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Mediterranean-style diet for the primary and secondary prevention of cardiovascular disease.

Background: The Seven Countries study in the 1960s showed that populations in the Mediterranean region experienced lower coronary heart disease (CHD) mortality probably as a result of different dietary patterns. Later observational studies have confirmed the benefits of adherence to a Mediterranean dietary pattern on cardiovascular disease (CVD) risk factors but clinical trial evidence is more limited. Objectives: To determine the effectiveness of a Mediterranean-style diet for the primary and secondary prevention of CVD. Search methods: We searched the following electronic databases: the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 9); MEDLINE (Ovid, 1946 to 25 September 2018); Embase (Ovid, 1980 to 2018 week 39); Web of Science Core Collection (Thomson Reuters, 1900 to 26 September 2018); DARE Issue 2 of 4, 2015 (Cochrane Library); HTA Issue 4 of 4, 2016 (Cochrane Library); NHS EED Issue 2 of 4, 2015 (Cochrane Library). We searched trial registers and applied no language restrictions. Selection criteria: We selected randomised controlled trials (RCTs) in healthy adults and adults at high risk of CVD (primary prevention) and those with established CVD (secondary prevention). Both of the following key components were required to reach our definition of a Mediterranean-style diet: high monounsaturated/saturated fat ratio (use of olive oil as main cooking ingredient and/or consumption of other traditional foods high in monounsaturated fats such as tree nuts) and a high intake of plant-based foods, including fruits, vegetables and legumes. Additional components included: low to moderate red wine consumption; high consumption of whole grains and cereals; low consumption of meat and meat products and increased consumption of fish; moderate consumption of milk and dairy products. The intervention could be dietary advice, provision of relevant foods, or both. The comparison group received either no intervention, minimal intervention, usual care or another dietary intervention. Outcomes included clinical events and CVD risk factors. We included only studies with follow-up periods of three months or more defined as the intervention period plus post intervention follow-up. Data collection and analysis: Two review authors independently assessed studies for inclusion, extracted data and assessed risk of bias. We conducted four main comparisons:1. Mediterranean dietary intervention versus no intervention or minimal intervention for primary prevention;2. Mediterranean dietary intervention versus another dietary intervention for primary prevention;3. Mediterranean dietary intervention versus usual care for secondary prevention;4. Mediterranean dietary intervention versus another dietary intervention for secondary prevention. Main results: In this substantive review update, 30 RCTs (49 papers) (12,461 participants randomised) and seven ongoing trials met our inclusion criteria. The majority of trials contributed to primary prevention: comparisons 1 (nine trials) and 2 (13 trials). Secondary prevention trials were included for comparison 3 (two trials) and comparison 4 (four trials plus an additional two trials that were excluded from the main analyses due to published concerns regarding the reliability of the data).Two trials reported on adverse events where these were absent or minor (low- to moderate-quality evidence). No trials reported on costs or health-related quality of life. Primary preventionThe included studies for comparison 1 did not report on clinical endpoints (CVD mortality, total mortality or non-fatal endpoints such as myocardial infarction or stroke). The PREDIMED trial (included in comparison 2) was retracted and re-analysed following concerns regarding randomisation at two of 11 sites. Low-quality evidence shows little or no effect of the PREDIMED (7747 randomised) intervention (advice to follow a Mediterranean diet plus supplemental extra-virgin olive oil or tree nuts) compared to a low-fat diet on CVD mortality (hazard ratio (HR) 0.81, 95% confidence interval (CI) 0.50 to 1.32) or total mortality (HR 1.0, 95% CI 0.81 to 1.24) over 4.8 years. There was, however, a reduction in the number of strokes with the PREDIMED intervention (HR 0.60, 95% CI 0.45 to 0.80), a decrease from 24/1000 to 14/1000 (95% CI 11 to 19), moderate-quality evidence). For CVD risk factors for comparison 1 there was low-quality evidence for a possible small reduction in total cholesterol (-0.16 mmol/L, 95% CI -0.32 to 0.00) and moderate-quality evidence for a reduction in systolic (-2.99 mmHg (95% CI -3.45 to -2.53) and diastolic blood pressure (-2.0 mmHg, 95% CI -2.29 to -1.71), with low or very low-quality evidence of little or no effect on LDL or HDL cholesterol or triglycerides. For comparison 2 there was moderate-quality evidence of a possible small reduction in LDL cholesterol (-0.15 mmol/L, 95% CI -0.27 to -0.02) and triglycerides (-0.09 mmol/L, 95% CI -0.16 to -0.01) with moderate or low-quality evidence of little or no effect on total or HDL cholesterol or blood pressure. Secondary preventionFor secondary prevention, the Lyon Diet Heart Study (comparison 3) examined the effect of advice to follow a Mediterranean diet and supplemental canola margarine compared to usual care in 605 CHD patients over 46 months and there was low-quality evidence of a reduction in adjusted estimates for CVD mortality (HR 0.35, 95% CI 0.15 to 0.82) and total mortality (HR 0.44, 95% CI 0.21 to 0.92) with the intervention. Only one small trial (101 participants) provided unadjusted estimates for composite clinical endpoints for comparison 4 (very low-quality evidence of uncertain effect). For comparison 3 there was low-quality evidence of little or no effect of a Mediterranean-style diet on lipid levels and very low-quality evidence for blood pressure. Similarly, for comparison 4 where only two trials contributed to the analyses there was low or very low-quality evidence of little or no effect of the intervention on lipid levels or blood pressure. Authors' conclusions: Despite the relatively large number of studies included in this review, there is still some uncertainty regarding the effects of a Mediterranean-style diet on clinical endpoints and CVD risk factors for both primary and secondary prevention. The quality of evidence for the modest benefits on CVD risk factors in primary prevention is low or moderate, with a small number of studies reporting minimal harms. There is a paucity of evidence for secondary prevention. The ongoing studies may provide more certainty in the future.

The Cochrane database of systematic reviews · meta-analysis · 230 citationsread the source →

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

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

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

Pharmacological and psychotherapeutic interventions for management of obsessive-compulsive disorder in adults: a systematic review and network meta-analysis.

Background: Several interventions are available for management of obsessive-compulsive disorder in adults, but few studies have compared their relative efficacy in a single analysis. We aimed to simultaneously compare all available treatments using both direct and indirect data. Methods: In this systematic review and network meta-analysis, we searched the two controlled trials registers maintained by the Cochrane Collaboration Common Mental Disorders group for trials published up to Feb 16, 2016. We selected randomised controlled trials in which an active psychotherapeutic or pharmacological intervention had been used in adults with obsessive-compulsive disorder. We allowed all comorbidities except for schizophrenia or bipolar disorder. We excluded studies that focused exclusively on treatment-resistant patient populations defined within the same study. We extracted data from published reports. The primary outcome was symptom severity as measured by the Yale-Brown Obsessive Compulsive Scale. We report mean differences with 95% credible intervals compared with placebo. This study is registered with PROSPERO, number CRD42012002441. Findings: We identified 1480 articles in our search and included 53 articles (54 trials; 6652 participants) in the network meta-analysis. Behavioural therapy (mean difference -14·48 [95% credible interval -18·61 to -10·23]; 11 trials and 287 patients), cognitive therapy (-13·36 [-18·40 to -8·21]; six trials and 172 patients), behavioural therapy and clomipramine (-12·97 [-19·18 to -6·74]; one trial and 31 patients), cognitive behavioural therapy and fluvoxamine (-7·50 [-13·89 to -1·17]; one trial and six patients), cognitive behavioural therapy (-5·37 [-9·10 to -1·63]; nine trials and 231 patients), clomipramine (-4·72 [-6·85 to -2·60]; 13 trials and 831 patients), and all SSRIs (class effect -3·49 [95% credible interval -5·12 to -1·81]; 37 trials and 3158 patients) had greater effects than did drug placebo. Clomipramine was not better than were SSRIs (-1·23 [-3·41 to 0·94]). Psychotherapeutic interventions had a greater effect than did medications, but a serious limitation was that most psychotherapeutic trials included patients who were taking stable doses of antidepressants (12 [80%] of the 15 psychotherapy trials explicitly allowed antidepressants). Interpretation: A range of interventions is effective in the management of obsessive-compulsive disorder, but considerable uncertainty and limitations exist regarding their relative efficacy. Taking all the evidence into account, the combination of psychotherapeutic and psychopharmacological interventions is likely to be more effective than are psychotherapeutic interventions alone, at least in severe obsessive-compulsive disorder. Funding: National Institute for Health Research.

The lancet. Psychiatry · systematic review · 236 citationsread the source →

Randomized Clinical Trial of Family-Based Treatment and Cognitive-Behavioral Therapy for Adolescent Bulimia Nervosa.

Objective: There is a paucity of randomized clinical trials (RCTs) for adolescents with bulimia nervosa (BN). Prior studies suggest cognitive-behavioral therapy adapted for adolescents (CBT-A) and family-based treatment for adolescent bulimia nervosa (FBT-BN) could be effective for this patient population. The objective of this study was to compare the relative efficacy of these 2 specific therapies, FBT-BN and CBT-A. In addition, a smaller participant group was randomized to a nonspecific treatment (supportive psychotherapy [SPT]), whose data were to be used if there were no differences between FBT-BN and CBT-A at end of treatment. Method: This 2-site (Chicago and Stanford) randomized controlled trial included 130 participants (aged 12-18 years) meeting DSM-IV criteria for BN or partial BN (binge eating and purging once or more per week for 6 months). Outcomes were assessed at baseline, end of treatment, and 6 and 12 months posttreatment. Treatments involved 18 outpatient sessions over 6 months. The primary outcome was defined as abstinence from binge eating and purging for 4 weeks before assessment, using the Eating Disorder Examination. Results: Participants in FBT-BN achieved higher abstinence rates than in CBT-A at end of treatment (39% versus 20%; p = .040, number needed to treat [NNT] = 5) and at 6-month follow-up (44% versus 25%; p = .030, NNT = 5). Abstinence rates between these 2 groups did not differ statistically at 12-month follow-up (49% versus 32%; p = .130, NNT = 6). Conclusion: In this study, FBT-BN was more effective in promoting abstinence from binge eating and purging than CBT-A in adolescent BN at end of treatment and 6-month follow-up. By 12-month follow-up, there were no statistically significant differences between the 2 treatments. Clinical trial registration information: Study of Treatment for Adolescents With Bulimia Nervosa; http://clinicaltrials.gov/; NCT00879151.

Journal of the American Academy of Child and Adolescent Psychiatry · randomised controlled trial · 113 citationsread the source →

Health behaviour outcomes of a family based intervention for paediatric obesity in primary care: A randomized type II hybrid effectiveness-implementation trial.

Background: Paediatric obesity is a multifaceted public health problem. Family based behavioural interventions are the recommended approach for the prevention of excess weight gain in children and adolescents, yet few have been tested under "real-world" conditions. Objectives: To evaluate the effectiveness of a family based intervention, delivered in coordination with paediatric primary care, on child and family health outcomes. Methods: A sample of 240 families with racially and ethnically diverse (86% non-White) and predominantly low-income children (49% female) ages 6 to 12 years (M = 9.5 years) with body mass index (BMI) ≥85th percentile for age and gender were identified in paediatric primary care. Participants were randomized to either the Family Check-Up 4 Health (FCU4Health) program (N = 141) or usual care plus information (N = 99). FCU4Health, an assessment-driven individually tailored intervention designed to preempt excess weight gain by improving parenting skills was delivered for 6 months in clinic, at home and in the community. Child BMI and body fat were assessed using a bioelectrical impedance scale and caregiver-reported health behaviours (eg, diet, physical activity and family health routines) were obtained at baseline, 3, 6 and 12 months. Results: Change in child BMI and percent body fat did not differ by group assignment. Path analysis indicated significant group differences in child health behaviours at 12 months, mediated by improved family health routines at 6 months. Conclusion: The FCU4Health, delivered in coordination with paediatric primary care, significantly impacted child and family health behaviours that are associated with the development and maintenance of paediatric obesity. BMI did not significantly differ.

Pediatric obesity · randomised controlled trial · 23 citationsread the source →

Effect of creatine supplementation and resistance-exercise training on muscle insulin-like growth factor in young adults.

The purpose of this study was to compare changes in muscle insulin-like growth factor-I (IGF-I) content resulting from resistance-exercise training (RET) and creatine supplementation (CR). Male (n=24) and female (n=18) participants with minimal resistance-exercise-training experience (=1 year) who were participating in at least 30 min of structured physical activity (i.e., walking, jogging, cycling) 3-5 x/wk volunteered for the study. Participants were randomly assigned in blocks (gender) to supplement with creatine (CR: 0.25 g/kg lean-tissue mass for 7 days; 0.06 g/kg lean-tissue mass for 49 days; n=22, 12 males, 10 female) or isocaloric placebo (PL: n=20, 12 male, 8 female) and engage in a whole-body RET program for 8 wk. Eighteen participants were classified as vegetarian (lacto-ovo or vegan; CR: 5 male, 5 female; PL: 3 male, 5 female). Muscle biopsies (vastus lateralis) were taken before and after the intervention and analyzed for IGF-I using standard immunohistochemical procedures. Stained muscle cross-sections were examined microscopically and IGF-I content quantified using image-analysis software. Results showed that RET increased intramuscular IGF-I content by 67%, with greater accumulation from CR (+78%) than PL (+54%; p=.06). There were no differences in IGF-I between vegetarians and nonvegetarians. These findings indicate that creatine supplementation during resistance-exercise training increases intramuscular IGF-I concentration in healthy men and women, independent of habitual dietary routine.

International journal of sport nutrition and exercise metabolism · randomised controlled trial · 52 citationsread the source →

Twelve-Step affiliation and 3-year substance use outcomes among adolescents: social support and religious service attendance as potential mediators.

Aims: Twelve-Step affiliation among adolescents is little understood. We examined 12-Step affiliation and its association with substance use outcomes 3 years post-treatment intake among adolescents seeking chemical dependency (CD) treatment in a private, managed-care health plan. We also examined the effects of social support and religious service attendance on the relationship. Design: We analyzed data for 357 adolescents, aged 13-18, who entered treatment at four Kaiser Permanente Northern California CD programs between March 2000 and May 2002 and completed both baseline and 3-year follow-up interviews. Measures: Measures at follow-up included alcohol and drug use, 12-Step affiliation, social support and frequency of religious service attendance. Findings: At 3 years, 68 adolescents (19%) reported attending any 12-Step meetings, and 49 (14%) reported involvement in at least one of seven 12-Step activities, in the previous 6 months. Multivariate logistic regression analyses indicated that after controlling individual and treatment factors, 12-Step attendance at 1 year was marginally significant, while 12-Step attendance at 3 years was associated with both alcohol and drug abstinence at 3 years [odds ratio (OR) 2.58, P < 0.05 and OR 2.53, P < 0.05, respectively]. Similarly, 12-Step activity involvement was associated significantly with 30-day alcohol and drug abstinence. There are possible mediating effects of social support and religious service attendance on the relationship between post-treatment 12-Step affiliation and 3-year outcomes. Conclusions: The findings suggest the importance of 12-Step affiliation in maintaining long-term recovery, and help to understand the mechanism through which it works among adolescents.

Addiction (Abingdon, England) · cohort or longitudinal · 51 citationsread the source →

Safety, tolerability, and immunogenicity of a 21-valent pneumococcal conjugate vaccine, V116, in healthy adults: phase 1/2, randomised, double-blind, active comparator-controlled, multicentre, US-based trial.

