Behavioral Intervention for Physical Activity and Sexual Dysfunction in Multiple Sclerosis

NCT ID: NCT04768777

Last Updated: 2024-12-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2026-12-30

Brief Summary

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.

Conditions

Multiple Sclerosis, Relapsing-Remitting; Sexual Dysfunction

Keywords

physical activity; sexual behaviour

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Behavioral Intervention for Physical Activity in MS (BIPAMS)

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

Group Type: EXPERIMENTAL

Behavioural intervention for physical activity for multiple sclerosis (BIPAMS)

Intervention Type: BEHAVIORAL

The current behavioral intervention consists of two primary components; an internet website and one-on-one video chats with a behavioral coach. The internet website involves content delivered through interactive video courses.The interactive video courses are based on elements of social cognitive theory. Each course consists of an introduction, the primary content, and a take home message.The interactive courses include embedded, supplementary options such as videos on content and worksheets related to the topic.A pedometer is provided for tracking steps, and these steps will be entered into the website so progress can be monitored. The chats support adherence to the intervention,discussion of website material,supportive accountability,and reporting of adverse events/injuries. The chats are conducted face-to-face through an online videoconferencing platform. There are a total of 12 chats over 16 weeks. Chats occur on weeks 1-8, 10-11, 13 and16.

waitlist control condition

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Behavioural intervention for physical activity for multiple sclerosis (BIPAMS)

The current behavioral intervention consists of two primary components; an internet website and one-on-one video chats with a behavioral coach. The internet website involves content delivered through interactive video courses.The interactive video courses are based on elements of social cognitive theory. Each course consists of an introduction, the primary content, and a take home message.The interactive courses include embedded, supplementary options such as videos on content and worksheets related to the topic.A pedometer is provided for tracking steps, and these steps will be entered into the website so progress can be monitored. The chats support adherence to the intervention,discussion of website material,supportive accountability,and reporting of adverse events/injuries. The chats are conducted face-to-face through an online videoconferencing platform. There are a total of 12 chats over 16 weeks. Chats occur on weeks 1-8, 10-11, 13 and16.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Female

2. Diagnosed of relapsing remmiting multiple sclerosis

3. Relapse free in the past 30 days

4. Initial confirmation of sexual dysfunction (based on a semi-structured interview on sexual dysfunction diagnostic criteria in DSM-5)

5. Currently in a committed relationship with a partner who does not have a sexual disorder or sexual dysfunction

6. Internet and email access

7. Willingness to complete the questionnaires, wear the pedometer, and undergo randomization

8. Insufficient physical activity [not meeting current physical activity guidelines based on a health contribution score of less than 14 units from the Godin Leisure-Time Exercise Questionnaire (GLTEQ)]

9. Ability to ambulate without assistance [self-report and Patient-Determined Disease Steps (PDDS) score between 0 and 2 (mild ambulatory disability)]

10. Age between 18 and 45 years

11. English as primary language

-

Exclusion Criteria

1. Moderate or high risk for contraindications of possible injury or death when undertaking strenous or maximal exercise

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Multiple Sclerosis Society

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Donald Lein

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Central Contacts

Donald Lein, PhD

Role: CONTACT

Phone: 2059340241

Email: dlein@uab.edu

Ashlie Ithurburn

Role: CONTACT

Phone: 2059751306

Email: akji@uab.edu

Other Identifiers

IRB-300006813

Identifier Type: -

Identifier Source: org_study_id