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Sexual Health Promotion in People with Severe Mental Illness: the RESPECT feasibility RCT

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JournalNIHR Journals Library
DateAccepted/In press - 6 Feb 2019
Original languageEnglish

Abstract

Abstract
Background: People with serious mental health illness (SMI) have sexual health needs, but there is limited evidence regarding effective interventions to promote their sexual health.

Objectives: to develop a sexual health promotion intervention for people with SMI, and conduct a feasibility trial in order to establish acceptability, and parameters for a fully powered trial.

Design: a two-armed randomised controlled, open feasibility study comparing usual care alone, with usual care plus the adjunctive intervention.

Setting: Five community mental health providers in Leeds, Barnsley, Brighton and London.

Participants: Adults aged ≥18 years, with SMI and receiving care from community mental health teams.

Interventions: A remote, web-based computer randomisation system allocated participants to usual care plus RESPECT intervention (3 sessions of 1 hour) (intervention arm) or usual care only (control arm). The intervention was an interactive manualised package of exercises, quizzes and discussion topic focusing in knowledge, motivation and behavioural intentions to adopt safer sexual behaviours.

Main outcome measures: Feasibility parameters including establishing the percentage of people who were eligible, consented, and retained in each arm of the trial, retention for the intervention, as well as the completeness of the data collection. Data were collected on knowledge, motivation to adopt safer sexual, behaviour, sexual behaviour, sexual stigma, sexual health service use, and quality of life. Data were collected at baseline, and then at 3 and 6 months post randomisation

Results: Of a target of 100, 72 people participated in the trial over 12 months. Of the 36 randomised to the intervention arm, 27 received some of the intervention (75.0%). At three months, 59 of the 72 participants completed follow-up questionnaires (81.9%) (30 intervention; 29 usual care). Only the first 38 participants were followed up at six months. However, data was collected on 38 (76.3% retention); (13 intervention and 16 control). No adverse events were reported. Participant feedback confirmed that both the design and intervention were acceptable. The economic analysis indicted high completion rates and completeness of data among participants who continued the trial.

Limitations: The original target of 100 participants was not achieved. Follow-up data at 6 months was only possible for the first 38 participants due to study deadlines for data collection to cease. Later recruited participants were only followed up for three months.

Conclusions: Despite the limitations, the findings suggest that it is both acceptable and feasible to undertake a health promotion study for people with serious mental health problems.

Future work: A fully powered RCT would be required in order to establish the clinical effectiveness of the intervention.

Study Registration: ISRCTN15747739

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