moreRESPECT: A study of an intervention aimed at improving the sexual health of people with severe mental illness
| ISRCTN | ISRCTN36391109 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36391109 |
| IRAS number | 309345 |
| Secondary identifying numbers | CPMS 56541, NIHR133865, IRAS 309345 |
- Submission date
- 10/07/2023
- Registration date
- 25/07/2023
- Last edited
- 19/03/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
People with severe mental illness (SMI) have significant needs in terms of physical health compared to the general population. Initiatives have commenced to address this; however, sexual health has been missed off the agenda. Like everyone else, positive sexual relationships are important for people with SMI, but this is rarely discussed in routine mental health care. Therefore, they can be unaware of important information such as where to get sexual health advice, how to reduce risk of sexually transmitted infections, contraceptive choices and finding relationships that are mutually respectful, not violent or abusive.
In a National Institute for Health and Care Research (NIHR)-funded feasibility study, this research team developed a 3-session support package that helped people with SMI to think about their own sexual health and provided useful information about how to improve their sexual health. Following the success of the feasibility study, this full trial will examine the effectiveness and cost-effectiveness of the intervention by recruiting 400 people with SMI from National Health Service (NHS) community mental health teams across England and Scotland.
Who can participate?
This study will recruit 400 participants with SMI from community mental health teams from NHS mental health services across England and Scotland.
What does the study involve?
People who agree to take part will be randomly allocated to either usual care (control arm) or usual care plus the moreRESPECT intervention (intervention arm). Data will be collected at baseline and then at 3-, 6-, 9- and 12 months post-randomisation. As part of a nested process evaluation, interviews with a small group of participants will also be conducted at 6 months post randomisation to find out how they found the support package and whether it worked better for some than others and in what circumstances.
What are the possible benefits and risks of participating?
We cannot promise that taking part in this study will help participants directly. However, some people who took part in a previous study told us that they found taking part interesting, thought-provoking, and informative. The results of this study may help us find out how we can improve sexual health for people with a severe mental illness. Taking part will involve participants setting aside some time to meet with a member of the study team to complete the study’s questionnaires. Participants in the sexual health information sessions group will also need to meet with a trained health professional three times. These may be face-to-face meetings or video call meetings. Participants safety and well-being are very important to us. Our team are trained to ensure participants comfort and minimise distress. We are aware that some participants may find some of the topics and questions about sex embarrassing. Some of the questions may also trigger upsetting memories. We will provide information for local and national support and will have a process to supporting those who may become upset or distressed.
Where is the study run from?
Glasgow Caledonian University (GCU) (UK)
When is the study starting and how long is it expected to run for?
September 2022 to September 2026
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).
Who is the main contact?
morerespect-trial@york.ac.uk
Contact information
Scientific
Glasgow Caledonian University (GCU), Cowcaddens Rd
Glasgow
G4 0BA
United Kingdom
 ORCID ID |
0000-0002-4480-0806 |
|---|---|
| Phone | +44 (0)141 331 8379 |
| Elizabeth.hughes@gcu.ac.uk |
Public
York Trials Unit
Department of Health Sciences
University of York
ARRC Building
York
YO10 5DD
United Kingdom
| Phone | +44 1904 321947 |
|---|---|
| laura.wiley@york.ac.uk |
Public
York Trials Unit
Department of Health Sciences
University of York
ARRC Building
York
YO10 5DD
United Kingdom
| Phone | +44 1904 321947 |
|---|---|
| morerespect-trial@york.ac.uk |
Public
York Trials Unit, Department of Health Sciences, University of York, ARRC Building
York
YO10 5DD
United Kingdom
| Phone | +44 (0)1904 32(1926) |
|---|---|
| samantha.gascoyne@york.ac.uk |
Public
York Trials Unit, Department of Health Sciences, University of York, ARRC Building
York
YO10 5DD
United Kingdom
| Phone | +44 (0)1904 32(3905) |
|---|---|
| mo.hammouda@york.ac.uk |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | https://www.morerespect.co.uk/ |
| Scientific title | MoreRESPECT: A randomised controlled trial of a sexual health promotion intervention for people with severe mental illness delivered in community mental health settings |
| Study acronym | MoreRESPECT |
| Study hypothesis | A bespoke sexual health intervention designed for people with severe mental illness reduces unprotected sexual acts and is cost-effective |
| Ethics approval(s) |
Approved 05/07/2023, North West – Preston REC (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 207 104 8143; preston.rec@hra.nhs.uk), ref: 23/NW/0157 |
| Condition | Sexual health promotion intervention for people with severe mental illness |
| Intervention | 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 involvement (baseline) and then at 3, 6, 9 and 12 months after randomisation. Intervention (Sexual health information sessions plus usual care): In addition to continuing with usual care and support that is usually available, participants will be invited to attend sexual health information sessions delivered by a trained health professional. This will comprise of 3 x 1 hour sessions delivered either face-to-face or via video call. Each time intervention participants meet with a health professional they will discuss things such as: understanding sexually transmitted infections; 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 usual care and support that is usually available to them. |
| Intervention type | Behavioural |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 01/09/2022 |
| Overall study end date | 30/06/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 400; UK Sample Size: 400 |
| Participant 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. |
| Participant 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. |
| Recruitment start date | 25/09/2023 |
| Recruitment end date | 31/08/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
St. Marys Road
Leeds
LS7 3JX
United Kingdom
Beverley Road
Willerby
Hull
HU10 6ED
United Kingdom
4 St Pancras Way
London
NW1 0PE
United Kingdom
St Ann's Hospital
St Ann's Road
London
N15 3TH
United Kingdom
Wakefield
WF1 3SP
United Kingdom
Darlington
DL2 2TS
United Kingdom
Exeter
EX2 5AF
United Kingdom
Atlas Way
Sheffield
S4 7QQ
United Kingdom
Taunton
TA1 5DA
United Kingdom
London
SW17 0YF
United Kingdom
C E M E Centre
Marsh Way
Rainham
RM13 8GQ
United Kingdom
London Road
Bracknell
RG12 2UT
United Kingdom
Newbridge Hill
Bath
BA1 3QE
United Kingdom
Sponsor information
University/education
Cowcaddens Rd
Glasgow
G4 0BA
Scotland
United Kingdom
| Sharron.Dolan@gcu.ac.uk | |
| Website | https://www.gcu.ac.uk/ |
"ROR" |
https://ror.org/03dvm1235 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/09/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Results from this study will be written up and submitted to peer-reviewed journals, irrespective of the outcome, around one year after the overall trial end date. The findings will be presented at relevant national and international conferences. A summary of the trial results will be produced and made available to participants via a lay summary or blog that will be sent to every site to be distributed to those who participated. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 20/09/2023 | No | No |
Editorial Notes
19/03/2025: The following changes have been made:
1. Study participating centres Fieldhead Hospital, West Park Hospital, Wonford House Hospital, Sheffield Health & Social Care NHS Foundation Trust, Musgrove Park Hospital, Springfield University Hospital, North East London NHS Foundation Trust, Berkshire Healthcare NHS Foundation Trust, and Avon and Wiltshire Mental Health Partnership NHS Trust were added.
2. The contacts were updated.
3. The sponsor was changed from Edinburgh Napier University to Glasgow Caledonian University (GCU).
18/03/2024: Study website and study participating centres Camden and Islington NHS Foundation Trust and Barnet, Enfield and Haringey Mental Health NHS Trust were added.
20/09/2023: A link to the HRA research summary was added.
01/09/2023: The recruitment start date was changed from 01/09/2023 to 25/09/2023.
21/08/2023: Another public contact email address has been added.
10/07/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
