Protocol for a Randomised Controlled Feasibility Trial of an Integrated Psychosexual Intervention for Sexual Difficulties in People with Multiple Sclerosis: the PIMS Trial

Overview

Journal Pilot Feasibility Stud

Publisher Biomed Central

Date 2025 Mar 12

PMID 40069906

Authors

Ashley Brown

Sam Norton

Whitney Scott

Barbara Barrett

Qazi Rahman

Lesley Catterall

Denise Middleton

Malgorzata Gosia Kuran

Eli Silber

Rona Moss-Morris

Affiliations

Soon will be listed here.

Abstract

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.

References

Graham C, Gouick J, Krahe C, Gillanders D . A systematic review of the use of Acceptance and Commitment Therapy (ACT) in chronic disease and long-term conditions. Clin Psychol Rev. 2016; 46:46-58. DOI: 10.1016/j.cpr.2016.04.009. View

Mohammadi K, Rahnama P, Montazeri A, Foley F . The multiple sclerosis intimacy and sexuality questionnaire-19: reliability, validity, and factor structure of the Persian version. J Sex Med. 2014; 11(9):2225-31. DOI: 10.1111/jsm.12531. View

Locke E, Latham G . Building a practically useful theory of goal setting and task motivation. A 35-year odyssey. Am Psychol. 2002; 57(9):705-17. DOI: 10.1037//0003-066x.57.9.705. View

Sekhon M, Cartwright M, Francis J . Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC Health Serv Res. 2017; 17(1):88. PMC: 5267473. DOI: 10.1186/s12913-017-2031-8. View

Tepavcevic D, Kostic J, Basuroski I, Stojsavljevic N, Pekmezovic T, Drulovic J . The impact of sexual dysfunction on the quality of life measured by MSQoL-54 in patients with multiple sclerosis. Mult Scler. 2008; 14(8):1131-6. DOI: 10.1177/1352458508093619. View

Leavitt C, Maurer T, Clyde T, Clarke R, Busby D, Yorgason J . Linking Sexual Mindfulness to Mixed-Sex Couples' Relational Flourishing, Sexual Harmony, and Orgasm. Arch Sex Behav. 2021; 50(6):2589-2602. DOI: 10.1007/s10508-021-02054-0. View

Toates F . An integrative theoretical framework for understanding sexual motivation, arousal, and behavior. J Sex Res. 2009; 46(2-3):168-93. DOI: 10.1080/00224490902747768. View

Teare M, Dimairo M, Shephard N, Hayman A, Whitehead A, Walters S . Sample size requirements to estimate key design parameters from external pilot randomised controlled trials: a simulation study. Trials. 2014; 15:264. PMC: 4227298. DOI: 10.1186/1745-6215-15-264. View

Gunzler C, Berner M . Efficacy of psychosocial interventions in men and women with sexual dysfunctions--a systematic review of controlled clinical trials: part 2--the efficacy of psychosocial interventions for female sexual dysfunction. J Sex Med. 2012; 9(12):3108-25. DOI: 10.1111/j.1743-6109.2012.02965.x. View

10.

Harris P, Taylor R, Thielke R, Payne J, Gonzalez N, Conde J . Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2008; 42(2):377-81. PMC: 2700030. DOI: 10.1016/j.jbi.2008.08.010. View

11.

Fraser C, McGurl J . Psychometric testing of the Americanized version of the Guy's Neurological Disability Scale. J Neurosci Nurs. 2007; 39(1):13-9. DOI: 10.1097/01376517-200702000-00004. View

12.

Spitzer R, Kroenke K, Williams J, Lowe B . A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006; 166(10):1092-7. DOI: 10.1001/archinte.166.10.1092. View

13.

Strizzi J, Fernandez-Agis I, Alarcon-Rodriguez R, Parron-Carreno T . Adaptation of the New Sexual Satisfaction Scale-Short Form Into Spanish. J Sex Marital Ther. 2015; 42(7):579-88. DOI: 10.1080/0092623X.2015.1113580. View

14.

Arshi M, Sheybani F, Eghlima M, Shati M, Moghanibashi-Mansourieh A, Moshayyedi M . Group social work intervention enhances the sexual satisfaction of women with Multiple Sclerosis: a randomized controlled trial study. Soc Work Health Care. 2020; 59(5):322-333. DOI: 10.1080/00981389.2020.1762148. View

15.

Sazesh S, Saeieh S, Farid M, Refaei M, Yazdkhasti M . Effectiveness of Group Counseling with a Client-Centered Approach Based on the GATHER Principles on Sexual Satisfaction in Women with Multiple Sclerosis: A Randomized Clinical Trial. Iran J Med Sci. 2021; 46(2):103-111. PMC: 7966937. DOI: 10.30476/ijms.2020.82616.1074. View

16.

Mark K, Herbenick D, Fortenberry J, Sanders S, Reece M . A psychometric comparison of three scales and a single-item measure to assess sexual satisfaction. J Sex Res. 2013; 51(2):159-69. DOI: 10.1080/00224499.2013.816261. View

17.

Brotto L, Zdaniuk B, Chivers M, Jabs F, Grabovac A, Lalumiere M . A randomized trial comparing group mindfulness-based cognitive therapy with group supportive sex education and therapy for the treatment of female sexual interest/arousal disorder. J Consult Clin Psychol. 2021; 89(7):626-639. DOI: 10.1037/ccp0000661. View

18.

Fletcher S, Castro-Borrero W, Remington G, Treadaway K, Lemack G, Frohman E . Sexual dysfunction in patients with multiple sclerosis: a multidisciplinary approach to evaluation and management. Nat Clin Pract Urol. 2009; 6(2):96-107. DOI: 10.1038/ncpuro1298. View

19.

Petersen M, Kristensen E, Giraldi L, Giraldi A . Sexual dysfunction and mental health in patients with multiple sclerosis and epilepsy. BMC Neurol. 2020; 20(1):41. PMC: 6995085. DOI: 10.1186/s12883-020-1625-7. View

20.

Xiao Y, Wang J, Luo H . Sildenafil citrate for erectile dysfunction in patients with multiple sclerosis. Cochrane Database Syst Rev. 2012; (4):CD009427. DOI: 10.1002/14651858.CD009427.pub2. View