeated measures of point prevalence; others only providing 7-day point prevalence abstinence. All 12 studies pooled using their most rigorous 26-week measures of abstinence provided an RR of 1.67 (95% CI 1.46 to 1.90; I(2) = 59%). Six studies verified quitting biochemically at six months (RR 1.83; 95% CI 1.54 to 2.19). Authors' conclusions: The current evidence supports a beneficial impact of mobile phone-based smoking cessation interventions on six-month cessation outcomes. While all studies were good quality, the fact that those studies with biochemical verification of quitting status demonstrated an even higher chance of quitting further supports the positive findings. However, it should be noted that most included studies were of text message interventions in high-income countries with good tobacco control policies. Therefore, caution should be taken in generalising these results outside of this type of intervention and context.

The Cochrane database of systematic reviews · meta-analysis · 373 citationsread the source →

Double-blind, randomized comparison of memantine and escitalopram for the treatment of major depressive disorder comorbid with alcohol dependence.

Objective: The aim of the study was to evaluate possible new treatments for major depressive disorder in patients with comorbid alcohol dependence in a municipal alcohol treatment unit. The efficacy of memantine, a noncompetitive glutamate N-methyl-D-aspartate (NMDA)-receptor blocker used for the treatment of moderate to severe Alzheimer's disease, was compared with that of escitalopram, a selective serotonin reuptake inhibitor antidepressant. Method: Eighty alcohol-dependent outpatients with major depressive disorder (DSM-IV criteria) seeking treatment from municipal alcohol treatment clinics in Helsinki, Finland, were randomly assigned 1:1 to receive memantine 20 mg/day or escitalopram 20 mg/day. During the study period, patients continued their routine treatment at the clinics. Abstinence was not required. Concomitant interventions or imposed treatment goals were not offered by the study physician. The patients returned to the treatment clinics at weeks 1, 2, 4, 12, and 26 for data collection and for medication checking and dispensing. Outcome measures were the Montgomery-Asberg Depression Rating Scale (MADRS) and Beck Depression Inventory-II for depression, Hamilton Rating Scale for Anxiety (HAM-A) and Beck Anxiety Inventory for anxiety, Consortium to Establish a Registry for Alzheimer's Disease test battery for cognitive functions, and Social and Occupational Functioning Assessment Scale for social and occupational functions and quality-of-life measures. Twenty-nine patients in each group completed the study. All primary and secondary outcome statistical analyses were performed by an independent source for intent-to-treat populations, which included all patients randomly assigned to treatment. The study was conducted from December 2004 to May 2006. Results: Both treatments significantly reduced the baseline level of depression and anxiety according to MADRS and HAM-A, which were the primary measures (p < .0001). There was no significant difference between the memantine and escitalopram groups. Assessed cognitive functioning scores were primarily within the normative range and were unchanged in both groups. Quality-of-life outcomes equally improved in both treatment groups. Conclusions: These data provide new evidence for the safety and potential efficacy of memantine and escitalopram for major depressive disorder in patients with comorbid alcohol dependence. Clinical trials registration: ClinicalTrials.gov identifier NCT00368862.

The Journal of clinical psychiatry · randomised controlled trial · 81 citationsread the source →

Txt2stop: a pilot randomised controlled trial of mobile phone-based smoking cessation support.

Aim: To conduct a pilot randomised controlled trial of mobile phone-based smoking cessation support intervention for the UK population. Design: Randomised controlled trial (txt2stop). Setting: Community. Participants: 200 participants responding to radio, poster and leaflet-based promotions regarding the trial. Main outcome measures: The response rate for the outcome measures planned for the main trial. Participants' qualitative responses to open-ended questions about the intervention content. Secondary outcomes were the outcomes planned for the main trial including the point prevalence of self-reported smoking at 4 weeks and pooled effect estimate for the short-term results for the STOMP and txt2stop trials. Results: The response rate at 4 weeks was 96% and at 6 months was 92%. The results at 4 weeks show a doubling of self-reported quitting relative risk (RR) 2.08 (95% CI 1.11 to 3.89), 26% vs 12%. The pooled effect estimate combining txt2stop and a previous New Zealand trial in the short term is RR 2.18 (95% CI 1.79 to 2.65). Conclusions: Mobile phone-based smoking cessation is an innovative means of delivering smoking cessation support, which doubles the self-reported quit rate in the short term. It could represent an important, but as yet largely unused, medium to deliver age-appropriate public health measures. The long-term effect of this mobile phone-based smoking cessation support will be established by a large randomised controlled trial currently in recruitment.

Tobacco control · randomised controlled trial · 128 citationsread the source →

Do u smoke after txt? Results of a randomised trial of smoking cessation using mobile phone text messaging.

Objectives: To determine the effectiveness of a mobile phone text messaging smoking cessation programme. Design: Randomised controlled trial Setting: New Zealand Participants: 1705 smokers from throughout New Zealand who wanted to quit, were aged over 15 years, and owned a mobile phone were randomised to an intervention group that received regular, personalised text messages providing smoking cessation advice, support, and distraction, or to a control group. All participants received a free month of text messaging; starting for the intervention group on their quit day to assist with quitting, and starting for the control group at six months to encourage follow up. Follow up data were available for 1624 (95%) at six weeks and 1265 (74%) at six months. Main outcome measures: The main trial outcome was current non-smoking (that is, not smoking in the past week) six weeks after randomisation. Secondary outcomes included current non-smoking at 12 and 26 weeks. Results: More participants had quit at six weeks in the intervention compared to the control group: 239 (28%) v 109 (13%), relative risk 2.20 (95% confidence interval 1.79 to 2.70), p < 0.0001. This treatment effect was consistent across subgroups defined by age, sex, income level, or geographic location (p homogeneity > 0.2). The relative risk estimates were similar in sensitivity analyses adjusting for missing data and salivary cotinine verification tests. Reported quit rates remained high at six months, but there was some uncertainty about between group differences because of incomplete follow up. Conclusions: This programme offers potential for a new way to help young smokers to quit, being affordable, personalised, age appropriate, and not location dependent. Future research should test these findings in different settings, and provide further assessment of long term quit rates.

Tobacco control · randomised controlled trial · 430 citationsread the source →

Telemedicine in postoperative follow-up of STOMa PAtients: a randomized clinical trial (the STOMPA trial).

Background: A stoma has severe impact on the patient's quality of life (QoL). Postoperative home community follow-up by teleconsultation (TC) and stoma nurses may reduce the burden of travel and improve QoL. Methods: A university hospital and five district medical centres participated. Patients with a stoma were randomized to follow-up by either TC (intervention) or hospital (control). Stoma nurses performed the clinical examination at the TC studio, aided remotely by hospital nurses and surgeons. The primary endpoint was the EQ-5D™ index score; secondary endpoints were the Stoma Quality-of-Life Scale, the OutPatient Experiences Questionnaire, and use of hospital resources. Results: A total of 110 patients were randomized to hospital (58 patients) or TC (52) follow-up; 64 patients (hospital 38, TC 26) were followed for more than 12 months and 246 consultations (hospital 151, TC 95) were performed. There were no differences in QoL: EQ-5D™ index score (P = 0·301) and EQ-5D™ visual analogue scale (VAS) score (P = 0·775); Work/Social Function (P = 0·822); Sexuality/Body Image (P = 0·253) and Stoma Function (P = 0·074). Hospital follow-up performed better for organization of care (staff collaboration, P = 0·004; met same persons, P = 0·003) and communication (surgeon understandable, P < 0·001; surgeon caring P = 0·003). TC did not increase the number of hospital consultations (P = 0·684) and reduced the number of journeys of more than 8 h (P = 0·007). Conclusion: Telemedicine follow-up by stoma nurses did not improve the QoL of patients, but decreased the readmission rate and burden of travel. Registration number NCT01600508 ( https://www.clinicaltrials.gov).

The British journal of surgery · randomised controlled trial · 53 citationsread the source →

Is short-term palliative care cost-effective in multiple sclerosis? A randomized phase II trial.

Context: Palliative care is being advocated for noncancer patients but needs evidence of effectiveness and cost-effectiveness. Objective: We evaluated the cost-effectiveness of a new palliative care service for people with multiple sclerosis (MS). Methods: We used a randomized fast-track Phase II controlled trial. Patients in South East London who were severely affected by MS were referred by clinicians to the trial. After baseline interview, patients were randomly allocated to either a multiprofessional palliative care team (PCT) immediately (fast track) or the control care group who continued best usual care for three months and then were offered the PCT. Data were collected at baseline, 6, 12, 18, and 26 weeks on use of services, patient symptoms, other outcomes, and caregiver burden. Results: Fifty-two patients were randomized: 25 fast track and 21 control patients completed the trial. There was a high level of disability, and mean Expanded Disability Status Scale score was 7.7 (median 8, standard deviation 1.0). At 12 weeks, caregiver burden was 4.47 points lower (95% confidence interval [CI]: 1.05-7.89) in the fast track compared to the control group. Mean service costs, including inpatient care and informal care, over the 0-12-week follow-up were pound1,789 lower for the fast-track group (bootstrapped 95% CI: - pound5,224 to pound1,902). There was a trend toward lower community costs in the fast-track group and no differences in costs to informal caregivers. Conclusions: The trial suggests that short-term palliative care for people severely affected by MS and their caregivers will be cost-effective and warrants further study. The fast-track trial design could be used to assess this.

Journal of pain and symptom management · randomised controlled trial · 123 citationsread the source →

Factors associated with return to work of breast cancer survivors: a systematic review.

Background: The breast cancer survival rate is the highest among all types of cancers, and survivors returning to work after completing treatment is extremely important in regards to economy and rehabilitation. The aim of this systematic review study is to identify the prevalence of breast cancer survivors who return to work (RTW) and the factors associated to RTW. Methods: A computer based literature search was carried out. "PubMed, Cochrane Library, Embase, Web of Science, and Science Direct" databases were searched systematically. Our search strategy identified a total of 12,116 papers of which 26 studies met the inclusion criteria and quality assessment. These were original papers published between January 2003 and January 2013. Results: The trends in RTW differ among countries for the breast cancer survivors. The time to RTW after successful cancer treatment also varies among the countries and by ethnicity. The prevalence of the RTW varies from 43% to 93% within one year of diagnosis. The prevalence of the RTW for the Netherland is the lowest in the world (43%). The United States survivors showed the highest RTW (93%) within 12 months of the diagnosis. Numerous barriers and facilitators were identified as factors that affect RTW. For instance, socio-demographic factors such as education and ethnicity; treatment oriented factors such as chemotherapy; work related factors such as heavy physical work; disease related factors such as poor health condition and fatigue; and psychological factors such as depression and emotional distress, act as barriers of RTW. In contrast, social, family, employer support, and financial independency emerge as key facilitators in enabling breast cancer survivors to return and continue work. Conclusion: Minimising these identified barriers and strengthening these facilitators could further improve the work condition and increase the percentage of RTW among the breast cancer survivors.

BMC public health · systematic review · 249 citationsread the source →

Tumour necrosis factor-α inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis: a systematic review and economic evaluation.

