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Pilot randomised controlled trial of the ENGAGER collaborative care intervention for prisoners with common mental health problems, near to and after release.

ABSTRACT: 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.

SUBMITTER: Lennox C

PROVIDER: S-EPMC5501110 | biostudies-other | 2018

REPOSITORIES: biostudies-other

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Project description: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.

Project description:BACKGROUND:Following up released prisoners is demanding, particularly for those prisoners with mental health problems, for whom stigma and chaotic lifestyles are problematic. Measurement of mental health outcomes after release is challenging. To evaluate mental healthcare for offender populations, using high-quality randomised controlled trials, evidenced-based methods must be developed to engage them while in custody, to locate and re-interview them after release, and to collect potentially stigmatising mental health outcomes data. METHODS:We developed an initial theoretical model and operational procedures for collecting baseline and follow-up data informed by a literature search, focus groups, and case studies. Male prisoners from five prisons in two sites were invited to participate. The inclusion criteria included individuals who were above threshold on nine-item Patient Health Questionnaire, seven-item Generalized Anxiety Disorder, or post-traumatic stress disorder scales, or who had reported mental health problems in the past 2 years or had been assessed with a likely personality disorder. Potential participants were interviewed to generate baseline data and were re-contacted before their release. We then contacted them for a follow-up interview, which included repeating the earlier data collection measures 2-8 weeks after release. A qualitative formative process evaluation produced and refined a model procedure for the recruitment and retention of male prison leavers in trials, identified the mechanisms which promoted engagement and retention, and mapped these against a theoretical behaviour change model. RESULTS:We developed a flexible procedure which was successful in recruiting male prison leavers to a pilot trial: 185/243 (76%, 95% confidence interval (CI) 70-81%) of those approached agreed to participate. We also retained 63% (95% CI 54-71%) of those eligible to participate in a follow-up interview 2-8 weeks after release. Mental health outcomes data was collected at both these time points. CONCLUSIONS:It is possible to design acceptable procedures to achieve sustained engagement critical for delivering and evaluating interventions in prison and in the community and to collect mental health outcomes data. These procedures may reduce attrition bias in future randomised controlled trials of mental health interventions for prison leavers. This procedure has been replicated and successfully delivered in a subsequent pilot trial and a definitive randomised controlled trial.

Project description:UK, home-based patients with COPD receive specialist care from respiratory physicians, nurses, and general practitioners (GPs), but increasing complexity of therapeutic options and a GP/Nurse workforce crisis suggests merit in testing the role of home visits by a clinical pharmacist. We conducted a non-randomised intervention study with a contemporaneous comparator group, in Glasgow (Scotland). A clinical pharmacist (working closely with a consultant respiratory physician) visited patients with COPD living at home, assessing respiratory and other co-morbid conditions, and medicines then, with patient approval, agreed treatment modifications with a consultant physician. Comparator group-patients were drawn from another hospital out-patient clinic. Main outcomes were exacerbations during 4-months of follow-up and respiratory hospitalisations (number and duration) after 1 year. In the intervention group, 86 patients received a median of three home visits; 87 received usual care (UC). At baseline, patients in the intervention group were similar to those in UC in terms of respiratory hospitalisations although slightly younger, more likely to receive specific maintenance antibiotics/Prednisolone and to have had exacerbations. Sixty-two (72.1%) of the intervention group received dose changes; 45 (52.3%) had medicines stopped/started and 21 (24.4%) received an expedited review at the specialist respiratory consultant clinic; 46 (53.5%) were referred to other healthcare services. Over one-third were referred for bone scans and 11% received additional investigations. At follow-up, 54 (63.5%) of intervention group participants had an exacerbation compared with 75 (86.2%) in the UC group (p?=?0.001); fewer had respiratory hospitalisations (39 (45.3%) vs. 66 (76.7%); p?<?0.001). Hospitalisations were shorter in the intervention group. Pharmacist-consultant care for community dwelling patients with COPD, changed clinical management and improved outcomes. A randomised controlled trial would establish causality.

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: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:BackgroundJob loss, austerity measures, financial difficulties and house repossession contribute to the risk of self-harm and suicide during recessions. Navigating the benefits system and accessing sources of welfare and debt advice is a difficult experience for vulnerable people, further contributing to their distress. Whilst there is some evidence that advice-type interventions can lead to financial gain, there is mixed evidence for their effectiveness in improving mental health in those experiencing financial difficulties. There have been no interventions targeting those who have self-harmed due to economic hardship.MethodsOur aim was to determine the feasibility and acceptability of a brief psychosocial intervention (the 'HOPE' service) for people presenting to hospital emergency departments (ED) following self-harm or in acute distress because of financial, employment or welfare (benefit) difficulties. Nineteen people consented to random allocation to the intervention or control arm on a 2:1 basis. Participants randomised to the intervention arm (n =?13) received up to six sessions of 1:1 support provided by community support staff trained in Motivational Interviewing (MI). Control participants (n =?6) received a one-off session signposting them to relevant support organisations. Fourteen participants were followed up after 3 months. Participants and mental health workers took part in qualitative interviews. The acceptability of outcome measures including the PHQ-9, GAD-7, repeat self-harm, EQ5D-5 L and questions about debt, employment and welfare benefits were explored.ResultsInterviews indicated the main benefits of the service as the resolution of specific financial problems and receiving support when participants were feeling most vulnerable. Randomisation was acceptable to most participants although not always fully understood and control participants could be disappointed. Recruitment was slow (1-2 per month). The outcome measures were acceptable and appeared sensitive to change.DiscussionThe HOPE intervention is feasible and acceptable. There was evidence of need and it is a relatively inexpensive intervention. Refining aspects of the intervention would be straightforward. A full-scale RCT would be feasible, if broadened eligibility criteria led to increased recruitment and improvements were made to staff training and support.Trial registrationISRCTN58531248.

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Pilot randomised controlled trial of the ENGAGER collaborative care intervention for prisoners with common mental health problems, near to and after release.

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