Background: A pneumococcal conjugate vaccine (PCV) specifically focused on serotypes associated with adult residual disease burden is urgently needed. We aimed to assess V116, an investigational 21-valent PCV, that contains pneumococcal polysaccharides (PnPs), which account for 74-94% of invasive pneumococcal disease in adults aged 65 years or older. Methods: We did a phase 1/2, randomised, double-blind, active comparator-controlled, multicentre, non-inferiority and superiority trial. The phase 1 study was done at two clinical sites in the USA, and the phase 2 study was done in 18 clinical sites in the USA. Eligible participants were healthy adults with or without chronic medical conditions assessed as stable, aged 18-49 years in the phase 1 trial and aged 50 years or older in the phase 2 trial. Participants were excluded if they had a history of invasive pneumococcal disease or other culture-positive pneumococcal disease within the past 3 years, known hypersensitivity to a vaccine component, known or suspected impairment of immunological function, were pregnant or were breastfeeding, or had previously received any pneumococcal vaccine. Participants had to abstain from sexual activity or use protocol approved contraception. All participants were centrally randomly assigned to a vaccine group using an interactive response technology system. Participants and investigators were masked to group assignment. In phase 1, participants were randomly assigned (1:1:1) to receive a single dose of V116-1 (2 μg per pneumococcal polysaccharide [PnP] per 0·5 mL) or V116-2 (4 μg per PnP per 1·0 mL) or the 23-valent unconjugated PnP vaccine, PPSV23 (25 μg per PnP per 0·5 mL). In phase 2, participants were randomly assigned (1:1) to receive one dose of V116 (4 μg per PnP per 1·0 mL) or PPSV23 (25 μg per PnP per 0·5 mL), stratified by age. Safety analyses included all randomly assigned participants who received study vaccine; immunogenicity analyses were per protocol. For both phases, the primary safety outcome was the proportion of participants with solicited injection-site adverse events and solicited systemic adverse events up to day 5 after vaccination and the proportion of participants with vaccine-related serious adverse events to 6 months after vaccination. In phase 2, primary immunogenicity outcomes were to test non-inferiority of V116 compared with PPSV23 as measured by serotype-specific opsonophagocytic antibody geometric mean titres (OPA-GMT) ratios for the serotypes common to the two vaccines at 30 days after vaccination (using a 0·33 margin) and to test superiority of V116 compared with PPSV23 as measured by serotype-specific OPA-GMT ratios for the serotypes unique to V116 at 30 days after vaccination (using a 1·0 margin). This trial is registered with Clinicaltrials.gov, NCT04168190. Findings: Between Dec 6 and 26, 2019, 92 volunteers were screened and 90 (98%) enrolled for phase 1 (59 [66%] women; 31 [34%] men); 30 participants were assigned to each group and received study vaccine. 30 (100%) participants in the V116-1 group, 29 (97%) in the V116-2 group, and 30 (100%) participants in the PPSV23 group were included in the per-protocol immunogenicity evaluation. From Sept 23, 2020, to Jan 12, 2021, 527 volunteers were screened, and 510 (97%) participants were enrolled in the phase 2 trial. 508 participants (>99%; 254 [100%] of 254 participants randomly assigned to the V116 group and 254 [99%] of 256 randomly assigned to PPSV23 group) received study vaccine (281 [55%] women; 227 [45%] men). 252 (99%) of 254 of participants in the V116 group and 254 (99%) of 256 participants in the PPSV23 group were included in the primary immunogenicity analyses. There were no vaccine-related serious adverse events or vaccine-related deaths in either study phase. In both phases, the most common solicited injection site adverse event was injection site pain (phase 1 22 [73%] participants in V116-1 group, 23 [77%] participants in V116-2 group, and 17 [57%] participants in the PPSV23 group; phase 2 118 [46%] of 254 participants in the V116 group and 96 [38%] of 254 in the PPSV23 group]. The most common solicited systemic adverse events in phase 1 was fatigue (eight [27%] participants in the V116-1 group, eight [27%] participants in the V116-2 group, and five [17%] participants in PPSV23 group) and myalgia (eight [27%] participants in the V116-1 group, nine (30%) participants in the V116-2 group, and four (13%) participants in the PPSV23 group]. In phase 2, the most frequently reported solicited systemic adverse event was fatigue (49 [19%] participants in V116 group, and 31 [12%] participants in PPSV23 group). In both phases, most of the solicited adverse events in all vaccine groups were mild and of short duration (≤3 days). V116 met non-inferiority criteria compared with PPSV23 for the 12 shared serotypes and met superiority criteria compared to PPSV23 for the nine unique serotypes. Interpretation: V116 was well tolerated with a safety profile generally similar to PPSV23; consistent with licensed pneumococcal conjugate vaccines. Functional OPA antibodies were induced to all V116 vaccine serotypes. The vaccine was non-inferior to PPSV23 for the 12 serotypes common to both vaccines and superior to PPSV23 for the nine unique serotypes in V116. Our findings support the development of V116 for prevention of pneumococcal disease in adults. Funding: Merck Sharp & Dohme, subsidiary of Merck & Co, Rahway, NJ, USA.

The Lancet. Infectious diseases · randomised controlled trial · 73 citationsread the source →

The association between adherence to antiretroviral therapy and viral suppression under dolutegravir-based regimens: an observational cohort study from Uganda.

Introduction: Millions of people living with HIV (PLWH) take oral antiretroviral therapy (ART), which requires a lifetime of consistent medication adherence. The relationship between adherence and poor HIV outcomes is well documented. Newer ART regimens that include dolutegravir (DTG) could be more forgiving, but empirical evidence on the relationship between adherence and viral suppression under DTG is only emerging. Methods: In this observational cohort study (secondary analysis of data from a randomized trial), we used data from 313 ART clients from a large HIV clinic in Kampala, Uganda. Over the 4-year study period (January 2018-January 2022), 91% switched from non-DTG regimens to DTG regimens. We measured adherence using Medication Event Monitoring Systems-caps and extracted prescription information and viral load measures from electronic health records. We estimated unadjusted linear regressions and adjusted models that included individual and time fixed-effects. Results: Under non-DTG regimens, 96% of participants were virally suppressed (defined as viral load < 200 copies/ml) when adherence was 90% or higher in the 3 months before viral load measurement. Viral suppression was 32 percentage points lower when adherence was between 0% and 49% (95% CI -0.44, -0.20, p < 0.01), 12 percentage points lower when adherence was between 50% and 79% (95% CI -0.23, -0.02, p < 0.01), and not significantly different when adherence was between 80% and 89% (effect of 0.00, 95% CI -0.06, 0.07, p = 0.81). In contrast, for participants taking DTG, there was no statistically significant difference in viral suppression among any of the four adherence levels; more than 95% were virally suppressed at each adherence level. On average, switching to DTG increased viral suppression by 6 percentage points in our adjusted models (95% CI 0.00, 0.13, p = 0.03). Conclusions: There was no significant association between adherence levels and viral suppression among PLWH taking DTG regimens, suggesting a high degree of forgiveness for missed doses. The use of DTG should be prioritized over older regimens, particularly for those with low adherence. Clinical trial number: NCT03494777.

Journal of the International AIDS Society · cohort or longitudinal · 5 citationsread the source →

Keepin' It REAL-Mantente REAL in Mexico: a Cluster Randomized Controlled Trial of a Culturally Adapted Substance Use Prevention Curriculum for Early Adolescents.

This study assesses the efficacy of a version of the keepin' it REAL (kiREAL) substance use prevention curriculum for middle school students that was culturally adapted for Mexico, renamed Mantente REAL (MREAL), and tested in a cluster randomized controlled trial in Mexico's three largest cities. Student participants were in 7th grade in public middle schools (N = 5523, 49% female, mean age = 11.9). A representative sample of 12 schools from each city, stratified by whether they held morning or afternoon sessions, was randomized to three conditions: culturally adapted MREAL, original kiREAL translated into Spanish, or a treatment-as-usual control group. Regular classroom teachers were trained to deliver the adapted MREAL or the kiREAL manualized curricula. Students with active parental consent completed pretest and post-test questionnaires, 7-8 months apart, at the beginning and end of the 2017-2018 academic year. We assessed the MREAL intervention, relative to kiREAL and controls, with general linear models adjusted for baseline, attrition (24%), non-normal distributions, stratification by city, and school-level clustering. Among students already using the substance more often at pretest, MREAL students had relatively more desirable outcomes, compared to kiREAL and/or to controls, in recent use of alcohol, cigarettes, "hard drugs," heavy episodic drinking, and intoxication. MREAL students reported relatively less violence victimization and perpetration of bullying and relatively more use of three of the intervention's REAL drug resistance strategies (Explain, Avoid, Leave). The adapted version of kiREAL for Mexico showed numerous desired outcomes in areas deliberately targeted in the cultural adaptation. Full protocol can be accessed through Clinical Trials.gov. ID: NCT03233386, "'Keepin' It REAL in Mexico: An adaptation and multisite RCT".

Prevention science : the official journal of the Society for Prevention Research · randomised controlled trial · 15 citationsread the source →

The adult respiratory distress syndrome cognitive outcomes study: long-term neuropsychological function in survivors of acute lung injury.

Rationale: Cognitive and psychiatric morbidity is common and potentially modifiable after acute lung injury (ALI). However, practical measures of neuropsychological function for use in multicenter trials are lacking. Objectives: To determine whether a validated telephone-based neuropsychological test battery is feasible in a multicenter trial. To determine the frequency and risk factors for long-term neuropsychological impairment. Methods: As an adjunct study to the Acute Respiratory Distress Syndrome Clinical Trials Network Fluid and Catheter Treatment Trial, we assessed neuropsychological function at 2 and 12 months post-hospital discharge. Measurements and main results: Of 406 eligible survivors, we approached 261 to participate and 213 consented. We tested 122 subjects at least once, including 102 subjects at 12 months. Memory, verbal fluency, and executive function were impaired in 13% (12 of 92), 16% (15 of 96), and 49% (37 of 76) of long-term survivors. Long-term cognitive impairment was present in 41 of the 75 (55%) survivors who completed cognitive testing. Depression, post-traumatic stress disorder, or anxiety was present in 36% (37 of 102), 39% (40 of 102), and 62% (63 of 102) of long-term survivors. Enrollment in a conservative fluid-management strategy (P = 0.005) was associated with cognitive impairment and lower partial pressure of arterial oxygen during the trial was associated with cognitive (P = 0.02) and psychiatric impairment (P = 0.02). Conclusions: Neuropsychological function can be assessed by telephone in a multicenter trial. Long-term neuropsychological impairment is common in survivors of ALI. Hypoxemia is a risk factor for long-term neuropsychological impairment. Fluid management strategy is a potential risk factor for long-term cognitive impairment; however, given the select population studied and an unclear mechanism, this finding requires confirmation.

American journal of respiratory and critical care medicine · clinical trial · 434 citationsread the source →

Centrally Assisted Collaborative Telecare for Posttraumatic Stress Disorder and Depression Among Military Personnel Attending Primary Care: A Randomized Clinical Trial.

Importance: It is often difficult for members of the US military to access high-quality care for posttraumatic stress disorder (PTSD) and depression. Objective: To determine effectiveness of a centrally assisted collaborative telecare (CACT) intervention for PTSD and depression in military primary care. Design, setting, and participants: The STEPS-UP study (Stepped Enhancement of PTSD Services Using Primary Care) is a randomized trial comparing CACT with usual integrated mental health care for PTSD or depression. Patients, mostly men in their 20s, were enrolled from 18 primary care clinics at 6 military installations from February 2012 to August 2013 with 12-month follow-up completed in October 2014. Interventions: Randomization was to CACT (n = 332) or usual care (n = 334). The CACT patients received 12 months of stepped psychosocial and pharmacologic treatment with nurse telecare management of caseloads, symptoms, and treatment. Main outcomes and measures: Primary outcomes were severity scores on the PTSD Diagnostic Scale (PDS; scored 0-51) and Symptom Checklist depression items (SCL-20; scored 0-4). Secondary outcomes were somatic symptoms, pain severity, health-related function, and mental health service use. Results: Of 666 patients, 81% were male and the mean (SD) age was 31.1 (7.7) years. The CACT and usual care patients had similar baseline mean (SD) PDS PTSD (29.4 [9.4] vs 28.9 [8.9]) and SCL-20 depression (2.1 [0.6] vs 2.0 [0.7]) scores. Compared with usual care, CACT patients reported significantly greater mean (SE) 12-month decrease in PDS PTSD scores (-6.07 [0.68] vs -3.54 [0.72]) and SCL-20 depression scores -0.56 [0.05] vs -0.31 [0.05]). In the CACT group, significantly more participants had 50% improvement at 12 months compared with usual care for both PTSD (73 [25%] vs 49 [17%]; relative risk, 1.6 [95% CI, 1.1-2.4]) and depression (86 [30%] vs 59 [21%]; relative risk, 1.7 [95% CI, 1.1-2.4]), with a number needed to treat for a 50% improvement of 12.5 (95% CI, 6.9-71.9) and 11.1 (95% CI, 6.2-50.5), respectively. The CACT patients had significant improvements in somatic symptoms (difference between mean 12-month Patient Health Questionnaire 15 changes, -1.37 [95% CI, -2.26 to -0.47]) and mental health-related functioning (difference between mean 12-month Short Form-12 Mental Component Summary changes, 3.17 [95% CI, 0.91 to 5.42]), as well as increases in telephone health contacts and appropriate medication use. Conclusions and relevance: Central assistance for collaborative telecare with stepped psychosocial management modestly improved outcomes of PTSD and depression among military personnel attending primary care. Trial registration: clinicaltrials.gov Identifier: NCT01492348.

JAMA internal medicine · randomised controlled trial · 53 citationsread the source →

The regulation of emotions in adolescents: Age differences and emotion-specific patterns.

Two experiments addressed the issue of age-related differences and emotion-specific patterns in emotion regulation during adolescence. Experiment 1 examined emotion-specific patterns in the effectiveness of reappraisal and distraction strategies in 14-year-old adolescents (N = 50). Adolescents were instructed to answer spontaneously or to downregulate their responses by using either distraction or cognitive reappraisal strategies before viewing negative pictures and were asked to rate their emotional state after picture presentation. Results showed that reappraisal effectiveness was modulated by emotional content but distraction was not. Reappraisal was more effective than distraction at regulating fear or anxiety (threat-related pictures) but was similar to distraction regarding other emotions. Using the same paradigm, Experiment 2 examined in 12-year-old (N = 56), 13-year-old (N = 49) and 15-year-old adolescents (N = 54) the age-related differences a) in the effectiveness of reappraisal and distraction when implemented and b) in the everyday use of regulation strategies using the Cognitive Emotion Regulation Questionnaire. Results revealed that regulation effectiveness was equivalent for both strategies in 12-year-olds, whereas a large improvement in reappraisal effectiveness was observed in 13- and 15-year-olds. No age differences were observed in the reported use of reappraisal, but older adolescents less frequently reported using distraction and more frequently reported using the rumination strategy. Taken together, these experiments provide new findings regarding the use and the effectiveness of cognitive regulation strategies during adolescence in terms of age differences and emotion specificity.

PloS one · clinical trial · 67 citationsread the source →

Reliability and validity of the Chinese version of the Social Anxiety Scale for Adolescents.

This study evaluated the psychometric properties of the Chinese version of the Social Anxiety Scale for Adolescents (SAS-A) in a sample of 296 adolescents (49% boys) in Grades 7, 8, 9, 10, and 12 with a mean age of 15.52 years. Confirmatory factor analysis replicated the three-factor structure of the SAS-A in the Chinese sample: Fear of Negative Evaluation (FNE), Social Avoidance and Distress in New Situations (SAD-New), and Social Avoidance and Distress-General (SAD-General). Internal consistency and test-retest reliability were appropriate. The results also revealed a clear and predictable pattern of relationships between the SAS-A and the Questionnaire about Interpersonal Difficulties for Adolescents and the International Personality Item Pool. Chinese boys reported greater SAD-General than Chinese girls, and this difference increased with grade. The SAS-A scores were compared to previously collected data from the USA and Spain, revealing that Chinese adolescents scored significantly higher in social anxiety than American and Spanish adolescents.

Child psychiatry and human development · cohort or longitudinal · 41 citationsread the source →

Determinants of breastfeeding initiation and cessation among employed mothers: a prospective cohort study.

Background: The U.S. continues to have one of the lowest breastfeeding rates in the industrialized world. Studies have shown that full-time employment and early return to work decreased breastfeeding duration, but little is known about the relationship between leave policies and breastfeeding initiation and cessation. This study aimed to identify workplace-related barriers and facilitators associated with breastfeeding initiation and cessation in the first 6 months postpartum. Methods: A prospective cohort study design was utilized to recruit 817 Minnesota women aged 18 and older while hospitalized for childbirth. Selection criteria included English-speaking, employed mothers with a healthy, singleton birth. These women were followed up using telephone interviews at 6 weeks, 12 weeks, and 6 months after childbirth. The main study outcomes were breastfeeding initiation, measured during hospital enrollment, and breastfeeding cessation by 6 months postpartum. Results: Women were 30 years old; 86 % were White, and 73 % were married. Breastfeeding rates were 81 % at childbirth, 67 % at 6 weeks, 49 % at 12 weeks, and 33 % at 6 months postpartum. Logistic regression revealed the odds of breastfeeding initiation were higher for women who: held professional jobs, were primiparae, had graduate degree, did not smoke prenatally, had no breastfeeding problems, and had family or friends who breastfeed. Survival analyses showed the hazard for breastfeeding cessation by 6 months was: higher for women who returned to work at any time during the 6 months postpartum versus those who did not return, lower for professional workers, higher among single than married women, higher for every educational category compared to graduate school, and higher for those with no family or friends who breastfeed. Conclusions: While employer paid leave policy did not affect breastfeeding initiation or cessation, women who took shorter leaves were more likely to stop breastfeeding in the first 6 months postpartum. Future research should examine women's awareness of employer policies regarding paid and unpaid leave.

