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BACKGROUND:Individuals with a history of recurrent depression have a high risk of repeated depressive relapse/recurrence. Maintenance antidepressant medication (m-ADM) for at least 2 years is the current recommended treatment, but many individuals are interested in alternatives to m-ADM. Mindfulness-based cognitive therapy (MBCT) has been shown to reduce the risk of relapse/recurrence compared with usual care but has not yet been compared with m-ADM in a definitive trial.
OBJECTIVES:
To establish whether MBCT with support to taper and/or discontinue antidepressant medication (MBCT-TS) is superior to and more cost-effective than an approach of m-ADM in a primary care setting for patients with a history of recurrent depression followed up over a 2-year period in terms of preventing depressive relapse/recurrence. Secondary aims examined MBCT's acceptability and mechanism of action.
DESIGN:
Single-blind, parallel, individual randomised controlled trial.
SETTING:
UK general practices.
PARTICIPANTS:
Adult patients with a diagnosis of recurrent depression and who were taking m-ADM.
INTERVENTIONS:
Participants were randomised to MBCT-TS or m-ADM with stratification by centre and symptomatic status. Outcome data were collected blind to treatment allocation and the primary analysis was based on the principle of intention to treat. Process studies using quantitative and qualitative methods examined MBCT's acceptability and mechanism of action.
MAIN OUTCOMES MEASURES:
The primary outcome measure was time to relapse/recurrence of depression. At each follow-up the following secondary outcomes were recorded: number of depression-free days, residual depressive symptoms, quality of life, health-related quality of life and psychiatric and medical comorbidities.
RESULTS:
In total, 212 patients were randomised to MBCT-TS and 212 to m-ADM. The primary analysis did not find any evidence that MBCT-TS was superior to m-ADM in terms of the primary outcome of time to depressive relapse/recurrence over 24 months [hazard ratio (HR) 0.89, 95% confidence interval (CI) 0.67 to 1.18] or for any of the secondary outcomes. Cost-effectiveness analysis did not support the hypothesis that MBCT-TS is more cost-effective than m-ADM in terms of either relapse/recurrence or quality-adjusted life-years. In planned subgroup analyses, a significant interaction was found between treatment group and reported childhood abuse (HR 1.89, 95% CI 1.06 to 3.38), with delayed time to relapse/recurrence for MBCT-TS participants with a more abusive childhood compared with those with a less abusive history. Although changes in mindfulness were specific to MBCT (and not m-ADM), they did not predict outcome in terms of relapse/recurrence at 24 months. In terms of acceptability, the qualitative analyses suggest that many people have views about (dis)/continuing their ADM, which can serve as a facilitator or a barrier to taking part in a trial that requires either continuation for 2 years or discontinuation.
CONCLUSIONS:
There is no support for the hypothesis that MBCT-TS is superior to m-ADM in preventing depressive relapse/recurrence among individuals at risk for depressive relapse/recurrence. Both treatments appear to confer protection against relapse/recurrence. There is an indication that MBCT may be most indicated for individuals at greatest risk of relapse/recurrence. It is important to characterise those most at risk and carefully establish if and why MBCT may be most indicated for this group.
BACKGROUND:Mindfulness-based approaches for adults are effective at enhancing mental health, but few controlled trials have evaluated their effectiveness among young people.
AIMS:
To assess the acceptability and efficacy of a schools-based universal mindfulness intervention to enhance mental health and well-being.
METHOD:
A total of 522 young people aged 12-16 in 12 secondary schools either participated in the Mindfulness in Schools Programme (intervention) or took part in the usual school curriculum (control).
RESULTS:
Rates of acceptability were high. Relative to the controls, and after adjusting for baseline imbalances, children who participated in the intervention reported fewer depressive symptoms post-treatment (P = 0.004) and at follow-up (P = 0.005) and lower stress (P = 0.05) and greater well-being (P = 0.05) at follow-up. The degree to which students in the intervention group practised the mindfulness skills was associated with better well-being (P<0.001) and less stress (P = 0.03) at 3-month follow-up.
