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حَدَّثَنَا عَلِيُّ بْنُ خَشْرَمٍ، أَخْبَرَنَا عِيسَى بْنُ يُونُسَ، عَنِ الأَعْمَشِ، عَنْ إِبْرَاهِيمَ، عَنْ عَلْقَمَةَ، عَنْ عَبْدِ اللَّهِ، قَالَ ‏:‏ لَمَّا نَزَلَتْ‏:‏ ‏(‏ الَّذِينَ آمَنُوا وَلَمْ يَلْبِسُوا إِيمَانَهُمْ بِظُلْمٍ ‏)‏ شَقَّ ذَلِكَ عَلَى الْمُسْلِمِينَ فَقَالُوا يَا رَسُولَ اللَّهِ وَأَيُّنَا لاَ يَظْلِمُ نَفْسَهُ ‏.‏ قَالَ ‏"‏ لَيْسَ ذَلِكَ إِنَّمَا هُوَ الشِّرْكُ أَلَمْ تَسْمَعُوا مَا قَالَ لُقْمَانُ لاِبْنِهِ ‏:‏ ‏(‏ يَا بُنَيَّ لاَ تُشْرِكْ بِاللَّهِ إِنَّ الشِّرْكَ لَظُلْمٌ عَظِيمٌ ‏)‏ ‏"‏ ‏.‏ قَالَ أَبُو عِيسَى هَذَا حَدِيثٌ حَسَنٌ صَحِيحٌ ‏.‏

Narrated 'Abdullah:"When (the following) was revealed: It is those who believe and confuse not their belief with Zulm (wrong) (6:82) - That bothered some Muslims, so they said: 'O Messenger of Allah! Which of us has not wronged himself?' He said: 'It is not that, it is only Shirk, have you not heard what Luqman said to his son: O my son! Do not commit Shirk with Allah. Verily Shirk is a tremendous Zulm (wrong) (31:)

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Mind matters: A meta-analysis on parental mentalization and sensitivity as predictors of infant–parent attachment.

Major developments in attachment research over the past 2 decades have introduced parental mentalization as a predictor of infant-parent attachment security. Parental mentalization is the degree to which parents show frequent, coherent, or appropriate appreciation of their infants' internal states. The present study examined the triangular relations between parental mentalization, parental sensitivity, and attachment security. A total of 20 effect sizes (N = 974) on the relation between parental mentalization and attachment, 82 effect sizes (N = 6,664) on the relation between sensitivity and attachment, and 24 effect sizes (N = 2,029) on the relation between mentalization and sensitivity were subjected to multilevel meta-analyses. The results showed a pooled correlation of r = .30 between parental mentalization and infant attachment security, and rs of .25 for the correlations between sensitivity and attachment security, and between parental mentalization and sensitivity. A meta-analytic structural equation model was performed to examine the combined effects of mentalization and sensitivity as predictors of infant attachment. Together, the predictors explained 12% of the variance in attachment security. After controlling for the effect of sensitivity, the relation between parental mentalization and attachment remained, r = .24; the relation between sensitivity and attachment remained after controlling for parental mentalization, r = .19. Sensitivity also mediated the relation between parental mentalization and attachment security, r = .07, suggesting that mentalization exerts both direct and indirect influences on attachment security. The results imply that parental mentalization should be incorporated into existing models that map the predictors of infant-parent attachment. (PsycINFO Database Record

Psychological Bulletin · meta-analysis · 414 citationsread the source →

Self-help cognitive behavior therapy for working women with problematic hot flushes and night sweats (MENOS@Work): a multicenter randomized controlled trial.

Objective: The aim of the study was to examine the efficacy of an unguided, self-help cognitive behavior therapy (SH-CBT) booklet on hot flush and night sweat (HFNS) problem rating, delivered in a work setting. Methods: Women aged 45 to 60 years, having 10 or more problematic HFNS a week, were recruited to a multicenter randomized controlled trial, via the occupational health/human resources departments of eight organizations. Participants were 1:1 randomized to SH-CBT or no treatment waitlist control (NTWC). The primary outcome was HFNS problem rating; secondary outcomes included HFNS frequency, work and social adjustment, sleep, mood, beliefs and behaviors, and work-related variables (absence, performance, turnover intention, and work impairment due to presenteeism). Intention-to-treat analysis was used, and between-group differences estimated using linear mixed models. Results: A total of 124 women were randomly allocated to SH-CBT (n = 60) and NTWC (n = 64). 104 (84%) were assessed for primary outcome at 6 weeks and 102 (82%) at 20 weeks. SH-CBT significantly reduced HFNS problem rating at 6 weeks (SH-CBT vs NTWC adjusted mean difference, -1.49; 95% CI, -2.11 to -0.86; P < 0.001) and at 20 weeks (-1.09; 95% CI, -1.87 to -0.31; P < 0.01). SH-CBT also significantly reduced HFNS frequency, improved work and social adjustment; sleep, menopause beliefs, HFNS beliefs/behaviors at 6 and 20 weeks; improved wellbeing and somatic symptoms and reduced work impairment due to menopause-related presenteeism at 20 weeks, compared with the NTWC. There was no difference between groups in other work-related outcomes. Conclusions: A brief, unguided SH-CBT booklet is a potentially effective management option for working women experiencing problematic HFNS.

Menopause (New York, N.Y.) · randomised controlled trial · 49 citationsread the source →

Improvement in resiliency factors among adolescents with neurofibromatosis who participate in a virtual mind-body group program.

Purpose: To examine effects of a virtual mind-body group for adolescents with neurofibromatoses (NF1 and NF2; Resilient Youth with Neurofibromatosis; RY-NF) on multiple resiliency factors against a health education attention control (Health Education for Youth with Neurofibromatosis; HE-NF) using data from a randomized controlled trial. Specifically, our research question was whether adolescents randomized to the RY-NF (versus the HE-NF) would have greater improvements in resiliency factors at post-intervention and whether these gains would be maintained at 6-month follow-up. Methods: Adolescents with NF (n = 51; M age 12-17) were randomly assigned to RY-NF (n = 27) or HE-NF (n = 24). Resiliency factors (mindfulness, coping, gratitude, optimism, and social support) were collected at baseline, post-intervention (88%), and 6-month follow-up (82%). Results: Participation in the RY-NF was associated with greater pre-to-post improvements in gratitude (Mdifference = 4.38; 95% CI-0.52-8.23; p = .027) and mindfulness (Mdifference= 9.41; 95% CI 4.40-14.42.; p < .001) compared to HE-NF; improvements sustained at 6 months. There were no group differences on any additional resiliency factors. However, participation in the RY-NF was associated with pre-to-post- improvements in coping (Mdifference= 9.16; 95% CI 2.93-15.39; p = .005), and social support (Mdifference= 6.79; 95% CI 1.96-11.63; p = .007); improvements sustained at 6 months. Conclusions: Participation in the RY-NF resulted in sustained improvement in several resiliency factors. Promoting resiliency may help adolescents successfully navigate challenges associated with NF.

Journal of neuro-oncology · randomised controlled trial · 14 citationsread the source →

Using expressive writing to improve cancer caregiver and patient health: A randomized controlled feasibility trial.

Purpose: This study examined the feasibility and preliminary efficacy of Expressive Writing (EW) in improving informal cancer caregiver (IC) and patient health, and enhancing ICs' emotion regulation. Method: Fifty-eight breast cancer ICs and patients participated in a randomized controlled feasibility trial of remote EW. ICs were randomly assigned to the EW or control group and completed 3 weekly writing sessions. ICs and patients completed health and emotion regulation assessments at baseline, intervention completion, and 3 months post-intervention. Screening, recruitment, assessment process, randomization, retention, treatment adherence, and treatment fidelity were computed for feasibility. Effect sizes were calculated using the PROMIS Depression Short Form, RAND Short Form 36 Health Survey, Breast Cancer Prevention Trial Hormonal Symptom checklist, healthcare utilization, and the Emotion Regulation Questionnaire for efficacy. Results: Of the 232 interested individuals, 82 were screened, and 60 enrolled (6 monthly). Two individuals withdrew and 19 were lost to follow-up, leaving 39 individuals. ICs completed at least one assessment and two sessions, and patients completed at least two assessments. All sessions were administered as intended. ICs generally followed instructions (88%-100%), wrote the full time (66.7%-100%), and were engaged (M(SD) = 3.00(1.29)-4.00(0.00)). EW had small-to-medium effects in improving IC health (g = -0.27-0.04) and small-to-large effects in improving patient health (g = -0.28-0.86). EW moderately decreased suppression (g = 0.53-0.54) and slightly increased reappraisal, at least 3 months post-intervention (g = -0.34-0.20). Conclusions: Remote EW may be feasible with cancer ICs and improve cancer IC and patient health. However, it can benefit from additional retention strategies and rigorous testing. Trial registration: CenterWatch Clinical Trials Listing Service (#TX217874); ClinicalTrials.gov (#NCT06123416).

European journal of oncology nursing : the official journal of European Oncology Nursing Society · randomised controlled trial · 3 citationsread the source →

Stability of maternal depressive symptoms among urban, low-income, African American adolescent mothers.

Background: Maternal depressive symptomatology is an important public health issue with negative consequences for both mothers and infants. Methods: This study examined prevalence and patterns of depressive symptoms among 181 urban, low-income, first-time, African American adolescent mothers recruited from urban hospitals following delivery. Follow-up evaluations were conducted at 6 (N=148; 82%) and 24 (N=147; 81%) month home visits. Depressive symptoms were measured with Beck Depression Inventory (BDI). Results: Half of mothers (49%) had BDI scores >9 at baseline, with significant correlations between BDI scores across all visits (r=0.28-0.50). Depressive symptom trajectories analyzed using group-based trajectory modeling revealed three trajectories of depressive symptoms: Low (41%), Medium (45%), and High (14%). The high depressive symptom group reported lower self-esteem, more negative life events, and lower parenting satisfaction than the low and moderate depressive symptoms groups. Limitations: Depressive symptoms were self-reported and not verified with a clinical interview. Findings are limited to urban, low-income, African American adolescent mothers and may not be generalizable to other populations. Conclusions: The high prevalence and relative stability of depressive symptoms through 2years of parenting suggest the need for early identification and treatment of maternal depressive symptoms. Brief screening for maternal depressive symptoms conducted during pediatric well-child visits is a feasible and effective method for identifying mothers with depressive symptoms, however, screening measures can not differentiate between high and low levels of depressive symptoms. Brief intervention may be an effective treatment for mothers with mild symptoms of depression; mothers with moderate to severe symptoms may require more intensive intervention.

Journal of affective disorders · randomised controlled trial · 43 citationsread the source →

Smoking cessation for people with severe mental illness (SCIMITAR+): a pragmatic randomised controlled trial.

Background: People with severe mental illnesses such as schizophrenia are three times more likely to smoke than the wider population, contributing to widening health inequalities. Smoking remains the largest modifiable risk factor for this health inequality, but people with severe mental illness have not historically engaged with smoking cessation services. We aimed to test the effectiveness of a combined behavioural and pharmacological smoking cessation intervention targeted specifically at people with severe mental illness. Methods: In the smoking cessation intervention for severe mental illness (SCIMITAR+) trial, a pragmatic, randomised controlled study, we recruited heavy smokers with bipolar disorder or schizophrenia from 16 primary care and 21 community-based mental health sites in the UK. Participants were eligible if they were aged 18 years or older, and smoked at least five cigarettes per day. Exclusion criteria included substantial comorbid drug or alcohol problems and people who lacked capacity to consent at the time of recruitment. Using computer-generated random numbers, participants were randomly assigned (1:1) to a bespoke smoking cessation intervention or to usual care. Participants, mental health specialists, and primary care physicians were unmasked to assignment. The bespoke smoking cessation intervention consisted of behavioural support from a mental health smoking cessation practitioner and pharmacological aids for smoking cessation, with adaptations for people with severe mental illness-such as, extended pre-quit sessions, cut down to quit, and home visits. Access to pharmacotherapy was via primary care after discussion with the smoking cessation specialist. Under usual care participants were offered access to local smoking cessation services not specifically designed for people with severe mental illnesses. The primary endpoint was smoking cessation at 12 months ascertained via carbon monoxide measurements below 10 parts per million and self-reported cessation for the past 7 days. Secondary endpoints were biologically verified smoking cessation at 6 months; number of cigarettes smoked per day, Fagerström Test for Nicotine Dependence (FTND) and Motivation to Quit (MTQ) questionnaire; general and mental health functioning determined via the Patient Health Questionnaire-9 (PHQ-9), the Generalised Anxiety Disorder-7 (GAD-7) questionnaire, and 12-Item Short Form Health Survey (SF-12); and body-mass index (BMI). This trial was registerd with the ISRCTN registry, number ISRCTN72955454, and is complete. Findings: Between Oct 7, 2015, and Dec 16, 2016, 526 eligible patients were randomly assigned to the bespoke smoking cessation intervention (n=265) or usual care (n=261). 309 (59%) participants were male, median age was 47·2 years (IQR 36·3-54·5), with high nicotine dependence (mean 24 cigarettes per day [SD 13·2]), and the most common severe mental disorders were schizophrenia or other psychotic illness (n=343 [65%]), bipolar disorder (n=115 [22%]), and schizoaffective disorder (n=66 [13%]). 234 (88%) of intervention participants engaged with the treatment programme and attended 6·4 (SD 3·5) quit smoking sessions, with an average duration of 39 min (SD 17; median 35 min, range 5-120). Verified quit data at 12 months were available for 219 (84%) of 261 usual care and 223 (84%) of 265 intervention participants. The proportion of participants who had quit at 12 months was higher in the intervention group than in the usual care group, but non-significantly (34 [15%] of 223 [13% of those assigned to group] vs 22 [10%] of 219 [8% of those assigned to group], risk difference 5·2%, 95% CI -1·0 to 11·4; odds ratio [OR] 1·6, 95% CI 0·9 to 2·9; p=0·10). The proportion of participants who quit at 6 months was significantly higher in the intervention group than in the usual care group (32 [14%] of 226 vs 14 [6%] of 217; risk difference 7·7%, 95% CI 2·1 to 13·3; OR 2·4, 95% CI 1·2 to 4·6; p=0·010). The incidence rate ratio for number of cigarettes smoked per day at 6 months was 0·90 (95% CI 0·80 to 1·01; p=0·079), and at 12 months was 1·00 (0·89 to 1·13; p=0·95). At both 6 months and 12 months, the intervention group was non-significantly favoured in the FTND (adjusted mean difference 6 months -0·18, 95% CI -0·53 to 0·17, p=0·32; and 12 months -0·01, -0·39 to 0·38, p=0·97) and MTQ questionnaire (adjusted mean difference 0·58, -0·01 to 1·17, p=0·056; and 12 months 0·64, 0·04 to 1·24, p=0·038). The PHQ-9 showed no difference between the groups (adjusted mean difference at 6 months 0·20, 95% CI -0·85 to 1·24 vs 12 months -0·12, -1·18 to 0·94). For the SF-12 survey, we saw evidence of improvement in physical health in the intervention group at 6 months (adjusted mean difference 1·75, 95% CI 0·21 to 3·28), but this difference was not evident at 12 months (0·59, -1·07 to 2·26); and we saw no difference in mental health between the groups at 6 or 12 months (adjusted mean difference at 6 months -0·73, 95% CI -2·82 to 1·36, and 12 months -0·41, -2·35 to 1·53). The GAD-7 questionnaire showed no difference between the groups (adjusted mean difference at 6 months -0·32 95% CI -1·26 to 0·62 vs 12 months -0·10, -1·05 to 0·86). No difference in BMI was seen between the groups (adjusted mean difference 6 months 0·16, 95% CI -0·54 to 0·85; 12 months 0·25, -0·62 to 1·13). Interpretation: This bespoke intervention is a candidate model of smoking cessation for clinicians and policy makers to address high prevalence of smoking. The incidence of quitting at 6 months shows that smoking cessation can be achieved, but the waning of this effect by 12 months means more effort is needed for sustained quitting. Funding: National Institute for Health Research Health Technology Assessment Programme.

The lancet. Psychiatry · randomised controlled trial · 134 citationsread the source →

Mindfulness-based stress reduction for family caregivers: a randomized controlled trial.

