Developing and assessing the feasibility of a psychosexual treatment for sexual difficulties in people with multiple sclerosis.

A randomised controlled feasibility trial comparing an integrated psychosexual intervention for sexual difficulties in people with Multiple Sclerosis to sexual education alone

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12202900

Enrollment

Registered

2023-02-28

Start date

2022-11-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adults with multiple sclerosis experiencing sexual difficulties Nervous System Diseases

Interventions

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 t

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 9, 2026