Sexual health promotion in people with severe mental illness: the RESPECT feasibility RCT

Hughes, E., Mitchell, N., Gascoyne, S., Moe-Byrne, T., Edmondson, A. ORCID: 0000-0002-0224-1997, Coleman, E., Millett, L., Ali, S., Dare, C., Hewitt, C., Johnson, S., Llewellyn, C., Mercer, C., Nolan, F., Walker, C. and Watson, J., 2019. Sexual health promotion in people with severe mental illness: the RESPECT feasibility RCT. Health Technology Assessment, 23 (65), pp. 1-136. ISSN 1366-5278

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Abstract

Background: People with serious mental illness 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 serious mental illness, and to conduct a feasibility trial in order to establish the 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 serious mental illness and receiving care from community mental health teams.

Interventions: A remote, web-based computer randomisation system allocated participants to usual care plus the RESPECT (Randomised Evaluation of Sexual health Promotion Effectiveness informing Care and Treatment) intervention (three sessions of 1 hour) (intervention arm) or usual care only (control arm). The intervention was an interactive manualised package of exercises, quizzes and discussion topics focusing on 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 were 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 months and 6 months post randomisation.

Results: Of a target of 100 participants, 72 people participated in the trial over 12 months. Of the 36 participants randomised to the intervention arm, 27 received some of the intervention (75.0%). At 3 months, 59 of the 72 participants completed follow-up questionnaires (81.9%) (30 participants from the intervention arm and 29 participants from the control arm). Only the first 38 participants were followed up at 6 months. However, data were collected on 29 out of 38 participants (76.3% retention): 13 in the intervention arm and 16 in the control arm. No adverse events were reported. Participant feedback confirmed that both the design and the intervention were acceptable. The economic analysis indicated high completion rates and completeness of data among participants who continued the trial.

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

Future work: A fully powered randomised controlled trial would be required to establish the clinical effectiveness of the intervention.

Item Type:	Journal article
Publication Title:	Health Technology Assessment
Creators:	Hughes, E., Mitchell, N., Gascoyne, S., Moe-Byrne, T., Edmondson, A., Coleman, E., Millett, L., Ali, S., Dare, C., Hewitt, C., Johnson, S., Llewellyn, C., Mercer, C., Nolan, F., Walker, C. and Watson, J.
Publisher:	National Institute for Health Research
Date:	December 2019
Volume:	23
Number:	65
ISSN:	1366-5278
Identifiers:	Number Type 10.3310/hta23650 DOI 1322317 Other
Rights:	© Queen’s Printer and Controller of HMSO 2019. This work was produced by Hughes et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.
Divisions:	Schools > School of Social Sciences
Record created by:	Linda Sullivan
Date Added:	09 Jun 2020 14:45
Last Modified:	22 Jun 2020 13:49
URI:	https://irep.ntu.ac.uk/id/eprint/39951

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