BMC pregnancy and childbirth · 89 citationsread the source →

Feeding Practices Among Portuguese Parents of 5- to 10-Year-Olds: Psychometric Properties of the Comprehensive Feeding Practices Questionnaire.

Background: Parents, as primary caregivers, are responsible for most decisions related to children's lifestyle. One of the key elements in children's lifestyle is parents' feeding practices and given the relevance of these practices for children's weight and health-related outcomes, it is important to have valid and reliable measures available to address them in both research and practice. In the current study, we examined the psychometric properties of the Comprehensive Feeding Practices Questionnaire (CFPQ) in a sample of Portuguese parents of children aged 5-to-10. We evaluated the questionnaire's factor structure, criterion-related validity and test-retest reliability. Methods: Primary caregivers (N = 507) of children aged 5-to-10 completed the CFPQ and the Physical Activity Parenting Practices questionnaire, and a subset of the participants (n = 125) completed the CFPQ at a second assessment point, 1 month later. Results: The 49-item 12-factor model originally proposed revealed a poor fit to the data. Following empirically and theoretically driven model modifications, we found a good fit to the data in a model comprising 40 items, organized into seven factors (Monitoring, Emotion regulation, Child control, Pressure to eat, Restriction, Healthy family environment and Promote nutrition autonomy). We combined items into new factors depicting food parenting practices that reflect contents for each of the domains of the map of food parenting practices. Criterion-related validity analyses identified that feeding and physical activity parenting practices were positively associated. Internal consistency reliability and test-retest reliability findings suggest that the CFPQ factors were relatively reliable and stable over time. Conclusion: Findings suggest that the 40-item version of the CFPQ organized into seven factors is an adequate instrument to evaluate parents' feeding practices among Portuguese parents of children aged 5-to-10. Key messages: Parents' feeding practices are important to evaluate children's health-related outcomes The Comprehensive Feeding Practices Questionnaire is a widely used measure The original 12-factor structure was not suitable for parents of children aged 5-to-10 A 7-factor model based on the content map in food parenting practices had the best fit Parents' feeding and physical activity practices seem to be implemented in tandem.

Child: care, health and development · 1 citationsread the source →

Adverse Childhood Experiences and Mental Health Conditions Among Adolescents.

Purpose: Adverse childhood experiences (ACEs) have been linked with poor physical and mental health. This study examined adult respondents' (e.g. parental) reports from the 2016-17 National Survey of Children's Health, a nationally representative study of health outcomes and social contexts of U.S. households with noninstitutionalized children. Methods: Logistic regression was used to examine associations between ACEs and reports of current depression, anxiety, conduct/behavioral problems, attention-deficit/hyperactivity disorder, and substance use disorder among youth (n = 29,617; 49% female) aged 12-17 years. Results: ACEs were associated with an increased likelihood of all current mental health diagnoses, particularly for youth exposed to four or more ACEs. Conclusion: Although data relied on cross-sectional adult reports, results provide evidence of a graded association between ACEs exposure and adolescents' mental health conditions; associations with substance use disorder were particularly marked. Early childhood, multilevel, trauma-informed interventions are needed to prevent negative youth outcomes associated with ACEs.

The Journal of adolescent health : official publication of the Society for Adolescent Medicine · 119 citationsread the source →

Financial Hardships Experienced by Cancer Survivors: A Systematic Review.

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

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

Use of the Healthy Lifestyle Coaching Chatbot App to Promote Stair-Climbing Habits Among Office Workers: Exploratory Randomized Controlled Trial

BACKGROUND: Lack of time for exercise is common among office workers given their busy lives. Because of occupational restrictions and difficulty in taking time off, it is necessary to suggest effective ways for workers to exercise regularly. Sustaining lifestyle habits that increase nonexercise activity in daily life can solve the issue of lack of exercise time. Healthy Lifestyle Coaching Chatbot is a messenger app based on the habit formation model that can be used as a tool to provide a health behavior intervention that emphasizes the importance of sustainability and involvement. OBJECTIVE: This study aimed to assess the efficacy of the Healthy Lifestyle Coaching Chatbot intervention presented via a messenger app aimed at stair-climbing habit formation for office workers. METHODS: From February 1, 2018, to April 30, 2018, a total of 106 people participated in the trial after online recruitment. Participants were randomly assigned to the intervention group (n=57) or the control group (n=49). The intervention group received cues and intrinsic and extrinsic rewards for the entire 12 weeks. However, the control group did not receive intrinsic rewards for the first 4 weeks and only received all rewards as in the intervention group from the fifth to twelfth week. The Self-Report Habit Index (SRHI) of participants was evaluated every week, and the level of physical activity was measured at the beginning and end of the trial. SPSS Statistics version 21 (IBM Corp) was used for statistical analysis. RESULTS: After 4 weeks of intervention without providing the intrinsic rewards in the control group, the change in SRHI scores was 13.54 (SD 14.99) in the intervention group and 6.42 (SD 9.42) in the control group, indicating a significant difference between the groups (P=.04). When all rewards were given to both groups, from the fifth to twelfth week, the change in SRHI scores of the intervention and control groups was comparable at 12.08 (SD 10.87) and 15.88 (SD 13.29), respectively (P=.21). However, the level of physical activity showed a significant difference between the groups after 12 weeks of intervention (P=.045). CONCLUSIONS: This study provides evidence that intrinsic rewards are important to enhance the sustainability and effectiveness of an intervention. The Healthy Lifestyle Coaching Chatbot program can be a cost-effective method for healthy habit formation. TRIAL REGISTRATION: Clinical Research Information Service KCT0004009; https://tinyurl.com/w4oo7md.

JMIR mhealth and uhealth · randomised controlled trial · 95 citationsread the source →

What is kangaroo mother care? Systematic review of the literature.

Background: Kangaroo mother care (KMC), often defined as skin-to-skin contact between a mother and her newborn, frequent or exclusive breastfeeding, and early discharge from the hospital has been effective in reducing the risk of mortality among preterm and low birth weight infants. Research studies and program implementation of KMC have used various definitions. Objectives: To describe the current definitions of KMC in various settings, analyze the presence or absence of KMC components in each definition, and present a core definition of KMC based on common components that are present in KMC literature. Methods: We conducted a systematic review and searched PubMed, Embase, Scopus, Web of Science, and the World Health Organization Regional Databases for studies with key words "kangaroo mother care", "kangaroo care" or "skin to skin care" from 1 January 1960 to 24 April 2014. Two independent reviewers screened articles and abstracted data. Findings: We screened 1035 articles and reports; 299 contained data on KMC and neonatal outcomes or qualitative information on KMC implementation. Eighty-eight of the studies (29%) did not define KMC. Two hundred and eleven studies (71%) included skin-to-skin contact (SSC) in their KMC definition, 49 (16%) included exclusive or nearly exclusive breastfeeding, 22 (7%) included early discharge criteria, and 36 (12%) included follow-up after discharge. One hundred and sixty-seven studies (56%) described the duration of SSC. Conclusions: There exists significant heterogeneity in the definition of KMC. A large number of studies did not report definitions of KMC. Skin-to-skin contact is the core component of KMC, whereas components such as breastfeeding, early discharge, and follow-up care are context specific. To implement KMC effectively development of a global standardized definition of KMC is needed.

Journal of global health · systematic review · 105 citationsread the source →

Cannabinoids for the treatment of mental disorders and symptoms of mental disorders: a systematic review and meta-analysis.

Background: Medicinal cannabinoids, including medicinal cannabis and pharmaceutical cannabinoids and their synthetic derivatives, such as tetrahydrocannabinol (THC) and cannabidiol (CBD), have been suggested to have a therapeutic role in certain mental disorders. We analysed the available evidence to ascertain the effectiveness and safety of all types of medicinal cannabinoids in treating symptoms of various mental disorders. Methods: For this systematic review and meta-analysis we searched MEDLINE, Embase, PsycINFO, the Cochrane Central Register of Controlled Clinical Trials, and the Cochrane Database of Systematic Reviews for studies published between Jan 1, 1980, and April 30, 2018. We also searched for unpublished or ongoing studies on ClinicalTrials.gov, the EU Clinical Trials Register, and the Australian and New Zealand Clinical Trials Registry. We considered all studies examining any type and formulation of a medicinal cannabinoid in adults (≥18 years) for treating depression, anxiety, attention-deficit hyperactivity disorder (ADHD), Tourette syndrome, post-traumatic stress disorder, or psychosis, either as the primary condition or secondary to other medical conditions. We placed no restrictions on language, publication status, or study type (ie, both experimental and observational study designs were included). Primary outcomes were remission from and changes in symptoms of these mental disorders. The safety of medicinal cannabinoids for these mental disorders was also examined. Evidence from randomised controlled trials was synthesised as odds ratios (ORs) for disorder remission, adverse events, and withdrawals and as standardised mean differences (SMDs) for change in symptoms, via random-effects meta-analyses. The quality of the evidence was assessed with the Cochrane risk of bias tool and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. This study is registered with PROSPERO (CRD42017059372, CRD42017059373, CRD42017059376, CRD42017064996, and CRD42018102977). Findings: 83 eligible studies (40 randomised controlled trials, n=3067) were included: 42 for depression (23 randomised controlled trials; n=2551), 31 for anxiety (17 randomised controlled trials; n=605), eight for Tourette syndrome (two randomised controlled trials; n=36), three for ADHD (one randomised controlled trial; n=30), 12 for post-traumatic stress disorder (one randomised controlled trial; n=10), and 11 for psychosis (six randomised controlled trials; n=281). Pharmaceutical THC (with or without CBD) improved anxiety symptoms among individuals with other medical conditions (primarily chronic non-cancer pain and multiple sclerosis; SMD -0·25 [95% CI -0·49 to -0·01]; seven studies; n=252), although the evidence GRADE was very low. Pharmaceutical THC (with or without CBD) worsened negative symptoms of psychosis in a single study (SMD 0·36 [95% CI 0·10 to 0·62]; n=24). Pharmaceutical THC (with or without CBD) did not significantly affect any other primary outcomes for the mental disorders examined but did increase the number of people who had adverse events (OR 1·99 [95% CI 1·20 to 3·29]; ten studies; n=1495) and withdrawals due to adverse events (2·78 [1·59 to 4·86]; 11 studies; n=1621) compared with placebo across all mental disorders examined. Few randomised controlled trials examined the role of pharmaceutical CBD or medicinal cannabis. Interpretation: There is scarce evidence to suggest that cannabinoids improve depressive disorders and symptoms, anxiety disorders, attention-deficit hyperactivity disorder, Tourette syndrome, post-traumatic stress disorder, or psychosis. There is very low quality evidence that pharmaceutical THC (with or without CBD) leads to a small improvement in symptoms of anxiety among individuals with other medical conditions. There remains insufficient evidence to provide guidance on the use of cannabinoids for treating mental disorders within a regulatory framework. Further high-quality studies directly examining the effect of cannabinoids on treating mental disorders are needed. Funding: Therapeutic Goods Administration, Australia; Commonwealth Department of Health, Australia; Australian National Health and Medical Research Council; and US National Institutes of Health.

The lancet. Psychiatry · meta-analysis · 309 citationsread the source →

Psychological therapies for women who experience intimate partner violence.

Background: Intimate partner violence (IPV) against women is prevalent and strongly associated with mental health problems. Women experiencing IPV attend health services frequently for mental health problems. The World Health Organization recommends that women who have experienced IPV and have a mental health diagnosis should receive evidence-based mental health treatments. However, it is not known if psychological therapies work for women in the context of IPV and whether they cause harm. Objectives: To assess the effectiveness of psychological therapies for women who experience IPV on the primary outcomes of depression, self-efficacy and an indicator of harm (dropouts) at six- to 12-months' follow-up, and on secondary outcomes of other mental health symptoms, anxiety, quality of life, re-exposure to IPV, safety planning and behaviours, use of healthcare and IPV services, and social support. Search methods: We searched the Cochrane Common Mental Disorders Controlled Trials Register (CCMDCTR), CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, and three other databases, to the end of October 2019. We also searched international trials registries to identify unpublished or ongoing trials and handsearched selected journals, reference lists of included trials and grey literature. Selection criteria: We included randomised controlled trials (RCTs), quasi-RCTs, cluster-RCTs and cross-over trials of psychological therapies with women aged 16 years and older who self-reported recent or lifetime experience of IPV. We included trials if women also experienced co-existing mental health diagnoses or substance abuse issues, or both. Psychological therapies included a wide range of interventions that targeted cognition, motivation and behaviour compared with usual care, no treatment, delayed or minimal interventions. We classified psychological therapies according to Cochrane Common Mental Disorders's psychological therapies list. Data collection and analysis: Two review authors extracted data and undertook 'Risk of Bias' assessment. Treatment effects were compared between experimental and comparator interventions at short-term (up to six months post-baseline), medium-term (six to under 12 months, primary outcome time point), and long-term follow-up (12 months and above). We used standardised mean difference (SMD) for continuous and odds ratio (OR) for dichotomous outcomes, and used random-effects meta-analysis, due to high heterogeneity across trials. Main results: We included 33 psychological trials involving 5517 women randomly assigned to experimental (2798 women, 51%) and comparator interventions (2719 women, 49%). Psychological therapies included 11 integrative therapies, nine humanistic therapies, six cognitive behavioural therapy, four third-wave cognitive behavioural therapies and three other psychologically-orientated interventions. There were no trials classified as psychodynamic therapies. Most trials were from high-income countries (19 in USA, three in Iran, two each in Australia and Greece, and one trial each in China, India, Kenya, Nigeria, Pakistan, Spain and UK), among women recruited from healthcare, community, shelter or refuge settings, or a combination of any or all of these. Psychological therapies were mostly delivered face-to-face (28 trials), but varied by length of treatment (two to 50 sessions) and staff delivering therapies (social workers, nurses, psychologists, community health workers, family doctors, researchers). The average sample size was 82 women (14 to 479), aged 37 years on average, and 66% were unemployed. Half of the women were married or living with a partner and just over half of the participants had experienced IPV in the last 12 months (17 trials), 6% in the past two years (two trials) and 42% during their lifetime (14 trials). Whilst 20 trials (61%) described reliable low-risk random-sampling strategies, only 12 trials (36%) described reliable procedures to conceal the allocation of participant status. While 19 trials measured women's depression, only four trials measured depression as a continuous outcome at medium-term follow-up. These showed a probable beneficial effect of psychological therapies in reducing depression (SMD -0.24, 95% CI -0.47 to -0.01; four trials, 600 women; moderate-certainty evidence). However, for self-efficacy, there may be no evidence of a difference between groups (SMD -0.12, 95% CI -0.33 to 0.09; one trial with medium-term follow-up data, 346 women; low-certainty evidence). Further, there may be no difference between the number of women who dropped out from the experimental or comparator intervention groups, an indicator of no harm (OR 1.04, 95% CI 0.75 to 1.44; five trials with medium-term follow-up data, 840 women; low-certainty evidence). Although no trials reported adverse events from psychological therapies or participation in the trial, only one trial measured harm outcomes using a validated scale. For secondary outcomes, trials measured anxiety only at short-term follow-up, showing that psychological therapies may reduce anxiety symptoms (SMD -0.96, 95% CI -1.29 to -0.63; four trials, 158 women; low-certainty evidence). However, within medium-term follow-up, low-certainty evidence revealed that there may be no evidence between groups for the outcomes safety planning (SMD 0.04, 95% CI -0.18 to 0.25; one trial, 337 women), post-traumatic stress disorder (SMD -0.24, 95% CI -0.54 to 0.06; four trials, 484 women) or re-exposure to any form of IPV (SMD 0.03, 95% CI -0.14 to 0.2; two trials, 547 women). Authors' conclusions: There is evidence that for women who experience IPV, psychological therapies probably reduce depression and may reduce anxiety. However, we are uncertain whether psychological therapies improve other outcomes (self-efficacy, post-traumatic stress disorder, re-exposure to IPV, safety planning) and there are limited data on harm. Thus, while psychological therapies probably improve emotional health, it is unclear if women's ongoing needs for safety, support and holistic healing from complex trauma are addressed by this approach. There is a need for more interventions focused on trauma approaches and more rigorous trials (with consistent outcomes at similar follow-up time points), as we were unable to synthesise much of the research.