Purpose: Caring for a family member with dementia is associated with chronic stress, which can have significant deleterious effects on caregivers. The purpose of the Balance Study was to compare a mindfulness-based stress reduction (MBSR) intervention to a community caregiver education and support (CCES) intervention for family caregivers of people with dementia. Design and methods: We randomly assigned 78 family caregivers to an MBSR or a CCES intervention, matched for time and attention. Study participants attended 8 weekly intervention sessions and participated in home-based practice. Surveys were completed at baseline, postintervention, and at 6 months. Participants were 32- to 82-year-old predominately non-Hispanic White women caring for a parent with dementia. Results: MBSR was more effective at improving overall mental health, reducing stress, and decreasing depression than CCES. Both interventions improved caregiver mental health and were similarly effective at improving anxiety, social support, and burden. Implications: MBSR could reduce stress and improve mental health in caregivers of family members with dementia residing in the community.

The Gerontologist · randomised controlled trial · 123 citationsread the source →

Effectiveness of the Extension for Community Health Outcomes Model as Applied to Primary Care for Autism: A Partial Stepped-Wedge Randomized Clinical Trial.

Importance: The Extension for Community Health Outcomes (ECHO) model is a widely adopted technology-based model for training primary care physicians and practitioners (PCPs) to care for patients with complex conditions. Despite its popularity, to our knowledge, direct effects of ECHO on clinical practice have not been tested in a large-scale study. Objective: To test the effectiveness of the ECHO model as applied to primary care for autism and whether it resulted in improved clinical practice, knowledge, and self-efficacy regarding autism screening and comorbidity management. Design, setting, and participants: Primary care physicians and practitioners were recruited to participate in a 6-month ECHO Autism program delivered by 1 of 10 academic medical center sites. A sequential, staggered rollout of ECHO Autism was delivered to 5 cohorts of participants (15 per site; 2 sites per cohort). Sites were randomized after recruitment to cohort/start time. Cohorts launched every 3 months. The ECHO Autism program used videoconferencing technology to connect community-based PCPs with interdisciplinary expert teams at academic medical centers. There were 148 participants (PCPs [family practice physicians, pediatricians, nurse practitioners, and physician assistants] providing outpatient services to underserved children) studied between December 2016 and November 2018. Interventions: The 6-month ECHO Autism program included twelve 2-hour sessions connecting PCP participants with an interdisciplinary expert team. Sessions included didactics, case-based learning, guided practice, and discussion. Main outcomes and measures: Coprimary outcomes were autism screening practices and comorbidity management (assessed by medical record review). Secondary outcomes were knowledge (assessed by direct testing) and self-efficacy (assessed by self-report survey). Assessments were conducted at baseline, mid-ECHO, post-ECHO, and follow-up (3 months after ECHO). Results: Ten sites were randomized to 1 of 5 cohorts. Participants were 82% female (n = 108), 76% white (n = 100), and 6% Hispanic or Latino (n = 8); the median age was 46 years (interquartile range, 37-55 years). Significant changes in autism screening and treatment of comorbidities in children with autism were not observed. Participants demonstrated significant improvements in knowledge (9%; 95% CI, 4-13; P < .001) and self-efficacy (29%; 95% CI, 25-32; P < .001). Conclusions and relevance: The ECHO model was developed to increase access to high-quality health care for underserved patients with complex conditions. Study results provide support for the model in improving clinician knowledge and confidence but little support for achieving practice change. Trial registration: ClinicalTrials.gov Identifier: NCT03677089.

JAMA pediatrics · randomised controlled trial · 63 citationsread the source →

Regret and unfinished business in parents bereaved by cancer: A mixed methods study

BACKGROUND: Prior research has demonstrated that the presence of regret and unfinished business is associated with poorer adjustment in bereavement. Though there is a growing literature on these constructs among caregivers of adult patients, the literature on regret and unfinished business in bereaved parents has been limited. AIM: The aim of this study was to examine regret and unfinished business in parents bereaved by cancer, as well as their associations with caregiving experiences and prolonged grief. DESIGN: This was a cross-sectional mixed methods study that utilized self-report questionnaires with open-ended items. SETTING/PARTICIPANTS: The multisite study took place at a tertiary cancer hospital and pediatric cancer clinical research institution. Participants were 118 parents (mothers = 82, fathers = 36) who lost a child aged 6 months to 25 years to cancer between 6 months and 6 years prior. RESULTS: ⩽ 0.05). Parents were on average moderately distressed by their regrets and unfinished business, and both regret-related and unfinished business-related distress were associated with distress while caregiving and prolonged grief symptoms. CONCLUSION: Findings have implications for how providers work with families, including increasing treatment decision-making support, supporting parents in speaking to their child about illness, and, in bereavement, validating choices made. Grief interventions that use cognitive-behavioral and meaning-centered approaches may be particularly beneficial.

Palliative Medicine · cohort or longitudinal · 70 citationsread the source →

Bed-sharing by breastfeeding mothers: who bed-shares and what is the relationship with breastfeeding duration?

Aim: To explore the link between breastfeeding duration and bed-sharing frequency among women reporting a prenatal intention to breastfeed. Methods: About 870 participants in a randomised breastfeeding trial, recruited at mid-pregnancy, provided weekly snapshots of breastfeeding and bed-sharing behaviour for 26 weeks following birth. Strength of prenatal breastfeeding intent was recorded at recruitment using Likert-type scales. Results: Outcomes were frequency of bed-sharing at home for at least one hour per week, and time to cessation of breastfeeding. There were insufficient data to classify bed-sharing pattern in 192/870 (22%) of mothers. Of the remainder, 44% (299/678) of participants 'rarely' or 'never' bed-shared, 28% (192/678) did so 'intermittently' and 28% (187/678) did so 'often'. These three groups did not differ significantly in marital status, income, infant gestational age, maternal age or delivery mode. Significantly, more participants who bed-shared 'often' reported strong prenatal breastfeeding intent (70% vs. 57% and 56% for 'intermittent' and 'rare' bed-share groups) and attached high prenatal importance to breastfeeding (95% vs. 87% and 82%). Significantly, more women who bed-shared frequently were breastfeeding at 6 months (p < 0.0001) than those who intermittently or rarely/never bed-shared. Conclusion: Women with strong motivation to breastfeed frequently bed-share. Given the complex relationship between bed-sharing and sudden infant death syndrome (SIDS) appropriate guidance balancing risk minimisation with support for breastfeeding mothers is crucial.

Acta paediatrica (Oslo, Norway : 1992) · randomised controlled trial · 48 citationsread the source →

Effective behaviour change techniques for physical activity and healthy eating in overweight and obese adults; systematic review and meta-regression analyses.

Purpose: This systematic review aims to explain the heterogeneity in results of interventions to promote physical activity and healthy eating for overweight and obese adults, by exploring the differential effects of behaviour change techniques (BCTs) and other intervention characteristics. Methods: The inclusion criteria specified RCTs with ≥ 12 weeks' duration, from January 2007 to October 2014, for adults (mean age ≥ 40 years, mean BMI ≥ 30). Primary outcomes were measures of healthy diet or physical activity. Two reviewers rated study quality, coded the BCTs, and collected outcome results at short (≤6 months) and long term (≥12 months). Meta-analyses and meta-regressions were used to estimate effect sizes (ES), heterogeneity indices (I2) and regression coefficients. Results: We included 48 studies containing a total of 82 outcome reports. The 32 long term reports had an overall ES = 0.24 with 95% confidence interval (CI): 0.15 to 0.33 and I2 = 59.4%. The 50 short term reports had an ES = 0.37 with 95% CI: 0.26 to 0.48, and I2 = 71.3%. The number of BCTs unique to the intervention group, and the BCTs goal setting and self-monitoring of behaviour predicted the effect at short and long term. The total number of BCTs in both intervention arms and using the BCTs goal setting of outcome, feedback on outcome of behaviour, implementing graded tasks, and adding objects to the environment, e.g. using a step counter, significantly predicted the effect at long term. Setting a goal for change; and the presence of reporting bias independently explained 58.8% of inter-study variation at short term. Autonomy supportive and person-centred methods as in Motivational Interviewing, the BCTs goal setting of behaviour, and receiving feedback on the outcome of behaviour, explained all of the between study variations in effects at long term. Conclusion: There are similarities, but also differences in effective BCTs promoting change in healthy eating and physical activity and BCTs supporting maintenance of change. The results support the use of goal setting and self-monitoring of behaviour when counselling overweight and obese adults. Several other BCTs as well as the use of a person-centred and autonomy supportive counselling approach seem important in order to maintain behaviour over time. Trial registration: PROSPERO CRD42015020624.

The international journal of behavioral nutrition and physical activity · meta-analysis · 494 citationsread the source →

Home-based prehabilitation: a systematic review and meta-analysis of randomised trials.

Background: Prehabilitation aims to enhance preoperative functional capacity through exercise, nutrition, and psychological programs. Home-based prehabilitation represents an alternative to hospital prehabilitation, with the advantage of not utilising hospital resources. This review aims to evaluate adherence and clinical effectiveness of home-based prehabilitation. Methods: We searched PubMed, Cochrane, and Embase up to October 1, 2024 for randomised controlled trials comparing home-based prehabilitation with standard care. The primary outcome was the proportion of patients with postoperative complications. Secondary outcomes included protocol adherence, and 6-min walking test. We used risk ratios (RR) and mean differences to summarise the results. The risk of bias was assessed using RoB 2 tool. Results: We included 29 randomised trials for a total of 3508 patients. Median adherence to home-based prehabilitation programs was 82%. Home-based prehabilitation reduced the proportion of patients with postoperative complications (508/1322 [38.4%] vs 578/1335 [43.3%], risk ratio 0.84, 95% confidence interval [CI] 0.72-0.98, P=0.02, I2=44%, low certainty). After home-based prehabilitation, 6-min walking test performance was better compared with control (MD 28.2 m (95% CI 9.5-46.9; P<0.01, I2=48). Preoperative depression (MD -0.65, 95% CI -0.87 to -0.43; P<0.001, I2=0%), postoperative anxiety (MD -0.50, 95% CI -0.75 to -0.25; P<0.001, I2=0%, low certainty) and length of hospital stays (MD -0.32 days, 95% CI -0.61 to -0.03; P=0.03, I2=45%, low certainty) were lower with home-based prehabilitation. Conclusions: Home-based prehabilitation reduced the proportion of patients with postoperative complications, but with low certainty of evidence. It also improved preoperative functional capacity, reduced hospital stays, depression and anxiety scores, with good adherence to the intervention. Systematic review protocol: PROSPERO (CRD42024591208).

British journal of anaesthesia · meta-analysis · 18 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 →

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

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

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

Parental education and inequalities in child mortality: a global systematic review and meta-analysis.

Background: The educational attainment of parents, particularly mothers, has been associated with lower levels of child mortality, yet there is no consensus on the magnitude of this relationship globally. We aimed to estimate the total reductions in under-5 mortality that are associated with increased maternal and paternal education, during distinct age intervals. Methods: This study is a comprehensive global systematic review and meta-analysis of all existing studies of the effects of parental education on neonatal, infant, and under-5 child mortality, combined with primary analyses of Demographic and Health Survey (DHS) data. The literature search of seven databases (CINAHL, Embase, MEDLINE, PsycINFO, PubMed, Scopus, and Web of Science) was done between Jan 23 and Feb 8, 2019, and updated on Jan 7, 2021, with no language or publication date restrictions. Teams of independent reviewers assessed each record for its inclusion of individual-level data on parental education and child mortality and excluded articles on the basis of study design and availability of relevant statistics. Full-text screening was done in 15 languages. Data extracted from these studies were combined with primary microdata from the DHS for meta-analyses relating maternal or paternal education with mortality at six age intervals: 0-27 days, 1-11 months, 1-4 years, 0-4 years, 0-11 months, and 1 month to 4 years. Novel mixed-effects meta-regression models were implemented to address heterogeneity in referent and exposure measures among the studies and to adjust for study-level covariates (wealth or income, partner's years of schooling, and sex of the child). This study was registered with PROSPERO (CRD42020141731). Findings: The systematic review returned 5339 unique records, yielding 186 included studies after exclusions. DHS data were compiled from 114 unique surveys, capturing 3 112 474 livebirths. Data extracted from the systematic review were synthesized together with primary DHS data, for meta-analysis on a total of 300 studies from 92 countries. Both increased maternal and paternal education showed a dose-response relationship linked to reduced under-5 mortality, with maternal education emerging as a stronger predictor. We observed a reduction in under-5 mortality of 31·0% (95% CI 29·0-32·6) for children born to mothers with 12 years of education (ie, completed secondary education) and 17·3% (15·0-18·8) for children born to fathers with 12 years of education, compared with those born to a parent with no education. We also showed that a single additional year of schooling was, on average, associated with a reduction in under-5 mortality of 3·04% (2·82-3·23) for maternal education and 1·57% (1·35-1·72) for paternal education. The association between higher parental education and lower child mortality was significant for both parents at all ages studied and was largest after the first month of life. The meta-analysis framework incorporated uncertainty associated with each individual effect size into the model fitting process, in an effort to decrease the risk of bias introduced by study design and quality. Interpretation: To our knowledge, this study is the first effort to systematically quantify the transgenerational importance of education for child survival at the global level. The results showed that lower maternal and paternal education are both risk factors for child mortality, even after controlling for other markers of family socioeconomic status. This study provides robust evidence for universal quality education as a mechanism to achieve the Sustainable Development Goal target 3.2 of reducing neonatal and child mortality. Funding: Research Council of Norway, Bill & Melinda Gates Foundation, and Rockefeller Foundation-Boston University Commission on Social Determinants, Data, and Decision Making (3-D Commission).

Lancet (London, England) · meta-analysis · 132 citationsread the source →

The global burden of perinatal common mental health disorders and substance use among migrant women: a systematic review and meta-analysis.

Background: There are one billion migrants globally, of whom 82 million are forced migrants. Pregnant migrants face pre-migration stressors such as conflict, transit stressors including poverty, and post-migration stressors including navigating the immigration system; these stressors can make them vulnerable to mental illness. We aimed to assess the global prevalence of and risk factors for perinatal mental health disorders or substance use among women who are migrants. Methods: In this systematic review and meta-analysis, we searched OVID MEDLINE, Embase, PsycINFO, CENTRAL, Global Health, Scopus, and Web of Science for studies published from database inception until July 8, 2022. Cohort, cross-sectional, and interventional studies with prevalence data for any mental illness in pregnancy or the postnatal period (ie, up to a year after delivery) or substance use in pregnancy were included. The primary outcome was the prevalence of perinatal common mental health disorders among women who are migrants, globally. Data for study quality and risk factors were also extracted. A random-effects meta-analysis was used to calculate pooled prevalence estimates, when appropriate. Sensitivity analyses were conducted according to study quality, sample representativeness, and method of outcome assessment. Risk factor data were synthesised narratively. This study is registered with PROSPERO, CRD42021226291. Findings: 18 650 studies were retrieved, of which 135 studies comprising data from 621 995 participants met the inclusion criteria. 123 (91%) of 135 studies were conducted in high-income host countries. Five (4%) of 135 studies were interventional, 40 (30%) were cohort, and 90 (66%) were cross-sectional. The most common regions of origin of participants were South America, the Middle East, and north Africa. Only 26 studies presented disaggregated data for forced migrants or economic migrants. The pooled prevalence of perinatal depressive disorders was 24·2% (range 0·5-95·5%; I2 98·8%; τ2 0·01) among all women who are migrants, 32·5% (1·5-81·6; 98·7%; 0·01) among forced migrants, and 13·7% (4·7-35·1; 91·5%; 0·01) among economic migrants (p<0·001). The pooled prevalence of perinatal anxiety disorders was 19·6% (range 1·2-53·1; I2 96·8%; τ2 0·01) among all migrants. The pooled prevalence of perinatal post-traumatic stress disorder (PTSD) among all migrant women was 8·9% (range 3·2-33·3; I2 97·4%; τ2 0·18). The pooled prevalence of perinatal PTSD among forced migrants was 17·1% (range 6·5-44·3; I2 96·6%; τ2 0·32). Key risk factors for perinatal depression were being a recently arrived immigrant (ie, approximately within the past year), having poor social support, and having a poor relationship with one's partner. Interpretation: One in four women who are migrants and who are pregnant or post partum experience perinatal depression, one in five perinatal anxiety, and one in 11 perinatal PTSD. The burden of perinatal mental illness appears higher among women who are forced migrants compared with women who are economic migrants. To our knowledge, we have provided the first pooled estimate of perinatal depression and PTSD among women who are forced migrants. Interpreting the prevalence estimate should be observed with caution due to the very wide range found within the included studies. Additionally, 66% of studies were cross-sectional representing low quality evidence. These findings highlight the need for community-based routine perinatal mental health screening for migrant communities, and access to interventions that are culturally sensitive, particularly for forced migrants who might experience a higher burden of disease than economic migrants. Funding: UK National Institute for Health Research (NIHR); March of Dimes European Preterm Birth Research Centre, Imperial College; Imperial College NIHR Biomedical Research Centre; and Nuffield Department of Population Health, University of Oxford.

