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Many male prisoners have significant mental health problems, including anxiety and depression. High proportions struggle with homelessness and substance misuse.
This study aims to evaluate whether the Engager intervention improves mental health outcomes following release.
The design is a parallel randomised superiority trial that was conducted in the North West and South West of England (ISRCTN11707331). Men serving a prison sentence of 2 years or less were individually allocated 1:1 to either the intervention (Engager plus usual care) or usual care alone. Engager included psychological and practical support in prison, on release and for 3–5 months in the community. The primary outcome was the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM), 6 months after release. Primary analysis compared groups based on intention-to-treat (ITT).
In total, 280 men were randomised out of the 396 who were potentially eligible and agreed to participate; 105 did not meet the mental health inclusion criteria. There was no mean difference in the ITT complete case analysis between groups (92 in each arm) for change in the CORE-OM score (1.1, 95% CI –1.1 to 3.2, P = 0.325) or secondary analyses. There were no consistent clinically significant between-group differences for secondary outcomes. Full delivery was not achieved, with 77% (108/140) receiving community-based contact.
Engager is the first trial of a collaborative care intervention adapted for prison leavers. The intervention was not shown to be effective using standard outcome measures. Further testing of different support strategies for prison with mental health problems is needed.
Historically, few randomized controlled trials (RCTs) have been conducted in primary care and problems have been experienced applying this methodology in these settings. In 2001, The Leeds Evaluation of Efficacy of Detoxification Study (LEEDS) was developed. This RCT aimed to compare two detoxification drugs to inform best practice for the treatment of opiate users presenting to primary care requesting detoxification. This paper presents descriptive data from a postal survey of 12 general practitioners (GPs) from 10 primary care practices who were involved in the LEEDS trial. The questionnaire was sent out in November 2004, used open and closed questions and was self-administered. It uncovered factors that affected patient recruitment, GPs' views on the trial and their experience of randomizing opiate using patients. Flexible solutions to overcoming recruitment difficulties are presented alongside idealistic solutions to the problems experienced. The implications of our experiences of conducting this RCT in primary care practices are discussed in the light of conducting RCTs in primary care settings. This will benefit other research teams and clinicians who may be planning to use a similar research methodology.
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