The Cochrane database of systematic reviews · meta-analysis · 78 citationsread the source →

Exercise training for bronchiectasis.

Background: Bronchiectasis is characterised by excessive sputum production, chronic cough, and acute exacerbations and is associated with symptoms of dyspnoea and fatigue, which reduce exercise tolerance and impair quality of life. Exercise training in isolation or in conjunction with other interventions is beneficial for people with other respiratory diseases, but its effects in bronchiectasis have not been well established. Objectives: To determine effects of exercise training compared to usual care on exercise tolerance (primary outcome), quality of life (primary outcome), incidence of acute exacerbation and hospitalisation, respiratory and mental health symptoms, physical function, mortality, and adverse events in people with stable or acute exacerbation of bronchiectasis. Search methods: We identified trials from the Cochrane Airways Specialised Register, ClinicalTrials.gov, and the World Health Organization trials portal, from their inception to October 2020. We reviewed respiratory conference abstracts and reference lists of all primary studies and review articles for additional references. Selection criteria: We included randomised controlled trials in which exercise training of at least four weeks' duration (or eight sessions) was compared to usual care for people with stable bronchiectasis or experiencing an acute exacerbation. Co-interventions with exercise training including education, respiratory muscle training, and airway clearance therapy were permitted if also applied as part of usual care. Data collection and analysis: Two review authors independently screened and selected trials for inclusion, extracted outcome data, and assessed risk of bias. We contacted study authors for missing data. We calculated mean differences (MDs) using a random-effects model. We used the GRADE approach to assess the certainty of evidence. Main results: We included six studies, two of which were published as abstracts, with a total of 275 participants. Five studies were undertaken with people with clinically stable bronchiectasis, and one pilot study was undertaken post acute exacerbation. All studies included co-interventions such as instructions for airway clearance therapy and/or breathing strategies, provision of an educational booklet, and delivery of educational sessions. The duration of training ranged from six to eight weeks, with a mix of supervised and unsupervised sessions conducted in the outpatient or home setting. No studies of children were included in the review; however we identified two studies as currently ongoing. No data were available regarding physical activity levels or adverse events. For people with stable bronchiectasis, evidence suggests that exercise training compared to usual care improves functional exercise tolerance as measured by the incremental shuttle walk distance, with a mean difference (MD) between groups of 87 metres (95% confidence interval (CI) 43 to 132 metres; 4 studies, 161 participants; low-certainty evidence). Evidence also suggests that exercise training improves six-minute walk distance (6MWD) (MD between groups of 42 metres, 95% CI 22 to 62; 1 study, 76 participants; low-certainty evidence). The magnitude of these observed mean changes appears clinically relevant as they exceed minimal clinically important difference (MCID) thresholds for people with chronic lung disease. Evidence suggests that quality of life improves following exercise training according to St George's Respiratory Questionnaire (SGRQ) total score (MD -9.62 points, 95% CI -15.67 to -3.56 points; 3 studies, 160 participants; low-certainty evidence), which exceeds the MCID of 4 points for this outcome. A reduction in dyspnoea (MD 1.0 points, 95% CI 0.47 to 1.53; 1 study, 76 participants) and fatigue (MD 1.51 points, 95% CI 0.80 to 2.22 points; 1 study, 76 participants) was observed following exercise training according to these domains of the Chronic Respiratory Disease Questionnaire. However, there was no change in cough-related quality of life as measured by the Leicester Cough Questionnaire (LCQ) (MD -0.09 points, 95% CI -0.98 to 0.80 points; 2 studies, 103 participants; moderate-certainty evidence), nor in anxiety or depression. Two studies reported longer-term outcomes up to 12 months after intervention completion; however exercise training did not appear to improve exercise capacity or quality of life more than usual care. Exercise training reduced the number of acute exacerbations of bronchiectasis over 12 months in people with stable bronchiectasis (odds ratio 0.26, 95% CI 0.08 to 0.81; 1 study, 55 participants). After an acute exacerbation of bronchiectasis, data from a single study (N = 27) suggest that exercise training compared to usual care confers little to no effect on exercise capacity (MD 11 metres, 95% CI -27 to 49 metres; low-certainty evidence), SGRQ total score (MD 6.34 points, 95%CI -17.08 to 29.76 points), or LCQ score (MD -0.08 points, 95% CI -0.94 to 0.78 points; low-certainty evidence) and does not reduce the time to first exacerbation (hazard ratio 0.83, 95% CI 0.31 to 2.22). Authors' conclusions: This review provides low-certainty evidence suggesting improvement in functional exercise capacity and quality of life immediately following exercise training in people with stable bronchiectasis; however the effects of exercise training on cough-related quality of life and psychological symptoms appear to be minimal. Due to inadequate reporting of methods, small study numbers, and variation between study findings, evidence is of very low to moderate certainty. Limited evidence is available to show longer-term effects of exercise training on these outcomes.

The Cochrane database of systematic reviews · meta-analysis · 29 citationsread the source →

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

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

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

Transcutaneous electrical nerve stimulation (TENS) for fibromyalgia in adults.

Background: Fibromyalgia is characterised by persistent, widespread pain; sleep problems; and fatigue. Transcutaneous electrical nerve stimulation (TENS) is the delivery of pulsed electrical currents across the intact surface of the skin to stimulate peripheral nerves and is used extensively to manage painful conditions. TENS is inexpensive, safe, and can be self-administered. TENS reduces pain during movement in some people so it may be a useful adjunct to assist participation in exercise and activities of daily living. To date, there has been only one systematic review in 2012 which included TENS, amongst other treatments, for fibromyalgia, and the authors concluded that TENS was not effective. Objectives: To assess the analgesic efficacy and adverse events of TENS alone or added to usual care (including exercise) compared with placebo (sham) TENS; no treatment; exercise alone; or other treatment including medication, electroacupuncture, warmth therapy, or hydrotherapy for fibromyalgia in adults. Search methods: We searched the following electronic databases up to 18 January 2017: CENTRAL (CRSO); MEDLINE (Ovid); Embase (Ovid); CINAHL (EBSCO); PsycINFO (Ovid); LILACS; PEDRO; Web of Science (ISI); AMED (Ovid); and SPORTDiscus (EBSCO). We also searched three trial registries. There were no language restrictions. Selection criteria: We included randomised controlled trials (RCTs) or quasi-randomised trials of TENS treatment for pain associated with fibromyalgia in adults. We included cross-over and parallel-group trial designs. We included studies that evaluated TENS administered using non-invasive techniques at intensities that produced perceptible TENS sensations during stimulation at either the site of pain or over nerve bundles proximal (or near) to the site of pain. We included TENS administered as a sole treatment or TENS in combination with other treatments, and TENS given as a single treatment or as a course of treatments. Data collection and analysis: Two review authors independently determined study eligibility by assessing each record and reaching agreement by discussion. A third review author acted as arbiter. We did not anonymise the records of studies before assessment. Two review authors independently extracted data and assessed risk of bias of included studies before entering information into a 'Characteristics of included studies' table. Primary outcomes were participant-reported pain relief from baseline of 30% or greater or 50% or greater, and Patient Global Impression of Change (PGIC). We assessed the evidence using GRADE and added 'Summary of findings' tables. Main results: We included eight studies (seven RCTs, one quasi-RCT, 315 adults (299 women), aged 18 to 75 years): six used a parallel-group design and two used a cross-over design. Sample sizes of intervention arms were five to 43 participants. Two studies, one of which was a cross-over design, compared TENS with placebo TENS (82 participants), one study compared TENS with no treatment (43 participants), and four studies compared TENS with other treatments (medication (two studies, 74 participants), electroacupuncture (one study, 44 participants), superficial warmth (one cross-over study, 32 participants), and hydrotherapy (one study, 10 participants)). Two studies compared TENS plus exercise with exercise alone (98 participants, 49 per treatment arm). None of the studies measured participant-reported pain relief of 50% or greater or PGIC. Overall, the studies were at unclear or high risk of bias, and in particular all were at high risk of bias for sample size. Only one study (14 participants) measured the primary outcome participant-reported pain relief of 30% or greater. Thirty percent achieved 30% or greater reduction in pain with TENS and exercise compared with 13% with exercise alone. One study found 10/28 participants reported pain relief of 25% or greater with TENS compared with 10/24 participants using superficial warmth (42 °C). We judged that statistical pooling was not possible because there were insufficient data and outcomes were not homogeneous. There were no data for the primary outcomes participant-reported pain relief from baseline of 50% or greater and PGIC.There was a paucity of data for secondary outcomes. One pilot cross-over study of 43 participants found that the mean (95% confidence intervals (CI)) decrease in pain intensity on movement (100-mm visual analogue scale (VAS)) during one 30-minute treatment was 11.1 mm (95% CI 5.9 to 16.3) for TENS and 2.3 mm (95% CI 2.4 to 7.7) for placebo TENS. There were no significant differences between TENS and placebo for pain at rest. One parallel group study of 39 participants found that mean ± standard deviation (SD) pain intensity (100-mm VAS) decreased from 85 ± 20 mm at baseline to 43 ± 20 mm after one week of dual-site TENS; decreased from 85 ± 10 mm at baseline to 60 ± 10 mm after single-site TENS; and decreased from 82 ± 20 mm at baseline to 80 ± 20 mm after one week of placebo TENS. The authors of seven studies concluded that TENS relieved pain but the findings of single small studies are unlikely to be correct. One study found clinically important improvements in Fibromyalgia Impact Questionnaire (FIQ) subscales for work performance, fatigue, stiffness, anxiety, and depression for TENS with exercise compared with exercise alone. One study found no additional improvements in FIQ scores when TENS was added to the first three weeks of a 12-week supervised exercise programme. No serious adverse events were reported in any of the studies although there were reports of TENS causing minor discomfort in a total of 3 participants. The quality of evidence was very low. We downgraded the GRADE rating mostly due to a lack of data; therefore, we have little confidence in the effect estimates where available. Authors' conclusions: There was insufficient high-quality evidence to support or refute the use of TENS for fibromyalgia. We found a small number of inadequately powered studies with incomplete reporting of methodologies and treatment interventions.

The Cochrane database of systematic reviews · meta-analysis · 48 citationsread the source →

Interventions for prevention of bullying in the workplace.

Background: Bullying has been identified as one of the leading workplace stressors, with adverse consequences for the individual employee, groups of employees, and whole organisations. Employees who have been bullied have lower levels of job satisfaction, higher levels of anxiety and depression, and are more likely to leave their place of work. Organisations face increased risk of skill depletion and absenteeism, leading to loss of profit, potential legal fees, and tribunal cases. It is unclear to what extent these risks can be addressed through interventions to prevent bullying. Objectives: To explore the effectiveness of workplace interventions to prevent bullying in the workplace. Search methods: We searched: the Cochrane Work Group Trials Register (August 2014); Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library 2016, issue 1); PUBMED (1946 to January 2016); EMBASE (1980 to January 2016); PsycINFO (1967 to January 2016); Cumulative Index to Nursing and Allied Health Literature (CINAHL Plus; 1937 to January 2016); International Bibliography of the Social Sciences (IBSS; 1951 to January 2016); Applied Social Sciences Index and Abstracts (ASSIA; 1987 to January 2016); ABI Global (earliest record to January 2016); Business Source Premier (BSP; earliest record to January 2016); OpenGrey (previously known as OpenSIGLE-System for Information on Grey Literature in Europe; 1980 to December 2014); and reference lists of articles. Selection criteria: Randomised and cluster-randomised controlled trials of employee-directed interventions, controlled before and after studies, and interrupted time-series studies of interventions of any type, aimed at preventing bullying in the workplace, targeted at an individual employee, a group of employees, or an organisation. Data collection and analysis: Three authors independently screened and selected studies. We extracted data from included studies on victimisation, perpetration, and absenteeism associated with workplace bullying. We contacted study authors to gather additional data. We used the internal validity items from the Downs and Black quality assessment tool to evaluate included studies' risk of bias. Main results: Five studies met the inclusion criteria. They had altogether 4116 participants. They were underpinned by theory and measured behaviour change in relation to bullying and related absenteeism. The included studies measured the effectiveness of interventions on the number of cases of self-reported bullying either as perpetrator or victim or both. Some studies referred to bullying using common synonyms such as mobbing and incivility and antonyms such as civility. Organisational/employer level interventionsTwo studies with 2969 participants found that the Civility, Respect, and Engagement in the Workforce (CREW) intervention produced a small increase in civility that translates to a 5% increase from baseline to follow-up, measured at 6 to 12 months (mean difference (MD) 0.17; 95% CI 0.07 to 0.28).One of the two studies reported that the CREW intervention produced a small decrease in supervisor incivility victimisation (MD -0.17; 95% CI -0.33 to -0.01) but not in co-worker incivility victimisation (MD -0.08; 95% CI -0.22 to 0.08) or in self-reported incivility perpetration (MD -0.05 95% CI -0.15 to 0.05). The study did find a decrease in the number of days absent during the previous month (MD -0.63; 95% CI -0.92 to -0.34) at 6-month follow-up. Individual/job interface level interventionsOne controlled before-after study with 49 participants compared expressive writing with a control writing exercise at two weeks follow-up. Participants in the intervention arm scored significantly lower on bullying measured as incivility perpetration (MD -3.52; 95% CI -6.24 to -0.80). There was no difference in bullying measured as incivility victimisation (MD -3.30 95% CI -6.89 to 0.29).One controlled before-after study with 60 employees who had learning disabilities compared a cognitive-behavioural intervention with no intervention. There was no significant difference in bullying victimisation after the intervention (risk ratio (RR) 0.55; 95% CI 0.24 to 1.25), or at the three-month follow-up (RR 0.49; 95% CI 0.21 to 1.15), nor was there a significant difference in bullying perpetration following the intervention (RR 0.64; 95% CI 0.27 to 1.54), or at the three-month follow-up (RR 0.69; 95% CI 0.26 to 1.81). Multilevel InterventionsA five-site cluster-RCT with 1041 participants compared the effectiveness of combinations of policy communication, stress management training, and negative behaviours awareness training. The authors reported that bullying victimisation did not change (13.6% before intervention and 14.3% following intervention). The authors reported insufficient data for us to conduct our own analysis. Due to high risk of bias and imprecision, we graded the evidence for all outcomes as very low quality. Authors' conclusions: There is very low quality evidence that organisational and individual interventions may prevent bullying behaviours in the workplace. We need large well-designed controlled trials of bullying prevention interventions operating on the levels of society/policy, organisation/employer, job/task and individual/job interface. Future studies should employ validated and reliable outcome measures of bullying and a minimum of 6 months follow-up.

The Cochrane database of systematic reviews · meta-analysis · 60 citationsread the source →

Systematic Review of Universal Resilience-Focused Interventions Targeting Child and Adolescent Mental Health in the School Setting.

Objective: To examine the effect of universal, school-based, resilience-focused interventions on mental health problems in children and adolescents. Method: Eligible studies were randomized controlled trials (RCTs) of universal, school-based interventions that included strategies to strengthen a minimum of 3 internal resilience protective factors, and included an outcome measure of mental health problems in children and adolescents aged 5 to 18 years. Six databases were searched from 1995 to 2015. Results were pooled in meta-analyses by mental health outcome (anxiety symptoms, depressive symptoms, hyperactivity, conduct problems, internalizing problems, externalizing problems, and general psychological distress), for all trials (5-18 years). Subgroup analyses were conducted by age (child: 5-10 years; adolescent: 11-18 years), length of follow-up (short: post-≤12 months; long: >12 months), and gender (narrative). Results: A total of 57 included trials were identified from 5,984 records, with 49 contributing to meta-analyses. For all trials, resilience-focused interventions were effective relative to a control in reducing 4 of 7 outcomes: depressive symptoms, internalizing problems, externalizing problems, and general psychological distress. For child trials (meta-analyses for 6 outcomes), interventions were effective for anxiety symptoms and general psychological distress. For adolescent trials (meta-analyses for 5 outcomes), interventions were effective for internalizing problems. For short-term follow-up, interventions were effective for 2 of 7 outcomes: depressive symptoms and anxiety symptoms. For long-term follow-up (meta-analyses for 5 outcomes), interventions were effective for internalizing problems. Conclusion: The findings may suggest most promise for using universal resilience-focused interventions at least for short-term reductions in depressive and anxiety symptoms for children and adolescents, particularly if a cognitive-behavioral therapy-based approach is used. The limited number of trials providing data amenable for meta-analysis for some outcomes and subgroups, the variability of interventions, study quality, and bias mean that it is not possible to draw more specific conclusions. Identifying what intervention qualities (such as number and type of protective factor) achieve the greatest positive effect per mental health problem outcome remains an important area for future research. Systematic review protocol and registration: Systematic Review of Universal Resilience Interventions Targeting Child and Adolescent Mental Health in the School Setting; http://dx.doi.org/10.1186/s13643-015-0172-6; PROSPERO CRD42015025908.