The Lancet. Public health · meta-analysis · 63 citationsread the source →

Exome Sequencing of Familial Bipolar Disorder.

Importance: Complex disorders, such as bipolar disorder (BD), likely result from the influence of both common and rare susceptibility alleles. While common variation has been widely studied, rare variant discovery has only recently become feasible with next-generation sequencing. Objective: To utilize a combined family-based and case-control approach to exome sequencing in BD using multiplex families as an initial discovery strategy, followed by association testing in a large case-control meta-analysis. Design, setting, and participants: We performed exome sequencing of 36 affected members with BD from 8 multiplex families and tested rare, segregating variants in 3 independent case-control samples consisting of 3541 BD cases and 4774 controls. Main outcomes and measures: We used penalized logistic regression and 1-sided gene-burden analyses to test for association of rare, segregating damaging variants with BD. Permutation-based analyses were performed to test for overall enrichment with previously identified gene sets. Results: We found 84 rare (frequency <1%), segregating variants that were bioinformatically predicted to be damaging. These variants were found in 82 genes that were enriched for gene sets previously identified in de novo studies of autism (19 observed vs. 10.9 expected, P = .0066) and schizophrenia (11 observed vs. 5.1 expected, P = .0062) and for targets of the fragile X mental retardation protein (FMRP) pathway (10 observed vs. 4.4 expected, P = .0076). The case-control meta-analyses yielded 19 genes that were nominally associated with BD based either on individual variants or a gene-burden approach. Although no gene was individually significant after correction for multiple testing, this group of genes continued to show evidence for significant enrichment of de novo autism genes (6 observed vs 2.6 expected, P = .028). Conclusions and relevance: Our results are consistent with the presence of prominent locus and allelic heterogeneity in BD and suggest that very large samples will be required to definitively identify individual rare variants or genes conferring risk for this disorder. However, we also identify significant associations with gene sets composed of previously discovered de novo variants in autism and schizophrenia, as well as targets of the FRMP pathway, providing preliminary support for the overlap of potential autism and schizophrenia risk genes with rare, segregating variants in families with BD.

JAMA psychiatry · meta-analysis · 83 citationsread the source →

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

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

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

Psychiatric and neuropsychiatric presentations associated with severe coronavirus infections: a systematic review and meta-analysis with comparison to the COVID-19 pandemic.

Background: Before the COVID-19 pandemic, coronaviruses caused two noteworthy outbreaks: severe acute respiratory syndrome (SARS), starting in 2002, and Middle East respiratory syndrome (MERS), starting in 2012. We aimed to assess the psychiatric and neuropsychiatric presentations of SARS, MERS, and COVID-19. Methods: In this systematic review and meta-analysis, MEDLINE, Embase, PsycINFO, and the Cumulative Index to Nursing and Allied Health Literature databases (from their inception until March 18, 2020), and medRxiv, bioRxiv, and PsyArXiv (between Jan 1, 2020, and April 10, 2020) were searched by two independent researchers for all English-language studies or preprints reporting data on the psychiatric and neuropsychiatric presentations of individuals with suspected or laboratory-confirmed coronavirus infection (SARS coronavirus, MERS coronavirus, or SARS coronavirus 2). We excluded studies limited to neurological complications without specified neuropsychiatric presentations and those investigating the indirect effects of coronavirus infections on the mental health of people who are not infected, such as those mediated through physical distancing measures such as self-isolation or quarantine. Outcomes were psychiatric signs or symptoms; symptom severity; diagnoses based on ICD-10, DSM-IV, or the Chinese Classification of Mental Disorders (third edition) or psychometric scales; quality of life; and employment. Both the systematic review and the meta-analysis stratified outcomes across illness stages (acute vs post-illness) for SARS and MERS. We used a random-effects model for the meta-analysis, and the meta-analytical effect size was prevalence for relevant outcomes, I2 statistics, and assessment of study quality. Findings: 1963 studies and 87 preprints were identified by the systematic search, of which 65 peer-reviewed studies and seven preprints met inclusion criteria. The number of coronavirus cases of the included studies was 3559, ranging from 1 to 997, and the mean age of participants in studies ranged from 12·2 years (SD 4·1) to 68·0 years (single case report). Studies were from China, Hong Kong, South Korea, Canada, Saudi Arabia, France, Japan, Singapore, the UK, and the USA. Follow-up time for the post-illness studies varied between 60 days and 12 years. The systematic review revealed that during the acute illness, common symptoms among patients admitted to hospital for SARS or MERS included confusion (36 [27·9%; 95% CI 20·5-36·0] of 129 patients), depressed mood (42 [32·6%; 24·7-40·9] of 129), anxiety (46 [35·7%; 27·6-44·2] of 129), impaired memory (44 [34·1%; 26·2-42·5] of 129), and insomnia (54 [41·9%; 22·5-50·5] of 129). Steroid-induced mania and psychosis were reported in 13 (0·7%) of 1744 patients with SARS in the acute stage in one study. In the post-illness stage, depressed mood (35 [10·5%; 95% CI 7·5-14·1] of 332 patients), insomnia (34 [12·1%; 8·6-16·3] of 280), anxiety (21 [12·3%; 7·7-17·7] of 171), irritability (28 [12·8%; 8·7-17·6] of 218), memory impairment (44 [18·9%; 14·1-24·2] of 233), fatigue (61 [19·3%; 15·1-23·9] of 316), and in one study traumatic memories (55 [30·4%; 23·9-37·3] of 181) and sleep disorder (14 [100·0%; 88·0-100·0] of 14) were frequently reported. The meta-analysis indicated that in the post-illness stage the point prevalence of post-traumatic stress disorder was 32·2% (95% CI 23·7-42·0; 121 of 402 cases from four studies), that of depression was 14·9% (12·1-18·2; 77 of 517 cases from five studies), and that of anxiety disorders was 14·8% (11·1-19·4; 42 of 284 cases from three studies). 446 (76·9%; 95% CI 68·1-84·6) of 580 patients from six studies had returned to work at a mean follow-up time of 35·3 months (SD 40·1). When data for patients with COVID-19 were examined (including preprint data), there was evidence for delirium (confusion in 26 [65%] of 40 intensive care unit patients and agitation in 40 [69%] of 58 intensive care unit patients in one study, and altered consciousness in 17 [21%] of 82 patients who subsequently died in another study). At discharge, 15 (33%) of 45 patients with COVID-19 who were assessed had a dysexecutive syndrome in one study. At the time of writing, there were two reports of hypoxic encephalopathy and one report of encephalitis. 68 (94%) of the 72 studies were of either low or medium quality. Interpretation: If infection with SARS-CoV-2 follows a similar course to that with SARS-CoV or MERS-CoV, most patients should recover without experiencing mental illness. SARS-CoV-2 might cause delirium in a significant proportion of patients in the acute stage. Clinicians should be aware of the possibility of depression, anxiety, fatigue, post-traumatic stress disorder, and rarer neuropsychiatric syndromes in the longer term. Funding: Wellcome Trust, UK National Institute for Health Research (NIHR), UK Medical Research Council, NIHR Biomedical Research Centre at University College London Hospitals NHS Foundation Trust and University College London.

The lancet. Psychiatry · meta-analysis · 1531 citationsread the source →

Relapse prevention interventions for smoking cessation.

Background: A number of treatments can help smokers make a successful quit attempt, but many initially successful quitters relapse over time. Several interventions have been proposed to help prevent relapse. Objectives: To assess whether specific interventions for relapse prevention reduce the proportion of recent quitters who return to smoking. Search methods: We searched the Cochrane Tobacco Addiction Group trials register, clinicaltrials.gov, and the ICTRP in May 2019 for studies mentioning relapse prevention or maintenance in their title, abstracts, or keywords. Selection criteria: Randomised or quasi-randomised controlled trials of relapse prevention interventions with a minimum follow-up of six months. We included smokers who quit on their own, were undergoing enforced abstinence, or were participating in treatment programmes. We included studies that compared relapse prevention interventions with a no intervention control, or that compared a cessation programme with additional relapse prevention components with a cessation programme alone. Data collection and analysis: We used standard methodological procedures expected by Cochrane. Main results: We included 81 studies (69,094 participants), five of which are new to this update. We judged 22 studies to be at high risk of bias, 53 to be at unclear risk of bias, and six studies to be at low risk of bias. Fifty studies included abstainers, and 30 studies helped people to quit and then tested treatments to prevent relapse. Twenty-eight studies focused on special populations who were abstinent because of pregnancy (19 studies), hospital admission (six studies), or military service (three studies). Most studies used behavioural interventions that tried to teach people skills to cope with the urge to smoke, or followed up with additional support. Some studies tested extended pharmacotherapy. We focused on results from those studies that randomised abstainers, as these are the best test of relapse prevention interventions. Of the 12 analyses we conducted in abstainers, three pharmacotherapy analyses showed benefits of the intervention: extended varenicline in assisted abstainers (2 studies, n = 1297, risk ratio (RR) 1.23, 95% confidence interval (CI) 1.08 to 1.41, I2 = 82%; moderate-certainty evidence), rimonabant in assisted abstainers (1 study, RR 1.29, 95% CI 1.08 to 1.55), and nicotine replacement therapy (NRT) in unaided abstainers (2 studies, n = 2261, RR 1.24, 95% Cl 1.04 to 1.47, I2 = 56%). The remainder of analyses of pharmacotherapies in abstainers had wide confidence intervals consistent with both no effect and a statistically significant effect in favour of the intervention. These included NRT in hospital inpatients (2 studies, n = 1078, RR 1.23, 95% CI 0.94 to 1.60, I2 = 0%), NRT in assisted abstainers (2 studies, n = 553, RR 1.04, 95% CI 0.77 to 1.40, I2 = 0%; low-certainty evidence), extended bupropion in assisted abstainers (6 studies, n = 1697, RR 1.15, 95% CI 0.98 to 1.35, I2 = 0%; moderate-certainty evidence), and bupropion plus NRT (2 studies, n = 243, RR 1.18, 95% CI 0.75 to 1.87, I2 = 66%; low-certainty evidence). Analyses of behavioural interventions in abstainers did not detect an effect. These included studies in abstinent pregnant and postpartum women at the end of pregnancy (8 studies, n = 1523, RR 1.05, 95% CI 0.99 to 1.11, I2 = 0%) and at postpartum follow-up (15 studies, n = 4606, RR 1.02, 95% CI 0.94 to 1.09, I2 = 3%), studies in hospital inpatients (5 studies, n = 1385, RR 1.10, 95% CI 0.82 to 1.47, I2 = 58%), and studies in assisted abstainers (11 studies, n = 5523, RR 0.98, 95% CI 0.87 to 1.11, I2 = 52%; moderate-certainty evidence) and unaided abstainers (5 studies, n = 3561, RR 1.06, 95% CI 0.96 to 1.16, I2 = 1%) from the general population. Authors' conclusions: Behavioural interventions that teach people to recognise situations that are high risk for relapse along with strategies to cope with them provided no worthwhile benefit in preventing relapse in assisted abstainers, although unexplained statistical heterogeneity means we are only moderately certain of this. In people who have successfully quit smoking using pharmacotherapy, there were mixed results regarding extending pharmacotherapy for longer than is standard. Extended treatment with varenicline helped to prevent relapse; evidence for the effect estimate was of moderate certainty, limited by unexplained statistical heterogeneity. Moderate-certainty evidence, limited by imprecision, did not detect a benefit from extended treatment with bupropion, though confidence intervals mean we could not rule out a clinically important benefit at this stage. Low-certainty evidence, limited by imprecision, did not show a benefit of extended treatment with nicotine replacement therapy in preventing relapse in assisted abstainers. More research is needed in this area, especially as the evidence for extended nicotine replacement therapy in unassisted abstainers did suggest a benefit.

The Cochrane database of systematic reviews · meta-analysis · 37 citationsread the source →

Comparative feasibility and preliminary efficacy of CBT for insomnia among adults seeking and not seeking addiction treatment.

Two out of three adults seeking treatment for alcohol or other substance use disorders report co-occurring symptoms of insomnia. This study compared the feasibility, acceptability, and preliminary efficacy of cognitive behavioural therapy for insomnia (CBT-I) among adults seeking and not seeking treatment for substance use. Adults with alcohol or other substance use disorders (n = 22, 32% female, 82% White; Mage  = 39.5) completed assessments at baseline, post-treatment, and at 6 week follow-up. Of those, 11 were and 11 were not enrolled in substance use treatment. All received CBT-I. Multiple imputation was used for missing data. Data were analysed using repeated measures analyses of variance. In the substance use treatment group, 6/11 completed post and 5/11 completed follow-up. In the non-treatment group, 9/11 completed post and 7/11 completed follow-up. Participants in both groups reported improvements in insomnia severity, sleep onset latency, and dysfunctional beliefs about sleep, with most effects evident at post and follow-up. There was a marginal group-by-time interaction in the change in frequency of substance use, with only participants not in substance use treatment reporting decreases at follow-up. Participants in substance use treatment reported significant reductions in substance-related problems and symptoms of post-traumatic stress disorder over time; however, they also reported more symptoms at baseline. CBT-I produces similar reductions in insomnia but is relatively less feasible among individuals in (versus not in) treatment for substance use disorder. This may be due to the more complex logistics of accessing CBT-I among those in treatment. We speculate that integrating CBT-I into treatment for addictions may improve feasibility in this population. clinicaltrials.gov NCT04198311.

Journal of sleep research · clinical trial · 6 citationsread the source →

Mobile Apps and Quality of Life in Patients With Breast Cancer and Survivors: Systematic Literature Review.

Background: Side effects of breast cancer treatment may persist long into survivorship, reducing quality of life (QOL) in patients with breast cancer and survivors. There is growing evidence for the use of digital health technologies, such as mobile apps, to support self-management, decrease symptom burden, and improve QOL in patients with cancer. However, an updated overview of the effects of mobile apps on QOL and well-being in patients with breast cancer and survivors is needed. Objective: The aim of this review was to provide an overview of breast cancer-specific, mobile app-driven lifestyle or behavioral interventions in patient care through to survivorship and their impact on QOL and mental well-being. Methods: A systematic search of PubMed, Scopus, and Web of Science was conducted to identify relevant studies. The inclusion criteria were limited to original studies involving a trial of a mobile app-driven lifestyle or behavioral intervention for patients with breast cancer or survivors and using QOL or well-being measures. The results of the studies that met the inclusion criterion were then synthesized in text and table format. The quality of the evidence was assessed with the Cochrane risk-of-bias tool. Results: A total of 17 studies with the number of participants ranging from 23 to 356 met the inclusion criterion. Of the 17 reviewed studies, 7 (41%) delivered an app-only intervention, and 10 (59%) combined an app with additional supporting materials, such as SMS text messaging, telecoaching, wearables, or printed materials. Among the 17 reviewed studies, 6 (35%) focused on aiding patients with breast cancer during the active treatment phase (excluding ongoing hormone therapy), whereas the remaining 11 (65%) focused on survivorship. The majority of the studies (14/17, 82%) observed some positive effects on QOL or well-being measures. Conclusions: The results of the review indicate that mobile apps are a promising avenue for improving QOL and well-being in breast cancer care. Positive effects were observed in patients undergoing active treatment in all reviewed studies, but effects were less clear after chemotherapy and in long-term survivors. Although lifestyle and behavioral digital interventions are still being developed, and further research should still be pursued, the available data suggest that current mobile health apps aid patients with breast cancer and survivors.

Journal of medical Internet research · systematic review · 47 citationsread the source →

Evaluation of an unconditional cash transfer program targeting children's first-1,000-days linear growth in rural Togo: A cluster-randomized controlled trial.

