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Evaluation of a complex intervention (Engager) for prisoners with common mental health problems, near to and after release: study protocol for a randomised controlled trial.

ABSTRACT: INTRODUCTION:The 'Engager' programme is a 'through-the-gate' intervention designed to support prisoners with common mental health problems as they transition from prison back into the community. The trial will evaluate the clinical and cost-effectiveness of the Engager intervention. METHODS AND ANALYSIS:The study is a parallel two-group randomised controlled trial with 1:1 individual allocation to either: (a) the Engager intervention plus standard care (intervention group) or (b) standard care alone (control group) across two investigation centres (South West and North West of England). Two hundred and eighty prisoners meeting eligibility criteria will take part. Engager is a person-centred complex intervention delivered by practitioners and aimed at addressing offenders' mental health and social care needs. It comprises one-to-one support for participants prior to release from prison and for up to 20 weeks postrelease. The primary outcome is change in psychological distress measured by the Clinical Outcomes in Routine Evaluation-Outcome Measure at 6?months postrelease. Secondary outcomes include: assessment of subjective met/unmet need, drug and alcohol use, health-related quality of life and well-being-related quality of life measured at 3, 6 and 12 months postrelease; change in objective social domains, drug and alcohol dependence, service utilisation and perceived helpfulness of services and change in psychological constructs related to desistence at 6 and 12 months postrelease; and recidivism at 12 months postrelease. A process evaluation will assess fidelity of intervention delivery, test hypothesised mechanisms of action and look for unintended consequences. An economic evaluation will estimate the cost-effectiveness. ETHICS AND DISSEMINATION:This study has been approved by the Wales Research Ethics Committee 3 (ref: 15/WA/0314) and the National Offender Management Service (ref: 2015-283). Findings will be disseminated to commissioners, clinicians and service users via papers and presentations. TRIAL REGISTRATION NUMBER:ISRCTN11707331; Pre-results.

SUBMITTER: Kirkpatrick T

PROVIDER: S-EPMC5879493 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature

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Evaluation of a complex intervention (Engager) for prisoners with common mental health problems, near to and after release: study protocol for a randomised controlled trial.

Kirkpatrick Tim T Lennox Charlotte C Taylor Rod R Anderson Rob R Maguire Michael M Haddad Mark M Michie Susan S Owens Christabel C Durcan Graham G Stirzaker Alex A Henley William W Stevenson Caroline C Carroll Lauren L Quinn Cath C Brand Sarah Louise SL Harris Tirril T Stewart Amy A Todd Roxanne R Rybczynska-Bunt Sarah S Greer Rebecca R Pearson Mark M Shaw Jenny J Byng Richard R

BMJ open 20180220 2

<h4>Introduction</h4>The 'Engager' programme is a 'through-the-gate' intervention designed to support prisoners with common mental health problems as they transition from prison back into the community. The trial will evaluate the clinical and cost-effectiveness of the Engager intervention.<h4>Methods and analysis</h4>The study is a parallel two-group randomised controlled trial with 1:1 individual allocation to either: (a) the Engager intervention plus standard care (intervention group) or (b) ...[more]

PMID: 29463586

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Project description:Rates of common mental health problems are much higher in prison populations, but access to primary care mental health support falls short of community equivalence. Discontinuity of care on release is the norm and is further complicated by substance use and a range of social problems, e.g. homelessness. To address these problems, we worked with criminal justice, third sector social inclusion services, health services and people with lived experiences (peer researchers), to develop a complex collaborative care intervention aimed at supporting men with common mental health problems near to and following release from prison. This paper describes an external pilot trial to test the feasibility of a full randomised controlled trial.Eligible individuals with 4 to 16 weeks left to serve were screened to assess for common mental health problems. Participants were then randomised at a ratio of 2:1 allocation to ENGAGER plus standard care (intervention) or standard care alone (treatment as usual). Participants were followed up at 1 and 3 months' post release. Success criteria for this pilot trial were to meet the recruitment target sample size of 60 participants, to follow up at least 50% of participants at 3 months' post release from prison, and to deliver the ENGAGER intervention. Estimates of recruitment and retention rates and 95% confidence intervals (CIs) are reported. Descriptive analyses included summaries (percentages or means) for participant demographics, and baseline characteristics are reported.Recruitment target was met with 60 participants randomised in 9 months. The average retention rates were 73% at 1 month [95% CI 61 to 83] and 47% at 3 months follow-up [95% CI 35 to 59]. Ninety percent of participants allocated to the intervention successfully engaged with a practitioner before release and 70% engaged following release.This pilot confirms the feasibility of conducting a randomised trial for prison leavers with common mental health problems. Based on this pilot study and some minor changes to the trial design and intervention, a full two-centre randomised trial assessing the clinical and cost-effectiveness of the ENGAGER intervention is currently underway.