Background: Tumour necrosis factor (TNF)-α inhibitors (anti-TNFs) are typically used when the inflammatory rheumatologic diseases ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-AxSpA) have not responded adequately to conventional therapy. Current National Institute for Health and Care Excellence (NICE) guidance recommends treatment with adalimumab, etanercept and golimumab in adults with active (severe) AS only if certain criteria are fulfilled but it does not recommend infliximab for AS. Anti-TNFs for patients with nr-AxSpA have not previously been appraised by NICE. Objective: To determine the clinical effectiveness, safety and cost-effectiveness within the NHS of adalimumab, certolizumab pegol, etanercept, golimumab and infliximab, within their licensed indications, for the treatment of severe active AS or severe nr-AxSpA (but with objective signs of inflammation). Design: Systematic review and economic model. Data sources: Fifteen databases were searched for relevant studies in July 2014. Review methods: Clinical effectiveness data from randomised controlled trials (RCTs) were synthesised using Bayesian network meta-analysis methods. Results from other studies were summarised narratively. Only full economic evaluations that compared two or more options and considered both costs and consequences were included in the systematic review of cost-effectiveness studies. The differences in the approaches and assumptions used across the studies, and also those in the manufacturer's submissions, were examined in order to explain any discrepancies in the findings and to identify key areas of uncertainty. A de novo decision model was developed with a generalised framework for evidence synthesis that pooled change in disease activity (BASDAI and BASDAI 50) and simultaneously synthesised information on function (BASFI) to determine the long-term quality-adjusted life-year and cost burden of the disease in the economic model. The decision model was developed in accordance with the NICE reference case. The model has a lifetime horizon (60 years) and considers costs from the perspective of the NHS and personal social services. Health effects were expressed in terms of quality-adjusted life-years. Results: In total, 28 eligible RCTs were identified and 26 were placebo controlled (mostly up to 12 weeks); 17 extended into open-label active treatment-only phases. Most RCTs were judged to have a low risk of bias overall. In both AS and nr-AxSpA populations, anti-TNFs produced clinically important benefits to patients in terms of improving function and reducing disease activity; for AS, the relative risks for ASAS 40 ranged from 2.53 to 3.42. The efficacy estimates were consistently slightly smaller for nr-AxSpA than for AS. Statistical (and clinical) heterogeneity was more apparent in the nr-AxSpA analyses than in the AS analyses; both the reliability of the nr-AxSpA meta-analysis results and their true relevance to patients seen in clinical practice are questionable. In AS, anti-TNFs are approximately equally effective. Effectiveness appears to be maintained over time, with around 50% of patients still responding at 2 years. Evidence for an effect of anti-TNFs delaying disease progression was limited; results from ongoing long-term studies should help to clarify this issue. Sequential treatment with anti-TNFs can be worthwhile but the drug survival response rates and benefits are reduced with second and third anti-TNFs. The de novo model, which addressed many of the issues of earlier evaluations, generated incremental cost-effectiveness ratios ranging from £19,240 to £66,529 depending on anti-TNF and modelling assumptions. Conclusions: In both AS and nr-AxSpA populations anti-TNFs are clinically effective, although more so in AS than in nr-AxSpA. Anti-TNFs may be an effective use of NHS resources depending on which assumptions are considered appropriate. Future work recommendations: Randomised trials are needed to identify the nr-AxSpA population who will benefit the most from anti-TNFs. Study registration: This study is registered as PROSPERO CRD42014010182. Funding: The National Institute for Health Research Health Technology Assessment programme.

Health technology assessment (Winchester, England) · systematic review · 61 citationsread the source →

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

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

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

Circadian rhythm in the assessment of postconcussion insomnia: a cross-sectional observational study.

Background: Insomnia is a major predictor of adverse outcomes in mild traumatic brain injury (mTBI), including concussion; although insomnia symptoms may be due to various sleep disorders, those related to circadian rhythm sleep-wake disorders (CRSWDs) require specific assessment and treatment. The objective of the current study was to determine the prevalence of CRSWD in a sample of treatment-seeking people with chronic insomnia symptoms after an mTBI. Methods: Participants aged 17-65 years who had experienced an mTBI and reported chronic insomnia were recruited from diverse community clinics in Ontario 3-24 months after their injury to participate in this cross-sectional observational study. Potential participants were screened by both telephone and intake interview. Exclusion criteria were alcohol or substance use disorders, preexisting brain disorder or previous neurosurgery, recent travel across more than 2 time zones or shift work. Assessments included a clinical interview, questionnaires, 2 weeks of actigraphy and a sleep diary, and a dim-light melatonin onset test. The main outcome measure was the proportion of patients with CRSWDs. Results: Of the 50 participants (32 [64%] female; median age 39.5 yr), 13 (26% [standard deviation 12%]) had an CRSWD. The most common circadian diagnosis was delayed sleep-wake phase disorder (10 participants [20%]). Interpretation: The prevalence of CRSWDs may be exceptionally high among people with chronic insomnia symptoms following mTBI. Proper detection and treatment of CRSWDs in this population is essential to facilitate recovery. The findings emphasize the relevance of a diagnostic circadian assessment in patients with mTBI presenting with chronic insomnia symptoms.

CMAJ open · cohort or longitudinal · 12 citationsread the source →

Extended and standard duration weight-loss programme referrals for adults in primary care (WRAP): a randomised controlled trial.

Background: Evidence exist that primary care referral to an open-group behavioural programme is an effective strategy for management of obesity, but little evidence on optimal intervention duration is available. We aimed to establish whether 52-week referral to an open-group weight-management programme would achieve greater weight loss and improvements in a range of health outcomes and be more cost-effective than the current practice of 12-week referrals. Methods: In this non-blinded, parallel-group, randomised controlled trial, we recruited participants who were aged 18 years or older and had body-mass index (BMI) of 28 kg/m2 or higher from 23 primary care practices in England. Participants were randomly assigned (2:5:5) to brief advice and self-help materials, a weight-management programme (Weight Watchers) for 12 weeks, or the same weight-management programme for 52 weeks. We followed-up participants over 2 years. The primary outcome was weight at 1 year of follow-up, analysed with mixed-effects models according to intention-to-treat principles and adjusted for centre and baseline weight. In a hierarchical closed-testing procedure, we compared combined behavioural programme arms with brief intervention, then compared the 12-week programme and 52-week programme. We did a within-trial cost-effectiveness analysis using person-level data and modelled outcomes over a 25-year time horizon using microsimulation. This study is registered with Current Controlled Trials, number ISRCTN82857232. Findings: Between Oct 18, 2012, and Feb 10, 2014, we enrolled 1269 participants. 1267 eligible participants were randomly assigned to the brief intervention (n=211), the 12-week programme (n=528), and the 52-week programme (n=528). Two participants in the 12-week programme had been found to be ineligible shortly after randomisation and were excluded from the analysis. 823 (65%) of 1267 participants completed an assessment at 1 year and 856 (68%) participants at 2 years. All eligible participants were included in the analyses. At 1 year, mean weight changes in the groups were -3·26 kg (brief intervention), -4·75 kg (12-week programme), and -6·76 kg (52-week programme). Participants in the behavioural programme lost more weight than those in the brief intervention (adjusted difference -2·71 kg, 95% CI -3·86 to -1·55; p<0·0001). The 52-week programme was more effective than the 12-week programme (-2·14 kg, -3·05 to -1·22; p<0·0001). Differences between groups were still significant at 2 years. No adverse events related to the intervention were reported. Over 2 years, the incremental cost-effectiveness ratio (ICER; compared with brief intervention) was £159 per kg lost for the 52-week programme and £91 per kg for the 12-week programme. Modelled over 25 years after baseline, the ICER for the 12-week programme was dominant compared with the brief intervention. The ICER for the 52-week programme was cost-effective compared with the brief intervention (£2394 per quality-adjusted life-year [QALY]) and the 12-week programme (£3804 per QALY). Interpretation: For adults with overweight or obesity, referral to this open-group behavioural weight-loss programme for at least 12 weeks is more effective than brief advice and self-help materials. A 52-week programme produces greater weight loss and other clinical benefits than a 12-week programme and, although it costs more, modelling suggests that the 52-week programme is cost-effective in the longer term. Funding: National Prevention Research Initiative, Weight Watchers International (as part of an UK Medical Research Council Industrial Collaboration Award).

Lancet (London, England) · randomised controlled trial · 156 citationsread the source →

Metformin inhibits mitochondrial adaptations to aerobic exercise training in older adults.

Metformin and exercise independently improve insulin sensitivity and decrease the risk of diabetes. Metformin was also recently proposed as a potential therapy to slow aging. However, recent evidence indicates that adding metformin to exercise antagonizes the exercise-induced improvement in insulin sensitivity and cardiorespiratory fitness. The purpose of this study was to test the hypothesis that metformin diminishes the improvement in insulin sensitivity and cardiorespiratory fitness after aerobic exercise training (AET) by inhibiting skeletal muscle mitochondrial respiration and protein synthesis in older adults (62 ± 1 years). In a double-blinded fashion, participants were randomized to placebo (n = 26) or metformin (n = 27) treatment during 12 weeks of AET. Independent of treatment, AET decreased fat mass, HbA1c, fasting plasma insulin, 24-hr ambulant mean glucose, and glycemic variability. However, metformin attenuated the increase in whole-body insulin sensitivity and VO2 max after AET. In the metformin group, there was no overall change in whole-body insulin sensitivity after AET due to positive and negative responders. Metformin also abrogated the exercise-mediated increase in skeletal muscle mitochondrial respiration. The change in whole-body insulin sensitivity was correlated to the change in mitochondrial respiration. Mitochondrial protein synthesis rates assessed during AET were not different between treatments. The influence of metformin on AET-induced improvements in physiological function was highly variable and associated with the effect of metformin on the mitochondria. These data suggest that prior to prescribing metformin to slow aging, additional studies are needed to understand the mechanisms that elicit positive and negative responses to metformin with and without exercise.

Aging cell · randomised controlled trial · 185 citationsread the source →

Disorders of eating behavior: correlation between hypothalamo-pituitary-thyroid function and psychopathological aspects.

Altered pituitary-thyroid (PT) function (TSH, FT4, FT3 plasma levels) was correlated with symptoms of Eating Disorders (ED) in 137 patients (65 ANR, 12 ANP, 19 ANBP, 26 BN, 8 EDNOS-AN, 7 EDNOS-BN) and 30 controls. PT hormone concentrations were assessed by immunofluorimetry and psychopathology by EDI-2 and HSCL-90. Values of TSH were decreased in ANP, BN, EDNOS-AN, of T4 in ANR, ANP, AN-BP, of T3 in ANR, ANP, ANBP, BN, EDNOS-AN, EDNOS-BN. TSH values correlated negatively with ineffectiveness in BN and EDNOS-AN, and with depression in EDNOS-AN. FT4 values correlated positively with perfectionism in ANR, ANP and ANBP, with interoceptive awareness in EDNOS-AN, and negatively with depression in EDNOS-AN and with body dissatisfaction in EDNOS-BN. FT3 values correlated positively with perfectionism in ANBP and BN, with ineffectiveness in ANR and ANP, with depression in EDNOS-AN, with hostility in ANR and EDNOS-BN, with interpersonal sensibility in ANP, with somatization in EDNOS-BN, and negatively with interpersonal distrust in EDNOS-AN. Prospective studies are needed to confirm whether or not altered PT parameters correlate with ED symptoms during the course of the diseases.

Psychoneuroendocrinology · clinical trial · 12 citationsread the source →

Exercise therapy for chronic fatigue syndrome.