Background: In 2014, the government of Togo implemented a pilot unconditional cash transfer (UCT) program in rural villages that aimed at improving children's nutrition, health, and protection. It combined monthly UCTs (approximately US$8.40 /month) with a package of community activities (including behavior change communication [BCC] sessions, home visits, and integrated community case management of childhood illnesses and acute malnutrition [ICCM-Nut]) delivered to mother-child pairs during the first "1,000 days" of life. We primarily investigated program impact at population level on children's height-for-age z-scores (HAZs) and secondarily on stunting (HAZ < -2) and intermediary outcomes including household's food insecurity, mother-child pairs' diet and health, delivery in a health facility and low birth weight (LBW), women's knowledge, and physical intimate partner violence (IPV). Methods and findings: We implemented a parallel-cluster-randomized controlled trial, in which 162 villages were randomized into either an intervention arm (UCTs + package of community activities, n = 82) or a control arm (package of community activities only, n = 80). Two different representative samples of children aged 6-29 months and their mothers were surveyed in each arm, one before the intervention in 2014 (control: n = 1,301, intervention: n = 1,357), the other 2 years afterwards in 2016 (control: n = 996, intervention: n = 1,035). Difference-in-differences (DD) estimates of impact were calculated, adjusting for clustering. Children's average age was 17.4 (± 0.24 SE) months in the control arm and 17.6 (± 0.19 SE) months in the intervention arm at baseline. UCTs had a protective effect on HAZ (DD = +0.25 z-scores, 95% confidence interval [CI]: 0.01-0.50, p = 0.039), which deteriorated in the control arm while remaining stable in the intervention arm, but had no impact on stunting (DD = -6.2 percentage points [pp], relative odds ratio [ROR]: 0.74, 95% CI: 0.51-1.06, p = 0.097). UCTs positively impacted both mothers' and children's (18-23 months) consumption of animal source foods (ASFs) (respectively, DD = +4.5 pp, ROR: 2.24, 95% CI: 1.09-4.61, p = 0.029 and DD = +9.1 pp, ROR: 2.65, 95% CI: 1.01-6.98, p = 0.048) and household food insecurity (DD = -10.7 pp, ROR: 0.63, 95% CI: 0.43-0.91, p = 0.016). UCTs did not impact on reported child morbidity 2 week's prior to report (DD = -3.5 pp, ROR: 0.80, 95% CI: 0.56-1.14, p = 0.214) but reduced the financial barrier to seeking healthcare for sick children (DD = -26.4 pp, ROR: 0.23, 95% CI: 0.08-0.66, p = 0.006). Women who received cash had higher odds of delivering in a health facility (DD = +10.6 pp, ROR: 1.53, 95% CI: 1.10-2.13, p = 0.012) and lower odds of giving birth to babies with birth weights (BWs) <2,500 g (DD = -11.8, ROR: 0.29, 95% CI: 0.10-0.82, p = 0.020). Positive effects were also found on women's knowledge (DD = +14.8, ROR: 1.86, 95% CI: 1.32-2.62, p < 0.001) and physical IPV (DD = -7.9 pp, ROR: 0.60, 95% CI: 0.36-0.99, p = 0.048). Study limitations included the short evaluation period (24 months) and the low coverage of UCTs, which might have reduced the program's impact. Conclusions: UCTs targeting the first "1,000 days" had a protective effect on child's linear growth in rural areas of Togo. Their simultaneous positive effects on various immediate, underlying, and basic causes of malnutrition certainly contributed to this ultimate impact. The positive impacts observed on pregnancy- and birth-related outcomes call for further attention to the conception period in nutrition-sensitive programs. Trial registration: ISRCTN Registry ISRCTN83330970.

PLoS medicine · randomised controlled trial · 27 citationsread the source →

Effect of a Web-Based Guided Self-help Intervention for Prevention of Major Depression in Adults With Subthreshold Depression: A Randomized Clinical Trial.

Importance: Evidence-based treatments for major depressive disorder (MDD) are not very successful in improving functional and health outcomes. Attention has increasingly been focused on the prevention of MDD. Objective: To evaluate the effectiveness of a web-based guided self-help intervention for the prevention of MDD. Design, setting, and participants: Two-group randomized clinical trial conducted between March 1, 2013, and March 4, 2015. Participants were recruited in Germany from the general population via a large statutory health insurance company (ie, insurance funded by joint employer-employee contributions). Participants included 406 self-selected adults with subthreshold depression (Centre for Epidemiologic Studies Depression Scale score ≥16, no current MDD according to Diagnostic and Statistical Manual of Mental Disorders [Fourth Edition, Text Revision] criteria). Interventions: All participants had unrestricted access to usual care (visits to the primary care clinician) and were randomized to either a web-based guided self-help intervention (cognitive-behavioral and problem-solving therapy supported by an online trainer; n = 202) or a web-based psychoeducation program (n = 204). Main outcomes and measures: The primary outcome was time to onset of MDD in the intervention group relative to the control group over a 12-month follow-up period as assessed by blinded diagnostic raters using the telephone-administered Structured Clinical Interview for DSM-IV Axis Disorders at 6- and 12-month follow-up, covering the period to the previous assessment. Results: Among 406 randomized patients (mean age, 45 years; 73.9% women), 335 (82%) completed the telephone follow-up at 12 months. Fifty-five participants (27%) in the intervention group experienced MDD compared with 84 participants (41%) in the control group. Cox regression analyses controlling for baseline depressive symptom severity revealed a hazard ratio of 0.59 (95% CI, 0.42-0.82; P = .002) at 12-month follow-up. The number needed to treat to avoid 1 new case of MDD was 5.9 (95% CI, 3.9-14.6). Conclusions and relevance: Among patients with subthreshold depression, the use of a web-based guided self-help intervention compared with enhanced usual care reduced the incidence of MDD over 12 months. Further research is needed to understand whether the effects are generalizable to both first onset of depression and depression recurrence as well as efficacy without the use of an online trainer. Trial registration: German Clinical Trial Registry Identifier: DRKS00004709.

JAMA · randomised controlled trial · 154 citationsread the source →

Standardized Rehabilitation and Hospital Length of Stay Among Patients With Acute Respiratory Failure: A Randomized Clinical Trial.

Importance: Physical rehabilitation in the intensive care unit (ICU) may improve the outcomes of patients with acute respiratory failure. Objective: To compare standardized rehabilitation therapy (SRT) to usual ICU care in acute respiratory failure. Design, setting, and participants: Single-center, randomized clinical trial at Wake Forest Baptist Medical Center, North Carolina. Adult patients (mean age, 58 years; women, 55%) admitted to the ICU with acute respiratory failure requiring mechanical ventilation were randomized to SRT (n=150) or usual care (n=150) from October 2009 through May 2014 with 6-month follow-up. Interventions: Patients in the SRT group received daily therapy until hospital discharge, consisting of passive range of motion, physical therapy, and progressive resistance exercise. The usual care group received weekday physical therapy when ordered by the clinical team. For the SRT group, the median (interquartile range [IQR]) days of delivery of therapy were 8.0 (5.0-14.0) for passive range of motion, 5.0 (3.0-8.0) for physical therapy, and 3.0 (1.0-5.0) for progressive resistance exercise. The median days of delivery of physical therapy for the usual care group was 1.0 (IQR, 0.0-8.0). Main outcomes and measures: Both groups underwent assessor-blinded testing at ICU and hospital discharge and at 2, 4, and 6 months. The primary outcome was hospital length of stay (LOS). Secondary outcomes were ventilator days, ICU days, Short Physical Performance Battery (SPPB) score, 36-item Short-Form Health Surveys (SF-36) for physical and mental health and physical function scale score, Functional Performance Inventory (FPI) score, Mini-Mental State Examination (MMSE) score, and handgrip and handheld dynamometer strength. Results: Among 300 randomized patients, the median hospital LOS was 10 days (IQR, 6 to 17) for the SRT group and 10 days (IQR, 7 to 16) for the usual care group (median difference, 0 [95% CI, -1.5 to 3], P = .41). There was no difference in duration of ventilation or ICU care. There was no effect at 6 months for handgrip (difference, 2.0 kg [95% CI, -1.3 to 5.4], P = .23) and handheld dynamometer strength (difference, 0.4 lb [95% CI, -2.9 to 3.7], P = .82), SF-36 physical health score (difference, 3.4 [95% CI, -0.02 to 7.0], P = .05), SF-36 mental health score (difference, 2.4 [95% CI, -1.2 to 6.0], P = .19), or MMSE score (difference, 0.6 [95% CI, -0.2 to 1.4], P = .17). There were higher scores at 6 months in the SRT group for the SPPB score (difference, 1.1 [95% CI, 0.04 to 2.1, P = .04), SF-36 physical function scale score (difference, 12.2 [95% CI, 3.8 to 20.7], P = .001), and the FPI score (difference, 0.2 [95% CI, 0.04 to 0.4], P = .02). Conclusions and relevance: Among patients hospitalized with acute respiratory failure, SRT compared with usual care did not decrease hospital LOS. Trial registration: clinicaltrials.gov Identifier: NCT00976833.

JAMA · randomised controlled trial · 299 citationsread the source →

Digital Cognitive Behavioral Therapy for Insomnia Using a Smartphone Application in China: A Pilot Randomized Clinical Trial.

Importance: Digital cognitive behavioral therapy for insomnia (DCBT-I) requires adaptation to different sociocultural contexts. Moreover, studies comparing DCBT-I and sleep education in the same operating interface are lacking. Objective: To investigate the efficacy of a smartphone-based Chinese culture-adapted DCBT-I application (app) for insomnia compared with sleep education using the same app. Design, setting, and participants: This was a single-blinded, randomized clinical trial conducted from March 2021 to January 2022. Screening and randomization were conducted at Peking University First Hospital. Follow-up visits were performed online or in the same hospital. After assessing for eligibility, eligible participants were enrolled and allocated (1:1) to DCBT-I or sleep education groups. Data were analyzed from January to February 2022. Interventions: A Chinese smartphone-based app with the same interface was used in both DCBT-I and sleep education groups over 6 weeks, with 1-, 3-, and 6-month follow-ups. Main outcomes and measures: The primary outcome was Insomnia Severity Index (ISI) scores with the intention-to-treat principle. Secondary and exploratory outcomes included sleep diary measures; self-reported scales assessing dysfunctional beliefs about sleep, mental health, and quality of life; and smart bracelet measures. Results: Of 82 participants (mean [SD] age, 49.67 [14.49] years; 61 [74.4%] females), with 41 randomized to sleep education and 41 randomized to DCBT-I; 77 participants completed the 6-week intervention (39 participants in the sleep education group and 38 participants in the DCBT-I group; full analysis data set) and 73 completed the 6-month follow-up (per protocol data set). Mean (SD) ISI scores in the DCBT-I group were significantly lower than those in the sleep education group after the 6-week intervention (12.7 [4.8] points vs 14.9 [5.0] points; Cohen d = 0.458; P = .048) and at the 3-month follow-up (12.1 [5.4] points vs 14.8 [5.5] points; Cohen d = 0.489; P = .04). There were significant improvements from before to after the intervention for both the sleep education and DCBT-I groups, with large effect sizes(sleep education: d = 1.13; DCBT-I: d = 1.71). Some of the sleep diary measures and self-reported scales showed more improvements in the DCBT-I group than sleep education group, such as total sleep time (mean [SD]: 3 months, 403.9 [57.6] minutes vs 363.2 [72.3] minutes; 6 months, 420.3 [58.0] minutes vs 389.7 [59.4] minutes) and sleep efficiency (mean [SD]: 3 months, 87.4% [8.3%] vs 76.7% [12.1%]; 6 months, 87.5% [8.2%] vs 78.1% [10.9%]). Conclusions and relevance: In this randomized clinical trial, the smartphone-based Chinese culture-adapted DCBT-I improved insomnia severity compared with sleep education. Future multicenter clinical trials with large sample sizes are needed to validate its effectiveness in the Chinese population. Trial registration: ClinicalTrials.gov Identifier: NCT04779372.

JAMA network open · randomised controlled trial · 36 citationsread the source →

Improving Social Connectedness for Homebound Older Adults: Randomized Controlled Trial of Tele-Delivered Behavioral Activation Versus Tele-Delivered Friendly Visits.

Objective: To test the acceptability and effectiveness of a lay-coach-facilitated, videoconferenced, short-term behavioral activation (Tele-BA) intervention for improving social connectedness among homebound older adults. Methods: We employed a two-site, participant-randomized controlled trial with 89 older adults (averaging 74 years old) who were recipients of, and initially screened by, home-delivered meals programs. All participants reported loneliness; many reported being socially isolated and/or dissatisfaction with social support. Participants received five weekly videoconference sessions of either Tele-BA or Tele-FV (friendly visits; active control). Three primary outcomes were social interaction (Duke Social Support Index [DSSI] Social Interaction Subscale), subjective loneliness (PROMIS Social Isolation Scale), and DSSI Satisfaction with Social Support Subscale. Depression severity (PHQ-9) and disability (WHODAS 2.0) were secondary outcomes. Mixed-effects regression models were fit to evaluate outcomes at 6- and 12-weeks follow-up. Results: Compared to Tele-FV participants, Tele-BA participants had greater increase in social interaction (t [81] = 2.42, p = 0.018) and satisfaction with social support (t [82] = 2.00, p = 0.049) and decrease in loneliness (t [81] = -3.08, p = 0.003), depression (t [82] = -3.46, p = 0.001), and disability (t [81] = -2.29, p = 0.025). Conclusion: A short-term, lay-coach-facilitated Tele-BA is a promising intervention for the growing numbers of homebound older adults lacking social connectedness. The intervention holds promise for scalability in programs that already serve homebound older adults. More research is needed to solidify the clinical evidence base, cost-effectiveness and sustainability of Tele-BA delivered by lay coaches for homebound and other older adults.

The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry · randomised controlled trial · 110 citationsread the source →

Efficacy of a brief psychological intervention to reduce distress in healthcare workers during the COVID-19 pandemic: A randomized controlled trial.

Introduction: The COVID-19 pandemic has led to a sharp increase in mental health problems among healthcare workers (HCWs). Accessible interventions for HCWs are needed to reduce distress during the pandemic. Objective: This study evaluated the efficacy of a brief psychological intervention (RECHARGE) delivered by videoconferencing to reduce psychological distress in HCWs. Method: This single-blind, parallel, randomized controlled trial enrolled HCWs in Switzerland who screened positive for psychological distress. Participants were randomly allocated to RECHARGE, that taught behavioral strategies or active treatment as usual (ATAU). Primary outcome was the total score on the Kessler Psychological Distress Scale (K10) measured at baseline, post-intervention, 2-month (primary outcome time point), and 6-month follow-up. Secondary outcomes included worry, anxiety and depression, burnout, traumatic stress, moral injury distress, and work performance. Results: Between August 2020 and May 2021, 160 HCWs were enrolled in the study (RECHARGE = 82, ATAU = 78). Relative to ATAU, at 2 months RECHARGE led to a greater reduction in psychological distress (mean difference = 1.86, 95% confidence interval [CI .28, .34], p = .02; effect size = .37), and greater reductions in worry, burnout, and moral injury distress. These effects were not maintained at 6 months. Conclusions: This trial provides initial evidence that a brief psychological intervention delivered via videoconferencing results in significant reductions in mental health problems arising during the COVID-19 pandemic. Booster sessions or digital tools may be needed to maintain the initial gains achieved by RECHARGE. This intervention may have utility in improving the mental health of HCWs both during pandemics and everyday stressors. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Psychological trauma : theory, research, practice and policy · randomised controlled trial · 7 citationsread the source →

Group-based compassion-focused therapy for prolonged grief symptoms in adults - Results from a randomized controlled trial.

Prolonged grief disorder is a debilitating condition, which affects approximately one out of ten who lose a loved one. While existing meta-analyses have synthesized evidence regarding the overall effect of psychological interventions for pathological grief across different types of psychotherapy, it remains clinically relevant to explore whether specific types of psychological interventions are efficacious in the treatment of grief. The present study investigated the efficacy of group-based Compassion-Focused Therapy (CFT) for adults who had lost a spouse or a parent, and who reported clinically relevant levels of prolonged grief symptoms (PGS) at 11 months post-loss. A total of 82 participants were randomized to the CFT group (n = 42) or the waitlist control (n = 40). Time × group interactions showed no statistically significant effects of the intervention on the primary outcome PGS at post-intervention or 6-month follow-up. Likewise, no statistically significant effects were found for any of the secondary outcomes or process variables, with the exception of posttraumatic stress symptoms and self-reassurance. Taken together, in the present study group-based CFT did not emerge as an efficacious treatment for PGS. Possible explanations include that CFT may not target core maintaining processes in PGS and that the group-based, 8-week operationalization of CFT may be less than optimal.

Psychiatry research · randomised controlled trial · 11 citationsread the source →

Effects of family-focused therapy on suicidal ideation and behavior in youth at high risk for bipolar disorder.