Project description:IntroductionIn India about 95% of individuals who need treatment for common mental disorders like depression, stress and anxiety and substance use are unable to access care. Stigma associated with help seeking and lack of trained mental health professionals are important barriers in accessing mental healthcare. Systematic Medical Appraisal, Referral and Treatment (SMART) Mental Health integrates a community-level stigma reduction campaign and task sharing with the help of a mobile-enabled electronic decision support system (EDSS)-to reduce psychiatric morbidity due to stress, depression and self-harm in high-risk individuals. This paper presents and discusses the protocol for process evaluation of SMART Mental Health.Methods and analysisThe process evaluation will use mixed quantitative and qualitative methods to evaluate implementation fidelity and identify facilitators of and barriers to implementation of the intervention. Case studies of six intervention and two control clusters will be used. Quantitative data sources will include usage analytics extracted from the mHealth platform for the trial. Qualitative data sources will include focus group discussions and interviews with recruited participants, primary health centre doctors, community health workers (Accredited Social Health Activits) who participated in the project and local community leaders. The design and analysis will be guided by Medical Research Council framework for process evaluations, the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework, and the normalisation process theory.Ethics and disseminationThe study has been approved by the ethics committee of the George Institute for Global Health, India and the Institutional Ethics Committee, All India Institute of Medical Sciences (AIIMS), New Delhi. Findings of the study will be disseminated through peer-reviewed publications, stakeholder meetings, digital and social media platforms.Trial registration numberCTRI/2018/08/015355.

Project description:BackgroundMental health disorders in children and young people (CYP) are increasing but the provision of current evidence-based treatment for common mental health problems is limited. Treatment effects vary widely with no clear superiority of a single treatment approach. Further evaluation of contemporary and effective treatments in CYP is needed. Metacognitive therapy (MCT) has shown enhanced efficacy over 'gold standard' approaches in adult mental health, but so far has not been evaluated in a randomised trial of CYP. As such, we aim to assess the acceptability and feasibility of group-MCT for CYP with common mental health problems in comparison to usual treatment within Child and Adolescent Mental Health Services (CAMHS).MethodYoMeta is a multicentre, two-arm, single-blind randomised feasibility trial comparing group-MCT to usual care in CYP with common mental health problems in CAMHS. CYP (target sample n = 100) with a common mental health problem will be recruited across at least three CAMHS services in the UK. Participants in the intervention arm will receive up to eight sessions of group-MCT delivered by a CAMHS mental health practitioner. The control arm will receive usual care in CAMHS which includes individual or group-based therapy. Feasibility will be assessed by the success of recruitment, retention, and data quality. Acceptability of the intervention will be assessed by the number of sessions attended and through qualitative interviews aimed at exploring CYP acceptability and understanding of the intervention. Symptoms of psychological distress will be assessed using the Revised Children Anxiety and Depression Scale (RCADS) at 20 weeks. We will also assess psychological well-being, symptoms of depression, metacognitive beliefs, quality of life, and measures to support economic evaluation (health status and health and social care use). Qualitative interviews will be conducted to understand practitioner's views on training and delivery of group-MCT.DiscussionThe trial is designed to evaluate the acceptability and feasibility of group-MCT for CYP with common mental health problems. Group-MCT may aid in improving access to treatment, reduce waiting times, and improve outcomes for CYP with common mental health disorders. The study will provide important information and data to evaluate future research potential and confirm sample size estimation for a definitive large-scale RCT to test the effectiveness and cost-effectiveness of group-MCT in CYP.Trial registrationNCT05260060; ISCTRN18335255.

Project description:BackgroundCommon mental disorders are one of the leading causes for sickness absence and early retirement due to reduced health. Furthermore, a treatment gap for common mental disorders has been described worldwide. Within this study, psychotherapeutic consultation at work defined as a tailored, module-based and work-related psychotherapeutic intervention will be applied to improve mental health care.MethodsThis study comprises a randomised controlled multicentre trial with 1:1 allocation to an intervention and control group. In total, 520 employees with common mental disorders shall be recruited from companies being located around five study centres in Germany. Besides care as usual, the intervention group will receive up to 17 sessions of psychotherapy. The first session will include basics diagnostics and medical indication of treatment and the second session will include work-related diagnostics. Then, participants of the intervention group may receive work-related psychotherapeutic consultation for up to ten sessions. Further psychotherapeutic consultation during return to work for up to five sessions will be offered where appropriate. The control group will receive care as usual and the first intervention session of basic diagnostics and medical indication of treatment. After enrolment to the study, participants will be followed up after nine (first follow-up) and fifteen (second follow-up) months. Self-reported days of sickness absence within the last 6 months at the second follow-up will be used as the primary outcome and self-efficacy at the second follow-up as the secondary outcome. Furthermore, a cost-benefit assessment related to costs of common mental disorders for social insurances and companies will be performed.DiscussionPsychotherapeutic consultation at work represents a low threshold care model aiming to overcome treatment gaps for employees with common mental disorders. If successfully implemented and evaluated, it might serve as a role model to the care of employees with common mental disorders and might be adopted in standard care in cooperation with sickness and pension insurances in Germany.Trial registrationThe friaa project was registered at the German Clinical Trial Register (DRKS) at 01.03.2021 (DRKS00023049): https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023049 .

Dataset Information

Evaluation of a complex intervention (Engager) for prisoners with common mental health problems, near to and after release: study protocol for a randomised controlled trial.

Publications

Evaluation of a complex intervention (Engager) for prisoners with common mental health problems, near to and after release: study protocol for a randomised controlled trial.

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