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

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. Trial registration Current Controlled Trials ISRCTN15747739. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 65. See the NIHR Journals Library website for further project information.

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A Bespoke Sexual Health Promotion Intervention for People with Serious Mental Illness in Community Mental Health Services in the UK Compared with Treatment as Usual: the RESPECT Feasibility Randomised Controlled trial

10.21203/rs.3.rs-15657/v1 ◽

2020 ◽

Author(s):

Elizabeth Hughes ◽

Natasha Mitchell ◽

Samantha Gascoyne ◽

Thirimon Byrne ◽

Amanda Edmondson ◽

...

Keyword(s):

Mental Health ◽

Health Promotion ◽

Mental Illness ◽

Community Mental Health ◽

Data Collection ◽

Sexual Health ◽

Serious Mental Illness ◽

Community Mental Health Services ◽

Health Promotion Intervention ◽

Randomised Controlled

Abstract BackgroundPeople 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.MethodThe 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. A nested qualitative study obtained the views of participants regarding the acceptability of the study using individual telephone interviews conducted by lived experience researchers. ResultsOf 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. Based on analysis of the qualitative interviews, the methods of recruitment, the quality of the participant information, the data collection, and the intervention were deemed to be acceptable to the participants (n=22). ConclusionsThe 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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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

BMC Public Health ◽

10.1186/s12889-020-09661-x ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Elizabeth Hughes ◽

Natasha Mitchell ◽

Samantha Gascoyne ◽

Thirimon Moe-Byrne ◽

Amanda Edmondson ◽

...

Keyword(s):

Mental Health ◽

Health Promotion ◽

Mental Illness ◽

Community Mental Health ◽

Data Collection ◽

Sexual Health ◽

Community Mental Health Services ◽

Health Promotion Intervention ◽

Randomised Controlled ◽

The Uk

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 trial (RCT) comparing Sexual health promotion intervention (3 individual sessions of 1 h) (I) or treatment as usual (TAU) 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. A nested qualitative study obtained the views of participants regarding the acceptability of the study using individual telephone interviews conducted by lived experience researchers. 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 TAU) and at 6 months, 76.3% (13 I and 16 TAU) completed the follow-up data collection. 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. Based on analysis of the qualitative interviews, the methods of recruitment, the quality of the participant information, the data collection, and the intervention were deemed to be acceptable to the participants (n = 22). 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. Study registration ISRCTN RegistryISRCTN15747739 prospectively registered 5th July 2016.

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