Title: An Integrated Psychosexual Intervention for Sexual Difficulties in People with Multiple Sclerosis (PIMS) : A Feasibility Study
Funder: Department of Health and Social Care

Abstract: Background: Multiple Sclerosis (MS) is a relapsing remitting and/or progressive incurable neurological condition. Sexual difficulties (SDs) are one of the many distressing symptoms of MS; reported by 50-80% of people with MS (PwMS). Although research shows that sexual difficulties negatively impact quality of life (QoL), and that QoL is directly related to MS-related service costs, there are no specific NHS-led psychosocial interventions for SDs in MS. Current treatment is limited to education and medication. There is evidence to support psychosexual interventions to treat SDs in the general population and in some LTCs. However, these interventions fail to take MS-specific issues into account. Thus, there is a need to adapt current psychosexual interventions to address SDs in PwMS and to determine effectiveness of this approach. Research question: Is a full-scale RCT of an integrated psychosexual intervention (PIMS) delivered by MS HCPs feasible and acceptable to people with Multiple Sclerosis and sexual difficulties? Aims and Objectives: To adapt an existing psychosexual intervention integrating Acceptance and Commitment Therapy (ACT), psychosexual education, and mindfulness, drawing on theory, evidence, and PPI and HCPs feedback for delivery in the NHS To evaluate the feasibility of a larger scale RCT Select outcomes of interest for a full-scale trial Explore the feasibility of collecting health economics data and estimates of changes in service use associated with the intervention and measures of QoL Methods: The study has two components: 1) intervention adaptation and 2) the feasibility radnmsied controlled trial. The adaptation will be done in collaboration with PwMS, MS healthcare practitioners (HCPs) and MS charities. Cyclical feedback from these groups will contribute to study materials and facilitator training. MS HCPs will be trained to deliver the intervention. 50 PwMS across 3 NHS sites will be recruited to the RCT. Clinical Trials Unit will conduct 1:1 randomisation to the intervention (PIMS) or standard care, stratified by NHS centre and gender while maintaining allocation concealment. Those in the intervention arm will receive 6-8 1-hour sessions with an intervention facilitator. The control arm will receive a standardised standard-care package. Assessment will be conducted at baseline, 4 and 10 weeks follow up. Data on recruitment, retention, and adherence rates as well as adverse events will be collected and summarised. Between group differences at the 4- and 10-week follow-up outcome assessments will be estimated with 95%CIs using linear mixed-effects models, with random intercepts to account for the repeated assessments within individuals. A nested qualitative study will assess acceptability. Timelines for delivery: The study will be 24 months, with adaptation between months 1-7, RCT over months 8-20. Expected outputs include HCPs training manual, and a self-help guide (PIMS) for PwMS and SDs and feasibility data. Anticipated Impact and Dissemination: Improved treatment of SDs in MS. Results will be disseminated as 3-4 peer reviewed publications, presented at conferences and public engagement events, and through the MS Trust. Additionally, this study may raise awareness of SDs in other LTCs, and facilitate greater comfort in patients disclosing SDs to HCPs and HCPs comfort in raising the issue.

Lay abstract: Multiple Sclerosis (MS) is a condition of the brain and spinal cord that affects many aspects of quality of life. Sexual difficulties are one of the many hidden and troubling symptoms of MS; sexual difficulties affect up to 50-80% of people with MS and include sexual dysfunctions (e.g. erectile dysfunction), sexual distress (e.g. worry about sex due to pain), and loss of pleasure. Sexual difficulties can arise as a result of nerve damage, or through MS symptoms (e.g. fatigue, bladder/bowel problems, pain) and psychological factors resulting from living with MS (e.g. poor body image and fear of rejection by sexual partners). The burden of obtaining treatment for sexual difficulties often falls on the person with MS. NHS support, if available, is usually limited to education and medications. Additionally, healthcare professionals are not always experienced in or comfortable with talking about this subject. The people with MS we spoke to said they wanted sexual difficulties to be discussed routinely in appointments, and for a wider range of sexual difficulty management options to be offered. Psychosexual interventions, a type of psychological therapy used to treat sexual difficulties, show promise in treating MS related sexual difficulties but have not been robustly evaluated. Psychosexual interventions combine education (e.g. knowledge about how common sexual difficulties are in MS and factors maintaining them), with other elements such as intimacy-specific mindfulness practices (e.g. learning to focus on pleasurable sensations) and challenging beliefs about body image, sexuality, and relationships. This project will adapt a psychosexual intervention so that it is appropriate for people with MS and collect information about its use at three hospitals. This will provide preliminary evidence about the intervention and how well it works. This will inform a future larger study that would and assess the interventions effectiveness scaled up across a larger number of centres. Fifty people with MS experiencing sexual difficulties will receive either the psychosexual intervention or standard care. NHS healthcare professionals who work with people with MS (e.g. MS specialist nurses, physiotherapists, continence nurses) will be trained to deliver the intervention. Standard care will involve clinicians asking standardised questions about sexual difficulties, discussing medication (if relevant), and signposting to other resources such as educational information available online. Our patient and public involvement group will meet regularly and will be actively involved in all stages of the project. They have informed this application. They will help adapt the intervention, create study materials (e.g. training manuals for nurses), and inform our interpretation of the results. The research findings will be made widely available in peer-reviewed journals and at academic conferences and shared at community events for people with MS and care providers, which our patient and public involvement group will help to organise.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: NEUROLOGICAL