Background: Chronic fatigue syndrome (CFS) is characterised by persistent, medically unexplained fatigue, as well as symptoms such as musculoskeletal pain, sleep disturbance, headaches and impaired concentration and short-term memory. CFS presents as a common, debilitating and serious health problem. Treatment may include physical interventions, such as exercise therapy, which was last reviewed in 2004. Objectives: The objective of this review was to determine the effects of exercise therapy (ET) for patients with CFS as compared with any other intervention or control.• Exercise therapy versus 'passive control' (e.g. treatment as usual, waiting-list control, relaxation, flexibility).• Exercise therapy versus other active treatment (e.g. cognitive-behavioural therapy (CBT), cognitive treatment, supportive therapy, pacing, pharmacological therapy such as antidepressants).• Exercise therapy in combination with other specified treatment strategies versus other specified treatment strategies (e.g. exercise combined with pharmacological treatment vs pharmacological treatment alone). Search methods: We searched The Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register (CCDANCTR), the Cochrane Central Register of Controlled Trials (CENTRAL) and SPORTDiscus up to May 2014 using a comprehensive list of free-text terms for CFS and exercise. We located unpublished or ongoing trials through the World Health Organization (WHO) International Clinical Trials Registry Platform (to May 2014). We screened reference lists of retrieved articles and contacted experts in the field for additional studies Selection criteria: Randomised controlled trials involving adults with a primary diagnosis of CFS who were able to participate in exercise therapy. Studies had to compare exercise therapy with passive control, psychological therapies, adaptive pacing therapy or pharmacological therapy. Data collection and analysis: Two review authors independently performed study selection, risk of bias assessments and data extraction. We combined continuous measures of outcomes using mean differences (MDs) and standardised mean differences (SMDs). We combined serious adverse reactions and drop-outs using risk ratios (RRs). We calculated an overall effect size with 95% confidence intervals (CIs) for each outcome. Main results: We have included eight randomised controlled studies and have reported data from 1518 participants in this review. Three studies diagnosed individuals with CFS using the 1994 criteria of the Centers for Disease Control and Prevention (CDC); five used the Oxford criteria. Exercise therapy lasted from 12 to 26 weeks. Seven studies used variations of aerobic exercise therapy such as walking, swimming, cycling or dancing provided at mixed levels in terms of intensity of the aerobic exercise from very low to quite rigorous, whilst one study used anaerobic exercise. Control groups consisted of passive control (eight studies; e.g. treatment as usual, relaxation, flexibility) or CBT (two studies), cognitive therapy (one study), supportive listening (one study), pacing (one study), pharmacological treatment (one study) and combination treatment (one study). Risk of bias varied across studies, but within each study, little variation was found in the risk of bias across our primary and secondary outcome measures. Investigators compared exercise therapy with 'passive' control in eight trials, which enrolled 971 participants. Seven studies consistently showed a reduction in fatigue following exercise therapy at end of treatment, even though the fatigue scales used different scoring systems: an 11-item scale with a scoring system of 0 to 11 points (MD -6.06, 95% CI -6.95 to -5.17; one study, 148 participants; low-quality evidence); the same 11-item scale with a scoring system of 0 to 33 points (MD -2.82, 95% CI -4.07 to -1.57; three studies, 540 participants; moderate-quality evidence); and a 14-item scale with a scoring system of 0 to 42 points (MD -6.80, 95% CI -10.31 to -3.28; three studies, 152 participants; moderate-quality evidence). Serious adverse reactions were rare in both groups (RR 0.99, 95% CI 0.14 to 6.97; one study, 319 participants; moderate-quality evidence), but sparse data made it impossible for review authors to draw conclusions. Study authors reported a positive effect of exercise therapy at end of treatment with respect to sleep (MD -1.49, 95% CI -2.95 to -0.02; two studies, 323 participants), physical functioning (MD 13.10, 95% CI 1.98 to 24.22; five studies, 725 participants) and self-perceived changes in overall health (RR 1.83, 95% CI 1.39 to 2.40; four studies, 489 participants). It was not possible for review authors to draw conclusions regarding the remaining outcomes. Investigators compared exercise therapy with CBT in two trials (351 participants). One trial (298 participants) reported little or no difference in fatigue at end of treatment between the two groups using an 11-item scale with a scoring system of 0 to 33 points (MD 0.20, 95% CI -1.49 to 1.89). Both studies measured differences in fatigue at follow-up, but neither found differences between the two groups using an 11-item fatigue scale with a scoring system of 0 to 33 points (MD 0.30, 95% CI -1.45 to 2.05) and a nine-item Fatigue Severity Scale with a scoring system of 1 to 7 points (MD 0.40, 95% CI -0.34 to 1.14). Serious adverse reactions were rare in both groups (RR 0.67, 95% CI 0.11 to 3.96). We observed little or no difference in physical functioning, depression, anxiety and sleep, and we were not able to draw any conclusions with regard to pain, self-perceived changes in overall health, use of health service resources and drop-out rate. With regard to other comparisons, one study (320 participants) suggested a general benefit of exercise over adaptive pacing, and another study (183 participants) a benefit of exercise over supportive listening. The available evidence was too sparse to draw conclusions about the effect of pharmaceutical interventions. Authors' conclusions: Patients with CFS may generally benefit and feel less fatigued following exercise therapy, and no evidence suggests that exercise therapy may worsen outcomes. A positive effect with respect to sleep, physical function and self-perceived general health has been observed, but no conclusions for the outcomes of pain, quality of life, anxiety, depression, drop-out rate and health service resources were possible. The effectiveness of exercise therapy seems greater than that of pacing but similar to that of CBT. Randomised trials with low risk of bias are needed to investigate the type, duration and intensity of the most beneficial exercise intervention.

The Cochrane database of systematic reviews · meta-analysis · 20 citationsread the source →

Exercise therapy for chronic fatigue syndrome.

Background: Chronic fatigue syndrome (CFS) is characterised by persistent, medically unexplained fatigue, as well as symptoms such as musculoskeletal pain, sleep disturbance, headaches and impaired concentration and short-term memory. CFS presents as a common, debilitating and serious health problem. Treatment may include physical interventions, such as exercise therapy, which was last reviewed in 2004. Objectives: The objective of this review was to determine the effects of exercise therapy (ET) for patients with CFS as compared with any other intervention or control.• Exercise therapy versus 'passive control' (e.g. treatment as usual, waiting-list control, relaxation, flexibility).• Exercise therapy versus other active treatment (e.g. cognitive-behavioural therapy (CBT), cognitive treatment, supportive therapy, pacing, pharmacological therapy such as antidepressants).• Exercise therapy in combination with other specified treatment strategies versus other specified treatment strategies (e.g. exercise combined with pharmacological treatment vs pharmacological treatment alone). Search methods: We searched The Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register (CCDANCTR), the Cochrane Central Register of Controlled Trials (CENTRAL) and SPORTDiscus up to May 2014 using a comprehensive list of free-text terms for CFS and exercise. We located unpublished or ongoing trials through the World Health Organization (WHO) International Clinical Trials Registry Platform (to May 2014). We screened reference lists of retrieved articles and contacted experts in the field for additional studies SELECTION CRITERIA: Randomised controlled trials involving adults with a primary diagnosis of CFS who were able to participate in exercise therapy. Studies had to compare exercise therapy with passive control, psychological therapies, adaptive pacing therapy or pharmacological therapy. Data collection and analysis: Two review authors independently performed study selection, risk of bias assessments and data extraction. We combined continuous measures of outcomes using mean differences (MDs) and standardised mean differences (SMDs). We combined serious adverse reactions and drop-outs using risk ratios (RRs). We calculated an overall effect size with 95% confidence intervals (CIs) for each outcome. Main results: We have included eight randomised controlled studies and have reported data from 1518 participants in this review. Three studies diagnosed individuals with CFS using the 1994 criteria of the Centers for Disease Control and Prevention (CDC); five used the Oxford criteria. Exercise therapy lasted from 12 to 26 weeks. Seven studies used variations of aerobic exercise therapy such as walking, swimming, cycling or dancing provided at mixed levels in terms of intensity of the aerobic exercise from very low to quite rigorous, whilst one study used anaerobic exercise. Control groups consisted of passive control (eight studies; e.g. treatment as usual, relaxation, flexibility) or CBT (two studies), cognitive therapy (one study), supportive listening (one study), pacing (one study), pharmacological treatment (one study) and combination treatment (one study). Risk of bias varied across studies, but within each study, little variation was found in the risk of bias across our primary and secondary outcome measures. Investigators compared exercise therapy with 'passive' control in eight trials, which enrolled 971 participants. Seven studies consistently showed a reduction in fatigue following exercise therapy at end of treatment, even though the fatigue scales used different scoring systems: an 11-item scale with a scoring system of 0 to 11 points (MD -6.06, 95% CI -6.95 to -5.17; one study, 148 participants; low-quality evidence); the same 11-item scale with a scoring system of 0 to 33 points (MD -2.82, 95% CI -4.07 to -1.57; three studies, 540 participants; moderate-quality evidence); and a 14-item scale with a scoring system of 0 to 42 points (MD -6.80, 95% CI -10.31 to -3.28; three studies, 152 participants; moderate-quality evidence). Serious adverse reactions were rare in both groups (RR 0.99, 95% CI 0.14 to 6.97; one study, 319 participants; moderate-quality evidence), but sparse data made it impossible for review authors to draw conclusions. Study authors reported a positive effect of exercise therapy at end of treatment with respect to sleep (MD -1.49, 95% CI -2.95 to -0.02; two studies, 323 participants), physical functioning (MD 13.10, 95% CI 1.98 to 24.22; five studies, 725 participants) and self-perceived changes in overall health (RR 1.83, 95% CI 1.39 to 2.40; four studies, 489 participants). It was not possible for review authors to draw conclusions regarding the remaining outcomes. Investigators compared exercise therapy with CBT in two trials (351 participants). One trial (298 participants) reported little or no difference in fatigue at end of treatment between the two groups using an 11-item scale with a scoring system of 0 to 33 points (MD 0.20, 95% CI -1.49 to 1.89). Both studies measured differences in fatigue at follow-up, but neither found differences between the two groups using an 11-item fatigue scale with a scoring system of 0 to 33 points (MD 0.30, 95% CI -1.45 to 2.05) and a nine-item Fatigue Severity Scale with a scoring system of 1 to 7 points (MD 0.40, 95% CI -0.34 to 1.14). Serious adverse reactions were rare in both groups (RR 0.67, 95% CI 0.11 to 3.96). We observed little or no difference in physical functioning, depression, anxiety and sleep, and we were not able to draw any conclusions with regard to pain, self-perceived changes in overall health, use of health service resources and drop-out rate. With regard to other comparisons, one study (320 participants) suggested a general benefit of exercise over adaptive pacing, and another study (183 participants) a benefit of exercise over supportive listening. The available evidence was too sparse to draw conclusions about the effect of pharmaceutical interventions. Authors' conclusions: Patients with CFS may generally benefit and feel less fatigued following exercise therapy, and no evidence suggests that exercise therapy may worsen outcomes. A positive effect with respect to sleep, physical function and self-perceived general health has been observed, but no conclusions for the outcomes of pain, quality of life, anxiety, depression, drop-out rate and health service resources were possible. The effectiveness of exercise therapy seems greater than that of pacing but similar to that of CBT. Randomised trials with low risk of bias are needed to investigate the type, duration and intensity of the most beneficial exercise intervention.

The Cochrane database of systematic reviews · meta-analysis · 16 citationsread the source →

Exercise therapy for chronic fatigue syndrome.

Background: Chronic fatigue syndrome (CFS) is characterised by persistent, medically unexplained fatigue, as well as symptoms such as musculoskeletal pain, sleep disturbance, headaches and impaired concentration and short-term memory. CFS presents as a common, debilitating and serious health problem. Treatment may include physical interventions, such as exercise therapy, which was last reviewed in 2004. Objectives: The objective of this review was to determine the effects of exercise therapy (ET) for patients with CFS as compared with any other intervention or control.• Exercise therapy versus 'passive control' (e.g. treatment as usual, waiting-list control, relaxation, flexibility).• Exercise therapy versus other active treatment (e.g. cognitive-behavioural therapy (CBT), cognitive treatment, supportive therapy, pacing, pharmacological therapy such as antidepressants).• Exercise therapy in combination with other specified treatment strategies versus other specified treatment strategies (e.g. exercise combined with pharmacological treatment vs pharmacological treatment alone). Search methods: We searched The Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register (CCDANCTR), the Cochrane Central Register of Controlled Trials (CENTRAL) and SPORTDiscus up to May 2014 using a comprehensive list of free-text terms for CFS and exercise. We located unpublished or ongoing trials through the World Health Organization (WHO) International Clinical Trials Registry Platform (to May 2014). We screened reference lists of retrieved articles and contacted experts in the field for additional studies Selection criteria: Randomised controlled trials involving adults with a primary diagnosis of CFS who were able to participate in exercise therapy. Studies had to compare exercise therapy with passive control, psychological therapies, adaptive pacing therapy or pharmacological therapy. Data collection and analysis: Two review authors independently performed study selection, risk of bias assessments and data extraction. We combined continuous measures of outcomes using mean differences (MDs) and standardised mean differences (SMDs). We combined serious adverse reactions and drop-outs using risk ratios (RRs). We calculated an overall effect size with 95% confidence intervals (CIs) for each outcome. Main results: We have included eight randomised controlled studies and have reported data from 1518 participants in this review. Three studies diagnosed individuals with CFS using the 1994 criteria of the Centers for Disease Control and Prevention (CDC); five used the Oxford criteria. Exercise therapy lasted from 12 to 26 weeks. Seven studies used variations of aerobic exercise therapy such as walking, swimming, cycling or dancing provided at mixed levels in terms of intensity of the aerobic exercise from very low to quite rigorous, whilst one study used anaerobic exercise. Control groups consisted of passive control (eight studies; e.g. treatment as usual, relaxation, flexibility) or CBT (two studies), cognitive therapy (one study), supportive listening (one study), pacing (one study), pharmacological treatment (one study) and combination treatment (one study). Risk of bias varied across studies, but within each study, little variation was found in the risk of bias across our primary and secondary outcome measures. Investigators compared exercise therapy with 'passive' control in eight trials, which enrolled 971 participants. Seven studies consistently showed a reduction in fatigue following exercise therapy at end of treatment, even though the fatigue scales used different scoring systems: an 11-item scale with a scoring system of 0 to 11 points (MD -6.06, 95% CI -6.95 to -5.17; one study, 148 participants; low-quality evidence); the same 11-item scale with a scoring system of 0 to 33 points (MD -2.82, 95% CI -4.07 to -1.57; three studies, 540 participants; moderate-quality evidence); and a 14-item scale with a scoring system of 0 to 42 points (MD -6.80, 95% CI -10.31 to -3.28; three studies, 152 participants; moderate-quality evidence). Serious adverse reactions were rare in both groups (RR 0.99, 95% CI 0.14 to 6.97; one study, 319 participants; moderate-quality evidence), but sparse data made it impossible for review authors to draw conclusions. Study authors reported a positive effect of exercise therapy at end of treatment with respect to sleep (MD -1.49, 95% CI -2.95 to -0.02; two studies, 323 participants), physical functioning (MD 13.10, 95% CI 1.98 to 24.22; five studies, 725 participants) and self-perceived changes in overall health (RR 1.83, 95% CI 1.39 to 2.40; four studies, 489 participants). It was not possible for review authors to draw conclusions regarding the remaining outcomes. Investigators compared exercise therapy with CBT in two trials (351 participants). One trial (298 participants) reported little or no difference in fatigue at end of treatment between the two groups using an 11-item scale with a scoring system of 0 to 33 points (MD 0.20, 95% CI -1.49 to 1.89). Both studies measured differences in fatigue at follow-up, but neither found differences between the two groups using an 11-item fatigue scale with a scoring system of 0 to 33 points (MD 0.30, 95% CI -1.45 to 2.05) and a nine-item Fatigue Severity Scale with a scoring system of 1 to 7 points (MD 0.40, 95% CI -0.34 to 1.14). Serious adverse reactions were rare in both groups (RR 0.67, 95% CI 0.11 to 3.96). We observed little or no difference in physical functioning, depression, anxiety and sleep, and we were not able to draw any conclusions with regard to pain, self-perceived changes in overall health, use of health service resources and drop-out rate. With regard to other comparisons, one study (320 participants) suggested a general benefit of exercise over adaptive pacing, and another study (183 participants) a benefit of exercise over supportive listening. The available evidence was too sparse to draw conclusions about the effect of pharmaceutical interventions. Authors' conclusions: Patients with CFS may generally benefit and feel less fatigued following exercise therapy, and no evidence suggests that exercise therapy may worsen outcomes. A positive effect with respect to sleep, physical function and self-perceived general health has been observed, but no conclusions for the outcomes of pain, quality of life, anxiety, depression, drop-out rate and health service resources were possible. The effectiveness of exercise therapy seems greater than that of pacing but similar to that of CBT. Randomised trials with low risk of bias are needed to investigate the type, duration and intensity of the most beneficial exercise intervention.

