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The RESPECT Study: A Feasibility Randomised Controlled Trial of a Sexual Health Promotion Intervention for People with Serious Mental Illness in Community Mental Health Services in the UK

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JournalBMC Public Health
DateAccepted/In press - 7 Oct 2020
Original languageEnglish

Abstract

Background: People with serious mental illness (SMI) have sexual health needs but there is little evidence to inform effective interventions to address them. In fact, there are few studies that have addressed this topic for people with SMI outside USA and Brazil. Therefore, the aim of the study was to establish the acceptability and feasibility of a trial of a sexual health promotion intervention for people with SMI in the UK.
Method: The RESPECT study was a two-armed randomised controlled, open feasibility study comparing Sexual health promotion intervention (3 individual sessions of 1 hour) (I) or usual care (UC) for adults aged 18 or over, with SMI, within community mental health services in four UK cities. The main outcome of interest was the percentage who consented to participate, and retained in each arm of the trial, retention for the intervention, and completeness of data collection.
Results: Of a target sample of 100, a total of 72 people were enrolled in the trial over 12 months. Recruitment in the initial months was low and so an extension was granted. However this extension meant that the later recruited participants would only be followed up to the 3 month point. There was good retention in the intervention and the study as a whole; 77.8% of those allocated to intervention (n=28) received it. At three months, 81.9% (30 I; 29 UC) and at 6 months, 76.3% (13 I and 16 UC) completed the follow-up interviews. No adverse events were reported. There was good completeness of the data. The sexual health outcomes for the intervention group changed in favour of the intervention.
Conclusions: The target of 100 participants was not achieved within the study’s timescale. However, effective strategies were identified that improved recruitment in the final few months.
Retention rates and completeness of data in both groups indicate that it is acceptable and feasible to undertake a study promoting sexual health for people with SMI. A fully powered RCT is required to establish effectiveness of the intervention in adoption of safer sex.

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