Background: Youth who are at clinical and familial risk for bipolar disorder (BD) often have significant suicidal ideation (SI). In a randomized trial, we examined whether family-focused therapy (FFT) is associated with reductions in SI and suicidal behaviors in high-risk youth. Methods: Participants (ages 9-17 years) met diagnostic criteria for unspecified BD or major depressive disorder with active mood symptoms and had at least one relative with BD type I or II. Participants were randomly allocated to 12 sessions in 4 months of FFT or 6 sessions in 4 months of psychoeducation (enhanced care, EC), with pharmacotherapy as needed. Clinician- and child-rated assessments of mood, suicidal thoughts and behaviors, and family conflict were obtained at baseline and 4-6 month intervals over 1-4 years. Results: Participants (N=127; mean 13.2±2.6 yrs., 82 female) were followed over an average of 105.9±64.0 weeks. Youth with high baseline levels of SI who received FFT had lower levels of (and fewer weeks with) SI at follow-up compared to youth with high baseline SI who received EC. Participants in FFT had longer intervals without suicidal behaviors than participants in EC. Youths' ratings of family conflict significantly mediated the effects of treatment on SI at follow-up. Limitations: Family conflict was based on questionnaires rather than observer ratings of family interactions. Conclusions: Family psychoeducation with skill training can be an effective deterrent to suicidal thoughts and behaviors in youth at high risk for BD. Reducing parent/offspring conflict should be a central objective of psychosocial interventions for high-risk youth with SI.

Journal of affective disorders · randomised controlled trial · 20 citationsread the source →

Reducing Stress and Preventing Depression (RESPOND): Randomized Controlled Trial of Web-Based Rumination-Focused Cognitive Behavioral Therapy for High-Ruminating University Students.

Background: Prevention of depression is a priority to reduce its global disease burden. Targeting specific risk factors, such as rumination, may improve prevention. Rumination-focused Cognitive Behavioral Therapy (RFCBT) was developed to specifically target depressive rumination. Objective: The primary objective of this study was to test whether guided Web-based RFCBT (i-RFCBT) would prevent the incidence of major depression relative to usual care in UK university students. The secondary objective was to test the feasibility and estimated effect sizes of unguided i-RFCBT. Methods: To address the primary objective, a phase III randomized controlled trial was designed and powered to compare high risk university students (N=235), selected with elevated worry/rumination, recruited via an open access website in response to circulars within universities and internet advertisements, randomized to receive either guided i-RFCBT (interactive Web-based RFCBT, supported by asynchronous written Web-based support from qualified therapists) or usual care control. To address the secondary objective, participants were also randomized to an adjunct arm of unguided (self-administered) i-RFCBT. The primary outcome was the onset of a major depressive episode over 15 months, assessed with structured diagnostic interviews at 3 (postintervention), 6, and 15 months post randomization, conducted by telephone, blind to the condition. Secondary outcomes of symptoms of depression and anxiety and levels of worry and rumination were self-assessed through questionnaires at baseline and the same follow-up intervals. Results: Participants were randomized to guided i-RFCBT (n=82), unguided i-RFCBT (n=76), or usual care (n=77). Guided i-RFCBT reduced the risk of depression by 34% relative to usual care (hazard ratio [HR] 0.66, 95% CI 0.35 to 1.25; P=.20). Participants with higher levels of baseline stress benefited most from the intervention (HR 0.43, 95% CI 0.21 to 0.87; P=.02). Significant improvements in rumination, worry, and depressive symptoms were found in the short-to-medium term. Of the 6 modules, guided participants completed a mean of 3.46 modules (SD 2.25), with 46% (38/82) being compliant (completing ≥4 modules). Similar effect sizes and compliance rates were found for unguided i-RFCBT. Conclusions: Guided i-RFCBT can reduce the onset of depression in high-risk young people reporting high levels of worry/rumination and stress. The feasibility study argues for formally testing unguided i-RFCBT for prevention: if the observed effect sizes are robustly replicated in a phase III trial, it has potential as a scalable prevention intervention. Trial registration: ISRCTN Registry ISRCTN12683436; https://www.isrctn.com/ISRCTN12683436 (Archived by WebCite at http://www.webcitation.org/77fqycyBX). International registered report identifier (irrid): RR2-10.1186/s13063-015-1128-9.

Journal of medical Internet research · randomised controlled trial · 66 citationsread the source →

Results from a randomized controlled trial testing StressProffen; an application-based stress-management intervention for cancer survivors.

Background: In-person cognitive-behavioral stress-management interventions are consistently associated with reduced cancer distress. However, face-to-face delivery is an access barrier for many patients, and there is a need to develop remote-delivered interventions. The current study evaluated the preliminary efficacy of an application (app)-based cancer stress-management intervention, StressProffen, in a randomized controlled trial. Methods: Cancer survivors, maximum 1-year posttreatment (N = 172), were randomized to StressProffen (n = 84) or a usual care control group (n = 88). Participants received a blended delivery care model: (a) one face-to-face introduction session, (b) 10 app-based cognitive-behavioral stress-management modules, and (c) follow-up phone calls at weeks 2-3 and 6-7. Outcome measures included stress (Perceived Stress Scale), anxiety and depression (Hospital Anxiety Depression Scale), and health-related quality of life (HRQoL; Short-Form Health Surveys [SF-36]) at 3-months post-intervention, analyzed with change scores as dependent variables in linear regression models. Results: Participants were primarily women (82%), aged 20-78 years (mean 52, SD 11.2), with mixed cancer types (majority breast cancer; 48%). Analysis of 149 participants completing questionnaires at baseline and 3 months revealed significant intervention effects: decreased stress (mean difference [MD] -2.8; 95% confidence interval [CI], [-5.2 to -0.4]; P = .022) and improved HRQoL (Role Physical MD = 17.7, [CI 3.7-31.3], P = .013; Social Functioning MD = 8.5, [CI 0.7-16.2], P = .034; Role Emotional MD = 19.5, [CI 3.7-35.2], P = .016; Mental Health MD = 6.7, [CI 1.7-11.6], P = .009). No significant changes were observed for anxiety or depression. Conclusions: Digital-based cancer stress-management interventions, such as StressProffen, have the potential to provide easily accessible, effective psychosocial support for cancer survivors.

Cancer medicine · randomised controlled trial · 39 citationsread the source →

Augmenting psychoeducation with a mobile intervention for bipolar disorder: a randomized controlled trial.

Background: Psychosocial interventions for bipolar disorder are frequently unavailable and resource intensive. Mobile technology may improve access to evidence-based interventions and may increase their efficacy. We evaluated the feasibility, acceptability and efficacy of an augmentative mobile ecological momentary intervention targeting self-management of mood symptoms. Methods: This was a randomized single-blind controlled trial with 82 consumers diagnosed with bipolar disorder who completed a four-session psychoeducational intervention and were assigned to 10 weeks of either: 1) mobile device delivered interactive intervention linking patient-reported mood states with personalized self-management strategies, or 2) paper-and-pencil mood monitoring. Participants were assessed at baseline, 6 weeks (mid-point), 12 weeks (post-treatment), and 24 weeks (follow up) with clinician-rated depression and mania scales and self-reported functioning. Results: Retention at 12 weeks was 93% and both conditions were associated with high satisfaction. Compared to the paper-and-pencil condition, participants in the augmented mobile intervention condition showed significantly greater reductions in depressive symptoms at 6 and 12 weeks (Cohen׳s d for both were d=0.48). However, these effects were not maintained at 24-weeks follow up. Conditions did not differ significantly in the impact on manic symptoms or functional impairment. Limitations: This was not a definitive trial and was not powered to detect moderators and mediators. Conclusions: Automated mobile-phone intervention is feasible, acceptable, and may enhance the impact of brief psychoeducation on depressive symptoms in bipolar disorder. However, sustainment of gains from symptom self-management mobile interventions, once stopped, may be limited.

Journal of affective disorders · randomised controlled trial · 125 citationsread the source →

Early liver transplantation for severe alcohol-related hepatitis not responding to medical treatment: a prospective controlled study.

Background: Early liver transplantation for severe alcohol-related hepatitis is an emerging treatment option. We aimed to assess the risk of alcohol relapse 2 years after early liver transplantation for alcohol-related hepatitis compared with liver transplantation for alcohol-related cirrhosis after at least 6 months of abstinence. Methods: We conducted a multicentre, non-randomised, non-inferiority, controlled study in 19 French and Belgian hospitals. All participants were aged 18 years or older. There were three groups of patients recruited prospectively: patients with severe alcohol-related hepatitis who did not respond to medical treatment and were eligible for early liver transplantation according to a new selection scoring system based on social and addiction items that can be quantified in points (early transplantation group); patients with alcohol-related cirrhosis listed for liver transplantation after at least 6 months of abstinence (standard transplantation group); patients with severe alcohol-related hepatitis not responding to medical treatment not eligible for early liver transplantation according to the selection score (not eligible for early transplantation group), this group did not enter any further liver transplantation processes. We also defined a historical control group of patients with severe alcohol-related hepatitis unresponsive to medical therapy and non-transplanted. The primary outcome was the non-inferiority of 2-year rate of alcohol relapse after transplantation in the early transplantation group compared with the standard transplantation group using the alcohol timeline follow back (TLFB) method and a prespecified non-inferiority margin of 10%. Secondary outcomes were the pattern of alcohol relapse, 2-year survival rate post-transplant in the early transplantation group compared with the standard transplantation group, and 2-year overall survival in the early transplantation group compared with patients in the not eligible for early transplantation group and historical controls. This trial is registered with ClinicalTrials.gov, NCT01756794. Findings: Between Dec 5, 2012, and June 30, 2016, we included 149 patients with severe alcohol-related hepatitis: 102 in the early transplantation group and 47 in the not eligible for early transplantation group. 129 patients were included in the standard transplantation group. 68 patients in the early transplantation group and 93 patients in the standard transplantation group received a liver transplant. 23 (34%) patients relapsed in the early transplantation group, and 23 (25%) patients relapsed in the standard transplantation group; therefore, the non-inferiority of early transplantation versus standard transplantation was not demonstrated (absolute difference 9·1% [95% CI -∞ to 21·1]; p=0·45). The 2-year rate of high alcohol intake was greater in the early transplantation group than the standard transplantation group (absolute difference 16·7% [95% CI 5·8-27·6]) The time spent drinking alcohol was not different between the two groups (standardised difference 0·24 [95% CI -0·07 to 0·55]), but the time spent drinking a large quantity of alcohol was higher in the early transplantation group than the standard transplantation group (standardised difference 0·50 [95% CI 0·17-0·82]). 2-year post-transplant survival was similar between the early transplantation group and the standard transplantation group (hazard ratio [HR] 0·87 [95% CI 0·33-2·26]); 2-year overall survival was higher in the early transplantation group than the not eligible for early transplantation group and historical controls (HR 0·27 [95% CI 0·16-0·47] and 0·21 [0·13-0·32]). Interpretation: We cannot conclude non-inferiority in terms of rate of alcohol relapse post-transplant between early liver transplantation and standard transplantation. High alcohol intake is more frequent after early liver transplantation. This prospective controlled study confirms the important survival benefit related to early liver transplantation for severe alcohol-related hepatitis; and this study provides objective data on survival and alcohol relapse to tailor the management of patients with severe alcohol-related hepatitis. Funding: The present study has been granted by the French Ministry of Health-Programme Hospitalier de Recherche Clinique 2010.

The lancet. Gastroenterology & hepatology · randomised controlled trial · 103 citationsread the source →

Post-deployment screening for mental disorders and tailored advice about help-seeking in the UK military: a cluster randomised controlled trial.

Background: The effectiveness of post-deployment screening for mental disorders has not been assessed in a randomised controlled trial. We aimed to assess whether post-deployment screening for post-traumatic stress disorder (PTSD), depression, anxiety, or alcohol misuse was effective. We defined screening as the presumptive identification of a previously unrecognised disorder using tests to distinguish those who probably had the disorder from those who probably did not so that those people with a probable disorder could be referred appropriately, and assessed effectiveness and consequences for help-seeking by the odds ratio at follow-up between those receiving tailored help-seeking advice and those who received general mental health advice. Methods: We did a cluster randomised controlled trial among Royal Marines and Army personnel in the UK military after deployment to Afghanistan. Platoons were randomly assigned (1:1 initially, then 2:1) by stratified block randomisation with randomly varying block sizes of two and four to the screening group, which received tailored help-seeking advice, or the control group, which received general mental health advice. Initial assessment took place 6-12 weeks after deployment; follow-up assessments were done 10-24 months later. Follow-up measures were the PTSD Checklist-Civilian Version, Patient Health Questionnaire-9, Generalised Anxiety Disorder-7 scale, Alcohol Use Disorder Identification Test (AUDIT), and self-reported help-seeking from clinical and welfare providers comparing those receiving tailored advice and those receiving only general advice. All participants and all investigators other than the person who analysed the data were masked to allocation. The primary outcomes were PTSD, depression or generalised anxiety disorder, and alcohol misuse at follow-up. A key secondary outcome was assessment of whether post-deployment screening followed by tailored advice would modify help-seeking behaviour. Comparisons were made between screening and control groups, with primary analyses by intention to treat. This trial is registered with the ISRCTN Registry, number ISRCTN19965528. Findings: Between Oct 24, 2011, and Oct 31, 2014, 434 platoons comprising 10 190 personnel were included: 274 (6350 personnel) in the screening group and 160 (3840 personnel) in the control group. 5577 (88%) of 6350 personnel received screening and 3996 (63%) completed follow-up, whereas 3149 (82%) of 3840 received the control questionnaire and 2369 (62%) completed follow-up. 1958 (35%) of 5577 personnel in the screening group declined to see the tailored advice, but those with PTSD (83%) or anxiety or depression (84%) were more likely than non-cases (64%) to view the advice (both p<0·0001). At follow-up, there were no significant differences in prevalence between groups for PTSD (adjusted odds ratio 0·92, 95% CI 0·75-1·14), depression or anxiety (0·91, 0·71-1·16), alcohol misuse (0·88, 0·73-1·06), or seeking support for mental disorders (0·92, 0·78-1·08). Interpretation: Post-deployment screening for mental disorders based on tailored advice was not effective at reducing prevalence of mental health disorders nor did it increase help-seeking. Countries that have implemented post-deployment screening programmes for mental disorders should consider monitoring the outcomes of their programmes. Funding: The US Army Medical Research and Materiel Command-Military Operational Medicine Research Program (USAMRMC-MOMRP).

Lancet (London, England) · randomised controlled trial · 38 citationsread the source →

Digital cognitive behavioural therapy for insomnia versus digital sleep education control in an Australian community-based sample: a randomised controlled trial.

Background: Insomnia is a prevalent condition in Australia that increases the risk of depression and anxiety symptoms. Cognitive behaviour therapy for insomnia (CBT-i) is the recommended 'first line' treatment but is accessed by a minority of people with insomnia. Aims: To improve CBT-i access in Australia, we aimed to develop and test a self-guided interactive digital CBT-i program. Methods: An online randomised controlled trial was conducted from August 2022 to August 2023 to investigate the effect of digital CBT-i, versus digital sleep education control, on symptoms of insomnia (ISI), depression (PHQ-9), anxiety (GAD-7), fatigue, sleepiness and maladaptive beliefs about sleep at 8-week follow-up. The control group accessed the intervention after the 8-week follow-up. Questionnaires were additionally administered at 16 and 24 weeks. Intent-to-treat mixed models and complete-case chi-squared analyses were used. Results: Participants included 62 adults with insomnia symptoms (age M (SD) = 52.5 (16.3), 82% female, ISI = 18.6 (2.9)). There were no between-group differences in baseline characteristics or missing 8-week data (14.5%). After adjusting for baseline scores, CBT-i was associated with lower insomnia (Diffadj (95% CI) = 7.32 (5.0-9.6), P < 0.001, d = 1.64), depression (3.36 (1.3-5.4), p = 0.002, d = 0.84), fatigue (5.2 (2.5-7.9), P < 0.001, d = 1.00) and maladaptive beliefs about sleep (11.0 (4.1-18.0), P = 0.002, d = 0.82), but not anxiety symptoms at 8 weeks (1.84 (-0.1 to 3.8), p = 0.060, d = 0.50). Compared to control, CBT-i was associated with greater rates of insomnia remission (ISI <8; 0.0%, vs 40.0%, P < 0.001) and response at 8 weeks (ISI reduction ≥6; 7.1% vs 72.0%, P < 0.001). Improvements in insomnia and depression were maintained at 24 weeks in the CBT-i group. Conclusions: This interactive digital CBT-i program resulted in large and sustained improvements in symptoms of insomnia, depression, fatigue and maladaptive beliefs about sleep in Australian adults with insomnia symptoms. Implementation programs are required to increase digital CBT-i access and uptake.

Internal medicine journal · randomised controlled trial · 7 citationsread the source →

Acceptance and commitment therapy as a web-based intervention for depressive symptoms: randomised controlled trial.