The Cochrane database of systematic reviews · meta-analysis · 10 citationsread the source →

Exercise therapy for chronic fatigue syndrome.

Background: Chronic fatigue syndrome (CFS) is characterised by persistent, medically unexplained fatigue, as well as symptoms such as musculoskeletal pain, sleep disturbance, headaches and impaired concentration and short-term memory. CFS presents as a common, debilitating and serious health problem. Treatment may include physical interventions, such as exercise therapy, which was last reviewed in 2004. Objectives: The objective of this review was to determine the effects of exercise therapy (ET) for patients with CFS as compared with any other intervention or control.• Exercise therapy versus 'passive control' (e.g. treatment as usual, waiting-list control, relaxation, flexibility).• Exercise therapy versus other active treatment (e.g. cognitive-behavioural therapy (CBT), cognitive treatment, supportive therapy, pacing, pharmacological therapy such as antidepressants).• Exercise therapy in combination with other specified treatment strategies versus other specified treatment strategies (e.g. exercise combined with pharmacological treatment vs pharmacological treatment alone). Search methods: We searched The Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register (CCDANCTR), the Cochrane Central Register of Controlled Trials (CENTRAL) and SPORTDiscus up to May 2014 using a comprehensive list of free-text terms for CFS and exercise. We located unpublished or ongoing trials through the World Health Organization (WHO) International Clinical Trials Registry Platform (to May 2014). We screened reference lists of retrieved articles and contacted experts in the field for additional studies Selection criteria: Randomised controlled trials involving adults with a primary diagnosis of CFS who were able to participate in exercise therapy. Studies had to compare exercise therapy with passive control, psychological therapies, adaptive pacing therapy or pharmacological therapy. Data collection and analysis: Two review authors independently performed study selection, risk of bias assessments and data extraction. We combined continuous measures of outcomes using mean differences (MDs) and standardised mean differences (SMDs). We combined serious adverse reactions and drop-outs using risk ratios (RRs). We calculated an overall effect size with 95% confidence intervals (CIs) for each outcome. Main results: We have included eight randomised controlled studies and have reported data from 1518 participants in this review. Three studies diagnosed individuals with CFS using the 1994 criteria of the Centers for Disease Control and Prevention (CDC); five used the Oxford criteria. Exercise therapy lasted from 12 to 26 weeks. Seven studies used variations of aerobic exercise therapy such as walking, swimming, cycling or dancing provided at mixed levels in terms of intensity of the aerobic exercise from very low to quite rigorous, whilst one study used anaerobic exercise. Control groups consisted of passive control (eight studies; e.g. treatment as usual, relaxation, flexibility) or CBT (two studies), cognitive therapy (one study), supportive listening (one study), pacing (one study), pharmacological treatment (one study) and combination treatment (one study). Risk of bias varied across studies, but within each study, little variation was found in the risk of bias across our primary and secondary outcome measures. Investigators compared exercise therapy with 'passive' control in eight trials, which enrolled 971 participants. Seven studies consistently showed a reduction in fatigue following exercise therapy at end of treatment, even though the fatigue scales used different scoring systems: an 11-item scale with a scoring system of 0 to 11 points (MD -6.06, 95% CI -6.95 to -5.17; one study, 148 participants; low-quality evidence); the same 11-item scale with a scoring system of 0 to 33 points (MD -2.82, 95% CI -4.07 to -1.57; three studies, 540 participants; moderate-quality evidence); and a 14-item scale with a scoring system of 0 to 42 points (MD -6.80, 95% CI -10.31 to -3.28; three studies, 152 participants; moderate-quality evidence). Serious adverse reactions were rare in both groups (RR 0.99, 95% CI 0.14 to 6.97; one study, 319 participants; moderate-quality evidence), but sparse data made it impossible for review authors to draw conclusions. Study authors reported a positive effect of exercise therapy at end of treatment with respect to sleep (MD -1.49, 95% CI -2.95 to -0.02; two studies, 323 participants), physical functioning (MD 13.10, 95% CI 1.98 to 24.22; five studies, 725 participants) and self-perceived changes in overall health (RR 1.83, 95% CI 1.39 to 2.40; four studies, 489 participants). It was not possible for review authors to draw conclusions regarding the remaining outcomes. Investigators compared exercise therapy with CBT in two trials (351 participants). One trial (298 participants) reported little or no difference in fatigue at end of treatment between the two groups using an 11-item scale with a scoring system of 0 to 33 points (MD 0.20, 95% CI -1.49 to 1.89). Both studies measured differences in fatigue at follow-up, but neither found differences between the two groups using an 11-item fatigue scale with a scoring system of 0 to 33 points (MD 0.30, 95% CI -1.45 to 2.05) and a nine-item Fatigue Severity Scale with a scoring system of 1 to 7 points (MD 0.40, 95% CI -0.34 to 1.14). Serious adverse reactions were rare in both groups (RR 0.67, 95% CI 0.11 to 3.96). We observed little or no difference in physical functioning, depression, anxiety and sleep, and we were not able to draw any conclusions with regard to pain, self-perceived changes in overall health, use of health service resources and drop-out rate. With regard to other comparisons, one study (320 participants) suggested a general benefit of exercise over adaptive pacing, and another study (183 participants) a benefit of exercise over supportive listening. The available evidence was too sparse to draw conclusions about the effect of pharmaceutical interventions. Authors' conclusions: Patients with CFS may generally benefit and feel less fatigued following exercise therapy, and no evidence suggests that exercise therapy may worsen outcomes. A positive effect with respect to sleep, physical function and self-perceived general health has been observed, but no conclusions for the outcomes of pain, quality of life, anxiety, depression, drop-out rate and health service resources were possible. The effectiveness of exercise therapy seems greater than that of pacing but similar to that of CBT. Randomised trials with low risk of bias are needed to investigate the type, duration and intensity of the most beneficial exercise intervention.

The Cochrane database of systematic reviews · meta-analysis · 27 citationsread the source →

The construct of generalized anxiety disorder in Alzheimer disease.

Objectives: The objectives of this study were to examine the criterion validity in Alzheimer disease (AD) of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) and the International Classification of Diseases, 10th Revision (ICD-10) criteria for generalized anxiety disorder (GAD), to clarify the symptoms associated with excessive anxiety and worry in AD, to examine the co-occurrence of GAD and depression in these patients, and to determine the neuropsychologic and functional impact of GAD in AD. Results: One hundred forty-four of a consecutive series of 552 patients with probable AD (26%) reported excessive anxiety and worry difficult to control for most of the 6 months before the psychiatric evaluation. Excessive anxiety and worry were significantly associated with restlessness, irritability, muscle tension, fears, and respiratory symptoms of anxiety. Using these symptoms as diagnostic criteria, 56 of the 552 patients (10%) met revised diagnostic criteria for GAD as compared with 15% when using DSM-IV criteria and 9% when using the ICD-10 criteria. GAD was present in 38 of the 144 patients (26%) with major depression and in 12 of the 261 patients (5%) without depression. Patients with both GAD and depression showed more severe cognitive deficits than patients with either GAD or depression only. Conclusion: The authors validated a set of diagnostic criteria for anxiety in dementia. These criteria include restlessness, irritability, muscle tension, fears, and respiratory symptoms in the context of excessive anxiety and worry. Anxiety in AD is a frequent comorbid condition of major depression.

The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry · cohort or longitudinal · 59 citationsread the source →

High-dose B vitamin supplementation and cognitive decline in Alzheimer disease: a randomized controlled trial.

Context: Blood levels of homocysteine may be increased in Alzheimer disease (AD) and hyperhomocysteinemia may contribute to disease pathophysiology by vascular and direct neurotoxic mechanisms. Even in the absence of vitamin deficiency, homocysteine levels can be reduced by administration of high-dose supplements of folic acid and vitamins B(6) and B(12). Prior studies of B vitamins to reduce homocysteine in AD have not had sufficient size or duration to assess their effect on cognitive decline. Objective: To determine the efficacy and safety of B vitamin supplementation in the treatment of AD. Design, setting, and patients: A multicenter, randomized, double-blind controlled clinical trial of high-dose folate, vitamin B(6), and vitamin B(12) supplementation in 409 (of 601 screened) individuals with mild to moderate AD (Mini-Mental State Examination scores between 14 and 26, inclusive) and normal folic acid, vitamin B(12), and homocysteine levels. The study was conducted between February 20, 2003, and December 15, 2006, at clinical research sites of the Alzheimer Disease Cooperative Study located throughout the United States. Intervention: Participants were randomly assigned to 2 groups of unequal size to increase enrollment (60% treated with high-dose supplements [5 mg/d of folate, 25 mg/d of vitamin B(6), 1 mg/d of vitamin B(12)] and 40% treated with identical placebo); duration of treatment was 18 months. Main outcome measure: Change in the cognitive subscale of the Alzheimer Disease Assessment Scale (ADAS-cog). Results: A total of 340 participants (202 in active treatment group and 138 in placebo group) completed the trial while taking study medication. Although the vitamin supplement regimen was effective in reducing homocysteine levels (mean [SD], -2.42 [3.35] in active treatment group vs -0.86 [2.59] in placebo group; P < .001), it had no beneficial effect on the primary cognitive measure, rate of change in ADAS-cog score during 18 months (0.372 points per month for placebo group vs 0.401 points per month for active treatment group, P = .52; 95% confidence interval of rate difference, -0.06 to 0.12; based on the intention-to-treat generalized estimating equations model), or on any secondary measures. A higher quantity of adverse events involving depression was observed in the group treated with vitamin supplements. Conclusion: This regimen of high-dose B vitamin supplements does not slow cognitive decline in individuals with mild to moderate AD. Trial registration: clinicaltrials.gov Identifier: NCT00056225.

JAMA · randomised controlled trial · 368 citationsread the source →

Efficacy of a cognitive–behavioral treatment for generalized anxiety disorder: Evaluation in a controlled clinical trial.

Recent advances in the understanding of worry have led to the development of treatments for generalized anxiety disorder (GAD). The present study tested a GAD treatment that targeted intolerance of uncertainty, erroneous beliefs about worry, poor problem orientation, and cognitive avoidance. Twenty-six primary GAD patients were randomly allocated to a treatment condition (n = 14) or a delayed treatment control condition (n = 12). Self-report, clinician, and significant other ratings assessed GAD and associated symptoms. The results show that the treatment led to statistically and clinically significant change at posttest and that gains were maintained at 6- and 12-month follow-ups. Furthermore, 20 of 26 participants (77%) no longer met GAD diagnostic criteria following treatment. With regard to the treatment's underlying model, the results show that intolerance of uncertainty significantly decreased over treatment and that gains were maintained at both follow-ups. Although nonspecific factors were not significant predictors of treatment outcome, their role in the treatment of GAD requires further investigation.

Journal of Consulting and Clinical Psychology · randomised controlled trial · 435 citationsread the source →

Electronic cigarettes for smoking cessation.

