Evidence map›Paper›PMID 40069906›Full record

ArticlePilot and feasibility studies2025

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

Ashley Brown, Sam Norton, Whitney Scott, Barbara Barrett, Qazi Rahman, Lesley Catterall, Denise Middleton, Malgorzata 'Gosia' Kuran, Eli Silber, Rona Moss-Morris

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Article in Pilot and feasibility studies, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

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2 · The registry

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3 · Its place in the literature

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4 · The record

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5 · Who and what money

Authors and funding

10 authors.

Ashley BrownDepartment of Psychology, Health Psychology Section, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. ashley.brown@kcl.ac.uk.ORCID http://orcid.org/0000-0001-6743-3773
Sam NortonDepartment of Psychology, Health Psychology Section, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
Whitney ScottDepartment of Psychology, Health Psychology Section, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
Barbara BarrettHealth Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
Qazi RahmanDepartment of Psychology, Health Psychology Section, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
Lesley CatterallMilton Keynes Community Health Services, Neurological Clinical Specialist Team, Central and Northwest London NHS Foundation Trust, Milton Keynes, UK.
Denise MiddletonMilton Keynes Community Health Services, Neurological Clinical Specialist Team, Central and Northwest London NHS Foundation Trust, Milton Keynes, UK.
Malgorzata 'Gosia' KuranDepartment of Neurology, King's College Hospital NHS Foundation Trust, London, UK.
Eli SilberDepartment of Neurology, King's College Hospital NHS Foundation Trust, London, UK.
Rona Moss-MorrisDepartment of Psychology, Health Psychology Section, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.

Funding

Research for Patient Benefit Programme NIHR202006
6 · The paper itself

Abstract

backgroundMultiple 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).

methodsThis 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 registrationThis 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.

Indexed as

Multiple SclerosisPsychosexual therapyRandomised controlled feasibility trialSexual dysfunction

Identifiers

PMID40069906
PMCPMC11895209

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.