Title: 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
Funder: Department of Health and Social Care

Abstract: There is evidence to suggest that people with Serious Mental illness (SMI) (e.g.schizophrenia and bipolar affective disorder) experience poor sexual health including greater levels of violence, sexual exploitation, sexually transmitted infections, and low rates of contraception. Reviews of interventions which aim promote sexual health have concluded that there is currently no reliable evidence on which to base interventions in the UK. Therefore the overall aim of this study is to assess the feasibility and acceptability of an intervention delivered within mental health services, as well as the feasibility and acceptability of conducting a randomised trial of this intervention. DESIGN: A feasibility study with randomisation; parallel arm individual randomised controlled trial comparing usual care alone, with usual care plus an adjunctive intervention to promote sexual health SETTING: Community mental Health services in 4 NHS Trusts: Leeds and York; South West Yorkshire, Camden and Islington; and Sussex NHS Trusts. TARGET POPULATION: People with serious mental illness using secondary community mental health teams and in receipt of Care Programme Approach (CPA) (excluding cognitive disorders). HEALTH TECHNOLOGY BEING ASSESSED :A manualised behavioural intervention (co-produced by clinicians, people with lived experiemce and academics in stage 1) which is designed to promote sexual health by assessing need and targeting specific needs (including referral to appropriate sexual health services) OUTCOMES: The main outcome is to establish the feasibility and acceptability of the intervention and the trial methodology. We will use a battery of quantitative outcome measures (to be specified in stage 1) related to sexual health knowledge, motivation, sexual behaviour, sexual stigma, violence in relationships, service use, and quality of life. In addition we will interview a sub-sample of participants in both arms to gather qualitative data on the acceptability of the outcome measures and the intervention itself. We include both arms as we are interested in whether the outcome measures in themselves led to greater interest in, and uptake of sexual health and family planning services and other related services, and whether involvement in the study has increased the likelihood of their conversations with their case manager being related to sexual health and relationship issues. ANALYSIS: All data will be presented descriptively with no formal statistical analyses undertaken. Recruitment rates, attendance data, withdrawals and outcome completion rates will be compared between study arms at each stage of the trial. HEALTH ECONOMICS: The economic analysis will evaluate the feasibility and challenges of measuring costs and outcomes in the target population to inform the choice of effectiveness and resource use measures for the full-scale study. OUTPUTS: The findings from this study, whilst not definitive in terms of clinical and cost effectiveness, will inform the parameters required to undertake a fully powered trial. We will publish in peer reviewed journals, produce a range of summaries to a variety of audiences and use social media to increase reach and impact.

Lay abstract: Background: People with serious mental illness (SMI) (people who experience long term, relapsing mental health problems that require ongoing support from NHS mental health services) often have additional physical health problems. However, these needs are not always addressed for a number of reasons including: lack of motivation, not reporting symptoms to their health workers, and what is known as "diagnostic over-shadowing" which means that physical ailments can be misinterpreted as a part of their mental illness (such as low energy levels and loss of appetite). As a response to these physical health needs, there is now a push for ways to help people with SMI access physical health care (including health checks at GP and assessment of physical health in mental health care). Despite this effort, one important area of health has been missed; sexual health. People with SMI, just like everyone else, hope to have safe and satisfying sexual relationships, and indeed this is an important part of building a life of recovery after a period of mental illness. However the reality for people with SMI is often more bleak. Some people are more at risk of sexually acquired infections such as HIV and hepatitis B (and C), and more likely to face violence and exploitation in their relationships. An examination of published studies (a review) has looked at whether there are any ways of working that help promote sexual health and safer relationships. This review found that it was possible to get people involved in studies that focused on sexual relationships and sexual behaviour, and that some studies showed that there were positive changes in sexual behaviour after taking part in a specially focused group intervention. However all the studies were done in the USA, and each was very different in how they were delivered. This has made it difficult to know what might help people with their sexual health and relationship needs here in the UK. Therefore, there is a need to develop an a package of care (intervention) that is relevant to the needs of people in the UK, and establish whether this is practical, and whether it is acceptable and useful for people it is aimed at (Feasibility study). This type of study examines the practical issues in establishing such a study and therefore can iron out any of these problems before further funding is granted to do a much larger study. A larger study would need enough people participating to be able to evaluate with confidence whether it makes a real difference to people (when compared with a group of people who wont receive the extra intervention). In our team, as well as sexual health and mental health clinicians and researchers, we have a group of people with lived experience (PWLE) who will be working at all stages of the project to make sure that what we produce is acceptable, practical, safe and comfortable. The RESPECT Study: In our project, we will develop an intervention that will then be delivered by specially trained mental health workers. People who agree to take part will be allocated by chance to the extra intervention (as well as usual care) or to just usual care by chance (randomly allocated). We will collect information on how many people we are able to sign up to the study, the numbers of people who drop out along the way, missed appointments for the intervention, as well as trying out the questionnaires chosen to assess sexual health knowledge, motivation, behaviour,and use of sexual health services and GP services for family planning. We will interview a small group of people about their experience of being part of the study. We will prepare a report and make recommendations as to whether this should be further funded, and write papers for academic and lay audiences about what we have learnt. We plan to make use of social media (Twitter and blogs) to make sure that our findings are available to everyone including people who use services, and those who run and commission mental health services, as well as mental health workers.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: INFECTION;MENTAL HEALTH;REPRODUCTIVE HEALTH AND CHILDBIRTH