CONCLUSIONS:
The findings provide promising evidence of the programme's acceptability and efficacy.
Depression co-occurs in 20% of people with cardiovascular disorders, can persist for years and predicts worse physical health outcomes. While psychosocial treatments have been shown to treat acute depression effectively in those with comorbid cardiovascular disorders, to date, there has been no evaluation of approaches aiming to prevent relapse and treat residual depression symptoms in this group. Consequently, the current study aimed to examine the feasibility and acceptability of a randomised controlled trial design evaluating an adapted version of mindfulness-based cognitive therapy (MBCT) designed specifically for people with comorbid depression and cardiovascular disorders. A three-arm feasibility randomised controlled trial was conducted, comparing MBCT adapted for people with cardiovascular disorders plus treatment as usual (TAU), mindfulness-based stress reduction (MBSR) plus TAU and TAU alone. Participants completed a set of self-report measures of depression severity, anxiety, quality of life, illness perceptions, mindfulness, self-compassion and affect and had their blood pressure taken immediately before, after and 3 months following the intervention. Those in the adapted-MBCT arm additionally underwent a qualitative interview to gather their views about the adapted intervention. Three thousand four hundred potentially eligible participants were approached when attending an outpatient appointment at a cardiology clinic or via a GP letter following a case note search. Two hundred forty-two (7.1%) were interested in taking part, 59 (1.7%) were screened as being suitable and 33 (< 1%) were eventually randomised to the three groups. Of 11 participants randomised to adapted-MBCT, 7 completed the full course, levels of home mindfulness practice were high and positive qualitative feedback about the intervention was given. Twenty-nine out of 33 randomised participants completed all the assessment measures at all three time points. The means Patient Health Questionnaire (PHQ)-9 scores for the MBCT-Heart and Living Mindfully (HeLM) group were lower at post-intervention and at the 3-month follow-up compared to the MBSR and TAU groups. The sample was heterogeneous in terms of whether they reported current depression or had a history of depression and the time since the onset of cardiovascular disorders (1 to 25 years). The adapted-MBCT intervention was feasible and acceptable to participants; however, certain aspects of the trial design were not. In particular, low recruitment rates were achieved and there was a high withdrawal rate between screening and randomisation. Moreover, the heterogeneity in the sample was high, meaning the adapted intervention was unlikely to be well tailored to all the participants needs. This suggests that if the decision is made to move to a definitive trial, study recruitment procedures will need to be revised to recruit a target sample that optimally matches the adapted intervention.
Depression co-occurs in 20% of people with cardiovascular disorders, can persist for years and predicts worse physical health outcomes. While psychosocial treatments have been shown to treat acute depression effectively in those with comorbid cardiovascular disorders, to date, there has been no evaluation of approaches aiming to prevent relapse and treat residual depression symptoms in this group. Consequently, the current study aimed to examine the feasibility and acceptability of a randomised controlled trial design evaluating an adapted version of mindfulness-based cognitive therapy (MBCT) designed specifically for people with comorbid depression and cardiovascular disorders. A three-arm feasibility randomised controlled trial was conducted, comparing MBCT adapted for people with cardiovascular disorders plus treatment as usual (TAU), mindfulness-based stress reduction (MBSR) plus TAU and TAU alone. Participants completed a set of self-report measures of depression severity, anxiety, quality of life, illness perceptions, mindfulness, self-compassion and affect and had their blood pressure taken immediately before, after and 3 months following the intervention. Those in the adapted-MBCT arm additionally underwent a qualitative interview to gather their views about the adapted intervention. Three thousand four hundred potentially eligible participants were approached when attending an outpatient appointment at a cardiology clinic or via a GP letter following a case note search. Two hundred forty-two (7.1%) were interested in taking part, 59 (1.7%) were screened as being suitable and 33 (< 1%) were eventually randomised to the three groups. Of 11 participants randomised to adapted-MBCT, 7 completed the full course, levels of home mindfulness practice were high and positive qualitative feedback about the intervention was given. Twenty-nine out of 33 randomised participants completed all the assessment measures at all three time points. The means Patient Health Questionnaire (PHQ)-9 scores for the MBCT-Heart and Living Mindfully (HeLM) group were lower at post-intervention and at the 3-month follow-up compared to the MBSR and TAU groups. The sample was heterogeneous in terms of whether they reported current depression or had a history of depression and the time since the onset of cardiovascular disorders (1 to 25 years). The adapted-MBCT intervention was feasible and acceptable to participants; however, certain aspects of the trial design were not. In particular, low recruitment rates were achieved and there was a high withdrawal rate between screening and randomisation. Moreover, the heterogeneity in the sample was high, meaning the adapted intervention was unlikely to be well tailored to all the participants needs. This suggests that if the decision is made to move to a definitive trial, study recruitment procedures will need to be revised to recruit a target sample that optimally matches the adapted intervention.
