Protocol for a randomised controlled feasibility trial of an integrated psychosexual intervention for sexual difficulties in people with Multiple Sclerosis: the PIMS trial

Background: Multiple Sclerosis (MS) is a long-term condition that significantly diminishes quality of life (QoL). Sexual difficulties (SDs) are common, but often overlooked symptom, affecting 50-80% of people with MS (PwMS). The emergence of SDs in MS results from the intricate interplay of disease processes, treatments, and psychosocial factors, contributing to a further decline in QoL and adverse effects on body image, relationships, and psychological well-being. Despite the limited treatment options, which mainly include medications and physiotherapy, there is promise in psychological interventions for addressing SDs in PwMS, although integrating them into routine care poses challenges. This protocol details the trial assessing the acceptability and feasibility of an eight-session, clinicians supported integrated Psychosexual Intervention for people with Multiple Sclerosis (PIMS). Methods: This is a multicentre interventional two-arm randomized feasibility trial with a nested qualitative study to gather preliminary data about the intervention and the feasibility of conducting a full-scale trial. We aim to recruit 50 PwMS across three research sites in England’s National Health Service (NHS). Participants will be randomised to either the PIMS intervention (comprised of 8 sessions: 6 self-led and 2-facilitator led over the course of 12 weeks) or psychosexual education (one appointment with a facilitator to discuss treatment options). 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. Patient reported outcomes (e.g., measures of sexual functioning and distress, psychological functioning, and quality of life) will be measured at baseline and follow up 14-weeks after randomisation. We will also use a nested qualitative study will use inductive thematic analysis to identify barriers to engagement with and delivery of the intervention, and to make appropriate modifications to PIMS. Discussion: The PIMS intervention will be the first integrated psychosexual intervention developed for people with Multiple Sclerosis in the UK. We will be using Assessing the feasibility of PIMS is an important first step to establishing future implementation and efficacy via a definitive randomised controlled trial. Trial registration: This trial is registered at ISRCTN: 12202900 https://doi.org/10.1186/ISRCTN12202900 Registration date: 28 ^th February 2023; Retrospectively registered IRAS identification: 305830 NIHR award reference: NIHR202006 Trial sponsorship: This trial is co-sponsored by South London and Maudsley NHS Foundation Trust and King’s College London. Contact: slam-ioppn.research@kcl.ac.uk Protocol version: 1.3, 21 ^st February 2024