Developing and assessing the feasibility of a psychosexual treatment for sexual difficulties in people with multiple sclerosis.

INTERVENTION: Randomisation and blinding Randomisation will be conducted by an independent clinical trials unit to ensure allocation concealment. Participants will be randomised using an online electronic system to the intervention or control group following a 1:1 ratio using randomly varying block sizes to maintain similar numbers across each group during the period of recruitment. Randomisation will be stratified by centre and three gender groups: 1) cisgender men, 2) cisgender women, and 3) transgender/nonbinary. There is an equal probability of being randomised to the PIMS or PSE arm for groups 1 and 2, and a 100% chance of being randomised to the PIMS treatment group for those in group 3. Interventions PIMS Intervention arm: PIMS is an adapted psychosexual intervention that is primarily self‐directed with support from trained MS HCPs. This is a theory based, integrative intervention combining education on primary and secondary MS specific sexual challenges, advice on available treatments for sexual difficulties, and techniques from sex/intimate relationship psychotherapy, acceptance and commitment therapy (ACT), and mindfulness. The purpose of this intervention is to target biological, cognitive, emotional, and behavioural aspects of sexual difficulties for people with MS. PIMS is comprised of 8 sessions: 6 self‐led sessions designed to take approximate 50 minutes and 2 facilitator led sessions (sessions 3 and 7) designed to take approximately 30 minutes. All sessions are supported by a therapy manual. Psychosexual education (PSE) arm: This treatment arm will be a one‐off 20‐minute session with a trained MS clinician. This will involve clinicians as CONDITION: Adults with multiple sclerosis experiencing sexual difficulties ; Nervous System Diseases PRIMARY OUTCOME: ; Feasibility will be assessed by collecting descriptive data on recruitment and retention rates and willingness to be randomised according to Consolidated Standards of Reporting Trials (CONSORT) feasibility and pilot trial guidelines. The outcomes will be collected by someone separate to the healthcare practitioners delivering the intervention. We will determine the following:; 1. Eligibility and recruitment rates; 2. Follow up/retention rates. Proportion of participants who were randomised that completed follow up assessment.; 3. Treatment adherence rates; 3.1. For both PIMS and PSE arms, we will record attendance at appointments.; 3.2. For PIMS arm, we will record adherence to treatment using self‐reported completion of activities and time spent on the content for each week; 4. Time needed to collect and analyse data; 5. Acceptability and satisfaction. This will be evaluated based on constructs identified as being part of a theoretical framework for acceptability that have been developed into an 8‐item scale for use in feasibility trials (Sekkhon, Cartwright, and Francis, 2017; 2018; 2022). Items are on 5‐point Likert response scales, though scale points differ based on the item. An average acceptability score is generated, with higher scores indicated greater acceptability. Wording of the items have been adapted for this study, as is directed by the scale authors. Participants in the PSE and PIMS arm will both respond to the scale.; ; We will also assess the acceptability of the four sexuality‐related measures (see below) to determine which are most relevant and acceptable to patients. To do this, participants will be asked to 1) rate how well they believe each scale captured their sexual difficulties, and 2) pick which of the 4 scales they found to be the most relevant. This will inform future primary outcome measures.; SECONDARY OUTCOME: ; At baseline and at 14‐week follow up:; 1. The Sexual Function Evaluation Questionnaire (SFEQ) will be used to assess level of sexual functioning. We will be calculating both subscales and general scores for use in between‐group analyses.; 2. The Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ‐19) was designed to assess MS‐specific se Xand intimacy related difficulties. This assesses difficulties arising from three causal levels: 1) disease mechanisms (e.g., loss of mobility), 2) treatment effects and disease symptoms (e.g., muscle spasms, incontinence), and 3) psycho‐social factors (e.g., body image difficulties).; 3. The Female Sexual Distress Scale‐Revised (FSDS‐R) will be used to assess general sexual distress. This scale will be used for both male and female participants as it has also been validated in male samples.; 4. The New Sexual Satisfaction Scale – Short form (NSSS‐S) is a 12‐item measure assessing overall sexual satisfaction.; 5. Disability using the Guys Neurological Disability Scale; 6. Quality of life using the EQ‐5D‐5L; 7. Depression symptoms will be measured via the Patient Health Questionnaire‐9 (PHQ‐9) and anxiety symptoms will be measured via the Generalised Anxiety Disorders‐7 questionnaire (GAD‐ 7). Sum scores will be generated for both measures.; 8. For mindfulness, we will use two sub‐scales from the Five Facet Mindfulness Questionnaire (FFMQ). An average score will be computed for the two subscales being used for this study.; 9. For health economics related to the study, the Adult Service Use Schedule (ADSUS) will collect information on the number of contacts the participant has with a range of primary and secondary health and social care services over a specified period. Service use data will be reported via descriptive statistics; no inferential tests will be performed.; INCLUSION CRITERIA: For PwMS in the intervention study: 1. Confirmed diagnosis of Multiple Sclerosis (using McDonalds revised criteria) 2. Attending the neurology clinic at one of the participating research sites 3. Aged =18 years 4. Affirmative response to the following question: Are you currently experiencing any sort of sexual or intimacy difficulty? 5. Able and willing to provide informed consent For facilitators participating in nested qualitative study: 6. Clinical staff at research sites that work with people with Multiple Sclerosis