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Protocol for a randomised controlled feasibility trial of an integrated psychosexual intervention for sexual
Ashley Brown1, Sam Norton2, Whitney Scott2,3
1Department of Psychology, Health Psychology Section, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. ashley.brown@kcl.ac.uk.
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. 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 . Registration date: 28th 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:
2.0, 10th February, 2025.
Insights
This study assesses the feasibility of the Psychosexual Intervention for people with Multiple Sclerosis (PIMS) program. PIMS aims to improve sexual difficulties and quality of life for individuals with MS.
Area of Science:
- Neurology
- Psychology
- Sexual Health
Background:
- Multiple Sclerosis (MS) significantly impacts quality of life (QoL).
- Sexual difficulties (SDs) affect 50-80% of people with MS (PwMS), stemming from disease processes, treatments, and psychosocial factors.
- Current treatments for SDs in MS are limited, highlighting the need for novel interventions.
Purpose of the Study:
- To assess the acceptability and feasibility of an eight-session, clinician-supported integrated Psychosexual Intervention for people with Multiple Sclerosis (PIMS).
- To gather preliminary data for a full-scale trial on PIMS intervention and its delivery.
- To identify barriers and facilitators to intervention engagement and delivery through a nested qualitative study.
Main Methods:
- A multicentre, two-arm randomized feasibility trial involving 50 PwMS across three NHS research sites.
- Participants randomized to either the PIMS intervention (8 sessions over 12 weeks) or psychosexual education.
- Feasibility assessed via recruitment/retention rates; patient-reported outcomes (sexual function, distress, QoL) measured at baseline and 14 weeks.
Main Results:
- Preliminary data on recruitment and retention rates will be collected.
- Patient-reported outcomes including sexual functioning, distress, and quality of life will be analyzed.
- Qualitative data will identify barriers and facilitators to intervention engagement and delivery.
Conclusions:
- The PIMS intervention is the first integrated psychosexual intervention developed for PwMS in the UK.
- Assessing PIMS feasibility is a crucial first step towards future implementation and efficacy trials.
- This study will inform modifications to PIMS for a definitive randomized controlled trial.
