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Behavioral Intervention for Physical Activity and Sexual Dysfunction in Multiple Sclerosis (BIPAMS-SD)

Primary Purpose

Multiple Sclerosis, Relapsing-Remitting, Sexual Dysfunction

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioural intervention for physical activity for multiple sclerosis (BIPAMS)
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Sclerosis, Relapsing-Remitting focused on measuring physical activity, sexual behaviour

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

-

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Behavioral Intervention for Physical Activity in MS (BIPAMS)

waitlist control condition

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from baseline Sexual Dysfunction at 16 weeks
The Female Sexual Function Index (FSFI): is a common generic measure of sexual dysfunction for women. The questionnaire consists of 19 questions that cover six subscales/domains of sexual function: sexual desire, sexual arousal, lubrication, orgasm, sexual satisfaction, and pain. The items further yield an overall score. Lower sum scores reflect more pronounced sexual dysfunction.

Secondary Outcome Measures

Change from baseline Sexual Dysfunction in MS at 16 weeks
The Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19) is the most widely used self-rating tool for sexual functions in MS (Sanders et al., 2000). The MSISQ-19 consists of 19 items focusing on the perceived influence of MS symptoms on sexual activity and satisfaction and the perceived influence of MS symptoms on the overall quality of intimate relationships. The scores classifies the type of sexual dysfunction in to primary, secondary, or tertiary sexual dysfunction.
Change from baseline Physical activity at 16 weeks
GLTEQ: Physical Activity Levels as measured by the Godin Leisure-Time Exercise Questionnaire. Participants will complete the Godin Leisure-Time Exercise Questionnaire (GLTEQ) as a measure of the frequency of strenuous, moderate, and mild leisure-time physical activity performed for periods of 15 minutes or more over a typical week. Summary scores are calculated by multiplying the number of strenuous, moderate, and mild bouts by 9, 5, and 3, respectively, and summing those values into an overall score that ranges from 0 to 119; higher scores are represent a greater volume of physical activity. This will be completed at baseline testing.
Change from baseline physical activity duration at 16 weeks
International Physical Activity Questionnaire (IPAQ). The IPAQ was developed by a working group initiated by the World Health Organization and the Centers for Disease Control and Prevention. The IPAQ asks participants about time spent in physical activity over the last seven days. Minutes of walking, sedentary-, moderate- and vigorous-intensity activities were calculated for the past week.

Full Information

First Posted
February 10, 2021
Last Updated
August 5, 2023
Sponsor
University of Alabama at Birmingham
Collaborators
National Multiple Sclerosis Society
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1. Study Identification

Unique Protocol Identification Number
NCT04768777
Brief Title
Behavioral Intervention for Physical Activity and Sexual Dysfunction in Multiple Sclerosis
Acronym
BIPAMS-SD
Official Title
Behavioral Intervention for Physical Activity and Sexual Dysfunction in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
National Multiple Sclerosis Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting, Sexual Dysfunction
Keywords
physical activity, sexual behaviour