Background: Depression is a highly prevalent disorder, causing a large burden of disease and substantial economic costs. Web-based self-help interventions seem promising in promoting mental health. Aims: To compare the efficacy of a guided web-based intervention based on acceptance and commitment therapy (ACT) with an active control (expressive writing) and a waiting-list control condition (Netherlands Trial Register NTR1296). Method: Adults with depressive symptoms from the general population were randomised to ACT (n = 82), expressive writing (n = 67) or waiting-list control (n = 87). The main outcome was reduction in depressive symptoms assessed with the Center for Epidemiological Studies - Depression scale. Results: Significant reductions in depressive symptoms were found following the ACT intervention, compared with the control group (Cohen's d = 0.56) and the expressive writing intervention (d = 0.36). The effects were sustained at 6-month and 12-month follow-up. Conclusions: Acceptance and commitment therapy as a web-based public mental health intervention for adults with depressive symptoms can be effective and applicable.

The British journal of psychiatry : the journal of mental science · randomised controlled trial · 66 citationsread the source →

A Comprehensive Lifestyle Peer Group-Based Intervention on Cardiovascular Risk Factors: The Randomized Controlled Fifty-Fifty Program.

Background: Cardiovascular diseases stem from modifiable risk factors. Peer support is a proven strategy for many chronic illnesses. Randomized trials assessing the efficacy of this strategy for global cardiovascular risk factor modification are lacking. Objectives: This study assessed the hypothesis that a peer group strategy would help improve healthy behaviors in individuals with cardiovascular risk factors. Methods: A total of 543 adults 25 to 50 years of age with at least 1 risk factor were recruited; risk factors included hypertension (20%), overweight (82%), smoking (31%), and physical inactivity (81%). Subjects were randomized 1:1 to a peer group-based intervention group (IG) or a self-management control group (CG) for 12 months. Peer-elected leaders moderated monthly meetings involving role-play, brainstorming, and activities to address emotions, diet, and exercise. The primary outcome was mean change in a composite score related to blood pressure, exercise, weight, alimentation, and tobacco (Fuster-BEWAT score, 0 to 15). Multilevel models with municipality as a cluster variable were applied to assess differences between groups. Results: Participants' mean age was 42 ± 6 years, 71% were female, and they had a mean baseline Fuster-BEWAT score of 8.42 ± 2.35. After 1 year, the mean scores were significantly higher in the IG (n = 277) than in the CG (n = 266) (IG mean score: 8.84; 95% confidence interval (CI): 8.37 to 9.32; CG mean score: 8.17; 95% CI: 7.55 to 8.79; p = 0.02). The increase in the overall score was significantly larger in the IG compared with the CG (difference: 0.75; 95% CI: 0.32 to 1.18; p = 0.02). The mean improvement in the individual components was uniformly greater in the IG, with a significant difference for the tobacco component. Conclusions: The peer group intervention had beneficial effects on cardiovascular risk factors, with significant improvements in the overall score and specifically on tobacco cessation. A follow-up assessment will be performed 1 year after the final assessment reported here to determine long-term sustainability of the improvements associated with peer group intervention. (Peer-Group-Based Intervention Program [Fifty-Fifty]; NCT02367963).

Journal of the American College of Cardiology · randomised controlled trial · 79 citationsread the source →

How and for whom does web-based acceptance and commitment therapy work? Mediation and moderation analyses of web-based ACT for depressive symptoms.

Background: Acceptance and Commitment Therapy (ACT) has been demonstrated to be effective in reducing depressive symptoms. However, little is known how and for whom therapeutic change occurs, specifically in web-based interventions. This study focuses on the mediators, moderators and predictors of change during a web-based ACT intervention. Methods: Data from 236 adults from the general population with mild to moderate depressive symptoms, randomized to either web-based ACT (n = 82) or one of two control conditions (web-based Expressive Writing (EW; n = 67) and a waiting list (n = 87)), were analysed. Single and multiple mediation analyses, and exploratory linear regression analyses were performed using PROCESS and linear regression analyses, to examine mediators, moderators and predictors on pre- to post- and follow-up treatment change of depressive symptoms. Results: The treatment effect of ACT versus the waiting list was mediated by psychological flexibility and two mindfulness facets. The treatment effect of ACT versus EW was not significantly mediated. The moderator analyses demonstrated that the effects of web-based ACT did not vary according to baseline patient characteristics when compared to both control groups. However, higher baseline depressive symptoms and positive mental health and lower baseline anxiety were identified as predictors of outcome across all conditions. Similar results are found for follow-up. Conclusions: The findings of this study corroborate the evidence that psychological flexibility and mindfulness are distinct process mechanisms that mediate the effects of web-based ACT intervention. The results indicate that there are no restrictions to the allocation of web-based ACT intervention and that web-based ACT can work for different subpopulations. Trial registration: Netherlands Trial Register NTR2736 . Registered 6 February 2011.

BMC psychiatry · randomised controlled trial · 26 citationsread the source →

Community psychosocial music intervention (CHIME) to reduce antenatal common mental disorder symptoms in The Gambia: a feasibility trial.

Objectives: Examine the feasibility of a Community Health Intervention through Musical Engagement (CHIME) in The Gambia to reduce common mental disorder (CMD) symptoms in pregnant women. Design: Feasibility trial testing a randomised stepped-wedge cluster design. Setting: Four local antenatal clinics. Participants: Women who were 14-24 weeks pregnant and spoke Mandinka or Wolof were recruited into the intervention (n=50) or control group (n=74). Intervention: Music-based psychosocial support sessions designed and delivered by all-female fertility societies. Sessions lasted 1 hour and were held weekly for 6 weeks. Delivered to groups of women with no preselection. Sessions were designed to lift mood, build social connection and provide health messaging through participatory music making. The control group received standard antenatal care. Outcomes: Demographic, feasibility, acceptability outcomes and the appropriateness of the study design were assessed. Translated measurement tools (Self-Reporting Questionnaire (SRQ-20); Edinburgh Postnatal Depression Scale (EPDS)) were used to assess CMD symptoms at baseline, post-intervention and 4-week follow-up. Results: All clinics and 82% of women approached consented to take part. A 33% attrition rate across all time points was observed. 72% in the intervention group attended at least three sessions. Audio and video analysis confirmed fidelity of the intervention and a thematic analysis of participant interviews demonstrated acceptability and positive evaluation. Results showed a potential beneficial effect with a reduction of 2.13 points (95% CI (0.89 to 3.38), p<0.01, n=99) on the SRQ-20 and 1.98 points (95% CI (1.06 to 2.90), p<0.01, n=99) on the EPDS at the post-intervention time point for the intervention group compared with standard care. Conclusion: Results demonstrate that CHIME is acceptable and feasible in The Gambia. To our knowledge, CHIME is the first example of a music-based psychosocial intervention to be applied to perinatal mental health in a low- and middle-income country context. Trial registration number: Pan African Clinical Trials Registry (PACTR201901917619299).

BMJ open · randomised controlled trial · 28 citationsread the source →

Standard gastroenterologist versus multidisciplinary treatment for functional gastrointestinal disorders (MANTRA): an open-label, single-centre, randomised controlled trial.

Background: Functional gastrointestinal disorders are common and costly to the health-care system. Most specialist care is provided by a gastroenterologist, but only a minority of patients have improvement in symptoms. Although they have proven to be effective, psychological, behavioural, and dietary therapies are not provided routinely. We aimed to compare the outcome of gastroenterologist-only standard care with multidisciplinary care. Methods: In an open-label, single-centre, pragmatic trial, consecutive new referrals of eligible patients aged 18-80 years with Rome IV criteria-defined functional gastrointestinal disorders were randomly assigned (1:2) to receive gastroenterologist-only standard care or multidisciplinary clinic care. The multidisciplinary clinic included gastroenterologists, dietitians, gut-focused hypnotherapists, psychiatrists, and behavioural (biofeedback) physiotherapists. Randomisation was stratified by Rome IV disorder and whether referred from gastroenterology or colorectal clinic. Outcomes were assessed at clinic discharge or 9 months after the initial visit. The primary outcome was a score of 4 (slightly better) or 5 (much better) on a 5-point Likert scale assessing global symptom improvement. Modified intention-to-treat analysis included all patients who attended at least one clinic visit and who had answered the primary outcome question. This study is registered with ClinicalTrials.gov, NCT03078634. Findings: Between March 16, 2017, and May 10, 2018, 1632 patients referred to the hospital gastrointestinal clinics were screened, of whom 442 were eligible for a screening telephone call and 188 were randomly assigned to receive either standard care (n=65) or multidisciplinary care (n=123). 144 patients formed the modified intention-to-treat analysis (n=46 in the standard-care group and n=98 in the multidisciplinary-care group), 90 (63%) of whom were women. 61 (62%) of 98 patients in the multidisciplinary-care group patients saw allied clinicians. 26 (57%) patients in the standard-care group and 82 (84%) patients in the multidisciplinary-care group had global symptom improvement (risk ratio 1·50 [95% CI 1·13-1·93]; p=0·00045). 29 (63%) patients in the standard-care group and 81 (83%) patients in the multidisciplinary-care group had adequate relief of symptoms in the past 7 days (p=0·010). Patients in the multidisciplinary-care group were more likely to experience a 50% or higher reduction in all Gastrointestinal Symptom Severity Index symptom clusters than were patients in the standard-care group. Of the patients with irritable bowel syndrome, a 50-point or higher reduction in IBS-SSS occurred in 10 (38%) of 26 patients in the standard care group compared with 39 (66%) of 59 patients in the multidisciplinary-care group (p=0·017). Of the patients with functional dyspepsia, a 50% reduction in the Nepean Dyspepsia Index was noted in three (11%) of 11 patients in the standard-care group and in 13 (46%) of 28 in the multidisciplinary-care group (p=0·47). After treatment, the median HADS scores were higher in the standard-care group than in the multidisciplinary-care group (13 [8-20] vs 10 [6-16]; p=0·096) and the median EQ-5D-5L quality of life visual analogue scale was lower in the standard-care group compared with the multidisciplinary-care group (70 [IQR 50-80] vs 75 [65-85]; p=0·0087). The eight SF-36 scales did not differ between the groups at discharge. After treatment, median Somatic Symptom Scale-8 score was higher in the standard-care group than in the multidisciplinary-care group (10 [IQR 7-7] vs 9 [5-13]; p=0·082). Cost per successful outcome was higher in the standard-care group than the multidisciplinary-care group. Interpretation: Integrated multidisciplinary clinical care appears to be superior to gastroenterologist-only care in relation to symptoms, specific functional disorders, psychological state, quality of life, and cost of care for the treatment of functional gastrointestinal disorders. Consideration should be given to providing multidisciplinary care for patients with a functional gastrointestinal disorder. Funding: None.

The lancet. Gastroenterology & hepatology · randomised controlled trial · 89 citationsread the source →

An internet-based intervention with brief nurse support to manage obesity in primary care (POWeR+): a pragmatic, parallel-group, randomised controlled trial.

Background: The obesity epidemic has major public health consequences. Expert dietetic and behavioural counselling with intensive follow-up is effective, but resource requirements severely restrict widespread implementation in primary care, where most patients are managed. We aimed to estimate the effectiveness and cost-effectiveness of an internet-based behavioural intervention (POWeR+) combined with brief practice nurse support in primary care. Methods: We did this pragmatic, parallel-group, randomised controlled trial at 56 primary care practices in central and south England. Eligible adults aged 18 years or older with a BMI of 30 kg/m(2) or more (or ≥28 kg/m(2) with hypertension, hypercholesterolaemia, or diabetes) registered online with POWeR+-a 24 session, web-based, weight management intervention lasting 6 months. After registration, the website automatically randomly assigned patients (1:1:1), via computer-generated random numbers, to receive evidence-based dietetic advice to swap foods for similar, but healthier, choices and increase fruit and vegetable intake, in addition to 6 monthly nurse follow-up (control group); web-based intervention and face-to-face nurse support (POWeR+Face-to-face [POWeR+F]; up to seven nurse contacts over 6 months); or web-based intervention and remote nurse support (POWeR+Remote [POWeR+R]; up to five emails or brief phone calls over 6 months). Participants and investigators were masked to group allocation at the point of randomisation; masking of participants was not possible after randomisation. The primary outcome was weight loss averaged over 12 months. We did a secondary analysis of weight to measure maintenance of 5% weight loss at months 6 and 12. We modelled the cost-effectiveness of each intervention. We did analysis by intention to treat, with multiple imputation for missing data. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN21244703. Findings: Between Jan 30, 2013, and March 20, 2014, 818 participants were randomly assigned to the control group (n=279), the POWeR+F group (n=269), or the POWeR+R group (n=270). Weight loss averaged over 12 months was recorded in 666 (81%) participants. The control group lost almost 3 kg over 12 months (crude mean weight: baseline 104·38 kg [SD 21·11; n=279], 6 months 101·91 kg [19·35; n=136], 12 months 101·74 kg [19·57; n=227]). The primary imputed analysis showed that compared with the control group, patients in the POWeR+F group achieved an additional weight reduction of 1·5 kg (95% CI 0·6-2·4; p=0·001) averaged over 12 months, and patients in the POWeR+R group achieved an additional 1·3 kg (0·34-2·2; p=0·007). 21% of patients in the control group had maintained a clinically important 5% weight reduction at month 12, compared with 29% of patients in the POWeR+F group (risk ratio 1·56, 0·96-2·51; p=0·070) and 32% of patients in the POWeR+R group (1·82, 1·31-2·74; p=0·004). The incremental overall cost to the health service per kg weight lost with the POWeR+ interventions versus the control strategy was £18 (95% CI -129 to 195) for POWeR+F and -£25 (-268 to 157) for POWeR+R; the probability of being cost-effective at a threshold of £100 per kg lost was 88% and 98%, respectively. No adverse events were reported. Interpretation: Weight loss can be maintained in some individuals by use of novel written material with occasional brief nurse follow-up. However, more people can maintain clinically important weight reductions with a web-based behavioural program and brief remote follow-up, with no increase in health service costs. Future research should assess the extent to which clinically important weight loss can be maintained beyond 1 year. Funding: Health Technology Assessment Programme of the National Institute for Health Research.

The lancet. Diabetes & endocrinology · randomised controlled trial · 85 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 →

Effect of Hydrolyzed Infant Formula vs Conventional Formula on Risk of Type 1 Diabetes: The TRIGR Randomized Clinical Trial.

Importance: Early exposure to complex dietary proteins may increase the risk of type 1 diabetes in children with genetic disease susceptibility. There are no intact proteins in extensively hydrolyzed formulas. Objective: To test the hypothesis that weaning to an extensively hydrolyzed formula decreases the cumulative incidence of type 1 diabetes in young children. Design, setting, and participants: An international double-blind randomized clinical trial of 2159 infants with human leukocyte antigen-conferred disease susceptibility and a first-degree relative with type 1 diabetes recruited from May 2002 to January 2007 in 78 study centers in 15 countries; 1081 were randomized to be weaned to the extensively hydrolyzed casein formula and 1078 to a conventional formula. The follow-up of the participants ended on February 28, 2017. Interventions: The participants received either a casein hydrolysate or a conventional adapted cow's milk formula supplemented with 20% of the casein hydrolysate. The minimum duration of study formula exposure was 60 days by 6 to 8 months of age. Main outcomes and measures: Primary outcome was type 1 diabetes diagnosed according to World Health Organization criteria. Secondary outcomes included age at diabetes diagnosis and safety (adverse events). Results: Among 2159 newborn infants (1021 female [47.3%]) who were randomized, 1744 (80.8%) completed the trial. The participants were observed for a median of 11.5 years (quartile [Q] 1-Q3, 10.2-12.8). The absolute risk of type 1 diabetes was 8.4% among those randomized to the casein hydrolysate (n = 91) vs 7.6% among those randomized to the conventional formula (n = 82) (difference, 0.8% [95% CI, -1.6% to 3.2%]). The hazard ratio for type 1 diabetes adjusted for human leukocyte antigen risk group, duration of breastfeeding, duration of study formula consumption, sex, and region while treating study center as a random effect was 1.1 (95% CI, 0.8 to 1.5; P = .46). The median age at diagnosis of type 1 diabetes was similar in the 2 groups (6.0 years [Q1-Q3, 3.1-8.9] vs 5.8 years [Q1-Q3, 2.6-9.1]; difference, 0.2 years [95% CI, -0.9 to 1.2]). Upper respiratory infections were the most common adverse event reported (frequency, 0.48 events/year in the hydrolysate group and 0.50 events/year in the control group). Conclusions and relevance: Among infants at risk for type 1 diabetes, weaning to a hydrolyzed formula compared with a conventional formula did not reduce the cumulative incidence of type 1 diabetes after median follow-up for 11.5 years. These findings do not support a need to revise the dietary recommendations for infants at risk for type 1 diabetes. Trial registration: clinicaltrials.gov Identifier: NCT00179777.