Journal of the American Academy of Child and Adolescent Psychiatry · systematic review · 274 citationsread the source →

The multi-dimensional burden of cirrhosis and hepatic encephalopathy on patients and caregivers.

Objectives: Cirrhosis and hepatic encephalopathy (HE) can adversely affect survival, but their effect on socioeconomic and emotional burden on the family is not clear. The aim was to study the emotional and socioeconomic burden of cirrhosis and HE on patients and informal caregivers. Methods: A cross-sectional study in two transplant centers (Veterans and University) of cirrhotic patients and their informal caregivers was performed. Demographics for patient/caregivers, model-for-end-stage liver disease (MELD) score, and cirrhosis complications were recorded. Patients underwent a cognitive battery, sociodemographic, and financial questionnaires. Caregivers were given the perceived caregiver burden (PCB; maximum=155) and Zarit Burden Interview (ZBI)-Short Form (maximum=48) and questionnaires for depression, anxiety, and social support. Results: A total of 104 cirrhotics (70% men, 44% previous HE, median MELD 12, 49% veterans) and their caregivers (66% women, 77% married, relationship duration 32±14 years) were included. Cirrhosis severely impacted the family unit with respect to work (only 56% employed), finances, and adherence. Those with previous HE had worse unemployment (87.5 vs. 19%, P=0.0001) and financial status (85 vs. 61%, P=0.019) and posed a higher caregiver burden; PCB (75 vs. 65, P=0.019) and ZBI (16 vs. 11, P=0.015) compared with others. Cognitive performance and MELD score were significantly correlated with employment and caregiver burden. Veterans and non-veterans were equally affected. On regression, depression score, MELD, and cognitive tests predicted both PCB and ZBI score. Conclusions: Previous HE and cognitive dysfunction are associated with worse employment, financial status, and caregiver burden. Cirrhosis-related expenses impact the family unit's daily functioning and medical adherence. A multidisciplinary approach to address this burden is required.

The American journal of gastroenterology · 279 citationsread the source →

Screening for Cognitive Impairment in Older Adults: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: Early identification of cognitive impairment may improve patient and caregiver health outcomes. Objective: To systematically review the test accuracy of cognitive screening instruments and benefits and harms of interventions to treat cognitive impairment in older adults (≥65 years) to inform the US Preventive Services Task Force. Data sources: MEDLINE, PubMed, PsycINFO, and Cochrane Central Register of Controlled Trials through January 2019, with literature surveillance through November 22, 2019. Study selection: Fair- to good-quality English-language studies of cognitive impairment screening instruments, and pharmacologic and nonpharmacologic treatments aimed at persons with mild cognitive impairment (MCI), mild to moderate dementia, or their caregivers. Data extraction and synthesis: Independent critical appraisal and data abstraction; random-effects meta-analyses and qualitative synthesis. Main outcomes and measures: Sensitivity, specificity; patient, caregiver, and clinician decision-making; patient function, quality of life, and neuropsychiatric symptoms; caregiver burden and well-being. Results: The review included 287 studies with more than 280 000 older adults. One randomized clinical trial (RCT) (n = 4005) examined the direct effect of screening for cognitive impairment on patient outcomes, including potential harms, finding no significant differences in health-related quality of life at 12 months (effect size, 0.009 [95% CI, -0.063 to 0.080]). Fifty-nine studies (n = 38 531) addressed the accuracy of 49 screening instruments to detect cognitive impairment. The Mini-Mental State Examination was the most-studied instrument, with a pooled sensitivity of 0.89 (95% CI, 0.85 to 0.92) and specificity of 0.89 (95% CI, 0.85 to 0.93) to detect dementia using a cutoff of 23 or less or 24 or less (15 studies, n = 12 796). Two hundred twenty-four RCTs and 3 observational studies including more than 240 000 patients or caregivers addressed the treatment of MCI or mild to moderate dementia. None of the treatment trials were linked with a screening program; in all cases, participants were persons with known cognitive impairment. Medications approved to treat Alzheimer disease (donepezil, galantamine, rivastigmine, and memantine) improved scores on the ADAS-Cog 11 by 1 to 2.5 points over 3 months to 3 years. Psychoeducation interventions for caregivers resulted in a small benefit for caregiver burden (standardized mean difference, -0.24 [95% CI, -0.36 to -0.13) over 3 to 12 months. Intervention benefits were small and of uncertain clinical importance. Conclusions and relevance: Screening instruments can adequately detect cognitive impairment. There is no empirical evidence, however, that screening for cognitive impairment improves patient or caregiver outcomes or causes harm. It remains unclear whether interventions for patients or caregivers provide clinically important benefits for older adults with earlier detected cognitive impairment or their caregivers.

JAMA · systematic review · 199 citationsread the source →

A 5-year experience with cardiopulmonary resuscitation using extracorporeal life support in non-postcardiotomy patients with cardiac arrest.

Background: Cardiopulmonary resuscitation (CPR) using extracorporeal life support (ECLS) system has been successfully used to support patients with in- and out-of-hospital cardiac arrest (IHCA, OHCA) when conventional measures have failed. The purpose of the current study is to report on our experience with extracorporeal CPR in non-postcardiotomy patients. Methods: We retrospectively analysed a total of 85 consecutive adult patients, who have been treated with ECLS between January 2007 and January 2012. Results: The mean CPR duration was 40 min (20-70 min). The mean ECLS support duration was 49 h (12-92 h). Twenty-eight patients (33%) had ECLS related complications. Forty patients (47%) were successfully weaned and 29 patients (34%) survived to hospital discharge. Among survivors, 93% were without severe neurologic deficit. Duration of CPR was shorter for survivors than for non-survivors [(25: 20-50 min) vs. (50: 25-86 min); p=0.003]. Immediately after ECLS start, the mean blood lactate level was lower (p=0.003), and the mean pH value was higher in the survivors' group (p<0.0001) compared to the non-survivors' group. The CPR duration for the IHCA group (25: 20-50 min) was shorter compared to the OHCA group (70: 55-110min; p<0.0001). The survival rate in this group was higher compared to the OHCA group (42% vs. 15%; p<0.02). Conclusions: CPR using modern miniaturized ECLS systems should be established in the treatment of prolonged cardiac arrest and unsuccessful conventional CPR in selected patients. CPR with ECLS for OHCA has worse outcomes compared to IHCA. Duration of CPR was independent risk factor for mortality after extracorporeal CPR.

Resuscitation · 145 citationsread the source →

Non-Residential Father-Child Involvement, Interparental Conflict and Mental Health of Children Following Divorce: A Person-Focused Approach.

Variable-centered research has found complex relationships between child well-being and two critical aspects of the post-divorce family environment: the level of non-residential father involvement (i.e., contact and supportive relationship) with their children and the level of conflict between the father and mother. However, these analyses fail to capture individual differences based on distinct patterns of interparental conflict, father support and father contact. Using a person-centered latent profile analysis, the present study examined (1) profiles of non-residential father contact, support, and interparental conflict in the 2 years following divorce (N = 240), when children (49 % female) were between 9 and 12 years of age and (2) differences across profiles in concurrent child adjustment outcomes as well as outcomes 6 years later. Four profiles of father involvement were identified: High Contact-Moderate Conflict-Moderate Support, Low Contact-Moderate Conflict-Low Support, High Conflict-Moderate Contact-Moderate Support, and Low Conflict-Moderate Contact-Moderate Support. Concurrently, children with fathers in the group with high conflict were found to have significantly greater internalizing and externalizing problems compared to all other groups. Six years later, children with fathers in the group with low contact and low support were found to have greater internalizing and externalizing problems compared to children with fathers in the high conflict group, and also greater internalizing problems compared to children with fathers in the low conflict group. These results provide insight into the complex relationship among non-residential fathers' conflict, contact, and support in child adjustment within divorcing families.

Journal of youth and adolescence · 15 citationsread the source →

Interventions to improve adherence to antiretroviral therapy: a systematic review and network meta-analysis.

Background: High adherence to antiretroviral therapy is crucial to the success of HIV treatment. We evaluated comparative effectiveness of adherence interventions with the aim of informing the WHO's global guidance on interventions to increase adherence. Methods: For this systematic review and network meta-analysis, we searched for randomised controlled trials of interventions that aimed to improve adherence to antiretroviral therapy regimens in populations with HIV. We searched Cochrane Central Register of Controlled Trials, Embase, and MEDLINE for reports published up to July 16, 2015, and searched major conference abstracts from Jan 1, 2013, to July 16, 2015. We extracted data from eligible studies for study characteristics, interventions, patients' characteristics at baseline, and outcomes for the study populations of interest. We used network meta-analyses to compare adherence and viral suppression for all study settings (global network) and for studies in low-income and middle-income countries only (LMIC network). Findings: We obtained data from 85 trials with 16 271 participants. Short message service (SMS; text message) interventions were superior to standard of care in improving adherence in both the global network (odds ratio [OR] 1·48, 95% credible interval [CrI] 1·00-2·16) and in the LMIC network (1·49, 1·04-2·09). Multiple interventions showed generally superior adherence to single interventions, indicating additive effects. For viral suppression, only cognitive behavioural therapy (1·46, 1·05-2·12) and supporter interventions (1·28, 1·01-1·71) were superior to standard of care in the global network; none of the interventions improved viral response in the LMIC network. For the global network, the time discrepancy (whether the study outcome was measured during or after intervention was withdrawn) was an effect modifier for both adherence to antiretroviral therapy (coefficient estimate -0·43, 95% CrI -0·75 to -0·11) and viral suppression (-0·48; -0·84 to -0·12), suggesting that the effects of interventions wane over time. Interpretation: Several interventions can improve adherence and viral suppression; generally, their estimated effects were modest and waned over time. Funding: WHO.

The lancet. HIV · systematic review · 182 citationsread the source →

Rates and Predictors of Seizure Freedom With Vagus Nerve Stimulation for Intractable Epilepsy.

Background: Neuromodulation-based treatments have become increasingly important in epilepsy treatment. Most patients with epilepsy treated with neuromodulation do not achieve complete seizure freedom, and, therefore, previous studies of vagus nerve stimulation (VNS) therapy have focused instead on reduction of seizure frequency as a measure of treatment response. Objective: To elucidate rates and predictors of seizure freedom with VNS. Methods: We examined 5554 patients from the VNS therapy Patient Outcome Registry, and also performed a systematic review of the literature including 2869 patients across 78 studies. Results: Registry data revealed a progressive increase over time in seizure freedom after VNS therapy. Overall, 49% of patients responded to VNS therapy 0 to 4 months after implantation (≥50% reduction seizure frequency), with 5.1% of patients becoming seizure-free, while 63% of patients were responders at 24 to 48 months, with 8.2% achieving seizure freedom. On multivariate analysis, seizure freedom was predicted by age of epilepsy onset >12 years (odds ratio [OR], 1.89; 95% confidence interval [CI], 1.38-2.58), and predominantly generalized seizure type (OR, 1.36; 95% CI, 1.01-1.82), while overall response to VNS was predicted by nonlesional epilepsy (OR, 1.38; 95% CI, 1.06-1.81). Systematic literature review results were consistent with the registry analysis: At 0 to 4 months, 40.0% of patients had responded to VNS, with 2.6% becoming seizure-free, while at last follow-up, 60.1% of individuals were responders, with 8.0% achieving seizure freedom. Conclusion: Response and seizure freedom rates increase over time with VNS therapy, although complete seizure freedom is achieved in a small percentage of patients. Abbreviations: AED, antiepileptic drugVNS, vagus nerve stimulation.

Neurosurgery · systematic review · 218 citationsread the source →

Mental Health Literacy for Supporting Children: A Systematic Review of Teacher and Parent/Carer Knowledge and Recognition of Mental Health Problems in Childhood.

The level of mental health literacy (MHL) in adults who work with or care for children is likely to influence the timeliness and adequacy of support that children receive for mental health problems. The aim of this study was to systematically review the literature on mental health literacy for supporting children (MHLSC, recognition/knowledge) among parents and teachers of school aged children (5 to 12 years old). A systematic search was conducted for quantitative studies published between 2000 and June 2021 using three databases (MEDLINE, PsycINFO and ERIC) and relevant citations reviewed in Scopus. To be included, studies needed to measure at least either 'mental health knowledge' or 'recognition'. Synthesis proceeded according to study design, adult population, child MHP, then MHL outcome. Study quality was assessed using AXIS. 3322 documents were screened, 39 studies met inclusion criteria. 49% of studies examined teachers' knowledge or recognition of ADHD; only five studies reported on parent samples. Synthesis found a nascent field that was disparate in definitions, methods and measures. Little research focussed on knowledge and recognition for internalizing problems, or on parents. Methods used for measuring knowledge/recognition (vignette vs screening) were associated with different outcomes and the quality of studies was most often low to moderate. Adults appear to have good recognition of childhood ADHD but their knowledge of internalizing disorders is less clear. Further research is required to develop standard definitions and validated measures so gaps in MHLSC can be better identified across populations who have a role in supporting children with their mental health.

Clinical child and family psychology review · systematic review · 29 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 →

Effectiveness and cost-effectiveness of home palliative care services for adults with advanced illness and their caregivers.

Background: Extensive evidence shows that well over 50% of people prefer to be cared for and to die at home provided circumstances allow choice. Despite best efforts and policies, one-third or less of all deaths take place at home in many countries of the world. Objectives: 1. To quantify the effect of home palliative care services for adult patients with advanced illness and their family caregivers on patients' odds of dying at home; 2. to examine the clinical effectiveness of home palliative care services on other outcomes for patients and their caregivers such as symptom control, quality of life, caregiver distress and satisfaction with care; 3. to compare the resource use and costs associated with these services; 4. to critically appraise and summarise the current evidence on cost-effectiveness. Search methods: We searched 12 electronic databases up to November 2012. We checked the reference lists of all included studies, 49 relevant systematic reviews, four key textbooks and recent conference abstracts. We contacted 17 experts and researchers for unpublished data. Selection criteria: We included randomised controlled trials (RCTs), controlled clinical trials (CCTs), controlled before and after studies (CBAs) and interrupted time series (ITSs) evaluating the impact of home palliative care services on outcomes for adults with advanced illness or their family caregivers, or both. Data collection and analysis: One review author assessed the identified titles and abstracts. Two independent reviewers performed assessment of all potentially relevant studies, data extraction and assessment of methodological quality. We carried out meta-analysis where appropriate and calculated numbers needed to treat to benefit (NNTBs) for the primary outcome (death at home). Main results: We identified 23 studies (16 RCTs, 6 of high quality), including 37,561 participants and 4042 family caregivers, largely with advanced cancer but also congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), HIV/AIDS and multiple sclerosis (MS), among other conditions. Meta-analysis showed increased odds of dying at home (odds ratio (OR) 2.21, 95% CI 1.31 to 3.71; Z = 2.98, P value = 0.003; Chi(2) = 20.57, degrees of freedom (df) = 6, P value = 0.002; I(2) = 71%; NNTB 5, 95% CI 3 to 14 (seven trials with 1222 participants, three of high quality)). In addition, narrative synthesis showed evidence of small but statistically significant beneficial effects of home palliative care services compared to usual care on reducing symptom burden for patients (three trials, two of high quality, and one CBA with 2107 participants) and of no effect on caregiver grief (three RCTs, two of high quality, and one CBA with 2113 caregivers). Evidence on cost-effectiveness (six studies) is inconclusive. Authors' conclusions: The results provide clear and reliable evidence that home palliative care increases the chance of dying at home and reduces symptom burden in particular for patients with cancer, without impacting on caregiver grief. This justifies providing home palliative care for patients who wish to die at home. More work is needed to study cost-effectiveness especially for people with non-malignant conditions, assessing place of death and appropriate outcomes that are sensitive to change and valid in these populations, and to compare different models of home palliative care, in powered studies.