Background: Electronic cigarettes (ECs) are handheld electronic vaping devices which produce an aerosol formed by heating an e-liquid. People who smoke report using ECs to stop or reduce smoking, but some organisations, advocacy groups and policymakers have discouraged this, citing lack of evidence of efficacy and safety. People who smoke, healthcare providers and regulators want to know if ECs can help people quit and if they are safe to use for this purpose. This review is an update of a review first published in 2014. Objectives: To evaluate the effect and safety of using electronic cigarettes (ECs) to help people who smoke achieve long-term smoking abstinence. Search methods: We searched the Cochrane Tobacco Addiction Group's Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and PsycINFO for relevant records to January 2020, together with reference-checking and contact with study authors. Selection criteria: We included randomized controlled trials (RCTs) and randomized cross-over trials in which people who smoke were randomized to an EC or control condition. We also included uncontrolled intervention studies in which all participants received an EC intervention. To be included, studies had to report abstinence from cigarettes at six months or longer and/or data on adverse events (AEs) or other markers of safety at one week or longer. Data collection and analysis: We followed standard Cochrane methods for screening and data extraction. Our primary outcome measures were abstinence from smoking after at least six months follow-up, AEs, and serious adverse events (SAEs). Secondary outcomes included changes in carbon monoxide, blood pressure, heart rate, blood oxygen saturation, lung function, and levels of known carcinogens/toxicants. We used a fixed-effect Mantel-Haenszel model to calculate the risk ratio (RR) with a 95% confidence interval (CI) for dichotomous outcomes. For continuous outcomes, we calculated mean differences. Where appropriate, we pooled data from these studies in meta-analyses. Main results: We include 50 completed studies, representing 12,430 participants, of which 26 are RCTs. Thirty-five of the 50 included studies are new to this review update. Of the included studies, we rated four (all which contribute to our main comparisons) at low risk of bias overall, 37 at high risk overall (including the 24 non-randomized studies), and the remainder at unclear risk. There was moderate-certainty evidence, limited by imprecision, that quit rates were higher in people randomized to nicotine EC than in those randomized to nicotine replacement therapy (NRT) (risk ratio (RR) 1.69, 95% confidence interval (CI) 1.25 to 2.27; I2 = 0%; 3 studies, 1498 participants). In absolute terms, this might translate to an additional four successful quitters per 100 (95% CI 2 to 8). There was low-certainty evidence (limited by very serious imprecision) of no difference in the rate of adverse events (AEs) (RR 0.98, 95% CI 0.80 to 1.19; I2 = 0%; 2 studies, 485 participants). SAEs occurred rarely, with no evidence that their frequency differed between nicotine EC and NRT, but very serious imprecision led to low certainty in this finding (RR 1.37, 95% CI 0.77 to 2.41: I2 = n/a; 2 studies, 727 participants). There was moderate-certainty evidence, again limited by imprecision, that quit rates were higher in people randomized to nicotine EC than to non-nicotine EC (RR 1.71, 95% CI 1.00 to 2.92; I2 = 0%; 3 studies, 802 participants). In absolute terms, this might again lead to an additional four successful quitters per 100 (95% CI 0 to 12). These trials used EC with relatively low nicotine delivery. There was low-certainty evidence, limited by very serious imprecision, that there was no difference in the rate of AEs between these groups (RR 1.00, 95% CI 0.73 to 1.36; I2 = 0%; 2 studies, 346 participants). There was insufficient evidence to determine whether rates of SAEs differed between groups, due to very serious imprecision (RR 0.25, 95% CI 0.03 to 2.19; I2 = n/a; 4 studies, 494 participants). Compared to behavioural support only/no support, quit rates were higher for participants randomized to nicotine EC (RR 2.50, 95% CI 1.24 to 5.04; I2 = 0%; 4 studies, 2312 participants). In absolute terms this represents an increase of six per 100 (95% CI 1 to 14). However, this finding was very low-certainty, due to issues with imprecision and risk of bias. There was no evidence that the rate of SAEs varied, but some evidence that non-serious AEs were more common in people randomized to nicotine EC (AEs: RR 1.17, 95% CI 1.04 to 1.31; I2 = 28%; 3 studies, 516 participants; SAEs: RR 1.33, 95% CI 0.25 to 6.96; I2 = 17%; 5 studies, 842 participants). Data from non-randomized studies were consistent with RCT data. The most commonly reported AEs were throat/mouth irritation, headache, cough, and nausea, which tended to dissipate over time with continued use. Very few studies reported data on other outcomes or comparisons and hence evidence for these is limited, with confidence intervals often encompassing clinically significant harm and benefit. Authors' conclusions: There is moderate-certainty evidence that ECs with nicotine increase quit rates compared to ECs without nicotine and compared to NRT. Evidence comparing nicotine EC with usual care/no treatment also suggests benefit, but is less certain. More studies are needed to confirm the degree of effect, particularly when using modern EC products. Confidence intervals were wide for data on AEs, SAEs and other safety markers. Overall incidence of SAEs was low across all study arms. We did not detect any clear evidence of harm from nicotine EC, but longest follow-up was two years and the overall number of studies was small. The main limitation of the evidence base remains imprecision due to the small number of RCTs, often with low event rates. Further RCTs are underway. To ensure the review continues to provide up-to-date information for decision-makers, this review is now a living systematic review. We will run searches monthly from December 2020, with the review updated as relevant new evidence becomes available. Please refer to the Cochrane Database of Systematic Reviews for the review's current status.

The Cochrane database of systematic reviews · meta-analysis · 313 citationsread the source →

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

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

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

Adherence to Internet-based and face-to-face cognitive behavioural therapy for depression: a meta-analysis.

Background: Internet-based cognitive behavioural therapy (iCBT) is an effective and acceptable treatment for depression, especially when it includes guidance, but its treatment adherence has not yet been systematically studied. We conducted a meta-analysis, comparing the adherence to guided iCBT with the adherence to individual face-to-face CBT. Methods: Studies were selected from a database of trials that investigate treatment for adult depression (see www.evidencebasedpsychotherapies.org), updated to January 2013. We identified 24 studies describing 26 treatment conditions (14 face-to-face CBT, 12 guided iCBT), by means of these inclusion criteria: targeting depressed adults, no comorbid somatic disorder or substance abuse, community recruitment, published in the year 2000 or later. The main outcome measure was the percentage of completed sessions. We also coded the percentage of treatment completers (separately coding for 100% or at least 80% of treatment completed). Results: We did not find studies that compared guided iCBT and face-to-face CBT in a single trial that met our inclusion criteria. Face-to-face CBT treatments ranged from 12 to 28 sessions, guided iCBT interventions consisted of 5 to 9 sessions. Participants in face-to-face CBT completed on average 83.9% of their treatment, which did not differ significantly from participants in guided iCBT (80.8%, P  =  .59). The percentage of completers (total intervention) was significantly higher in face-to-face CBT (84.7%) than in guided iCBT (65.1%, P < .001), as was the percentage of completers of 80% or more of the intervention (face-to-face CBT: 85.2%, guided iCBT: 67.5%, P  =  .003). Non-completers of face-to-face CBT completed on average 24.5% of their treatment, while non-completers of guided iCBT completed on average 42.1% of their treatment. Conclusion: We did not find studies that compared guided iCBT and face-to-face CBT in a single trial. Adherence to guided iCBT appears to be adequate and could be equal to adherence to face-to-face CBT.

PloS one · meta-analysis · 287 citationsread the source →

Efficacy of Smartphone Applications for Smoking Cessation: A Randomized Clinical Trial.

Importance: Smoking is a leading cause of premature death globally. Smartphone applications for smoking cessation are ubiquitous and address barriers to accessing traditional treatments, yet there is limited evidence for their efficacy. Objective: To determine the efficacy of a smartphone application for smoking cessation based on acceptance and commitment therapy (ACT) vs a National Cancer Institute smoking cessation application based on US clinical practice guidelines (USCPG). Design, setting, and participants: A 2-group, stratified, double-blind, individually randomized clinical trial was conducted from May 27, 2017, to September 28, 2018, among 2415 adult cigarette smokers (n = 1214 for the ACT-based smoking cessation application group and n = 1201 for the USCPG-based smoking cessation application group) with 3-, 6-, and 12-month postrandomization follow-up. The study was prespecified in the trial protocol. Follow-up data collection started on August 26, 2017, and ended at the last randomized participant's 12-month follow-up survey on December 23, 2019. Data were analyzed from February 25 to April 3, 2020. The primary analysis was performed on a complete-case basis, with intent-to-treat missing as smoking and multiple imputation sensitivity analyses. Interventions: iCanQuit, an ACT-based smoking cessation application, which taught acceptance of smoking triggers, and the National Cancer Institute QuitGuide, a USCPG-based smoking cessation application, which taught avoidance of smoking triggers. Main outcomes and measures: The primary outcome was self-reported 30-day point prevalence abstinence (PPA) at 12 months after randomization. Secondary outcomes were 7-day PPA at 12 months after randomization, prolonged abstinence, 30-day and 7-day PPA at 3 and 6 months after randomization, missing data imputed with multiple imputation or coded as smoking, and cessation of all tobacco products (including e-cigarettes) at 12 months after randomization. Results: Participants were 2415 adult cigarette smokers (1700 women [70.4%]; 1666 White individuals [69.0%] and 868 racial/ethnic minorities [35.9%]; mean [SD] age at enrollment, 38.2 [10.9] years) from all 50 US states. The 3-month follow-up data retention rate was 86.7% (2093), the 6-month retention rate was 88.4% (2136), and the 12-month retention rate was 87.2% (2107). For the primary outcome of 30-day PPA at the 12-month follow-up, iCanQuit participants had 1.49 times higher odds of quitting smoking compared with QuitGuide participants (28.2% [293 of 1040] vs 21.1% [225 of 1067]; odds ratio [OR], 1.49; 95% CI, 1.22-1.83; P < .001). Effect sizes were very similar and statistically significant for 7-day PPA at the 12-month follow-up (OR, 1.35; 95% CI, 1.12-1.63; P = .002), prolonged abstinence at the 12-month follow-up (OR, 2.00; 95% CI, 1.45-2.76; P < .001), abstinence from all tobacco products (including e-cigarettes) at the 12-month follow-up (OR, 1.60; 95% CI, 1.28-1.99; P < .001), 30-day PPA at 3-month follow-up (OR, 2.20; 95% CI, 1.68-2.89; P < .001), 30-day PPA at 6-month follow-up (OR, 2.03; 95% CI, 1.63-2.54; P < .001), 7-day PPA at 3-month follow-up (OR, 2.04; 95% CI, 1.64-2.54; P < .001), and 7-day PPA at 6-month follow-up (OR, 1.73; 95% CI, 1.42-2.10; P < .001). Conclusions and relevance: This trial provides evidence that, compared with a USCPG-based smartphone application, an ACT-based smartphone application was more efficacious for quitting cigarette smoking and thus can be an impactful treatment option. Trial registration: ClinicalTrials.gov Identifier: NCT02724462.

JAMA internal medicine · randomised controlled trial · 159 citationsread the source →

Quality of life of Danish colorectal cancer patients with and without a stoma.

Goals of the work: As part of a psychosocial intervention study, we wanted to prospectively assess the quality of life of colorectal cancer patients who were given a stoma at the time of their initial operation for cancer or later and those whose initial stoma was removed. Materials and methods: A total of 249 colorectal cancer patients were recruited and responded to a questionnaire 3, 6, 12 and 24 months after the initial operation (26-35% had a stoma during follow-up). Main results: Although most of the differences between stoma and non-stoma patients failed to reach significance, 22 out of 27 variables indicated a poorer quality of life for those with a stoma. Patients who currently had a stoma had significantly higher levels of depression (p = 0.013), poorer social functioning (p = 0.0085) and more problems with body image (p = 0.0001), future perspectives (p = 0.0058), micturition (p = 0.018) and side effects from chemotherapy (p = 0.008), but fewer problems with constipation (p = 0.034) than non-stoma patients. Male patients with a stoma had more sexual problems than males without a stoma (p = 0.015). Among those with a current stoma, quality of life seemed poorer among those whose stoma was made during follow-up compared with those with an initial stoma. Conclusions: Trends suggested that having a stoma led to poorer scores in most aspects of quality of life and that having a stoma made some time after the initial operation was more distressing than having a stoma made during the primary cancer operation.

Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · cohort or longitudinal · 92 citationsread the source →

Circulating microRNA changes in heart failure patients treated with cardiac resynchronization therapy: responders vs. non-responders.

