Developing and assessing the feasibility of a psychosexual treatment for sexual difficulties in people with multiple sclerosis.
| ISRCTN | ISRCTN12202900 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12202900 |
| IRAS number | 305830 |
| Secondary identifying numbers | IRAS 305830, CPMS 53293, NIHR202006 |
- Submission date
- 24/05/2022
- Registration date
- 28/02/2023
- Last edited
- 13/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English Summary
Background and study aims
Sexual difficulties are one of the key hidden and troubling symptoms of Multiple Sclerosis (MS); they affect up to 50-80% of people with MS and include sexual dysfunctions (e.g., erectile dysfunction), sexual distress (e.g., worry about sex due to pain), and loss of pleasure.
The burden of obtaining treatment for sexual difficulties often falls on the person with MS. NHS support, if available, is usually limited to education and medications. Additionally, healthcare professionals are not always experienced in or comfortable with talking about this subject. The people with MS we spoke to said they wanted sexual difficulties to be discussed routinely in appointments, and for a wider range of sexual difficulty management options to be offered.
A type of psychological intervention used to treat sexual difficulties, called ‘psychosexual interventions’ show promise in treating MS related sexual difficulties but have not been robustly evaluated. Psychosexual interventions combine education (e.g., knowledge about how common sexual difficulties are in MS), with other elements such as intimacy-specific practices (e.g., learning to focus on pleasurable sensations) and challenging unhelpful beliefs about body image, sexuality, and relationships.
This project will adapt a psychosexual intervention (called PIMS) so that it is appropriate for people with MS. The research will take place at King’s College Hospital, Queen Elizabeth Hospital, and Milton Keynes Community Health Services. This will provide preliminary evidence about the feasibility of the intervention and inform a future larger study.
As this is a preliminary trial, the aim is to explore design/delivery and acceptability of the PIMS intervention and outcome measures to staff and participants. This is to gather information to establish if it is worthwhile to run a large randomised controlled trial or if any changes should be made to the intervention and/or trial procedures before running a large trial.
Who can participate?
Adults with Multiple Sclerosis who are experiencing sexual and/or intimacy difficulties and who receive care at one of the trial sites. They must be willing and able to provide informed consent and be proficient in verbal and written English. Participants cannot be currently receiving other psychotherapy or be in other psychological intervention trials, experience a mental health disorder (e.g., psychosis) or have visual or hearing impairments that would prevent them from engaging in the intervention.
What does the study involve?
Fifty adults with MS experiencing sexual difficulties will be randomised (allocated by chance) to receive either 1) the (P)sychosexual (I)ntervention for Sexual Difficulties in People with (M)ultiple (S)clerosis (PIMS) or 2) a standardised MS psychosexual education package (PSE). NHS healthcare professionals who work with people with MS (e.g., MS specialist nurses, physiotherapists) will be trained to deliver both treatments. The PSE treatment will involve clinicians asking questions about sexual difficulties, discussing treatment, and directing to other resources during a one-off 20-minute appointment. PIMS will be comprised of 8 sessions that will be no more than 50 minutes long. Two of these sessions (session 3 and 7) will be facilitator led and will last approximately 30 minutes.
Participants will complete questionnaires about their mental health and sexual functioning, satisfaction, and communication before and after treatment. We will also conduct interviews with participants to get feedback and better understand their treatment experiences.
What are the possible benefits and risks of participating?
Benefits:
- All participants will receive treatments that will potentially improve their sexual challenges
- Both treatment groups may benefit from discussing their sexual challenges and treatment options with healthcare practitioners
- We anticipate the results from this study will allow us to:
- Improve the knowledge of how MS affects sexuality and intimacy
- Inform healthcare practitioners about how to help people with MS manage their condition
- Inform future research on sexual challenges in MS
Risks:
- Participation will require some time commitment to attend sessions with healthcare practitioners and work through self-guided material.
- It is possible that completing the questionnaires (at baseline and follow-up) may cause some distress, but this is rare.
- This study is being largely run remotely, including sessions with healthcare practitioners. It may be possible for participants to have face-to-face sessions with healthcare practitioners if this is mutually agreed. If attending face-to-face sessions, there may be a risk of transmission of COVID- 19 from attending a hospital setting.
- Given the topic of the PIMS intervention, the interview may involve discussing intimate issues around sex, relationships, and intimacy which may be distressing. However, participants will not be directly asked or required to share personal experiences.
Where is the study run from?
The day-to-day running and management of the project will be at the Health Psychology department King's College London (Guy's Hospital). The recruitment and intervention delivery will be done at our study sites: King's College Hospital, Queen Elizabeth Hospital, and Milton Keynes Community Health Services.
When is the study starting and how long is it expected to run for?
September 2021 to June 2024
Who is funding the study?
Funding to conduct the trial is provided by the National Institute for Health and Care Research (NIHR) (UK) Research for Patient Benefit (RfPB) funding stream.
Who is the main contact?