JAMA · randomised controlled trial · 97 citationsread the source →

Randomized controlled trial investigating the effects of a breastfeeding relaxation intervention on maternal psychological state, breast milk outcomes, and infant behavior and growth.

Background: Biological signaling and communication between mothers and infants during breastfeeding may shape infant behavior and feeding. This signaling is complex and little explored in humans, although it is potentially relevant for initiatives to improve breastfeeding rates. Objectives: The aim of this study was to investigate physiological and psychological aspects of mother-infant signaling during breastfeeding experimentally, testing the effects of a relaxation intervention on maternal psychological state, breast milk intake, milk cortisol levels, and infant behavior and growth. Methods: Primiparous breastfeeding mothers and full-term infants were randomly assigned to receive relaxation therapy [intervention relaxation group; n = 33 (RG)] or to the control group [n = 31 (CG); no relaxation therapy] at 2 wk postpartum. Both groups received standard breastfeeding support. Home visits were conducted at 2 (HV1), 6 (HV2), 12 (HV3) and 14 (HV4) wk to measure maternal stress and anxiety, breast milk intake and milk cortisol, and infant behavior and growth. Results: RG mothers had lower stress scores postintervention than the CG (HV3 ∆ = -3.13; 95% CI: -5.9, -0.3) and lower hindmilk cortisol at HV1 (∆ = -44.5%; 95% CI: -76.1%, -12.9%) but not at HV2. RG infants had longer sleep duration (∆ = 82 min/d; 95% CI: 16, 149 min/d) at HV2 and higher gains in weight and body mass index standardized deviation score than the CG infants (∆ = 0.76; 95% CI: 0.3, 1.22; and ∆ = 0.59; 95% CI: 0.09, 1.1, respectively). RG infants had a mean milk intake at HV3 that was 227 g/d higher than that of the CG infants (P = 0.031) after controlling for gender and milk intake at HV1. Conclusions: The trial shows the effectiveness of a simple relaxation intervention for improving maternal and infant outcomes and identifies some potential signaling mechanisms for investigation in future and larger studies, especially in settings where mothers are more stressed, such as those with preterm or low birth weight infants. This trial was registered at clinicaltrials.gov as NCT01971216.

The American journal of clinical nutrition · randomised controlled trial · 66 citationsread the source →

Effects of Family-Focused Therapy vs Enhanced Usual Care for Symptomatic Youths at High Risk for Bipolar Disorder: A Randomized Clinical Trial.

Importance: Behavioral high-risk phenotypes predict the onset of bipolar disorder among youths who have parents with bipolar disorder. Few studies have examined whether early intervention delays new mood episodes in high-risk youths. Objective: To determine whether family-focused therapy (FFT) for high-risk youths is more effective than standard psychoeducation in hastening recovery and delaying emergence of mood episodes during the 1 to 4 years after an active period of mood symptoms. Design, settings, and participants: This multisite randomized clinical trial included referred youths (aged 9-17 years) with major depressive disorder or unspecified (subthreshold) bipolar disorder, active mood symptoms, and at least 1 first- or second-degree relative with bipolar disorder I or II. Recruitment started from October 6, 2011, and ended on September 15, 2016. Independent evaluators interviewed participants every 4 to 6 months to measure symptoms for up to 4 years. Data analysis was performed from March 13 to November 3, 2019. Interventions: High-risk youths and parents were randomly allocated to FFT (12 sessions in 4 months of psychoeducation, communication training, and problem-solving skills training; n = 61) or enhanced care (6 sessions in 4 months of family and individual psychoeducation; n = 66). Youths could receive medication management in either condition. Main outcomes and measures: The coprimary outcomes, derived using weekly psychiatric status ratings, were time to recovery from prerandomization symptoms and time to a prospectively observed mood (depressive, manic, or hypomanic) episode after recovery. Secondary outcomes were time to conversion to bipolar disorder I or II and longitudinal symptom trajectories. Results: All 127 participants (82 [64.6%] female; mean [SD] age, 13.2 [2.6] years) were followed up for a median of 98 weeks (range, 0-255 weeks). No differences were detected between treatments in time to recovery from pretreatment symptoms. High-risk youths in the FFT group had longer intervals from recovery to the emergence of the next mood episode (χ2 = 5.44; P = .02; hazard ratio, 0.55; 95% CI, 0.48-0.92;), and from randomization to the next mood episode (χ2 = 4.44; P = .03; hazard ratio, 0.59; 95% CI, 0.35-0.97) than youths in enhanced care. Specifically, FFT was associated with longer intervals to depressive episodes (log-rank χ2 = 6.24; P = .01; hazard ratio, 0.53; 95% CI, 0.31-0.88) but did not differ from enhanced care in time to manic or hypomanic episodes, conversions to bipolar disorder, or symptom trajectories. Conclusions and relevance: Family skills-training for youths at high risk for bipolar disorder is associated with longer times between mood episodes. Clarifying the relationship between changes in family functioning and changes in the course of high-risk syndromes merits future investigation. Trial registration: ClinicalTrials.gov identifier: NCT01483391.

JAMA psychiatry · randomised controlled trial · 54 citationsread the source →

Intellectual, behavioral, and emotional functioning in children with syndromic craniosynostosis.

Objectives: To examine intellectual, behavioral, and emotional functioning of children who have syndromic craniosynostosis and to explore differences between diagnostic subgroups. Methods: A national sample of children who have syndromic craniosynostosis participated in this study. Intellectual, behavioral, and emotional outcomes were assessed by using standardized measures: Wechsler Intelligence Scale for Children, Third Edition, Child Behavior Checklist (CBCL)/6-18, Disruptive Behavior Disorder rating scale (DBD), and the National Institute of Mental Health Diagnostic Interview Schedule for Children. Results: We included 82 children (39 boys) aged 6 to 13 years who have syndromic craniosynostosis. Mean Full-Scale IQ (FSIQ) was in the normal range (M = 96.6; SD = 21.6). However, children who have syndromic craniosynostosis had a 1.9 times higher risk for developing intellectual disability (FSIQ < 85) compared with the normative population (P < .001) and had more behavioral and emotional problems compared with the normative population, including higher scores on the CBCL/6-18, DBD Total Problems (P < .001), Internalizing (P < .01), social problems (P < .001), attention problems (P < .001), and the DBD Inattention (P < .001). Children who have Apert syndrome had lower FSIQs (M = 76.7; SD = 13.3) and children who have Muenke syndrome had more social problems (P < .01), attention problems (P < .05), and inattention problems (P < .01) than normative population and with other diagnostic subgroups. Conclusions: Although children who have syndromic craniosynostosis have FSIQs similar to the normative population, they are at increased risk for developing intellectual disability, internalizing, social, and attention problems. Higher levels of behavioral and emotional problems were related to lower levels of intellectual functioning.

Pediatrics · 48 citationsread the source →

Interventions for preventing obesity in children.

Background: Prevention of childhood obesity is an international public health priority given the significant impact of obesity on acute and chronic diseases, general health, development and well-being. The international evidence base for strategies that governments, communities and families can implement to prevent obesity, and promote health, has been accumulating but remains unclear. Objectives: This review primarily aims to update the previous Cochrane review of childhood obesity prevention research and determine the effectiveness of evaluated interventions intended to prevent obesity in children, assessed by change in Body Mass Index (BMI). Secondary aims were to examine the characteristics of the programs and strategies to answer the questions "What works for whom, why and for what cost?" Search methods: The searches were re-run in CENTRAL, MEDLINE, EMBASE, PsychINFO and CINAHL in March 2010 and searched relevant websites. Non-English language papers were included and experts were contacted. Selection criteria: The review includes data from childhood obesity prevention studies that used a controlled study design (with or without randomisation). Studies were included if they evaluated interventions, policies or programs in place for twelve weeks or more. If studies were randomised at a cluster level, 6 clusters were required. Data collection and analysis: Two review authors independently extracted data and assessed the risk of bias of included studies.  Data was extracted on intervention implementation, cost, equity and outcomes. Outcome measures were grouped according to whether they measured adiposity, physical activity (PA)-related behaviours or diet-related behaviours.  Adverse outcomes were recorded. A meta-analysis was conducted using available BMI or standardised BMI (zBMI) score data with subgroup analysis by age group (0-5, 6-12, 13-18 years, corresponding to stages of developmental and childhood settings). Main results: This review includes 55 studies (an additional 36 studies found for this update). The majority of studies targeted children aged 6-12 years.  The meta-analysis included 37 studies of 27,946 children and demonstrated that programmes were effective at reducing adiposity, although not all individual interventions were effective, and there was a high level of observed heterogeneity (I(2)=82%).  Overall, children in the intervention group had a standardised mean difference in adiposity (measured as BMI or zBMI) of -0.15kg/m(2) (95% confidence interval (CI): -0.21 to -0.09).  Intervention effects by age subgroups were -0.26kg/m(2) (95% CI:-0.53 to 0.00) (0-5 years), -0.15kg/m(2) (95% CI -0.23 to -0.08) (6-12 years), and -0.09kg/m(2) (95% CI -0.20 to 0.03) (13-18 years). Heterogeneity was apparent in all three age groups and could not explained by randomisation status or the type, duration or setting of the intervention.  Only eight studies reported on adverse effects and no evidence of adverse outcomes such as unhealthy dieting practices, increased prevalence of underweight or body image sensitivities was found.  Interventions did not appear to increase health inequalities although this was examined in fewer studies. Authors' conclusions: We found strong evidence to support beneficial effects of child obesity prevention programmes on BMI, particularly for programmes targeted to children aged six to 12 years. However, given the unexplained heterogeneity and the likelihood of small study bias, these findings must be interpreted cautiously. A broad range of programme components were used in these studies and whilst it is not possible to distinguish which of these components contributed most to the beneficial effects observed, our synthesis indicates the following to be promising policies and strategies:·         school curriculum that includes healthy eating, physical activity and body image·         increased sessions for physical activity and the development of fundamental movement skills throughout the school week·         improvements in nutritional quality of the food supply in schools·         environments and cultural practices that support children eating healthier foods and being active throughout each day·         support for teachers and other staff to implement health promotion strategies and activities (e.g. professional development, capacity building activities)·         parent support and home activities that encourage children to be more active, eat more nutritious foods and spend less time in screen based activitiesHowever, study and evaluation designs need to be strengthened, and reporting extended to capture process and implementation factors, outcomes in relation to measures of equity, longer term outcomes, potential harms and costs. Childhood obesity prevention research must now move towards identifying how effective intervention components can be embedded within health, education and care systems and achieve long term sustainable impacts.  

The Cochrane database of systematic reviews · meta-analysis · 884 citationsread the source →

Randomized clinical trial examining the incremental efficacy of a 90-minute motivational alcohol intervention as an adjunct to standard batterer intervention for men.

Aims: The efficacy of batterer intervention programs to reduce intimate partner violence (IPV) is questionable, with individuals with alcohol problems particularly unlikely to benefit. We examined whether adding adjunctive alcohol intervention to batterer intervention reduced the likelihood of substance use and violence relative to batterer intervention alone. Design: Randomized clinical trial. Setting: Batterer intervention programs in Rhode Island, USA. Participants: A total of 252 hazardous drinking men in batterer intervention programs. Participants were randomized to receive 40 hours of standard batterer program (SBP) or the SBP plus a 90-minute alcohol intervention (SBP + BAI). None withdrew due to adverse effects. Data were collected at baseline, 3-, 6- and 12-month follow-up, with follow-up rates of 95, 89 and 82%, respectively. Measurements: Substance use was measured with a well-validated calendar-assisted interview. Violence was measured with a validated questionnaire. Arrest records were obtained for all participants. The primary substance use outcome was drinks per drinking day (DPDD) and the primary violence outcome was frequency of any physical IPV. Findings: Relative to SBP alone, men receiving SBP + BAI reported consuming fewer DPDD at 3-month follow-up [B = -1.36, 95% confidence interval (CI): -2.65, -0.04, P = 0.04] but not 6- or 12-month follow-up. In secondary analyses, men receiving SBP + BAI reported significantly greater abstinence at 3- (B = 0.09, 95% CI: 0.03, 0.14, P = 0.002) and 6-month (B = 0.06, 95% CI: 0.01, 0.11, P = 0.01) follow-up but not 12-month follow-up. There were no significant differences in physical IPV between men receiving SBP and men receiving SBP + BAI. In secondary analyses, men receiving SBP + BAI reported less severe physical aggression at 3-month (IRR = 0.18, 95% CI: 0.05, 0.65, P = 0.009) but not 6- or 12-month follow-up. Men receiving SBP + BAI reported less severe psychological aggression (B = -1.24, 95% CI: -2.47, -0.02, P = 0.04) and fewer injuries to partners at 3- and 6-month follow-up (IRR = 0.33, 95% CI: 0.12, 0.92, P = 0.03), with differences fading by 12 months. Conclusions: Men with a history of intimate partner violence and hazardous drinking who received a batterer intervention plus an alcohol intervention showed improved alcohol and violence outcomes initially, but improvements faded by 12 months.

Addiction (Abingdon, England) · randomised controlled trial · 49 citationsread the source →

Cognitive-behavioral group depression prevention compared to bibliotherapy and brochure control: nonsignificant effects in pilot effectiveness trial with college students.

Objective: Conduct a pilot trial testing whether a brief cognitive-behavioral (CB) group reduced depressive symptoms and secondary outcomes relative to bibliotherapy and brochure controls in college students with elevated depressive symptoms. Method: 82 college students (M age=19.0, SD=0.9; 70% female, 80% White) with elevated self-assessed depressive symptoms were randomized to a 6-session CB group, bibliotherapy, or educational brochure control condition, completing assessments at pretest, posttest, and at 6- and 12-month follow-up. Results: Planned contrasts found no significant effects for CB group on depressive symptoms compared to either bibliotherapy or brochure controls at posttest (d=-.08 and .06, respectively) or over follow-up (d=-.04 and -.10, respectively). There were no intervention effects for social adjustment and substance use, though CB group participants had improved knowledge of CB concepts at posttest, versus brochure controls. Condition differences in major depression onset were nonsignificant but suggested support for CB interventions (CB group=7.4%, bibliotherapy=4.5%, brochure control=15.2%). Conclusions: Unexpectedly modest support was found for a brief CB group depression prevention intervention, compared to bibliotherapy or brochure control, when provided to self-selected college students, suggesting that alternative screening or interventions approaches are needed for this population.

Behaviour research and therapy · randomised controlled trial · 17 citationsread the source →

D-Cycloserine as an augmentation strategy with cognitive-behavioral therapy for social anxiety disorder.

Objective: The authors examined whether D-cycloserine, a partial agonist at the glutamatergic N-methyl-d-aspartate receptor, augments and accelerates a full course of comprehensive cognitive-behavioral therapy (CBT) in adults with generalized social anxiety disorder. Method: This was a multisite randomized placebo-controlled efficacy study with 169 medication-free adults with generalized social anxiety disorder, of whom 144 completed the 12-week treatment and 131 completed the three follow-up assessments. Patients were randomly assigned to receive 50 mg of D-cycloserine or placebo 1 hour before each of five exposure sessions that were part of a 12-session cognitive-behavioral group treatment. Response and remission status was determined at baseline, throughout treatment, at end of treatment, and at 1-, 3-, and 6-month follow-up assessments by assessors who were blind to treatment condition. Results: D-Cycloserine-augmented and placebo-augmented CBT were associated with similar completion rates (87% and 82%), response rates (79.3% and 73.3%), and remission rates (34.5% and 24.4%) at the posttreatment assessment; response and remission rates were largely maintained at the follow-up assessments. Although D-cycloserine was associated with a 24%-33% faster rate of improvement in symptom severity and remission rates relative to placebo during the treatment phase, the groups did not differ in response and remission rates. Conclusions: D-Cycloserine did not augment a full course of comprehensive CBT for social anxiety disorder.

The American journal of psychiatry · randomised controlled trial · 72 citationsread the source →

A multifaith spiritually based intervention for generalized anxiety disorder: a pilot randomized trial

This pilot trial evaluated the efficacy of a multifaith spiritually based intervention (SBI) for generalized anxiety disorder (GAD). Patients meeting DSM-IV criteria for GAD of at least moderate severity were randomized to either 12 sessions of the SBI (n=11) delivered by a spiritual care counselor or 12 sessions of psychologist-administered cognitive-behavioral therapy (CBT; n=11). Outcome measures were completed at baseline, post-treatment, and 3-month and 6-month follow-ups. Primary efficacy measures included the Hamilton Anxiety Rating Scale, Beck Anxiety Inventory, and Penn State Worry Questionnaire. Data analysis was performed on the intent-to-treat sample using the Last Observation Carried Forward method. Eighteen patients (82%) completed the study. The SBI produced robust and clinically significant reductions from baseline in psychic and somatic symptoms of GAD and was comparable in efficacy to CBT. A reduction in depressive symptoms and improvement in social adjustment was also observed. Treatment response occurred in 63.6% of SBI-treated and 72.3% of CBT-treated patients. Gains were maintained at 3-month and 6-month follow-ups. These preliminary findings are encouraging and suggest that a multifaith SBI may be an effective treatment option for GAD. Further randomized controlled trials are needed to establish the efficacy of this intervention.