The Cochrane database of systematic reviews · meta-analysis · 369 citationsread the source →

Behavioural interventions to promote physical activity in a multiethnic population at high risk of diabetes: PROPELS three-arm RCT.

Background: Type 2 diabetes is a leading cause of mortality globally and accounts for significant health resource expenditure. Increased physical activity can reduce the risk of diabetes. However, the longer-term clinical effectiveness and cost-effectiveness of physical activity interventions in those at high risk of type 2 diabetes is unknown. Objectives: To investigate whether or not Walking Away from Diabetes (Walking Away) - a low-resource, 3-hour group-based behavioural intervention designed to promote physical activity through pedometer use in those with prediabetes - leads to sustained increases in physical activity when delivered with and without an integrated mobile health intervention compared with control. Design: Three-arm, parallel-group, pragmatic, superiority randomised controlled trial with follow-up conducted at 12 and 48 months. Setting: Primary care and the community. Participants: Adults whose primary care record included a prediabetic blood glucose measurement recorded within the past 5 years [HbA1c ≥ 42 mmol/mol (6.0%), < 48 mmol/mol (6.5%) mmol/mol; fasting glucose ≥ 5.5 mmol/l, < 7.0 mmol/l; or 2-hour post-challenge glucose ≥ 7.8 mmol/l, < 11.1 mmol/l] were recruited between December 2013 and February 2015. Data collection was completed in July 2019. Interventions: Participants were randomised (1 : 1 : 1) using a web-based tool to (1) control (information leaflet), (2) Walking Away with annual group-based support or (3) Walking Away Plus (comprising Walking Away, annual group-based support and a mobile health intervention that provided automated, individually tailored text messages to prompt pedometer use and goal-setting and provide feedback, in addition to biannual telephone calls). Participants and data collectors were not blinded; however, the staff who processed the accelerometer data were blinded to allocation. Main outcome measures: The primary outcome was accelerometer-measured ambulatory activity (steps per day) at 48 months. Other objective and self-reported measures of physical activity were also assessed. Results: A total of 1366 individuals were randomised (median age 61 years, median body mass index 28.4 kg/m2, median ambulatory activity 6638 steps per day, women 49%, black and minority ethnicity 28%). Accelerometer data were available for 1017 (74%) and 993 (73%) individuals at 12 and 48 months, respectively. The primary outcome assessment at 48 months found no differences in ambulatory activity compared with control in either group (Walking Away Plus: 121 steps per day, 97.5% confidence interval -290 to 532 steps per day; Walking Away: 91 steps per day, 97.5% confidence interval -282 to 463). This was consistent across ethnic groups. At the intermediate 12-month assessment, the Walking Away Plus group had increased their ambulatory activity by 547 (97.5% confidence interval 211 to 882) steps per day compared with control and were 1.61 (97.5% confidence interval 1.05 to 2.45) times more likely to achieve 150 minutes per week of objectively assessed unbouted moderate to vigorous physical activity. In the Walking Away group, there were no differences compared with control at 12 months. Secondary anthropometric, biomechanical and mental health outcomes were unaltered in either intervention study arm compared with control at 12 or 48 months, with the exception of small, but sustained, reductions in body weight in the Walking Away study arm (≈ 1 kg) at the 12- and 48-month follow-ups. Lifetime cost-effectiveness modelling suggested that usual care had the highest probability of being cost-effective at a threshold of £20,000 per quality-adjusted life-year. Of 50 serious adverse events, only one (myocardial infarction) was deemed possibly related to the intervention and led to the withdrawal of the participant from the study. Limitations: Loss to follow-up, although the results were unaltered when missing data were replaced using multiple imputation. Conclusions: Combining a physical activity intervention with text messaging and telephone support resulted in modest, but clinically meaningful, changes in physical activity at 12 months, but the changes were not sustained at 48 months. Future work: Future research is needed to investigate which intervention types, components and features can help to maintain physical activity behaviour change over the longer term. Trial registration: Current Controlled Trials ISRCTN83465245. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 77. See the NIHR Journals Library website for further project information.

Health technology assessment (Winchester, England) · randomised controlled trial · 17 citationsread the source →

Cash transfer interventions for sexual health: meanings and experiences of adolescent males and females in inner-city Johannesburg.

Background: In sub-Saharan Africa, there is growing interest in the use of cash transfer (CT) programs for HIV treatment and prevention. However, there is limited evidence of the consequences related to CT provision to adolescents in low-resourced urban settings. We explored the experiences of adolescents receiving CTs to assess the acceptability and unintended consequences of CT strategies in urban Johannesburg, South Africa. Methods: We collected qualitative data during a pilot randomized controlled trial of three CT strategies (monthly payments unconditional vs. conditional on school attendance vs. a once-off payment conditional on a clinic visit) involving 120 adolescents aged 16-18 years old in the inner city of Johannesburg. Interviews were conducted in isiZulu, Sesotho or English with a sub-sample of 49 participants who adhered to study conditions, 6 months after receiving CT (280 ZAR/ 20 USD) and up to 12 months after the program had ended. Interviews were transcribed and translated by three fieldworkers. Codes were generated using an inductive approach; transcripts were initially coded based on emerging issues and subsequently coded deductively using Atlas.ti 7.4. Results: CTs promoted a sense of independence and an adult social identity amongst recipients. CTs were used to purchase personal and household items; however, there were gender differences in spending and saving behaviours. Male participants' spending reflected their preoccupation with maintaining a public social status through which they asserted an image of the responsible adult. In contrast, female participants' expenditure reflected assumption of domestic responsibilities and independence from older men, with the latter highlighting CTs' potential to reduce transactional sexual partnerships. Cash benefits were short-lived, as adolescents reverted to previous behavior after the program's cessation. Conclusion: CT programs offer adolescent males and females in low-income urban settings a sense of agency, which is vital for their transition to adulthood. However, gender differences in the expenditure of CTs and the effects of ending CT programs must be noted, as these may present potential unintended risks.

BMC public health · randomised controlled trial · 14 citationsread the source →

Consumption of anthocyanin-rich cherry juice for 12 weeks improves memory and cognition in older adults with mild-to-moderate dementia.

Purpose: Dietary flavonoids, including anthocyanins, may positively influence cognition and may be beneficial for the prevention and treatment of dementia. We aimed to assess whether daily consumption of anthocyanin-rich cherry juice changed cognitive function in older adults with dementia. Blood pressure and anti-inflammatory effects were examined as secondary outcomes. Methods: A 12-week randomised controlled trial assessed cognitive outcomes in older adults (+70 year) with mild-to-moderate dementia (n = 49) after consumption of 200 ml/day of either a cherry juice or a control juice with negligible anthocyanin content. Blood pressure and inflammatory markers (CRP and IL-6) were measured at 6 and 12 weeks. ANCOVA controlling for baseline and RMANOVA assessed change in cognition and blood pressure. Results: Improvements in verbal fluency (p = 0.014), short-term memory (p = 0.014) and long-term memory (p ≤ 0.001) were found in the cherry juice group. A significant reduction in systolic (p = 0.038) blood pressure and a trend for diastolic (p = 0.160) blood pressure reduction was evident in the intervention group. Markers of inflammation (CRP and IL-6) were not altered. Conclusion: Inclusion of an anthocyanin-rich beverage may be a practical and feasible way to improve total anthocyanin consumption in older adults with mild-to-moderate dementia, with potential to improve specific cognitive outcomes.

European journal of nutrition · randomised controlled trial · 131 citationsread the source →

Age-Dependent Effects of Methylphenidate on the Human Dopaminergic System in Young vs Adult Patients With Attention-Deficit/Hyperactivity Disorder: A Randomized Clinical Trial.

Importance: Although numerous children receive methylphenidate hydrochloride for the treatment of attention-deficit/hyperactivity disorder (ADHD), little is known about age-dependent and possibly lasting effects of methylphenidate on the human dopaminergic system. Objectives: To determine whether the effects of methylphenidate on the dopaminergic system are modified by age and to test the hypothesis that methylphenidate treatment of young but not adult patients with ADHD induces lasting effects on the cerebral blood flow response to dopamine challenge, a noninvasive probe for dopamine function. Design, setting, and participants: A randomized, double-blind, placebo-controlled trial (Effects of Psychotropic Drugs on Developing Brain-Methylphenidate) among ADHD referral centers in the greater Amsterdam area in the Netherlands between June 1, 2011, and June 15, 2015. Additional inclusion criteria were male sex, age 10 to 12 years or 23 to 40 years, and stimulant treatment-naive status. Interventions: Treatment with either methylphenidate or a matched placebo for 16 weeks. Main outcomes and measures: Change in the cerebral blood flow response to an acute challenge with methylphenidate, noninvasively assessed using pharmacological magnetic resonance imaging, between baseline and 1 week after treatment. Data were analyzed using intent-to-treat analyses. Results: Among 131 individuals screened for eligibility, 99 patients met DSM-IV criteria for ADHD, and 50 participants were randomized to receive methylphenidate and 49 to placebo. Sixteen weeks of methylphenidate treatment increased the cerebral blood flow response to methylphenidate within the thalamus (mean difference, 6.5; 95% CI, 0.4-12.6; P = .04) of children aged 10 to 12 years old but not in adults or in the placebo group. In the striatum, the methylphenidate condition differed significantly from placebo in children but not in adults (mean difference, 7.7; 95% CI, 0.7-14.8; P = .03). Conclusions and relevance: We confirm preclinical data and demonstrate age-dependent effects of methylphenidate treatment on human extracellular dopamine striatal-thalamic circuitry. Given its societal relevance, these data warrant replication in larger groups with longer follow-up. Trial registration: identifier: NL34509.000.10 and trialregister.nl identifier: NTR3103.

JAMA psychiatry · randomised controlled trial · 66 citationsread the source →

Transtheoretical model-based mobile health application for PCOS.

Background: Lifestyle modification (diet, exercise, and behavioral interventions) is the first-line treatment for polycystic ovary syndrome (PCOS). The benefits of face-to-face lifestyle modification intervention in a short time have been demonstrated. However, few studies have investigated the mobile technology effects on lifestyle modification in PCOS. Therefore, we examined the effect of transtheoretical model-based mobile health application intervention program for PCOS. Methods: A randomised controlled, single-blind trial, was carried out from October 2018 to March 2019, which included 122 participants recruited from gynecology outpatient clinics of affiliated Hospital of Zunyi Medical University in Guizhou. The study participants were randomised into intervention (n = 61) and control groups (n = 61). Participants in the intervention group undertook a TTM-based mobile health application program in addition to routine care, and participants in the control group received only routine care. Results: Fifty-one participants in the intervention group and 49 in the control group completed the study. Compared to the control group, participants in the intervention group showed statistically significant decrease for BMI (P < 0.05), WC (P < 0.05), SAS (P < 0.05), and SDS (P < 0.05) scores at 6-month and 12-month, respectively. Behavior stage change of exercise and diet among paticipants with PCOS was significant at 6 months (c2 = 43.032, P < 0.05) and 12th months (c2 = 49.574, P < 0.05) between the intervention and control groups. Conclusions: This study showed that the TTM-based mobile health application program can decrease BMI, WC, anxiety, and depression, and improve exercise and diet adherence in patients with PCOS in the long term. The TTM-based mobile health application program can be applied for lifestyle modification in women with PCOS. Trial registration This study was approved by the ethics committee NO.[2019]1-028 in March 2018 and was registered at the Chinese Clinical Trial Registry (website: www.chictr.org.cn , registry number: ChiCTR2000034572).

Reproductive health · randomised controlled trial · 23 citationsread the source →

Family Nurture Intervention in preterm infants alters frontal cortical functional connectivity assessed by EEG coherence.

Aim: To assess the impact of Family Nurture Intervention (FNI) on cortical function in preterm infants at term age. Methods: Family Nurture Intervention is a NICU-based intervention designed to establish emotional connection between mothers and preterm infants. Infants born at 26-34 weeks postmenstrual age (PMA) were divided into two groups, standard care (SC, N = 49) and FNI (FNI, N = 56). Infants had EEG recordings of ~one hour duration with 124 lead nets between 37 and 44 weeks PMA. Coherence was measured between all pairs of electrodes in ten frequency bands. Data were summarised both within and between 12 regions during two sleep states (active, quiet). Results: Coherence levels were negatively correlated with PMA age in both groups. As compared to SC infants, FNI infants showed significantly lower levels of EEG coherence (1-18 Hz) largely within and between frontal regions. Conclusion: Coherence in FNI infants was decreased in regions where we previously found robust increases in EEG power. As coherence decreases with age, results suggest that FNI may accelerate brain maturation particularly in frontal brain regions, which have been shown in research by others to be involved in regulation of attention, cognition and emotion regulation; domains deficient in preterm infants.

Acta paediatrica (Oslo, Norway : 1992) · randomised controlled trial · 49 citationsread the source →

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

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

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

Spirituality-Based Intervention in Hypertension: EFfects on Blood PrEssure and EndotheliaL Function-FEEL Trial Results.

Background: Emerging evidence suggests that spirituality improves patient outcomes, however, this has undergone only limited evaluation in randomized trials. Hypertension is a major cause of cardiovascular morbidity and mortality worldwide. Objectives: To evaluate whether a spirituality-based intervention, compared to a control group, can reduce blood pressure (BP) and improve endothelial function after 12 weeks in patients with mild or moderate hypertension (HTN). Methods: Open randomized controlled trial of adults with stage I or II hypertension. Following baseline evaluation, including lifestyle questionnaires, and measurements of office and central blood pressure (BP), home blood pressure monitoring (HBPM) and flow mediated dilation (FMD), patients were randomized to a spirituality-based intervention, which included training for forgiveness, gratitude, optimism, and life purpose delivered by daily WhatsApp communications, or to the control group (CG). Main outcomes were between group difference in change from baseline to 12 weeks in office and central BP, HBPM and FMD, using t-tests, analyses of covariance (ANCOVA) adjusting for baseline differences, and, in addition, missing data imputation as a sensitivity analysis. Results: Fifty-one patients were randomized to spirituality-based intervention and 49 to control group. Baseline characteristics were well balanced between groups. Spirituality training, compared with control, improved 7.6 mmHg office systolic blood pressure (SBP), 4.1 mmHg central SBP and 4.1 percentage points FMD. Compared to control group, t-test demonstrated statistical significance for office SBP (-7.04 mmHg, p = 0.047) and FMD (7.46 percentage points, p < 0.001), and ANCOVA adjustment for baseline differences showed statistical significance for central SBP (-6.99 mmHg, p = 0.038) and FFMD (7.95 percentage points, p < 0.001) There was no significant effect on HBPM. Conclusion: A spirituality-based intervention was associated with improved control of office SBP and FMD. These findings will be prospectively evaluated in a nationwide larger and well-powered RCT.

Global heart · randomised controlled trial · 4 citationsread the source →

Underlying mechanisms and efficacy of a suicide-focused psychological intervention for psychosis, the Cognitive Approaches to Combatting Suicidality (CARMS): a multicentre, assessor-masked, randomised controlled trial in the UK.