Aims: MicroRNAs (miRNAs) play an important role in the pathogenesis of structural alterations of the failing heart through their ability to regulate negatively the expression levels of genes that govern the process of adaptive and maladaptive cardiac remodelling. We studied whether LV reverse remodelling after CRT was associated with changes of circulating miRNAs in patients with heart failure (HF) and dyssynchrony. Methods and results: A prospective, non-randomized self-control trial was performed in 81 patients with HF eligible for CRT. At baseline, to select the HF miRNA profile, we evaluated the expression of 84 miRNAs (implicated in the pathogenesis of structural alterations of the failing heart) in three groups of patients: healthy subjects (healthy group, n = 15); patients with HF (HF group, n = 81); and patients without HF matched for age, sex, and concomitant disease with HF patients (control group, n = 60). At 12 months, the selected miRNA profile was evaluated in plasma from responder (n = 55) and non-responder HF patients (n = 26) to CRT. In the test cohort, the HF patients were characterized by lower expression of 48 miRNAs (all P < 0.04) as compared with healthy subjects. In the validation cohort, the HF patients were characterized by lower expression of 24 miRNAs (all P < 0.03) as compared with control patients. At 12 months, 55 patients (68%) were considered responders and 26 non-responders to CRT (32%). Responders showed an increase in expression of 19 miRNAs (all P < 0.03) compared with baseline expression, whereas in the non-responders we observed an increase of six miRNAs (all P < 0.05) compared with baseline expression. At follow-up, miRNAs were differentially expressed between responders and non-responders. The responders were characterized by higher expression of five miRNAs (miRNA-26b-5p, miRNA-145-5p, miRNA-92a-3p, miRNA-30e-5p, and miRNA-29a-3p; P < 0.01 for all) as compared with non-responders. Conclusions: In responders, reverse remodelling is associated with favourable changes in miRNAs that regulate cardiac fibrosis, apoptosis, and hypertrophy.

European journal of heart failure · clinical trial · 134 citationsread the source →

Emollients improve treatment results with topical corticosteroids in childhood atopic dermatitis: a randomized comparative study.

The aim of the study was to investigate whether adding emollients to the standard topical corticosteroid therapy influences the outcome of children with atopic dermatitis. Fifty-two children aged between 2 and 12 yr were divided randomly in two subgroups consisting of 26 children each. Both groups applied 0.1% methylprednisolone aceponate cream on lesional atopic skin once daily for 2 wk and were observed for another 4 wk after treatment discontinuation. Group B used additionally emollients for the whole study period. Patients were evaluated at days 0 (baseline), 7, 14 (end of therapy), 28 and 42 (follow-up). Both groups demonstrated significant improvement of disease severity according to EASI (Eczema Area and Severity Index) scale (group A: 6.8 +/- 3.59 before and 0.87 +/- 1.25 after therapy, p < 0.001; group B: 9.6 +/- 8.39 before and 1.11 +/- 2.37 after therapy, p < 0.001). Xerosis improved significantly better in group B compared to group A, both clinically (group A: 1.38 +/- 0.57 scores before and 1.5 +/- 0.58 scores after therapy, p = 0.11; group B: 1.62 +/- 0.64 scores before and 0.12 +/- 0.33 scores after therapy, p < 0.001), and by corneometry assessment (group A: 41.7 +/- 9.1 units before and 51.3 +/- 11.3 units after therapy, p < 0.001; group B: 38.9 +/- 12.9 units before and 58.2 +/- 13.5 units after therapy, p < 0.001). A trend towards faster resolving of pruritus in group B (group A: 5.44 +/- 2.6 scores before and 3.22 +/- 2.31 scores after therapy, p = 0.001; group B: 5.87 +/- 2.79 scores before and 2.24 +/- 1.59 scores after therapy, p < 0.001) was also observed. In group B, the improvement was maintained for couple of weeks after treatment discontinuation, while in group A recurrence of the disease was noted (EASI at day 42 in group A vs. group B: 5.29 +/- 5.6 vs. 1.25 +/- 1.4, p = 0.01). Similar results were also observed for xerosis (p < 0.001) and pruritus (p = 0.002). Concomitant usage of emollients significantly improves xerosis and pruritus during corticosteroid treatment of atopic dermatitis and enables to maintain clinical improvement after therapy discontinuation.

Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · randomised controlled trial · 67 citationsread the source →

Social Media Use and Health and Well-being of Lesbian, Gay, Bisexual, Transgender, and Queer Youth: Systematic Review.

Background: Lesbian, gay, bisexual, transgender, and queer (LGBTQ) individuals are at higher risk of poor mental health and well-being. Social media platforms can provide LGBTQ youths with a space that counters heteronormative environments and potentially supports mental health and well-being. Mental health includes an individual's state of psychological and emotional well-being and not merely the absence of mental disorders. Objective: We sought to identify how LGBTQ youths and adolescents use social media for connection with other LGBTQ peers and groups, identity development, and social support and how these affect mental health and well-being. Methods: PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) procedures were used to guide this review. Searches were conducted in ACM Digital Library, CINAHL, Ovid Embase, Ovid MEDLINE, and Web of Science in March 2021. This review focused on LGBTQ youths aged 10 to 24 years. Included peer-reviewed studies must comprise social media; explore peer connection, identity development, or social support; and be published from 2012 onward. In total, 2 researchers extracted data and performed quality assessments independently using the Newcastle-Ottawa Scale for quantitative articles and the Critical Appraisal Skills Programme for qualitative articles. Qualitative synthesis was performed on articles that satisfied the eligibility criteria. Results: A total of 26 studies (n=15, 58% qualitative; n=8, 31% quantitative; n=3, 12% mixed methods) met the inclusion criteria. Of the 8 quantitative studies, 6 (75%) were cross-sectional, and 2 (25%) were cohort studies. All studies ranged from moderate to high quality. Social media was a popular tool used by LGBTQ youths to connect with LGBTQ communities. In qualitative data, we found that LGBTQ youths negotiated and explored identity and obtained support from peers on social media. Instagram, Tumblr, and Twitter were commonly used to access LGBTQ content owing to ease of anonymity. Identity management was the most studied social media affordance, important to LGBTQ youths for strategic disclosure. Key strategies for managing identities included being anonymous, censoring locations or content, restricting audiences, and using multiple accounts. Quantitative studies (3/8, 38%) showed that social media was associated with reduced mental health concerns and increased well-being among LGBTQ youths. Mental health concerns arising from social media use were attributed to discrimination, victimization, and policies that did not accommodate changed identities. Conclusions: We found that social media may support the mental health and well-being of LGBTQ youths through peer connection, identity management, and social support, but findings were limited by weaknesses in the evidence. More robust and longitudinal studies are needed to determine the relationship between social media use and LGBTQ mental health, particularly among adolescents. The findings may inform interventions to promote social media health literacy and the mental health and well-being of this vulnerable group. Trial registration: PROSPERO CRD42020222535; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=222535.

Journal of medical Internet research · systematic review · 84 citationsread the source →

Breastfeeding and maternal health outcomes: a systematic review and meta-analysis.

Aim: To evaluate the effect of breastfeeding on long-term (breast carcinoma, ovarian carcinoma, osteoporosis and type 2 diabetes mellitus) and short-term (lactational amenorrhoea, postpartum depression, postpartum weight change) maternal health outcomes. Methods: A systematic literature search was conducted in PubMed, Cochrane Library and CABI databases. Outcome estimates of odds ratios or relative risks or standardised mean differences were pooled. In cases of heterogeneity, subgroup analysis and meta-regression were explored. Results: Breastfeeding >12 months was associated with reduced risk of breast and ovarian carcinoma by 26% and 37%, respectively. No conclusive evidence of an association between breastfeeding and bone mineral density was found. Breastfeeding was associated with 32% lower risk of type 2 diabetes. Exclusive breastfeeding and predominant breastfeeding were associated with longer duration of amenorrhoea. Shorter duration of breastfeeding was associated with higher risk of postpartum depression. Evidence suggesting an association of breastfeeding with postpartum weight change was lacking. Conclusion: This review supports the hypothesis that breastfeeding is protective against breast and ovarian carcinoma, and exclusive breastfeeding and predominant breastfeeding increase the duration of lactational amenorrhoea. There is evidence that breastfeeding reduces the risk of type 2 diabetes. However, an association between breastfeeding and bone mineral density or maternal depression or postpartum weight change was not evident.

Acta paediatrica (Oslo, Norway : 1992) · meta-analysis · 628 citationsread the source →

Combined prevention for substance use, depression, and anxiety in adolescence: a cluster-randomised controlled trial of a digital online intervention.

Background: Substance use, depression, and anxiety in adolescence are major public health problems requiring new scalable prevention strategies. We aimed to assess the effectiveness of a combined online universal (ie, delivered to all pupils) school-based preventive intervention targeting substance use, depression, and anxiety in adolescence. Methods: We did a multicentre, cluster-randomised controlled trial in secondary schools in Australia, with pupils in year 8 or 9 (aged 13-14 years). Participating schools were randomly assigned (1:1:1:1) to one of four intervention conditions: (1) Climate Schools-Substance Use, focusing on substance use only; (2) Climate Schools-Mental Health, focusing on depression and anxiety only; (3) Climate Schools-Combined, focusing on the prevention of substance use, depression, and anxiety; or (4) active control. The interventions were delivered in school classrooms in an online delivery format and used a mixture of peer cartoon storyboards and classroom activities that were focused on alcohol, cannabis, anxiety, and depression. The interventions were delivered for 2 years and primary outcomes were knowledge related to alcohol, cannabis, and mental health; alcohol use, including heavy episodic drinking; and depression and anxiety symptoms at 12, 24, and 30 months after baseline. This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12613000723785) and an extended follow-up is underway. Findings: Between Sept 1, 2013, and Feb 28, 2014, we recruited 88 schools (12 391 pupils), of whom 71 schools and 6386 (51·5%) pupils were analysed (17 schools dropped out and 1308 pupils declined to participate). We allocated 18 schools (1739 [27·25%] pupils; 1690 [97·2%] completed at least one follow-up) to the substance use condition, 18 schools (1594 [25·0%] pupils; 1560 [97·9%] completed at least one follow-up) to the mental health condition, 16 schools (1497 [23·4%] pupils; 1443 [96·4%] completed at least one follow-up) to the combined condition, and 19 schools (1556 [23·4%] pupils; 1513 [97·2%] completed at least one follow-up) to the control condition. Compared with controls, the combined intervention group had increased knowledge related to alcohol and cannabis at 12, 24, and 30 months (standardised mean difference [SMD] for alcohol 0·26 [95% CI 0·14 to 0·39] and for cannabis 0·17 [0·06 to 0·28] at 30 months), increased knowledge related to mental health at 24 months (0·17 [0·08 to 0·27]), reduced growth in their odds of drinking and heavy episodic drinking at 12, 24, and 30 months (odds ratio for drinking 0·25 [95% CI 0·12 to 0·51], and for heavy episodic drinking 0·15 [0·04 to 0·58] at 30 months), and reduced increases in anxiety symptoms at 12 and 30 months (SMD -0·12 [95% CI -0·22 to -0·01] at 30 months). We found no difference in symptoms or probable diagnosis of depression. The combined intervention group also showed improvement in alcohol use outcomes compared with the substance use and mental health interventions and improvements in anxiety outcomes when compared with the mental health intervention only. Interpretation: Combined online prevention of substance use, depression, and anxiety led to increased knowledge of alcohol, cannabis, and mental health, reduced increase in the odds of any drinking and heavy episodic drinking, and reduced symptoms of anxiety over a 30-month period. These findings provide the first evidence of the effectiveness of an online universal school-based preventive intervention targeting substance use, depression, and anxiety in adolescence. Funding: Australian National Health and Medical Research Council.

The Lancet. Digital health · randomised controlled trial · 62 citationsread the source →

Dietary diversity and mental health in preschoolers in rural China.

Objective: To investigate the prevalence of mental health problems among preschoolers in rural China and examine the relationship between dietary diversity and mental health. Design: A cross-sectional survey analysis was performed. Child mental health was assessed with the Strengths and Difficulties Questionnaire (SDQ). Child dietary diversity was assessed with the dietary diversity score (DDS), which was calculated based on nine food groups using a 24-h recall method. Data were analysed using unadjusted and adjusted logistic regression models. Setting: Two nationally designated poverty counties in Hunan Province of China. Participants: Preschoolers (n 1334) aged 3-5 years, preschools (n 26). Results: Of 950 preschoolers with data on both dietary diversity and mental health, 663 (70 %) were classified as having at least one kind of mental health problem. The prevalences of emotional symptoms, conduct problems, symptoms of hyperactive/inattention, peer relationship problems and poor prosocial behaviour were 39, 27, 23, 12 and 26 %, respectively. Male preschoolers showed higher risks of having mental health problems than their female counterparts on each SDQ subscale except for conduct problems. Moreover, a higher DDS was significantly associated with a lower likelihood of having symptoms of hyperactivity/inattention, peer relationship problems and prosocial behaviour problems after adjustment for confounders (preschoolers' age, gender, cognitive ability, parental migration status, primary caregiver's education and household socio-economic status). Conclusions: The prevalence of mental health problems was high among preschoolers in rural China. Improving child dietary diversity might be an important strategy to consider in the design of interventions to improve child mental health.