Journal of Clinical Psychology · randomised controlled trial · 116 citationsread the source →

A pilot study and randomized controlled trial of the mindful self-compassion program.

Objectives: The aim of these two studies was to evaluate the effectiveness of the Mindful Self-Compassion (MSC) program, an 8-week workshop designed to train people to be more self-compassionate. Methods: Study 1 was a pilot study that examined change scores in self-compassion, mindfulness, and various wellbeing outcomes among community adults (N = 21; mean [M] age = 51.26, 95% female). Study 2 was a randomized controlled trial that compared a treatment group (N = 25; M age = 51.21; 78% female) with a waitlist control group (N = 27; M age = 49.11; 82% female). Results: Study 1 found significant pre/post gains in self-compassion, mindfulness, and various wellbeing outcomes. Study 2 found that compared with the control group, intervention participants reported significantly larger increases in self-compassion, mindfulness, and wellbeing. Gains were maintained at 6-month and 1-year follow-ups. Conclusions: The MSC program appears to be effective at enhancing self-compassion, mindfulness, and wellbeing.

Journal of clinical psychology · randomised controlled trial · 712 citationsread the source →

A randomised, blinded, placebo-controlled trial in dementia patients continuing or stopping neuroleptics (the DART-AD trial).

Background: There have been increasing concerns regarding the safety and efficacy of neuroleptics in people with dementia, but there are very few long-term trials to inform clinical practice. The aim of this study was to determine the impact of long-term treatment with neuroleptic agents upon global cognitive decline and neuropsychiatric symptoms in patients with Alzheimer disease. Methods and findings: Design: Randomised, blinded, placebo-controlled parallel two-group treatment discontinuation trial. Setting: Oxfordshire, Newcastle and Gateshead, London and Edinburgh, United Kingdom. Participants: Patients currently prescribed the neuroleptics thioridazine, chlorpromazine, haloperidol trifluoperazine or risperidone for behavioural or psychiatric disturbance in dementia for at least 3 mo. Interventions: Continue neuroleptic treatment for 12 mo or switch to an identical placebo. Outcome measures: Primary outcome was total Severe Impairment Battery (SIB) score. Neuropsychiatric symptoms were evaluated with the Neuropsychiatric Inventory (NPI). Results: 165 patients were randomised (83 to continue treatment and 82 to placebo, i.e., discontinue treatment), of whom 128 (78%) commenced treatment (64 continue/64 placebo). Of those, 26 were lost to follow-up (13 per arm), resulting in 51 patients per arm analysed for the primary outcome. There was no significant difference between the continue treatment and placebo groups in the estimated mean change in SIB scores between baseline and 6 mo; estimated mean difference in deterioration (favouring placebo) -0.4 (95% confidence interval [CI] -6.4 to 5.5), adjusted for baseline value (p = 0.9). For neuropsychiatric symptoms, there was no significant difference between the continue treatment and placebo groups (n = 56 and 53, respectively) in the estimated mean change in NPI scores between baseline and 6 mo; estimated mean difference in deterioration (favouring continue treatment) -2.4 (95% CI -8.2 to 3.5), adjusted for baseline value (p = 0.4). Both results became more pronounced at 12 mo. There was some evidence to suggest that those patients with initial NPI >/= 15 benefited on neuropsychiatric symptoms from continuing treatment. Conclusions: For most patients with AD, withdrawal of neuroleptics had no overall detrimental effect on functional and cognitive status. Neuroleptics may have some value in the maintenance treatment of more severe neuropsychiatric symptoms, but this benefit must be weighed against the side effects of therapy. Trial registration: Cochrane Central Registry of Controlled Trials/National Research Register (#ISRCTN33368770).

PLoS medicine · randomised controlled trial · 138 citationsread the source →

Cognitive behavioural therapy in addition to antispasmodic therapy for irritable bowel syndrome in primary care: randomised controlled trial.

Objectives: To determine whether cognitive behavioural therapy (CBT) in addition to antispasmodic treatment offers a cost-effective benefit to primary care patients with irritable bowel syndrome (IBS) and to identify predictors of outcome. Design: This was a randomised controlled trial in primary care of the addition of CBT to standard general practice management of IBS, using the antispasmodic agent mebeverine hydrochloride. The study set out to compare the addition of a standardised package of IBS-specific CBT to treatment with mebeverine hydrochloride. Setting: Ten general practices, serving a population of around 45,000 patients, located principally in south London, with some patients resident in north London. Participants: Patients identified as having IBS by their GPs, aged between 17 and 54 (mean 34) years and predominantly white; 82% were female and half had had IBS for more than 5 years. Interventions: Practice nurses delivered CBT in a randomised trial of the addition of CBT to mebeverine in patients who had IBS of moderate or greater severity after 2 weeks of GP care and 4 weeks of mebeverine. The Symptom Severity Scale (SSS) was used to identify patients with moderate or severe IBS. Patients who continued to report moderate or severe IBS after 4 weeks of mebeverine at a dose of 270 mg three times a day were randomised to receive six sessions of CBT in addition to mebeverine (72 patients) or mebeverine alone (77 patients). These patients were followed at 3, 6 and 12 months after treatment. As part of the baseline evaluation, blood tests for antiendomysial and antigliadin antibodies were carried out on 141 patients to determine the prevalence of coeliac disease in this population. Main outcome measures: The principal outcome measure was the SSS. Others included the Hospital Anxiety and Depression Scale, psychopathology, the Work and Social Adjustment Scale (WASA, disability), a modified version of the Illness Perception Questionnaire (illness perceptions), the Beliefs about Medicine Questionnaire (attitudes to medication), the Reported Adherence to Medication Scale (adherence to prescribed medication), the Client Service Receipt Inventory (economic analysis), the Cognitive Scale for Functional Bowel Disorders (illness cognitions) and the Behaviour Scale for IBS (IBS coping behaviour). Results: The addition of CBT produced a significant benefit compared with the mebeverine-only group at 3 months after treatment on all outcome measures, except for the adherence to medication scales. The difference between the groups was 107.8 points on the SSS, 24.5 points on question 4 of the SSS and 6.3 points on the WASA, representing therapeutic gains of approximately 20%, 28% and 40%, respectively. However, there was also evidence that these improvements began to wane, so that at 6 and 12 months follow-up significant therapeutic benefit of the addition of CBT could only be detected on question 4 of the SSS and on the WASA. The behaviour scale for IBS detected significant, positive changes in coping behaviours at up to 6 months after treatment. Three factors predicting a poor outcome were identified: male gender, believing that IBS had serious consequences and belief in an external aetiology, all of which were associated with greater than average disability at follow-up. The addition of CBT to mebeverine did not reduce overall treatment or social costs. The nested study on testing for coeliac disease provides cautious support for the inclusion of antiendomysial and antigliadin antibody testing in the investigation of patients thought to have IBS. Conclusions: Specially trained practice nurses can provide effective CBT to primary care patients with a clinical diagnosis of IBS, which although effective does not reduce service or social costs. Using a variety of measures the beneficial therapeutic effects of the addition of CBT to antispasmodic therapy persist for up to 6 months. Future research might include studies of the long-term follow-up of IBS patients treated with CBT, cost-benefit analyses comparing CBT with other therapeutic approaches to IBS, and evaluating means of training both non-specialist health professionals and GPs to deliver CBT.

Health technology assessment (Winchester, England) · randomised controlled trial · 48 citationsread the source →

Cognitive behavioral therapy for 4- to 7-year-old children with anxiety disorders: a randomized clinical trial.

Objective: To examine the efficacy of a developmentally appropriate parent-child cognitive behavioral therapy (CBT) protocol for anxiety disorders in children ages 4-7 years. Method: Design: Randomized wait-list controlled trial. Conduct: Sixty-four children (53% female, mean age 5.4 years, 80% European American) with anxiety disorders were randomized to a parent-child CBT intervention (n = 34) or a 6-month wait-list condition (n = 30). Children were assessed by interviewers blind to treatment assignment, using structured diagnostic interviews with parents, laboratory assessments of behavioral inhibition, and parent questionnaires. Analysis: Chi-square analyses of outcome rates and linear and ordinal regression of repeated measures, examining time by intervention interactions. Results: The response rate (much or very much improved on the Clinical Global Impression Scale for Anxiety) among 57 completers was 69% versus 32% (CBT vs. controls), p < .01; intent-to-treat: 59% vs. 30%, p = .016. Treated children showed a significantly greater decrease in anxiety disorders (effect size [ES] = .55) and increase in parent-rated coping (ES = .69) than controls, as well as significantly better CGI improvement on social phobia/avoidant disorder (ES = .95), separation anxiety disorder (ES = .82), and specific phobia (ES = .78), but not on generalized anxiety disorder. Results on the Child Behavior Checklist Internalizing scale were not significant and were limited by low return rates. Treatment response was unrelated to age or parental anxiety but was negatively predicted by behavioral inhibition. Gains were maintained at 1-year follow-up. Conclusions: Results suggest that developmentally modified parent-child CBT may show promise in 4- to 7-year-old children.

Journal of consulting and clinical psychology · randomised controlled trial · 114 citationsread the source →

Treating fibromyalgia with mindfulness-based stress reduction: results from a 3-armed randomized controlled trial.

Mindfulness-based stress reduction (MBSR) is a structured 8-week group program teaching mindfulness meditation and mindful yoga exercises. MBSR aims to help participants develop nonjudgmental awareness of moment-to-moment experience. Fibromyalgia is a clinical syndrome with chronic pain, fatigue, and insomnia as major symptoms. Efficacy of MBSR for enhanced well-being of fibromyalgia patients was investigated in a 3-armed trial, which was a follow-up to an earlier quasi-randomized investigation. A total of 177 female patients were randomized to one of the following: (1) MBSR, (2) an active control procedure controlling for nonspecific effects of MBSR, or (3) a wait list. The major outcome was health-related quality of life (HRQoL) 2 months post-treatment. Secondary outcomes were disorder-specific quality of life, depression, pain, anxiety, somatic complaints, and a proposed index of mindfulness. Of the patients, 82% completed the study. There were no significant differences between groups on primary outcome, but patients overall improved in HRQoL at short-term follow-up (P=0.004). Post hoc analyses showed that only MBSR manifested a significant pre-to-post-intervention improvement in HRQoL (P=0.02). Furthermore, multivariate analysis of secondary measures indicated modest benefits for MBSR patients. MBSR yielded significant pre-to-post-intervention improvements in 6 of 8 secondary outcome variables, the active control in 3, and the wait list in 2. In conclusion, primary outcome analyses did not support the efficacy of MBSR in fibromyalgia, although patients in the MBSR arm appeared to benefit most. Effect sizes were small compared to the earlier, quasi-randomized investigation. Several methodological aspects are discussed, e.g., patient burden, treatment preference and motivation, that may provide explanations for differences. In a 3-armed randomized controlled trial in female patients suffering from fibromyalgia, patients benefited modestly from a mindfulness-based stress reduction intervention.

Pain · randomised controlled trial · 168 citationsread the source →

Long-term effectiveness and safety of dexmethylphenidate extended-release capsules in adult ADHD.

Objective: This study evaluates dexmethylphenidate extended release (d-MPH-ER) in adults with ADHD. Method: Following a 5-week, randomized, controlled, fixed-dose study of d-MPH-ER 20 to 40 mg/d, 170 adults entered a 6-month open-label extension (OLE) to assess long-term safety, with flexible dosing of 20 to 40 mg/d. Exploratory effectiveness outcomes included change from Week 5 on ADHD Rating Scale (ADHD-RS) and proportion of responders on Clinical Global Impressions-Improvement (CGI-I) scale. Results: 103 patients completed OLE, and effectiveness was evaluable in 102 patients. d-MPH-ER was well tolerated; the most common adverse events (>15%) were headache, insomnia, and decreased appetite. Mean improvements in ADHD-RS score were -10.2 for patients switched from placebo to d-MPH-ER (n = 20) and -8.4 for those maintained on d-MPH-ER (n = 82). Respective CGI-I responder rates were 95.0% and 95.1%. Conclusion: Once-daily d-MPH-ER 20 to 40 mg is safe and effective for long-term treatment of adult ADHD.

Journal of attention disorders · randomised controlled trial · 36 citationsread the source →

Quality of Life of Adults With Congenital Heart Disease in 15 Countries: Evaluating Country-Specific Characteristics.

Background: Measuring quality of life (QOL) is fundamental to understanding the impact of disease and treatment on patients' lives. Objectives: This study aimed to explore QOL in an international sample of adults with congenital heart disease (CHD), the association between patient characteristics and QOL, and international variation in QOL and its relationship to country-specific characteristics. Methods: We enrolled 4,028 adults with CHD from 15 countries. QOL was assessed using a linear analog scale (LAS) (0 to 100) and the Satisfaction with Life Scale (SWLS) (5 to 35). Patient characteristics included sex, age, marital status, educational level, employment status, CHD complexity, and patient-reported New York Heart Association (NYHA) functional class. Country-specific characteristics included general happiness and 6 cultural dimensions. Linear mixed models were applied. Results: Median QOL was 80 on the LAS and 27 on the SWLS. Older age, lack of employment, no marriage history, and worse NYHA functional class were associated with lower QOL (p < 0.001). Patients from Australia had the highest QOL (LAS: 82) and patients from Japan the lowest (LAS: 72). Happiness scores and cultural dimensions were not associated with variation in QOL after adjustment for patient characteristics and explained only an additional 0.1% of the variance above and beyond patient characteristics (p = 0.56). Conclusions: This large-scale, international study found that overall QOL in adults with CHD was generally good. Variation in QOL was related to patient characteristics but not country-specific characteristics. Hence, patients at risk for poorer QOL can be identified using uniform criteria. General principles for designing interventions to improve QOL can be developed.

Journal of the American College of Cardiology · cohort or longitudinal · 116 citationsread the source →

Development and Validation of a Smartphone-Based Visual Acuity Test (Peek Acuity) for Clinical Practice and Community-Based Fieldwork.

Importance: Visual acuity is the most frequently performed measure of visual function in clinical practice and most people worldwide living with visual impairment are living in low- and middle-income countries. Objective: To design and validate a smartphone-based visual acuity test that is not dependent on familiarity with symbols or letters commonly used in the English language. Design, setting, and participants: Validation study conducted from December 11, 2013, to March 4, 2014, comparing results from smartphone-based Peek Acuity to Snellen acuity (clinical normal) charts and the Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart (reference standard). This study was nested within the 6-year follow-up of the Nakuru Eye Disease Cohort in central Kenya and included 300 adults aged 55 years and older recruited consecutively. Main outcomes and measures: Outcome measures were monocular logMAR visual acuity scores for each test: ETDRS chart logMAR, Snellen acuity, and Peek Acuity. Peek Acuity was compared, in terms of test-retest variability and measurement time, with the Snellen acuity and ETDRS logMAR charts in participants' homes and temporary clinic settings in rural Kenya in 2013 and 2014. Results: The 95% CI limits for test-retest variability of smartphone acuity data were ±0.033 logMAR. The mean differences between the smartphone-based test and the ETDRS chart and the smartphone-based test and Snellen acuity data were 0.07 (95% CI, 0.05-0.09) and 0.08 (95% CI, 0.06-0.10) logMAR, respectively, indicating that smartphone-based test acuities agreed well with those of the ETDRS and Snellen charts. The agreement of Peek Acuity and the ETDRS chart was greater than the Snellen chart with the ETDRS chart (95% CI, 0.05-0.10; P = .08). The local Kenyan community health care workers readily accepted the Peek Acuity smartphone test; it required minimal training and took no longer than the Snellen test (77 seconds vs 82 seconds; 95% CI, 71-84 seconds vs 73-91 seconds, respectively; P = .13). Conclusions and relevance: The study demonstrated that the Peek Acuity smartphone test is capable of accurate and repeatable acuity measurements consistent with published data on the test-retest variability of acuities measured using 5-letter-per-line retroilluminated logMAR charts.

JAMA ophthalmology · cohort or longitudinal · 251 citationsread the source →