Background: There is a need for theoretically grounded and testable suicide-focused psychological therapies, especially in people with severe mental health problems, specifically non-affective psychosis. We aimed to test both the underlying mechanisms and efficacy of a suicide-focused therapy, cognitive behavioural suicide prevention for psychosis (CBSPp). Methods: We did a multicentre, assessor-masked, randomised controlled trial conducted at four UK National Health Service (NHS) sites. Participants were eligible for enrolment if they were 18 years or older; met ICD-10 criteria for non-affective psychosis (F20-F29); had self-reported suicidal experiences in the 3 months before recruitment; were under the care of an NHS mental health services team; were not receiving a psychological therapy as part of a similar trial; had sufficient competency in the English language not to need an interpreter to participate; and were able to give informed consent. After screening for eligibility and completion of baseline assessments, participants were randomly allocated in a 1:1 ratio to either the treatment as usual group (control) or CBSPp therapy plus standard treatment group (treatment), with stratification by use of antidepressant medication and NHS site. Randomisation took place using an online Sealed Envelope randomisation procedure conducted and overseen by the Manchester Academic Health Sciences Centre Clinical Trials Unit (MCTU). This system was accessed only by specially allocated staff (eg, the CARMS Trial Manager or the MCTU Trial manager). When the system randomly allocated a participant, an unmasked email confirmation was sent to the unmasked coprincipal investigator and the CARMS Trial Manager (also unmasked). Assessors, the trial statistician, and one coprincipal investigator were masked to allocation group. Participants were informed of their randomised allocation group by an unmasked CARMS staff member. Experts-by-experience were involved in all stages of the research. For those in the treatment group, approximately 24 one-to-one therapy sessions were offered, usually weekly, for around 50 min per session. Assessments were conducted at baseline, month 6, and month 12. The primary outcome was suicide ideation severity measured by the 25-item Adult Suicide Ideation Questionnaire (ASIQ), assessed at month 6 relative to baseline. Outcome analyses used mixed models in the intention-to-treat population. Planned mediation indirect linear regression models examined appraisals of poor social support, emotional difficulties, interpersonal problem-solving difficulties, defeat, entrapment, and hopelessness as mediators at 6 months with allocation condition (treatment vs control) as the predictor variable and suicidal ideation severity (ASIQ) at 6 months as the outcome variable, whilst controlling for baseline levels of the mediator and outcome variables. The trial was registered before recruitment at ClinicalTrials.gov (NCT03114917) and ISRCTN (ISRCTN17776666) and is complete. Findings: We recruited participants from four NHS sites from June 21, 2017, to Nov 25, 2020, with the final 12-month assessment completed on Jan 10, 2022. 479 participants were screened for eligibility, and of these 329 (69%) provided consent and were enrolled. After 69 participants were lost to follow-up, 292 participants were randomly allocated to the treatment and control groups (149 [51%] and 143 [49%], respectively). At baseline, 161 (55%) participants were male and 130 (45%) were female; one participant (<1%) in the treatment group was missing gender data. Mean age was 35·1 years (SD 13·2; range 18-69), and 247 (85%) were White or Caucasian. Severity of suicidal ideation was not statistically different between the treatment (n=136) and the control groups (n=116) at 6 months (p=0·07; Cohen's d -0·20 [95% CI -0·42 to 0·02]). A significant indirect mediation effect (-2·85, -7·00 to -0·23) showed that therapy strengthened social support appraisals which, in turn, reduced suicidal ideation severity at 6 months more in the treatment group than in the control group. Suicide attempts were the most frequent severe adverse event (132 attempts in 26 participants in the treatment group vs 91 attempts in 30 participants in the control group). There were four deaths in the CARMS study, none of which were by suicide or considered related to treatment. Interpretation: CBSPp had no effect on suicidal ideation at 6 months, but it did have a significant indirect effect via improving appraisals of social support. It is important to explore how suicide-focused therapies can be developed and implemented in mental health services so that they maximally enhance appraisals of social support and social connection in ways that endure. Funding: Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health and Care Research partnership (reference number: 13/161/25).

The lancet. Psychiatry · randomised controlled trial · 4 citationsread the source →

Effect of Attendance of the Child on Body Weight, Energy Intake, and Physical Activity in Childhood Obesity Treatment: A Randomized Clinical Trial.

Importance: Family-based weight loss treatment (FBT) is considered the gold-standard treatment for childhood obesity and is provided to the parent and child. However, parent-based treatment (PBT), which is provided to the parent without the child, could be similarly effective and easier to disseminate. Objective: To determine whether PBT is similarly effective as FBT on child weight loss over 24 months. Secondary aims evaluated the effect of these 2 treatments on parent weight loss, child and parent dietary intake, child and parent physical activity, parenting style, and parent feeding behaviors. Design, setting, and participants: Randomized 2-arm noninferiority trial conducted at an academic medical center, University of California, San Diego, between July 2011 and July 2015. Participants included 150 overweight and obese 8- to 12-year-old children and their parents. Interventions: Both PBT and FBT were delivered in 20 one-hour group meetings with 30-minute individualized behavioral coaching sessions over 6 months. Treatments were similar in content; the only difference was the attendance of the child. Main outcomes and measures: The primary outcome measure was child weight loss (body mass index [BMI] and BMI z score) at 6, 12, and 18 months post treatment. Secondary outcomes were parent weight loss (BMI), child and parent energy intake, child and parent physical activity (moderate to vigorous physical activity minutes), parenting style, and parent feeding behaviors. Results: One hundred fifty children (mean BMI, 26.4; mean BMI z score, 2.0; mean age, 10.4 years; 66.4% girls) and their parent (mean BMI, 31.9; mean age, 42.9 years; 87.3% women; and 31% Hispanic, 49% non-Hispanic white, and 20% other race/ethnicity) were randomly assigned to either FBT or PBT. Child weight loss after 6 months was -0.25 BMI z scores in both PBT and FBT. Intention-to-treat analysis using mixed linear models showed that PBT was noninferior to FBT on all outcomes at 6-, 12-, and 18-month follow-up with a mean difference in child weight loss of 0.001 (95% CI, -0.06 to 0.06). Conclusions and relevance: Parent-based treatment was as effective on child weight loss and several secondary outcomes (parent weight loss, parent and child energy intake, and parent and child physical activity). Parent-based treatment is a viable model to provide weight loss treatment to children. Trial registration: Clinicaltrials.gov Identifier: NCT01197443.

JAMA pediatrics · randomised controlled trial · 60 citationsread the source →

Effectiveness of a brief behavioural intervention on psychological distress among women with a history of gender-based violence in urban Kenya: A randomised clinical trial.

Background: Gender-based violence (GBV) represents a major cause of psychological morbidity worldwide, and particularly in low- and middle-income countries (LMICs). Although there are effective treatments for common mental disorders associated with GBV, they typically require lengthy treatment programs that may limit scaling up in LMICs. The aim of this study was to test the effectiveness of a new 5-session behavioural treatment called Problem Management Plus (PM+) that lay community workers can be taught to deliver. Methods and findings: In this single-blind, parallel, randomised controlled trial, adult women who had experienced GBV were identified through community screening for psychological distress and impaired functioning in Nairobi, Kenya. Participants were randomly allocated in a 1:1 ratio either to PM+ delivered in the community by lay community health workers provided with 8 days of training or to facility-based enhanced usual care (EUC) provided by community nurses. Participants were aware of treatment allocation, but research assessors were blinded. The primary outcome was psychological distress as measured by the total score on the 12-item General Health Questionnaire (GHQ-12) assessed at 3 months after treatment. Secondary outcomes were impaired functioning (measured by the WHO Disability Adjustment Schedule [WHODAS]), symptoms of posttraumatic stress (measured by the Posttraumatic Stress Disorder Checklist [PCL]), personally identified problems (measured by Psychological Outcome Profiles [PSYCHLOPS]), stressful life events (measured by the Life Events Checklist [LEC]), and health service utilisation. Between 15 April 2015 and 20 August 2015, 1,393 women were screened for eligibility on the basis of psychological distress and impaired functioning. Of these, 518 women (37%) screened positive, of whom 421 (81%) were women who had experienced GBV. Of these 421 women, 209 were assigned to PM+ and 212 to EUC. Follow-up assessments were completed on 16 January 2016. The primary analysis was intention to treat and included 53 women in PM+ (25%) and 49 women in EUC (23%) lost to follow-up. The difference between PM+ and EUC in the change from baseline to 3 months on the GHQ-12 was 3.33 (95% CI 1.86-4.79, P = 0.001) in favour of PM+. In terms of secondary outcomes, for WHODAS the difference between PM+ and EUC in the change from baseline to 3-month follow-up was 1.96 (95% CI 0.21-3.71, P = 0.03), for PCL it was 3.95 (95% CI 0.06-7.83, P = 0.05), and for PSYCHLOPS it was 2.15 (95% CI 0.98-3.32, P = 0.001), all in favour of PM+. These estimated differences correspond to moderate effect sizes in favour of PM+ for GHQ-12 score (0.57, 95% CI 0.32-0.83) and PSYCHLOPS (0.67, 95% CI 0.31-1.03), and small effect sizes for WHODAS (0.26, 95% CI 0.02-0.50) and PCL (0.21, 95% CI 0.00-0.41). Twelve adverse events were reported, all of which were suicidal risks detected during screening. No adverse events were attributable to the interventions or the trial. Limitations of the study include no long-term follow-up, reliance on self-report rather than structured interview data, and lack of an attention control condition. Conclusions: Among a community sample of women in urban Kenya with a history of GBV, a brief, lay-administered behavioural intervention, compared with EUC, resulted in moderate reductions in psychological distress at 3-month follow-up. Trial registration: Australian New Zealand Clinical Trials Registry ACTRN12614001291673.

PLoS medicine · randomised controlled trial · 156 citationsread the source →

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

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

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

Standing frames for children with cerebral palsy: a mixed-methods feasibility study.

Background: Standing frames are recommended as part of postural management for young people with cerebral palsy (CP) Gross Motor Function Classification System (GMFCS) level IV or V. They may have a variety of benefits, including improving bone mineral density, gastrointestinal function and social participation. The NHS needs to know if these benefits are real, given the cost implications of use and the reported negative effects (e.g. pain). The lack of evidence for the clinical effectiveness of standing frames demonstrates the need for evaluative research. Objective(s): The aim of the study was to explore the acceptability of a future trial to determine the clinical effectiveness of standing frames. Design: A sequential mixed-methods design was used. The findings of each stage informed the next stage. We conducted surveys, focus groups and in-depth interviews. Participants: Professionals who work with young people who use standing frames and parents who have a child who uses a standing frame took part in a survey of current standing frame practice (n = 551), a series of focus groups (seven focus groups, 49 participants in total) and a survey of research trial acceptability and feasibility (n = 585). Twelve young people who use a standing frame were interviewed. Results: Standing frames were widely used as part of postural management for young people with CP both in school and at home but more frequently in school, and particularly by young people in primary school. Achieving the prescribed use was not always possible owing to resources, environment and family factors. Participation and activity engagement were important to young people. The majority of participants believed that standing frames research is necessary. Some reported concern that stopping standing frame use for a trial would cause irreversible damage. The maximum amount of time most health professionals and parents would agree to suspend standing frame use would be 12 weeks. Limitations: Owing to the nature of recruitment, we could not calculate response rates or determine non-response bias. Therefore, participants may not be representative of all standing frame users. Conclusions: Although parents and professionals who engaged in the qualitative aspect of this research and stakeholders who took part in the design workshops appreciated the lack of clinical evidence, our surveys, qualitative information and PPI demonstrated that most people had strong beliefs regarding the clinical effectiveness of standing frames. However, with key stakeholder engagement and careful planning, a trial would be acceptable. Future work: We recommend a carefully planned trial that includes a pilot phase. The trial should evaluate the following question: 'does using a standing frame in school improve patient-reported outcomes of participation (primary outcome), quality of life, subjective well-being, body function and body structure (secondary outcomes) in young children (aged 4-11 years) with CP GMFCS III-V?'. Funding: The National Institute for Health Research Health Technology Assessment programme.

Health technology assessment (Winchester, England) · randomised controlled trial · 13 citationsread the source →

A web-based psychoeducational program for informal caregivers of patients with Alzheimer's disease: a pilot randomized controlled trial.

Background: Although several face-to-face programs are dedicated to informal caregivers of persons with dementia, they are not always accessible to overburdened or isolated caregivers. Based on a face-to-face intervention program, we adapted and designed a Web-based fully automated psychoeducational program (called Diapason) inspired by a cognitive approach. Objective: This study aimed to evaluate through a pilot unblinded randomized controlled trial the efficacy and acceptability of a Web-based psychoeducational program for informal caregivers of persons with Alzheimer's disease (PWAD) based on a mixed methods research design. Methods: We recruited and randomized offline 49 informal caregivers of a PWAD in a day care center in Paris, France. They either received the Web-based intervention and usual care for 3 months (experimental group, n=25) or only usual care (control group, n=24). Caregivers' perceived stress (PSS-14, primary outcome), self-efficacy, burden, perceived health status, and depression (secondary outcomes) were measured during 3 face-to-face on-site visits: at baseline, at the end of the program (month 3), and after follow-up (month 6). Additionally, semistructured interviews were conducted with experimental group caregivers at month 6 and examined with thematic analysis. Results: Intention-to-treat analysis did not show significant differences in self-perceived stress between the experimental and control groups (P=.98). The experimental group significantly improved their knowledge of the illness (d=.79, P=.008) from baseline to month 3. Of the 25 participants allocated to the experimental group, 17 (71%) finished the protocol and entirely viewed at least 10 of 12 online sessions. On average, participants used the website 19.72 times (SD 12.88) and were connected for 262.20 minutes (SD 270.74). The results of the satisfaction questionnaire showed that most participants considered the program to be useful (95%, 19/20), clear (100%, 20/20), and comprehensive (85%, 17/20). Significant correlations were found between relationship and caregivers' program opinion (P=.01). Thus, positive opinions were provided by husbands and sons (3/3), whereas qualified opinions were primarily reported by daughters (8/11). Female spouses expressed negative (2/3) or neutral opinions (1/3). Caregivers expected more dynamic content and further interaction with staff and peers. Conclusions: In this study, quantitative results were inconclusive owing to small sample size. Qualitative results indicated/showed little acceptance of the program and high expectations from caregivers. Caregivers did not rule out their interest in this kind of intervention provided that it met their needs. More dynamic, personalized, and social interventions are desirable. Our recruitment issues pointed out the necessity of in-depth studies about caregivers' help-seeking behaviors and readiness factors. Trial registration: Clinicaltrials.gov NCT01430286; http://clinicaltrials.gov/ct2/show/NCT01430286 (Archived by WebCite at http://www.webcitation/6KxHaRspL).

Journal of medical Internet research · randomised controlled trial · 152 citationsread the source →

Effects of different types of written vaccination information on COVID-19 vaccine hesitancy in the UK (OCEANS-III): a single-blind, parallel-group, randomised controlled trial.

Background: The effectiveness of the COVID-19 vaccination programme depends on mass participation: the greater the number of people vaccinated, the less risk to the population. Concise, persuasive messaging is crucial, particularly given substantial levels of vaccine hesitancy in the UK. Our aim was to test which types of written information about COVID-19 vaccination, in addition to a statement of efficacy and safety, might increase vaccine acceptance. Methods: For this single-blind, parallel-group, randomised controlled trial, we aimed to recruit 15 000 adults in the UK, who were quota sampled to be representative. Participants were randomly assigned equally across ten information conditions stratified by level of vaccine acceptance (willing, doubtful, or strongly hesitant). The control information condition comprised the safety and effectiveness statement taken from the UK National Health Service website; the remaining conditions addressed collective benefit, personal benefit, seriousness of the pandemic, and safety concerns. After online provision of vaccination information, participants completed the Oxford COVID-19 Vaccine Hesitancy Scale (outcome measure; score range 7-35) and the Oxford Vaccine Confidence and Complacency Scale (mediation measure). The primary outcome was willingness to be vaccinated. Participants were analysed in the groups they were allocated. p values were adjusted for multiple comparisons. The study was registered with ISRCTN, ISRCTN37254291. Findings: From Jan 19 to Feb 5, 2021, 15 014 adults were recruited. Vaccine hesitancy had reduced from 26·9% the previous year to 16·9%, so recruitment was extended to Feb 18 to recruit 3841 additional vaccine-hesitant adults. 12 463 (66·1%) participants were classified as willing, 2932 (15·6%) as doubtful, and 3460 (18·4%) as strongly hesitant (ie, report that they will avoid being vaccinated for as long as possible or will never get vaccinated). Information conditions did not alter COVID-19 vaccine hesitancy in those willing or doubtful (adjusted p values >0·70). In those strongly hesitant, COVID-19 vaccine hesitancy was reduced, in comparison to the control condition, by personal benefit information (mean difference -1·49, 95% CI -2·16 to -0·82; adjusted p=0·0015), directly addressing safety concerns about speed of development (-0·91, -1·58 to -0·23; adjusted p=0·0261), and a combination of all information (-0·86, -1·53 to -0·18; adjusted p=0·0313). In those strongly hesitant, provision of personal benefit information reduced hesitancy to a greater extent than provision of information on the collective benefit of not personally getting ill (-0·97, 95% CI -1·64 to -0·30; adjusted p=0·0165) or the collective benefit of not transmitting the virus (-1·01, -1·68 to -0·35; adjusted p=0·0150). Ethnicity and gender were found to moderate information condition outcomes. Interpretation: In the approximately 10% of the population who are strongly hesitant about COVID-19 vaccines, provision of information on personal benefit reduces hesitancy to a greater extent than information on collective benefits. Where perception of risk from vaccines is most salient, decision making becomes centred on the personal. As such, messaging that stresses the counterbalancing personal benefits is likely to prove most effective. The messaging from this study could be used in public health communications. Going forwards, the study highlights the need for future health campaigns to engage with the public on the terrain that is most salient to them. Funding: National Institute for Health Research (NIHR) Oxford Biomedical Research Centre and NIHR Oxford Health Biomedical Research Centre.