Public health nutrition · 15 citationsread the source →

Prevalence and associated factors of mental and substance use problems among adults in Kenya: A community-based cross-sectional study.

Data on the burden and determinants of mental and substance use problems among women in urban and rural informal settlements in Kenya is sparse, thus limiting preventive and treatment efforts in these areas. To bridge the gap, we (a) determined the prevalence of depressive, anxiety and post-traumatic stress disorder (PTSD) symptoms and alcohol and drug use problems among women compared to their spouses and (b) examined the correlates of these outcomes. Data collection for this cross-sectional survey was conducted in 2022 in Mombasa, Kwale and Nairobi counties in Kenya. A total of 1528 adults (1048 women) took part. The 9-Item Patient Health Questionnaire, 7-Item Generalized Anxiety Disorder Scale, Primary Care PTSD Screen for DSM-5, Alcohol Use Disorders Identification Test, and Drug Use Disorders Identification Test were administered alongside other measures. Logistic regression was used to examine the correlates of mental and substance use problems. Overall, the prevalence of mental and substance use problems among women and men respectively was 28% (95% CI 25, 31%) vs 22% (95% CI 18, 26%) [depressive symptoms], 12% (95% CI 10, 14%) vs 8% (95% CI 6, 11%) [general anxiety symptoms], 22% (95% CI 19, 24%) vs 21% (95% CI 17, 25%) [PTSD symptoms], 4% (95% CI 3, 5%) vs 15% (95% CI 12, 19%) [alcohol use problems], and 2% (95% CI 1, 3%) vs 12% (95% CI 9, 15%) [drug use problems]. The prevalence of depressive and anxiety symptoms was significantly higher among women compared to their male counterparts. On the other hand, both current and past-year alcohol and drug use were significantly higher in men than women. Among women, stressful life events, urban residence, food insecurity, family debt, unemployment, poor self-rated health, poor eyesight, and higher educational level were the correlates for elevated depressive, anxiety and PTSD symptoms. Conversely, sexual abuse, living in rented houses, urban residence, verbal abuse, stressful life events, and somatic complaints were the correlates for depressive, anxiety and PTSD symptoms in men. Correlates against mental health problems included social support, higher subjective wellbeing, older age (>50 years), increased vigorous exercise and higher household income (in both sexes). Correlates for current alcohol use in women included stressful life events, urban residence, being sexually active, and living in a single family. Among men, higher household income was associated with current alcohol use. Correlates against current alcohol use included being married, living in a larger household (>5), being a Muslim and having multimorbidity (in both sexes). Correlates for current drug use included unemployment and sexual abuse. Female sex was associated with reduced odds of current drug use. The prevalence of depressive, anxiety and PTSD symptoms, and alcohol use problems is high in the study setting. However, needs vary by gender and study location, highlighting the importance of targeted approaches in mental health services. Our results also highlight the need for integrating mental health services into existing primary care as well as testing and scaling multi-component mental health interventions in this population.

PLOS global public healthread the source →

Social determinants of health in relation to firearm-related homicides in the United States: A nationwide multilevel cross-sectional study.

Background: Gun violence has shortened the average life expectancy of Americans, and better knowledge about the root causes of gun violence is crucial to its prevention. While some empirical evidence exists regarding the impacts of social and economic factors on violence and firearm homicide rates, to the author's knowledge, there has yet to be a comprehensive and comparative lagged, multilevel investigation of major social determinants of health in relation to firearm homicides and mass shootings. Methods and findings: This study used negative binomial regression models and geolocated gun homicide incident data from January 1, 2015, to December 31, 2015, to explore and compare the independent associations of key state-, county-, and neighborhood-level social determinants of health-social mobility, social capital, income inequality, racial and economic segregation, and social spending-with neighborhood firearm-related homicides and mass shootings in the United States, accounting for relevant state firearm laws and a variety of state, county, and neighborhood (census tract [CT]) characteristics. Latitude and longitude coordinates on firearm-related deaths were previously collected by the Gun Violence Archive, and then linked by the British newspaper The Guardian to CTs according to 2010 Census geographies. The study population consisted of all 74,134 CTs as defined for the 2010 Census in the 48 states of the contiguous US. The final sample spanned 70,579 CTs, containing an estimated 314,247,908 individuals, or 98% of the total US population in 2015. The analyses were based on 13,060 firearm-related deaths in 2015, with 11,244 non-mass shootings taking place in 8,673 CTs and 141 mass shootings occurring in 138 CTs. For area-level social determinants, lag periods of 3 to 17 years were examined based on existing theory, empirical evidence, and data availability. County-level institutional social capital (levels of trust in institutions), social mobility, income inequality, and public welfare spending exhibited robust relationships with CT-level gun homicide rates and the total numbers of combined non-mass and mass shooting homicide incidents and non-mass shooting homicide incidents alone. A 1-standard deviation (SD) increase in institutional social capital was linked to a 19% reduction in the homicide rate (incidence rate ratio [IRR] = 0.81, 95% CI 0.73-0.91, p < 0.001) and a 17% decrease in the number of firearm homicide incidents (IRR = 0.83, 95% CI 0.73-0.95, p = 0.01). Upward social mobility was related to a 25% reduction in the gun homicide rate (IRR = 0.75, 95% CI 0.66-0.86, p < 0.001) and a 24% decrease in the number of homicide incidents (IRR = 0.76, 95% CI 0.67-0.87, p < 0.001). Meanwhile, 1-SD increases in the neighborhood percentages of residents in poverty and males living alone were associated with 26%-27% and 12% higher homicide rates, respectively. Study limitations include possible residual confounding by factors at the individual/household level, and lack of disaggregation of gun homicide data by gender and race/ethnicity. Conclusions: This study finds that the rich-poor gap, level of citizens' trust in institutions, economic opportunity, and public welfare spending are all related to firearm homicide rates in the US. Further establishing the causal nature of these associations and modifying these social determinants may help to address the growing gun violence epidemic and reverse recent life expectancy declines among Americans.

PLoS medicine · 89 citationsread the source →

Improving quit rates of web-delivered interventions for smoking cessation: full-scale randomized trial of WebQuit.org versus Smokefree.gov.

Background and aims: Millions of people world-wide use websites to help them quit smoking, but effectiveness trials have an average 34% follow-up data retention rate and an average 9% quit rate. We compared the quit rates of a website using a new behavioral approach called Acceptance and Commitment Therapy (ACT; WebQuit.org) with the current standard of the National Cancer Institute's (NCI) Smokefree.gov website. Design: A two-arm stratified double-blind individually randomized trial (n = 1319 for WebQuit; n = 1318 for Smokefree.gov) with 12-month follow-up. Setting: United States. Participants: Adults (n = 2637) who currently smoked at least five cigarettes per day were recruited from March 2014 to August 2015. At baseline, participants were mean [standard deviation (SD)] age 46.2 years (13.4), 79% women and 73% white. Interventions: WebQuit.org website (experimental) provided ACT for smoking cessation; Smokefree.gov website (comparison) followed US Clinical Practice Guidelines for smoking cessation. Measurements: The primary outcome was self-reported 30-day point prevalence abstinence at 12 months. Findings: The 12-month follow-up data retention rate was 88% (2309 of 2637). The 30-day point prevalence abstinence rates at the 12-month follow-up were 24% (278 of 1141) for WebQuit.org and 26% (305 of 1168) for Smokefree.gov [odds ratio (OR) = 0.91; 95% confidence interval (CI) = 0.76, 1.10; P = 0.334] in the a priori complete case analysis. Abstinence rates were 21% (278 of 1319) for WebQuit.org and 23% (305 of 1318) for Smokefree.gov (OR = 0.89 (0.74, 1.07; P = 0.200) when missing cases were imputed as smokers. The Bayes factor comparing the primary abstinence outcome was 0.17, indicating 'substantial' evidence of no difference between groups. Conclusions: WebQuit.org and Smokefree.gov had similar 30-day point prevalence abstinence rates at 12 months that were descriptively higher than those of prior published website-delivered interventions and telephone counselor-delivered interventions.

Addiction (Abingdon, England) · randomised controlled trial · 71 citationsread the source →

Marital separation, reconciliation, and repartnering in later life.

Objective: The growth in gray divorce raises new questions about the marital dissolution process experienced by older adults. Our goal was to assess patterns of reconciliation among couples following marital separation, treating forming a union with a new partner as a competing risk. Background: Repartnering after a gray divorce is common, particularly among men. However, the extent to which older adults reconcile with their spouses is unknown. In line with the few prior studies on marital reconciliation among younger people, we anticipated that spouses with fewer resources and more marital-specific capital would be more likely to reconcile. Method: Using the 1998-2018 Health and Retirement Study, we tracked women and men who experienced a marital separation after age 50 to evaluate their propensities to reconcile with their spouse versus form a coresidential union (i.e., cohabitation or remarriage) with a new partner relative to remaining separated. Results: Roughly 7% of women and 11% of men reconciled with their spouses, whereas 12% of women and 26% of men instead formed unions with a new partner within 10 years of marital separation. We expected that having fewer resources and greater relationship-specific investments would encourage reconciliation, but results were mixed for women and men alike. Resources did tend to be positively associated with repartnering, particularly for men. Conclusion: Our study contributes to the emerging research on repartnering after late-life divorce as well as the limited literature on marital reconciliation by underscoring the utility of examining both reconciliation and repartnering as potential outcomes following marital separation.

Journal of marriage and the familyread the source →

Insomnia disorder subtypes derived from life history and traits of affect and personality.

Background: Insomnia disorder is the second most prevalent mental disorder, and it is a primary risk factor for depression. Inconsistent clinical and biomarker findings in patients with insomnia disorder suggest that heterogeneity exists and that subtypes of this disease remain unrecognised. Previous top-down proposed subtypes in nosologies have had insufficient validity. In this large-scale study, we aimed to reveal robust subtypes of insomnia disorder by use of data-driven analyses on a multidimensional set of biologically based traits. Methods: In this series of studies, we recruited participants from the Netherlands Sleep Registry, a database of volunteers aged 18 years or older, who we followed up online to survey traits, sleep, life events, and health history with 34 selected questionnaires of which participants completed at least one. We identified insomnia disorder subtypes by use of latent class analyses. We evaluated the value of our identified subtypes of insomnia disorder by use of a second, non-overlapping cohort who were recruited through a newsletter that was emailed to a new sample of Netherlands Sleep Registry participants, and by assessment of within-subject stability over several years of follow-up. We extensively tested the clinical validity of these subtypes for the development of sleep complaints, comorbidities (including depression), and response to benzodiazepines; in two subtypes of insomnia disorder, we also assessed the clinical relevance of these subtypes by use of an electroencephalogram biomarker and the effectiveness of cognitive behavioural therapy. To facilitate implementation, we subsequently constructed a concise subtype questionnaire and we validated this questionnaire in the second, non-overlapping cohort. Findings: 4322 Netherlands Sleep Registry participants completed at least one of the selected questionnaires, a demographic questionnaire, and an assessment of their Insomnia Severity Index (ISI) between March 2, 2010, and Oct 28, 2016. 2224 (51%) participants had probable insomnia disorder, defined as an ISI score of at least 10, and 2098 (49%) participants with a lower ISI score served as a control group. With a latent class analysis of the questionnaire responses of 2224 participants, we identified five novel insomnia disorder subtypes: highly distressed, moderately distressed but reward sensitive (ie, with intact responses to pleasurable emotions), moderately distressed and reward insensitive, slightly distressed with high reactivity (to their environment and life events), and slightly distressed with low reactivity. In a second, non-overlapping replication sample of 251 new participants who were assessed between June 12, 2017, and Nov 26, 2017, five subtypes were also identified to be optimal. In both the development sample and replication sample, each participant was classified as having only one subtype with high posterior probability (0·91-1·00). In 215 of the original sample of 2224 participants with insomnia who were reassessed 4·8 (SD 1·6) years later (between April 13, 2017, and June 21, 2017), the probability of maintaining their original subtype was 0·87, indicating a high stability of the classification. We found differences between the identified subtypes in developmental trajectories, response to treatment, the presence of an electroencephalogram biomarker, and the risk of depression that was up to five times different between groups, which indicated a clinical relevance of these subtypes. Interpretation: High-dimensional data-driven subtyping of people with insomnia has addressed an unmet need to reduce the heterogeneity of insomnia disorder. Subtyping facilitates identification of the underlying causes of insomnia, development of personalised treatments, and selection of patients with the highest risk of depression for inclusion in trials regarding prevention of depression. Funding: European Research Council and Netherlands Organization for Scientific Research.

