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moreRESPECT: A study of an intervention aimed at improving the sexual health of people with severe mental illness

MoreRESPECT: A randomised controlled trial of a sexual health promotion intervention for people with severe mental illness delivered in community mental health settings

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN36391109
Enrollment
300
Registered
2023-07-25
Start date
2024-01-03
Completion date
Unknown
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sexual health promotion intervention for people with severe mental illness Mental and Behavioural Disorders

Interventions

Participants will be randomly allocated to either the sexual health intervention group (in addition to usual care) or the usual care group. Data will be collected at the start of the participant’s inv
condoms and contraception
safer relationships, including assertiveness skills and negotiating skills relating to the type of sexual relationships they want to have. Control (Usual Care): Participants will continue with their

Sponsors

Glasgow Caledonian University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Adults aged > = 16 years 2. Diagnosed with a SMI* 3. In receipt of care from any form of adult community mental health service in each NHS site (outpatient clinics, day care, on caseload of community mental health team including assertive outreach; forensic, early intervention for psychosis, recovery colleges, depot clinics) 4. Willing and able to give informed consent to participate *There is no agreed definition of SMI, so we will adopt a pragmatic and inclusive definition: a Psychiatrist assessed and documented (care record) primary diagnosis of schizophrenia schizoaffective disorder, or delusional/psychotic illness, or bipolar disorder, or major depression (with or without psychotic features), or severe anxiety, or personality disorder.

Exclusion criteria

Exclusion criteria: 1. Pose a current risk to others (e.g. research staff) including risks of sexual and/or physical violence 2. A learning disability or other significant cognitive impairment 3. Those known to be on the sex offenders register

Design outcomes

Primary

MeasureTime frame
Number of unprotected sex acts (anal, vaginal, oral) are recorded using an adapted version (with permission) of the Sexual Risk Assessment Schedule (SERBAS) at baseline, 3, 6, 9 and 12 months

Secondary

MeasureTime frame
1. Knowledge about human immunodeficiency virus (HIV) and sexually transmitted infections is recorded using an adapted version (with permission) of the HIV-Knowledge Questionnaire (HIV-KQ) at baseline, 3, 6, 9 and 12 months 2. Perception of the risk of infection with a sexually transmitted infection (STI) is recorded using an adapted version of the Motivation to Engage in Safer Sex measure at baseline, 3, 6, 9 and 12 months 3. Attitudes towards the use of condoms as well as questions on self-efficacy in the use and negotiation of use of condoms are recorded using an adapted version (with permission) of the Condom Use Self-Efficacy Scale at baseline, 3, 6, 9 and 12 months 4. Engagement in risky or protective sexual behaviours is recorded using an adapted version (with permission) of the Behavioural Intentions for Safer Sex measure at baseline, 3, 6, 9 and 12 months 5. General questions about sexual health are recoded using items adapted from the National Survey of Sexual Attitudes and Lifestyle (NATSAL) questionnaire at baseline, 3, 6, 9 and 12 months 6. Health-related quality of life is measured using the EQ-5D-5L standardised instrument at baseline, 3, 6, 9 and 12 months 7. Quality of life for people with different mental health conditions is measured using the Recovering Quality of Life (ReQoL) standardised instrument at baseline, 3, 6, 9 and 12 months 8. Heath care resource use, including medications, is captured using a bespoke resource use questionnaire at baseline, 3, 6, 9 and 12 months

Countries

England, United Kingdom

Contacts

Public ContactLaura;Laura Wiley;Wiley

;

laura.wiley@york.ac.uk;morerespect-trial@york.ac.uk+44 1904 321947;+44 1904 321947

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 23, 2026