The Lancet. Public health · randomised controlled trial · 196 citationsread the source →

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

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

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

School-based programmes for preventing smoking.

Background: Helping young people to avoid starting smoking is a widely endorsed public health goal, and schools provide a route to communicate with nearly all young people. School-based interventions have been delivered for close to 40 years. Objectives: The primary aim of this review was to determine whether school smoking interventions prevent youth from starting smoking. Our secondary objective was to determine which interventions were most effective. This included evaluating the effects of theoretical approaches; additional booster sessions; programme deliverers; gender effects; and multifocal interventions versus those focused solely on smoking. Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane Tobacco Addiction Group's Specialised Register, MEDLINE, EMBASE, PsycINFO, ERIC, CINAHL, Health Star, and Dissertation Abstracts for terms relating to school-based smoking cessation programmes. In addition, we screened the bibliographies of articles and ran individual MEDLINE searches for 133 authors who had undertaken randomised controlled trials in this area. The most recent searches were conducted in October 2012. Selection criteria: We selected randomised controlled trials (RCTs) where students, classes, schools, or school districts were randomised to intervention arm(s) versus a control group, and followed for at least six months. Participants had to be youth (aged 5 to 18). Interventions could be any curricula used in a school setting to deter tobacco use, and outcome measures could be never smoking, frequency of smoking, number of cigarettes smoked, or smoking indices. Data collection and analysis: Two reviewers independently assessed studies for inclusion, extracted data and assessed risk of bias. Based on the type of outcome, we placed studies into three groups for analysis: Pure Prevention cohorts (Group 1), Change in Smoking Behaviour over time (Group 2) and Point Prevalence of Smoking (Group 3). Main results: One hundred and thirty-four studies involving 428,293 participants met the inclusion criteria. Some studies provided data for more than one group. Pure Prevention cohorts (Group 1) included 49 studies (N = 142,447). Pooled results at follow-up at one year or less found no overall effect of intervention curricula versus control (odds ratio (OR) 0.94, 95% confidence interval (CI) 0.85 to 1.05). In a subgroup analysis, the combined social competence and social influences curricula (six RCTs) showed a statistically significant effect in preventing the onset of smoking (OR 0.49, 95% CI 0.28 to 0.87; seven arms); whereas significant effects were not detected in programmes involving information only (OR 0.12, 95% CI 0.00 to 14.87; one study), social influences only (OR 1.00, 95% CI 0.88 to 1.13; 25 studies), or multimodal interventions (OR 0.89, 95% CI 0.73 to 1.08; five studies). In contrast, pooled results at longest follow-up showed an overall significant effect favouring the intervention (OR 0.88, 95% CI 0.82 to 0.96). Subgroup analyses detected significant effects in programmes with social competence curricula (OR 0.52, 95% CI 0.30 to 0.88), and the combined social competence and social influences curricula (OR 0.50, 95% CI 0.28 to 0.87), but not in those programmes with information only, social influence only, and multimodal programmes. Change in Smoking Behaviour over time (Group 2) included 15 studies (N = 45,555). At one year or less there was a small but statistically significant effect favouring controls (standardised mean difference (SMD) 0.04, 95% CI 0.02 to 0.06). For follow-up longer than one year there was a statistically nonsignificant effect (SMD 0.02, 95% CI -0.00 to 0.02).Twenty-five studies reported data on the Point Prevalence of Smoking (Group 3), though heterogeneity in this group was too high for data to be pooled. We were unable to analyse data for 49 studies (N = 152,544).Subgroup analyses (Pure Prevention cohorts only) demonstrated that at longest follow-up for all curricula combined, there was a significant effect favouring adult presenters (OR 0.88, 95% CI 0.81 to 0.96). There were no differences between tobacco-only and multifocal interventions. For curricula with booster sessions there was a significant effect only for combined social competence and social influences interventions with follow-up of one year or less (OR 0.50, 95% CI 0.26 to 0.96) and at longest follow-up (OR 0.51, 95% CI 0.27 to 0.96). Limited data on gender differences suggested no overall effect, although one study found an effect of multimodal intervention at one year for male students. Sensitivity analyses for Pure Prevention cohorts and Change in Smoking Behaviour over time outcomes suggested that neither selection nor attrition bias affected the results. Authors' conclusions: Pure Prevention cohorts showed a significant effect at longest follow-up, with an average 12% reduction in starting smoking compared to the control groups. However, no overall effect was detected at one year or less. The combined social competence and social influences interventions showed a significant effect at one year and at longest follow-up. Studies that deployed a social influences programme showed no overall effect at any time point; multimodal interventions and those with an information-only approach were similarly ineffective. Studies reporting Change in Smoking Behaviour over time did not show an overall effect, but at an intervention level there were positive findings for social competence and combined social competence and social influences interventions.

The Cochrane database of systematic reviews · meta-analysis · 210 citationsread the source →

Cognitive intervention programs for individuals with mild cognitive impairment: systematic review of the literature.

This systematic literature review addressed the efficacy of 15 cognitive intervention programs that have been tested in individuals presenting with mild cognitive impairment of the amnestic type (MCI-A) possibly at risk to progress toward dementia. MEDLINE, PsycINFO, and Current Content databases were searched using the following key terms: cognitive training, cognitive stimulation, cognitive rehabilitation, neuropsychological intervention, memory training, memory stimulation, and Mild Cognitive Impairment. The data showed statistically significant improvements at the end of training on 44% of objective measures of memory, when compared with 12% of objective measures of cognition other than memory. Statistically significant improvements after treatment were obtained on 49% of subjective measures of memory, quality of life, or mood. Samples sizes ranged from 1 to 193 patients with MCI-A but were usually < or =30. Five studies were randomized controlled trials, eight were quasiexperimental designs, and two were single-case investigations. Some programs focused only on memory, whereas other programs used multifaceted approaches targeting two or more cognitive functions. Eight were offered in groups, and seven took place on an individual basis. Recommendations to improve cognitive interventions in MCI-A are proposed, such as using large samples and a robust experimental design, as well as the implementation of a standardized cognitive training manual. Well standardized and validated direct and indirect measures of efficacy and noncognitive outcomes are also a crucial issue. A consensus meeting among all the experts working on cognitive training in this population should occur to provide guidelines to improve this treatment option.

The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry · systematic review · 184 citationsread the source →

Decisions to limit life-sustaining treatment for critically ill patients who lack both decision-making capacity and surrogate decision-makers.

Objective: Many intensive care unit (ICU) physicians have withdrawn life-support from a patient who lacked decision-making capacity and a surrogate decision-maker, yet little is known about the decision-making practices for these patients. We sought to determine how often such patients are admitted to the ICU of a metropolitan hospital and how end-of-life decisions are made for them. Design: Prospective, observational cohort study. Patients and setting: Consecutive adult patients admitted to the medical ICU of a metropolitan West Coast hospital during a 7-month period in 2003 to 2004. Measurements: Attending physicians completed a questionnaire about the decision-making process for each patient for whom they considered limiting life-support who lacked decisional capacity and a legally recognized surrogate decision-maker. Main results: Of the 303 patients admitted during the study period, 49 (16%; 95% confidence interval [CI], 12-21%) lacked decision-making capacity and a surrogate during the entire ICU stay. Compared with all other ICU patients, these patients were more likely to be male (88% vs. 69%; p = .002), white (42% vs. 23%; p = .028), and > or =65 yrs old (29% vs. 13%; p = .007). Physicians considered withholding or withdrawing treatment from 37% (18) of the 49 patients who lacked both decision-making capacity and a surrogate decision-maker. For 56% (10) of these 18 patients, the opinion of another attending physician was obtained; for 33% (6 of 18), the ICU team made the decision independently, and for 11% (2 of 18), the input of the courts or the hospital ethics committee was obtained. Overall, 27% of deaths (13 of 49) during the study period were in incapacitated patients who lacked a surrogate (95% CI, 15-41%). Conclusions: Sixteen percent of patients admitted to the medical ICU of this hospital lacked both decision-making capacity and a surrogate decision-maker. Decisions to limit life support were generally made by physicians without judicial or institutional review. Further research and debate are needed to develop optimal decision-making strategies for these difficult cases.

Critical care medicine · 88 citationsread the source →

A comparison of the life goals program and treatment as usual for individuals with bipolar disorder.

Objective: This randomized controlled study of 164 outpatients with bipolar disorder in a community mental health center who received standardized psychoeducation (Life Goals Program [LGP]) or treatment as usual sought to determine whether there were differences between the groups in medication adherence attitudes and behaviors. Methods: Patients were randomly assigned to treatment as usual (N=80) or treatment as usual plus LGP (N=84) and were assessed at baseline and at the three-, six-, and 12-month follow-up. Primary outcomes were change in score from baseline on the Drug Attitude Inventory (DAI) and on self-reported treatment adherence behaviors (SRTAB). Results: At baseline, there were no significant differences between the two groups. Slightly less than half (N=41, 49%) of the LGP group participated in most or all (four to six) LGP sessions, 14% (N=12) participated in one to three sessions, and 37% (N=31) did not participate in any sessions. At the 12-month follow-up there was improvement among all patients, with no significant differences between the two groups, in DAI scores, SRTAB, symptoms, psychopathology, and functional status. Greater depressive severity at baseline was associated with more negative attitudes toward treatment over time, although this finding was not significant (p=.056). Secondary analysis of persons in the LGP group found that compared with those who did not go to any LGP sessions, those with partial or full participation in LGP sessions had improved attitudes toward medication at the three- and six-month follow-up, but no difference was found between the three LGP subgroups by the 12-month follow-up. Conclusions: There were no differences between two groups in treatment attitudes at the 12-month follow-up. Low attendance rates mitigated effects on primary outcomes. Effects of LGP may become lost over time without ongoing intervention, and individuals with depression may have reduced response to LGP.

Psychiatric services (Washington, D.C.) · randomised controlled trial · 30 citationsread the source →

Intramedullary fixation of subtrochanteric fractures with long proximal femoral nail or long gamma nail: technical notes and preliminary results.

Introduction: The objective of this study was to prospectively evaluate the clinical outcome of traumatic subtrochanteric fractures fixed with long proximal femoral nail (PFN) or long gamma nail with particular emphasis on our experience of surgical techniques. Materials and methods: We reviewed the results of 49 consecutive patients who had undergone intramedullary fixation specifically with a long PFN or a long gamma nail for traumatic subtrochanteric fractures in our hospital during a 2-year period from January 2003 to December 2004. The average age of the patients was 53 years. Clinical and radiographic analyses were performed when follow-up was made at 6 weeks, 12 weeks, 6 months, 1 year and 2 years. Results: All the 49 traumatic subtrochanteric fractures healed uneventfully except 1 case of delayed union. Walking and squatting ability was completely restored in every case at follow-up examination 6 months postoperatively. Among them, 32 fractures were successfully reduced with traction on a fracture table under fluoroscopy, but cerclage wiring or cable bandage through a small incision was needed in the other 17 cases. The average operative time was 46 minutes (range, 21 to 98). Eighteen Seinsheimer type II fractures were left unlocked distally, and static distal interlocking with 1 bolt was carried out in the other 31 cases. No complications such as cutout or breakage of the implants were encountered. Conclusions: This study suggests that long PFN or long gamma nail is a reliable implant for subtrochanteric fractures, leading to high rate of bone union and minimal soft tissue damage. Intramedullary fixation has biological and biomechanical advantages, but the operation is technically demanding. Gradual learning and great patience is needed in order to make this method truly minimally invasive.

Annals of the Academy of Medicine, Singapore · cohort or longitudinal · 14 citationsread the source →

Effect of a family-based cognitive behavioural intervention on body mass index, self-esteem and symptoms of depression in children with obesity (aged 7-13): a randomised waiting list controlled trial.

Objective: We examined the effect of a 12-week family-based cognitive behavioural weight management programme developed for use in primary care settings. Methods: The sample consisted of 49 children with obesity (aged 7-13 years; mean ± SD: 10.68 ± 1.24). Families were randomly assigned to immediate start-up of treatment or to a 12-week waiting list condition. Outcome measures were body mass index standard deviation score (BMI SDS), self-esteem, symptoms of depression and blood parameters indicative of cardio-metabolic risk. Assessments were conducted at baseline, post-treatment, post-waiting list and 12 months after treatment termination. Results: The mean reduction for the treatment group was -0.16 BMI SDS units compared with an increase of 0.04 units for the waiting list group (p = .001). For the entire sample, there was a significant post-treatment improvement on BMI SDS (p = .001), all self-esteem measures (p = .001-.041) and symptoms of depression (p = .004). The mean BMI SDS reduction was -0.18 units post-treatment, and it was maintained at 12-month follow-up. Significant reductions were found in blood lipid levels of total cholesterol (p = .03), LDL-cholesterol (p = .005) and HDL-cholesterol (p = .01) at 12-month follow-up. The favourable effect on most of the psychological measures waned from post-treatment to follow-up, but not approaching baseline levels. Boys demonstrated significantly greater reductions in BMI SDS than girls (p = .001), while baseline psychiatric co-morbidity did not influence BMI SDS outcome. Conclusions: The treatment shows significant and favourable effects on BMI SDS, self-esteem and symptoms of depression compared with a waiting list condition.

Obesity research & clinical practice · randomised controlled trial · 35 citationsread the source →

Omega-3 fatty acid supplementation in patients with recurrent self-harm. Single-centre double-blind randomised controlled trial.

Background: Trials have demonstrated benefits of long-chain omega-3 essential fatty acid (n-3 EFA) supplementation in a variety of psychiatric disorders. Aims: To assess the efficacy of n-3 EFAs in improving psychological well-being in patients with recurrent self-harm. Method: Patients (n=49) presenting after an act of repeated self-harm were randomised to receive 1.2 g eicosapentaenoic acid plus 0.9 g decosahexaenoic acid (n=22) or placebo (n=27) for 12 weeks in addition to standard psychiatric care. Six psychological domains were measured at baseline and end point. Results: At 12 weeks, the n-3 EFA group had significantly greater improvements in scores for depression, suicidality and daily stresses. Scores for impulsivity, aggression and hostility did not differ. Conclusions: Supplementation achieved substantial reductions in surrogate markers of suicidal behaviour and improvements in well-being. Larger studies are warranted to determine if insufficient dietary intake of n-3 EFAs is a reversible risk factor for self-harm.

The British journal of psychiatry : the journal of mental science · randomised controlled trial · 105 citationsread the source →

A randomized controlled clinical trial of psychoanalytic psychotherapy for panic disorder.

Objective: The purpose of this study was to determine the efficacy of panic-focused psychodynamic psychotherapy relative to applied relaxation training, a credible psychotherapy comparison condition. Despite the widespread clinical use of psychodynamic psychotherapies, randomized controlled clinical trials evaluating such psychotherapies for axis I disorders have lagged. To the authors' knowledge, this is the first efficacy randomized controlled clinical trial of panic-focused psychodynamic psychotherapy, a manualized psychoanalytical psychotherapy for patients with DSM-IV panic disorder. Method: This was a randomized controlled clinical trial of subjects with primary DSM-IV panic disorder. Participants were recruited over 5 years in the New York City metropolitan area. Subjects were 49 adults ages 18-55 with primary DSM-IV panic disorder. All subjects received assigned treatment, panic-focused psychodynamic psychotherapy or applied relaxation training in twice-weekly sessions for 12 weeks. The Panic Disorder Severity Scale, rated by blinded independent evaluators, was the primary outcome measure. Results: Subjects in panic-focused psychodynamic psychotherapy had significantly greater reduction in severity of panic symptoms. Furthermore, those receiving panic-focused psychodynamic psychotherapy were significantly more likely to respond at treatment termination (73% versus 39%), using the Multicenter Panic Disorder Study response criteria. The secondary outcome, change in psychosocial functioning, mirrored these results. Conclusions: Despite the small cohort size of this trial, it has demonstrated preliminary efficacy of panic-focused psychodynamic psychotherapy for panic disorder.

The American journal of psychiatry · randomised controlled trial · 124 citationsread the source →