Behavioral Intervention for Sexual Dysfunction in Multiple Sclerosis

(BIPAMS-SD Trial)

Overseen By Ashlie Ithurburn

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Moderate or high exercise risk

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The prevalence of sexual dysfunction is higher among women with multiple sclerosis (MS) than women in the general population. The presence of sexual dysfunction is associated with decreased well-being and quality of life. There is limited research supporting pharmacological and other therapeutic approaches for managing sexual dysfunction in MS. Physical activity has beneficial effects on many of the consequences of MS, and physical activity represents a promising non-pharmacological approach for managing symptoms of sexual dysfunction in MS. The proposed research examines the effect of an Internet-delivered lifestyle physical activity intervention for improving sexual dysfunction in women with MS. The research proposed, if successful, will provide evidence for the efficacy of physical activity as a translatable approach for managing sexual dysfunction among women with MS.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on a physical activity intervention, so it's best to discuss your medications with the trial coordinators.

What data supports the effectiveness of the treatment Behavioral Intervention for Physical Activity for Multiple Sclerosis (BIPAMS) for sexual dysfunction in multiple sclerosis?

Research shows that exercise, including aquatic exercise, can improve sexual function in people with multiple sclerosis. Additionally, behavioral interventions that encourage physical activity have been effective in improving overall health and quality of life in people with MS, which may indirectly benefit sexual function. ^{1 2 3 4 5}

Is the behavioral intervention for physical activity in multiple sclerosis safe?

The available research does not provide specific safety data for the behavioral intervention, but it focuses on feasibility and acceptability, which are important for ensuring that the intervention can be safely and effectively implemented. ^{4 6 7 8 9}

How is the BIPAMS treatment different from other treatments for sexual dysfunction in multiple sclerosis?

The BIPAMS treatment is unique because it focuses on behavioral interventions to increase physical activity, which may improve sexual function in people with multiple sclerosis. Unlike standard treatments that might rely on medication, this approach uses exercise and lifestyle changes to address the issue. ^{1 5 10 11 12}

Eligibility Criteria

This trial is for women aged 18-45 with relapsing-remitting multiple sclerosis and sexual dysfunction, who are in a committed relationship. Participants must be able to walk without help, have low physical activity levels, internet access, speak English, and not be at risk of injury from exercise.

Inclusion Criteria

You have been diagnosed with sexual dysfunction using specific interview guidelines.

I have not had a relapse in the last 30 days.

I am between 18 and 45 years old.

Exclusion Criteria

You have a high risk of getting hurt or dying from intense exercise.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Waitlist Control

Participants will have 16-weeks of no intervention or interaction

16 weeks

Behavioral Intervention

A behavioral intervention involving an internet website and one-on-one video coaching calls for increasing physical activity in people with MS

16 weeks

Follow-up

Participants are monitored for changes in various outcomes such as sleep, depression, loneliness, emotion regulation, physical activity, pain, fatigue, couple satisfaction, anxiety, and sexual dysfunction

4 weeks

Treatment Details

Interventions

• Behavioural intervention for physical activity for multiple sclerosis (BIPAMS)

Trial Overview The study tests an online program promoting physical activity (BIPAMS) to improve sexual dysfunction in women with MS. It explores if regular exercise can enhance well-being and quality of life by managing symptoms related to sexual health.

Participant Groups

Group I: Behavioral Intervention for Physical Activity in MS (BIPAMS) Experimental Treatment 1 Intervention

A behavioral intervention that involves an internet website and one-on-one video coaching calls for increasing physical activity in people with MS.

Group II: waitlist control condition Active Control 1 Intervention

Participants will have 16-weeks of no intervention or interaction.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Multiple Sclerosis Society

Collaborator

Trials

100

Recruited

10,600+

Findings from Research

The behavior-change intervention aimed at increasing physical activity and reducing sedentary behavior in people with multiple sclerosis was found to be safe, with no significant difference in adverse events compared to usual care.

The intervention was deemed feasible and acceptable by both participants and therapists, with a high attendance rate of 97% among participants, indicating strong engagement, although some modifications were suggested for improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, feasibility, acceptability and effects of a behaviour-change intervention to change physical activity behaviour among people with multiple sclerosis: Results from the iStep-MS randomised controlled trial. Ryan, JM., Fortune, J., Stennett, A., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Psychobehavioral Treatment Options for Sexual Dysfunction in Multiple Sclerosis: A Systematic Review. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Prioritizing Components of a Dyadic Physical Activity Intervention for People With Moderate to Severe Multiple Sclerosis and Their Care Partners: A Modified e-Delphi Study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Pragmatic exercise intervention for people with multiple sclerosis (ExIMS trial): study protocol for a randomised controlled trial. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Changing Physical Activity Behavior in People With Multiple Sclerosis: A Systematic Review and Meta-Analysis. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Aquatic exercising may improve sexual function in females with multiple sclerosis - an exploratory study. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Physical Activity Together for Multiple Sclerosis (PAT-MS): A randomized controlled feasibility trial of a dyadic behaviour change intervention. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Safety, feasibility, acceptability and effects of a behaviour-change intervention to change physical activity behaviour among people with multiple sclerosis: Results from the iStep-MS randomised controlled trial. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Does the effect of a physical activity behavioral intervention vary by characteristics of people with multiple sclerosis? [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Methodological heterogeneity biases physical activity metrics derived from the Actigraph GT3X in multiple sclerosis: A rapid review and comparative study. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Sexual dysfunction in female and male people with multiple sclerosis: disability, depression and hormonal status matter. [2023]

11. England pubmed.ncbi.nlm.nih.gov

The Multiple Sclerosis Intimacy and Sexuality Questionnaire -- re-validation and development of a 15-item version with a large US sample. [2022]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Rate, burden, and treatment of sexual dysfunction in multiple sclerosis: The case for exercise training as a new treatment approach. [2021]