Importance: Social-emotional competence in early childhood influences long-term mental health and well-being. Interest in the potential to improve child health and educational outcomes through social and emotional learning (SEL) programs in early childhood education and care (ECEC) settings is increasing.Objective: To conduct a systematic review and meta-analysis of studies examining the social, emotional, and early learning outcomes associated with universal curriculum-based SEL programs delivered to children aged 2 to 6 years in center-based ECEC settings.
Data Sources: Keyword searches of Education Resources Information Center (ERIC), MEDLINE Complete, PsycINFO, and Proquest Dissertations and Theses Global databases were conducted to identify all relevant studies published from January 1, 1995, through December 31, 2017.
Study Selection: Studies included in this review examined universal curriculum-based SEL intervention delivered to children aged 2 to 6 years in a center-based ECEC setting. All assessed individual-level social and/or emotional skill after the SEL intervention and used an experimental or quasi-experimental design (ie, studies that did not or were not able to randomly allocate participants to intervention and control groups) with a control group.
Data Extraction and Synthesis: A total of 13 035 records were screened, of which 362 were identified for full-text review. A systematic literature review was conducted on 79 studies. Multilevel random-effects meta-analyses were conducted on 63 eligible studies from October 2 through 18, 2018.
Main Outcomes and Measures: Social competence, emotional competence, behavioral self-regulation, behavior and emotional challenges, and early learning outcomes.
Results: This review identified 79 unique experimental or quasi-experimental studies evaluating the effect of SEL interventions on preschooler outcomes, including a total of 18 292 unique participants. Sixty-three studies were included in this meta-analysis. Compared with control participants, children in intervention conditions showed significant improvement in social competence (Cohen d [SE], 0.30; [0.06]; 95% CI, 0.18-0.42; P < .001), emotional competence (Cohen d [SE], 0.54 [0.16]; 95% CI, 0.22-0.86; P < .001), behavioral self-regulation (Cohen d [SE], 0.28 [0.09]; 95% CI, 0.11-0.46; P < .001), and early learning skills (Cohen d [SE], 0.18 [0.08]; 95% CI, 0.02-0.33; P = .03) and reduced behavioral and emotional challenges (Cohen d [SE], 0.19 [0.04]; 95% CI, 0.11-0.28; P < .001). Several variables appeared to moderate program outcomes, including intervention leader, type of assessment, informant, child age, and study quality.
Conclusions and Relevance: According to results of this study, social and emotional learning programs appeared to deliver at a relatively low intensity may be an effective way to increase social competence, emotional competence, behavioral self-regulation, and early learning outcomes and reduce behavioral and emotional difficulties in children aged 2 to 6 years. Social and emotional learning programs appear to be particularly successful at increasing emotional knowledge, understanding, and regulation.