The RESPECT Study (Randomised Evaluation of Sexual health Promotion Effectiveness informing Care and Treatment): a feasibility study of an intervention aimed at improving the sexual health of people with severe mental illness

Not Applicable

Completed

• Conditions: Improving sexual health for those with severe mental illness; Mental and Behavioural Disorders

• Registration Number: ISRCTN15747739
• Lead Sponsor: niversity of Huddersfield (UK)

Brief Summary

2019 results in https://www.ncbi.nlm.nih.gov/pubmed/31854292 (added 20/12/2019) 2020 results in https://pubmed.ncbi.nlm.nih.gov/33203433/ (added 19/11/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-05
• Study Completion: 2018-08-31
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Current inclusion criteria as of 18/01/2018:
1. People on the case load of community mental health services
2. Aged 18 and over
3. Willing to provide written informed consent
4. Able to provide written informed consent

Previous inclusion criteria:
1. People on the case load of community mental health services
2. In receipt of Care Programme approach
3. Aged 18 and over
4. Willing to provide written informed consent
5. Able to provide written informed consent

Exclusion Criteria

1. Acute exacerbation of their mental illness that precludes them from active participation (as indicated by hospitalisation and/or being under the crisis/home treatment team at the time of consenting)
2. Severe physical illness that precludes them from active participation
3. Significant cognitive impairment (such as an organic brain disorder) as determined by psychiatrist or case notes
4. Non-English speaker (adapting the intervention is currently beyond the scope of this study)
5. Lacking capacity to consent (as guided by the Mental Capacity Act)
6. Unable or unwilling to give written informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The overall aim of the project is to establish the feasibility and acceptability of an evidence informed intervention to promote sexual health, and establish parameters for a future trial

Secondary Outcome Measures

Name	Time	Method
<br> 1. To develop an understanding of sexual health needs of people with SMI who use NHS mental health services<br> 2. To establish the use and uptake of sexual health services by people with SMI<br> 3. To establish the barriers to accessing information and service provision<br> 4. To establish treatment effectiveness through 3 and 6 month outcome quantitative data<br> 5. To establish workforce capacity to undertake such an intervention in mental health services<br> 6. To explore cost effectiveness in preparation for a large definitive randomised controlled trial<br> 7. To develop recommendations for care pathways between mental health and sexual health service<br>