The lancet. Psychiatry · 143 citationsread the source →

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

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

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

Within-Person Fluctuations in Objective Smartphone Use and Emotional Processes During Adolescence: An Intensive Longitudinal Study.

Since the advent of smartphones, peer interactions over digital platforms have become a primary mode of socializing among adolescents. Despite the rapid rise in digital social activity, it remains unclear how this dramatic shift has impacted adolescent social and emotional experiences. In an intensive, longitudinal design (N = 26, n = 206 monthly observations for up to 12 months, 12-17 years), we used digital phenotyping methods to objectively measure within-person fluctuations in smartphone use (screen time, pickups, notifications) across different categories (social media, communication, entertainment, games) and examined their prospective, bidirectional associations with positive and negative mood. Bayesian hierarchical models showed that when adolescents reported better mood than usual, they subsequently spent more time on communication apps and launched social media and communication apps upon pickup less often. Meanwhile, when adolescents used entertainment apps more than usual, they subsequently reported improved mood. These preliminary findings suggest a pattern where fluctuations in mood relate to subsequent changes in smartphone use that are primarily social, whereas the fluctuations in smartphone use relating to subsequent changes in mood were primarily entertainment-related. We found little evidence that within-person fluctuations in screen time or social media use were associated with increases in negative mood, as frequently theorized. These findings highlight the importance of disentangling the distinct components of smartphone use that relate to affective processes and examining their bidirectional, prospective relationships over time, due to the possibility of differential outcomes. This work is a necessary first step in identifying targets for intervention efforts promoting resilience and wellbeing during adolescence. Supplementary information: The online version contains supplementary material available at 10.1007/s42761-024-00247-z.

Affective science · 5 citationsread the source →

Social network interventions for health behaviours and outcomes: A systematic review and meta-analysis.

Background: There has been a growing interest in understanding the effects of social networks on health-related behaviour, with a particular backdrop being the emerging prominence of complexity or systems science in public health. Social network interventions specifically use or alter the characteristics of social networks to generate, accelerate, or maintain health behaviours. We conducted a systematic review and meta-analysis to investigate health behaviour outcomes of social network interventions. Methods and findings: We searched eight databases and two trial registries from 1990 to May 28, 2019, for English-language reports of randomised controlled trials (RCTs) and before-and-after studies investigating social network interventions for health behaviours and outcomes. Trials that did not specifically use social networks or that did not include a comparator group were excluded. We screened studies and extracted data from published reports independently. The primary outcome of health behaviours or outcomes at ≤6 months was assessed by random-effects meta-analysis. Secondary outcomes included those measures at >6-12 months and >12 months. This study is registered with the International Prospective Register of Systematic Reviews, PROSPERO: CRD42015023541. We identified 26,503 reports; after exclusion, 37 studies, conducted between 1996 and 2018 from 11 countries, were eligible for analysis, with a total of 53,891 participants (mean age 32.4 years [SD 12.7]; 45.5% females). A range of study designs were included: 27 used RCT/cluster RCT designs, and 10 used other study designs. Eligible studies addressed a variety of health outcomes, in particular sexual health and substance use. Social network interventions showed a significant intervention effect compared with comparator groups for sexual health outcomes. The pooled odds ratio (OR) was 1.46 (95% confidence interval [CI] 1.01-2.11; I2 = 76%) for sexual health outcomes at ≤6 months and OR 1.51 (95% CI 1.27-1.81; I2 = 40%) for sexual health outcomes at >6-12 months. Intervention effects for drug risk outcomes at each time point were not significant. There were also significant intervention effects for some other health outcomes including alcohol misuse, well-being, change in haemoglobin A1c (HbA1c), and smoking cessation. Because of clinical and measurement heterogeneity, it was not appropriate to pool data on these other behaviours in a meta-analysis. For sexual health outcomes, prespecified subgroup analyses were significant for intervention approach (p < 0.001), mean age of participants (p = 0.002), and intervention length (p = 0.05). Overall, 22 of the 37 studies demonstrated a high risk of bias, as measured by the Cochrane Risk of Bias tool. The main study limitations identified were the inclusion of studies of variable quality; difficulty in isolating the effects of specific social network intervention components on health outcomes, as interventions included other active components; and reliance on self-reported outcomes, which have inherent recall and desirability biases. Conclusions: Our findings suggest that social network interventions can be effective in the short term (<6 months) and longer term (>6 months) for sexual health outcomes. Intervention effects for drug risk outcomes at each time point were not significant. There were also significant intervention effects for some other health outcomes including alcohol misuse, well-being, change in HbA1c, and smoking cessation.

PLoS medicine · meta-analysis · 211 citationsread the source →

Understanding HIV risks among adolescent girls and young women in informal settlements of Nairobi, Kenya: Lessons for DREAMS.

Introduction: High incidence of HIV infection among adolescent girls and young women (AGYW) has been attributed to the numerous and often layered vulnerabilities that they encounter including violence against women, unfavourable power relations that are worsened by age-disparate sexual relations, and limited access to sexual and reproductive health information and services. For AGYW living in urban informal settlements (slums), these vulnerabilities are compounded by pervasive poverty, fragmented social networks, and limited access to social services including health and education. In this paper, we assess sexual risk behaviours and their correlates among AGYW in two slum settlements in Nairobi, Kenya, prior to the implementation of interventions under the Determined Resilient Empowered AIDS-free Mentored and Safe (DREAMS) Partnership. Methods: We drew on secondary data from the Transition to Adulthood study, the most recent representative study on adolescent sexual behaviour in the two settlements. The study was nested within the Nairobi Urban Health and Demographic Surveillance System (NUHDSS). Data were collected in 2009 from 1,390 AGYW aged 12-23 years. We estimated the proportions of AGYW reporting ever tested for HIV, condom use, multiple sexual partners and age-disparate sex by socio-demographic characteristics. "High risk" sexual behaviour was defined as a composite of these four variables and age at first sex. Multivariable regression analyses were performed to identify factors associated with risk behaviours. Results: Fifty-one percent of AGYW reported that they had ever tested for HIV and received results of their last test, with the proportion rising steeply by age (from 15% to 84% among those <15 years and 20-23 years, respectively). Of 578 AGYW who were sexually active in the 12 months preceding the survey, 26% reported using a condom at last sex, 4% had more than one sexual partner, and 26% had sex with men who were at least 5 years older or younger. All girls aged below 15 years who had sex (n = 9) had not used condoms at last sex. The likelihood of engaging in "high risk" sexual risk behaviour was higher among older AGYW (19-23 years), those in marital unions, of Luo ethnicity, out of school, living alone or with a friend (versus parents), living with spouse (versus parents), and those whose friends engaged in risky/anti-social behaviours. In contrast, Muslim faith, co-residence with both parents, and belonging to an organised social group were associated with lower odds of risky sexual behaviours. Conclusion: Our study findings suggest that multifaceted approaches addressing the educational and social mediators of AGYW's vulnerability and that also reach the people with whom AGYW live and interact, are needed to reduce the rapid onset of sexual risk during the adolescent years. There is a particular need to reach the youngest adolescent girls in poor urban settings, among whom condom use and awareness of HIV status is rare.

PloS one · 60 citationsread the source →

Comparison of behavioural activation with guided self-help for treatment of depression in adults with intellectual disabilities: a randomised controlled trial.

Background: Psychological therapies are first-line interventions for depression, but existing provision is not accessible for many adults with intellectual disabilities. We investigated the clinical and cost-effectiveness of a behavioural activation intervention (BeatIt) for people with intellectual disabilities and depression. BeatIt was compared with a guided self-help intervention (StepUp). Methods: We did a multicentre, single-blind, randomised, controlled trial with follow-up at 4 months and 12 months after randomisation. Participants aged 18 years or older, with mild to moderate intellectual disabilities and clinically significant depression were recruited from health and social care services in the UK. The primary outcome was the Glasgow Depression Scale for people with a Learning Disability (GDS-LD) score at 12 months. Analyses were done on an intention-to-treat basis. This trial is registered with ISCRTN, number ISRCTN09753005. Findings: Between Aug 8, 2013, and Sept 1, 2015, 161 participants were randomly assigned (84 to BeatIt; 77 to StepUp); 141 (88%) participants completed the trial. No group differences were found in the effects of BeatIt and StepUp based on GDS-LD scores at 12 months (12·03 [SD 7·99] GDS-LD points for BeatIt vs 12·43 [SD 7·64] GDS-LD points for StepUp; mean difference 0·26 GDS-LD points [95% CI -2·18 to 2·70]; p=0·833). Within-group improvements in GDS-LD scores occurred in both groups at 12 months (BeatIt, mean change -4·2 GDS-LD points [95% CI -6·0 to -2·4], p<0·0001; StepUp, mean change -4·5 GDS-LD points [-6·2 to -2·7], p<0·0001), with large effect sizes (BeatIt, 0·590 [95% CI 0·337-0·844]; StepUp, 0·627 [0·380-0·873]). BeatIt was not cost-effective when compared with StepUp, although the economic analyses indicated substantial uncertainty. Treatment costs were only approximately 3·6-6·8% of participants' total support costs. No treatment-related or trial-related adverse events were reported. Interpretation: This study is, to our knowledge, the first large randomised controlled trial assessing individual psychological interventions for people with intellectual disabilities and mental health problems. These findings show that there is no evidence that BeatIt is more effective than StepUp; both are active and potentially effective interventions. Funding: National Institute for Health Research.

The lancet. Psychiatry · randomised controlled trial · 49 citationsread the source →

Effectiveness of Family Integrated Care in neonatal intensive care units on infant and parent outcomes: a multicentre, multinational, cluster-randomised controlled trial.

Background: Despite evidence suggesting that parent involvement was beneficial for infant and parent outcomes, the Family Integrated Care (FICare) programme was one of the first pragmatic approaches to enable parents to become primary caregivers in the neonatal intensive care unit (NICU). We aimed to analyse the effect of FICare on infant and parent outcomes, safety, and resource use. Methods: In this multicentre, cluster-randomised controlled trial, we stratified 26 tertiary NICUs from Canada, Australia, and New Zealand by country and size, and assigned them, using a computer-generated random allocation sequence, to provide FICare or standard NICU care. Eligible infants were born at 33 weeks' gestation or earlier, and had no or low-level respiratory support; parents gave written informed consent for enrolment. To be eligible, parents in the FICare group had to commit to be present for at least 6 h a day, attend educational sessions, and actively care for their infant. The primary outcome, analysed at the individual level, was infant weight gain at day 21 after enrolment. Secondary outcomes were weight gain velocity, high frequency breastfeeding (≥6 times a day) at hospital discharge, parental stress and anxiety at enrolment and day 21, NICU mortality and major neonatal morbidities, safety, and resource use (including duration of oxygen therapy and hospital stay). This trial is registered with ClinicalTrials.gov, number NCT01852695. Findings: From Oct 1, 2012, 26 sites were randomly assigned to provide FICare (n=14) or standard care (n=12). One site assigned to FICare discontinued because of poor site enrolment. Parents and infants were enrolled between April 1, 2013, and Aug 31, 2015, with 895 infants being eligible in the FICare group and 891 in the standard care group. At day 21, weight gain was greater in the FICare group than in the standard care group (mean change in Z scores -0·071 [SD 0·42] vs -0·155 [0·42]; p<0·0002). Average daily weight gain was significantly higher in infants receiving FICare than those receiving standard care (mean daily weight gain 26·7 g [SD 9·4] vs 24·8 g [9·5]; p<0·0001). The high-frequency exclusive breastmilk feeding rate at discharge was higher for infants in the FICare group (279 [70%] of 396) than those in the standard care group (394 [63%] of 624; p=0·016). At day 21, parents in the FICare group had lower mean stress scores than did parents in the standard care group (2·3 [SD 0·8] vs 2·5 [0·8]; p<0·00043), and lower mean anxiety scores (70·8 [20·1] vs 74·2 [19·9]; p=0·0045). There were no significant differences between groups in the rates of the secondary outcomes of mortality, major morbidity, duration of oxygen therapy, and duration of hospital stay. Although the safety assessment was not completed, there were no adverse events. Interpretation: FICare improved infant weight gain, decreased parent stress and anxiety, and increased high-frequency exclusive breastmilk feeding at discharge, which together suggest that FICare is an important advancement in neonatal care. Further research is required to examine if these results translate into better long-term outcomes for families. Funding: Canadian Institutes of Health Research Partnerships for Health System Improvement, and Ontario Ministry of Health and Long-Term Care.

The Lancet. Child & adolescent health · randomised controlled trial · 374 citationsread the source →