Dr Ashley Brown, ashley.brown@kcl.ac.uk
Professor Rona Moss-Morris, rona.moss-morris@kcl.ac.uk
Contact information
Principal Investigator
Health Psychology Section (IoPPN)
King’s College London
5th Floor Bermondsey Wing
Guy’s Hospital
London
SE1 9RT
United Kingdom
 ORCID ID |
0000-0002-2927-3446 |
|---|---|
| Phone | +44 (0)20 7188 0178 |
| rona.moss-morris@kcl.ac.uk |
Scientific
Health Psychology Section (IoPPN)
King’s College London
5th Floor Bermondsey Wing
Guy’s Hospital
London
SE1 9RT
United Kingdom
| ORCID ID |
0000-0001-6743-3773 |
|---|---|
| ashley.brown@kcl.ac.uk |
Study information
| Study design | Two-armed parallel groups multicentre randomized controlled feasibility trial with nested qualitative process analysis |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Quality of life |
| Participant information sheet | 41818 facilitator PIS v1.0 20May2022.pdf |
| Scientific title | A randomised controlled feasibility trial comparing an integrated psychosexual intervention for sexual difficulties in people with Multiple Sclerosis to sexual education alone |
| Study acronym | PIMS |
| Study hypothesis | The primary aim is to test the feasibility of conducting a larger scale RCT of a newly developed psychosexual intervention for people with Multiple Sclerosis. We will assess the acceptability of the 1) trial methods 2) psychosexual intervention (PIMS), 3 proposed outcome measures for patients receiving PIMS, and 4) HCPs delivery of PIMS. Parameters for assessing feasibility include: eligibility rates, recruitment rates, follow-up/retention rates, treatment adherence, and satisfaction and acceptability of the novel intervention form both the patients and HCPs view points. Analysis of these variables, including data from a nested qualitative study, will inform the decision to proceed to a definitive trial. Secondary objectives 1. To explore treatment effects on self-report outcomes to determine that 95% confidence intervals for the effects are consistent with anticipated effects and minimum clinically important differences 2. To estimate key elements that would inform a power calculation to inform a power calculation for an efficacy study |
| Ethics approval(s) | Approved 24/06/2022, London - Harrow Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 207 104 8246; harrow.rec@hra.nhs.uk), ref: 22/LO/0441 |
| Condition | Adults with multiple sclerosis experiencing sexual difficulties |
| 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 asking standardised questions about sexual difficulties, discussing medication (if relevant), and signposting to other resources available online. Education components will be similar to those appearing in the PIMS intervention, without the inclusion of psychological components (e.g., identifying values). Content will be consistent with the latest NICE guidelines for managing Multiple Sclerosis and recommendations for managing sexual and intimacy challenges put forth by the MS Society and MS Trust. This arm will be acting as an enhanced standard care arm. |
| Intervention type | Behavioural |
| Primary outcome measure | 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 measures | 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 sex and 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. |
| Overall study start date | 01/09/2021 |
| Overall study end date | 30/06/2024 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 |
| Participant 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 |
| Participant exclusion criteria | For PwMS in the intervention study 1. Severe visual or hearing impairments which would impact the ability to engage in the intervention 2. Severe mental health disorder (e.g., psychosis) which would impact the ability to engage in the intervention 3. Currently receiving psychotherapy or are participating in any other psychological intervention trial 4. Insufficient verbal and/or written proficiency in English For facilitators participating in nested qualitative study: 5. Unable or unwilling to consent to participate in the follow up interviews |
| Recruitment start date | 01/11/2022 |
| Recruitment end date | 29/02/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
De Crespigny Park
Denmark Hill
London
SE5 8AB
United Kingdom
Bletchley
Milton Keynes
MK3 6EN
United Kingdom
Woolwich
London
SE18 4QH
United Kingdom
Sponsor information
Hospital/treatment centre
R&D Department
Room W1.08
Institute of Psychiatry, Psychology & Neuroscience (IoPPN)
De Crespigny Park
London
SE5 8AF
England
United Kingdom
| Phone | +44 (0)20 7848 0339 |
|---|---|
| slam-ioppn.research@kcl.ac.uk | |
| Website | http://www.slam.nhs.uk/ |
"ROR" |
https://ror.org/015803449 |
University/education
Room 5.31, James Clerk Maxwell Building
57 Waterloo Road
London
SE1 8WA
England
United Kingdom
| Phone | +44 (0)207 8483224 |
|---|---|
| vpri@kcl.ac.uk | |
| Website | https://www.kcl.ac.uk/ |
|
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | It is expected that results will be fed back to participants and will be disseminated through public engagement events (arranged with our patient and public involvement working group), academic publications, and presented at international conferences. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. The CI (Prof Rona Moss-Morris; rona.moss-morris@kcl.ac.uk) will be the contact to approve and send out copies of any data. Any data shared will be de-identified. Only data from participants who have consented to their data being shared/used in future research studies will be shared. A data file will be made at the end of the trial where the possibility of identification has been minimized and includes only data from those who have consented to this. Both quantitative and qualitative data may be requested. Data will only be shared for the purpose of research. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | For facilitators version 1.0 |
20/05/2022 | 06/06/2022 | No | Yes |
| Participant information sheet | For patients version 1.0 |
20/05/2022 | 06/06/2022 | No | Yes |
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol article | 11/03/2025 | 13/03/2025 | Yes | No |
Additional files
- 41818 PIS patients v1.0 20May2022.pdf
- For patients
- 41818 facilitator PIS v1.0 20May2022.pdf
- For facilitators
Editorial Notes
13/03/2025: Publication reference added.
07/02/2024: Internal review.
11/01/2024: The following changes were made:
1. The recruitment end date was changed from 31/01/2024 to 29/02/2024.
2. The intention to publish date was changed from 31/08/2024 to 31/12/2024.
17/08/2023: The recruitment end date has been changed from 31/07/2023 to 31/01/2024.
06/03/2023: Internal review.
06/06/2022: Trial's existence confirmed by King's College London.
