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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist women with multiple sclerosis (MS) who experience sexual dysfunction. It tests whether increasing physical activity through an online program, the Behavioral Intervention for Physical Activity for Multiple Sclerosis (BIPAMS), can improve sexual health. Participants will either join this online program or be part of a group with no intervention for 16 weeks. Suitable candidates have MS, have experienced sexual dysfunction, and do not exercise regularly. Participants should also be relapse-free for the past month and in a committed relationship. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance the quality of life for 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 prior data suggests that this behavioral intervention is safe for managing sexual dysfunction in women with MS?

Research has shown that increased physical activity can improve overall well-being for people with multiple sclerosis (MS). Studies indicate that physical activity programs, like the one under testing, are generally safe for individuals with MS. For instance, one study found that online tools to boost physical activity were well-received, with participants feeling better and experiencing no major side effects. Another study demonstrated that these programs can be safely used by those newly diagnosed with MS.

Since this trial tests a behavioral program rather than a new drug, safety concerns are minimal. Being active is a natural and low-risk way to potentially improve symptoms. Participants can feel confident that previous research has shown this approach to be safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Behavioral Intervention for Physical Activity in MS (BIPAMS) because it offers a fresh approach to addressing sexual dysfunction in people with multiple sclerosis. Unlike typical treatments that often focus on medication or physical therapy, this intervention uses an innovative combination of an internet-based platform and personalized video coaching calls to boost physical activity. By encouraging movement and exercise through a digital medium, BIPAMS aims to improve overall well-being and potentially alleviate sexual dysfunction symptoms in a more holistic and accessible way.

What evidence suggests that this behavioral intervention is effective for sexual dysfunction in MS?

Research shows that physical activity can improve sexual function in people with multiple sclerosis (MS). Studies have found that exercises, such as swimming, can alleviate sexual problems in MS patients. In this trial, participants may receive a Behavioral Intervention for Physical Activity in MS (BIPAMS), which includes an internet website and one-on-one video coaching calls to boost physical activity. This method is promising because it can be offered online, making it accessible to more people. Although more research is needed, early results suggest that increased activity might help manage sexual issues in women with MS. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 a woman with relapsing-remitting multiple sclerosis.

Exclusion Criteria

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. withpower.com withpower.com/trial/phase-multiple-sclerosis-relapsing-remitting-9-2021-c8be3

Behavioral Intervention for Sexual Dysfunction in Multiple ... Research shows that exercise, including aquatic exercise, can improve sexual function in people with multiple sclerosis. Additionally, behavioral ...

2. trial.medpath.com trial.medpath.com/clinical-trial/f9c686ebb43c2b84/nct04768777-behavioral-intervention-physical-activity-sexual-dysfunction-multiple-sclerosis

Behavioral Intervention for Physical Activity and Sexual ... The proposed research examines the effect of an Internet-delivered lifestyle physical activity intervention for improving sexual dysfunction in women with MS.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04768777

Behavioral Intervention for Physical Activity and Sexual ... The research proposed, if successful, will provide evidence for the efficacy of physical activity as a translatable approach for managing sexual dysfunction among ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29959105/

Phase-III, randomized controlled trial of the behavioral ... The proposed research will provide evidence for the effectiveness of a novel, widely scalable approach for increasing lifestyle physical activity.

5. epublications.marquette.edu epublications.marquette.edu/cgi/viewcontent.cgi?article=1221&context=exsci_fac

Primary Results of a Phase-III, Randomized Controlled Trial of ... Randomized controlled trial of an e-learning designed behavioral intervention for increasing physical activity behavior in multiple sclerosis. Mult Scler. J ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8339170/

Behavior Change Techniques in Physical Activity ... This review provides a comprehensive overview of BCTs as the active ingredients in behavior change interventions targeting physical activity in MS. Results from ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2211034824000257

Feasibility of a theory-based physical activity intervention ... This study provides evidence for feasibility and initial efficacy of a COM-B-based PA intervention for persons newly diagnosed with MS.

8. ijmsc.org ijmsc.org/view/physical-activity-in-multiple-sclerosis-real-world-data-from-saskatchewan-canada

Physical Activity in Multiple Sclerosis: Real-World Data ... Physical activity in people with multiple sclerosis (MS) has been associated with improved function, 1 participation, 2 and quality of life, 3 ...