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Behavioral Intervention for Physical Activity in MS (BIPAMS)
Arm Type
Experimental
Arm Description
A behavioral intervention that involves an internet website and one-on-one video coaching calls for increasing physical activity in people with MS.
Arm Title
waitlist control condition
Arm Type
No Intervention
Arm Description
Participants will have 16-weeks of no intervention or interaction.
Intervention Type
Behavioral
Intervention Name(s)
Behavioural intervention for physical activity for multiple sclerosis (BIPAMS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline Sexual Dysfunction at 16 weeks
Description
The Female Sexual Function Index (FSFI): is a common generic measure of sexual dysfunction for women. The questionnaire consists of 19 questions that cover six subscales/domains of sexual function: sexual desire, sexual arousal, lubrication, orgasm, sexual satisfaction, and pain. The items further yield an overall score. Lower sum scores reflect more pronounced sexual dysfunction.
Time Frame
Baseline, week 16
Secondary Outcome Measure Information:
Title
Change from baseline Sexual Dysfunction in MS at 16 weeks
Description
The Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19) is the most widely used self-rating tool for sexual functions in MS (Sanders et al., 2000). The MSISQ-19 consists of 19 items focusing on the perceived influence of MS symptoms on sexual activity and satisfaction and the perceived influence of MS symptoms on the overall quality of intimate relationships. The scores classifies the type of sexual dysfunction in to primary, secondary, or tertiary sexual dysfunction.
Time Frame
Baseline, week 16
Title
Change from baseline Physical activity at 16 weeks
Description
GLTEQ: Physical Activity Levels as measured by the Godin Leisure-Time Exercise Questionnaire. Participants will complete the Godin Leisure-Time Exercise Questionnaire (GLTEQ) as a measure of the frequency of strenuous, moderate, and mild leisure-time physical activity performed for periods of 15 minutes or more over a typical week. Summary scores are calculated by multiplying the number of strenuous, moderate, and mild bouts by 9, 5, and 3, respectively, and summing those values into an overall score that ranges from 0 to 119; higher scores are represent a greater volume of physical activity. This will be completed at baseline testing.
Time Frame
Baseline, week 16
Title
Change from baseline physical activity duration at 16 weeks
Description
International Physical Activity Questionnaire (IPAQ). The IPAQ was developed by a working group initiated by the World Health Organization and the Centers for Disease Control and Prevention. The IPAQ asks participants about time spent in physical activity over the last seven days. Minutes of walking, sedentary-, moderate- and vigorous-intensity activities were calculated for the past week.
Time Frame
Baseline, week 16
Other Pre-specified Outcome Measures:
Title
Stability and changes of Fatigue over time
Description
Fatigue Severity Scale (FSS); scores range between 1 (min) and 7 (max), higher scores reflect greater fatigue severity.
Time Frame
Baseline, week 16
Title
Change from Baseline Depression at 16 weeks
Description
Hospital Anxiety and Depression Scale (HADS); scores range between 0 (min) and 21 (max), higher scores reflect greater frequency of anxiety and depressive symptoms.
Time Frame
Baseline, week 16
Title
Change from Baseline Anxiety at 16 weeks
Description
Hospital Anxiety and Depression Scale (HADS); scores range between 0 (min) and 21 (max), higher scores reflect greater frequency of anxiety and depressive symptoms.
Time Frame
Baseline, week 16
Title
Change from Baseline Subjective sleep complaints at 16 weeks
Description
Insomnia Severity Index (ISI). This questionnaire is a seven-item screening measure for insomnia. The items, answered on a 5-point Likert scale ranging from 0 (=not at all) to 4 (=very much), refer in part to the Diagnostic and Statistical Manual of Mental Disorders criteria for insomnia by assessing difficulty falling asleep, difficulty remaining asleep, early morning awakenings, impaired daytime performance, low satisfaction with sleep, and worry about sleep. The higher the overall score, the more the participant is assumed to suffer from insomnia.
Time Frame
Baseline, week 16
Title
Change from Baseline Feelings of Loneliness at 16 weeks
Description
Short-form UCLA Loneliness Scale is a 3-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation.
Time Frame
Baseline, week 16
Title
Change from Baseline Pain severity at 16 weeks
Description
Short-form of McGill Pain Questionnaire : Change of self-report measures of Pain through the Short-form of McGill Pain.
Time Frame
Baseline, week 16
Title
Change from Baseline Emotion Regulation at 16 weeks
Description
Emotion Regulation Questionnaire(ERQ): A 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Lowersscores reflects better emotion regulation.
Time Frame
Baseline, week 16
Title
Change from Baseline Couple Satisfaction at 16 weeks
Description
Couple Satisfaction Index (CSI-4), is a seven-item questionnaire for assessing the level of couple satisfaction. The answers are given on a 7-point Likert scale (for question 1) and 6-point Likert scale (for question 2-4) with the following anchor points 0 (= extremely unhappy/not at all satisfied) to 6 or 5 (= Perfect/completely satisfied).
Time Frame
Baseline, week 16

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female Diagnosed of relapsing remmiting multiple sclerosis Relapse free in the past 30 days Initial confirmation of sexual dysfunction (based on a semi-structured interview on sexual dysfunction diagnostic criteria in DSM-5) Currently in a committed relationship with a partner who does not have a sexual disorder or sexual dysfunction Internet and email access Willingness to complete the questionnaires, wear the pedometer, and undergo randomization 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)] Ability to ambulate without assistance [self-report and Patient-Determined Disease Steps (PDDS) score between 0 and 2 (mild ambulatory disability)] Age between 18 and 45 years English as primary language - Exclusion Criteria: 1. Moderate or high risk for contraindications of possible injury or death when undertaking strenous or maximal exercise -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Donald Lein, PhD
Phone
2059340241
Email
dlein@uab.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ashlie Ithurburn
Phone
2059751306
Email
akji@uab.edu
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States

12. IPD Sharing Statement

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Behavioral Intervention for Physical Activity and Sexual Dysfunction in Multiple Sclerosis

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