Behavioral Intervention for Physical Activity and Sexual Dysfunction in Multiple Sclerosis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorUniversity of Alabama at Birmingham

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

None

Trial design

Design model

Sequential

Treatments tested in this trial

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

    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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Behavioral Intervention for Physical Activity in MS (BIPAMS)Experimental treatment 1 intervention
Group B: waitlist control conditionNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, week 16

Secondary outcomes

1

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.

Time frame
Baseline, week 16
2

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.

Time frame
Baseline, week 16
3

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.

Time frame
Baseline, week 16

Other outcomes

1

Stability and changes of Fatigue over time

Fatigue Severity Scale (FSS); scores range between 1 (min) and 7 (max), higher scores reflect greater fatigue severity.

Time frame
Baseline, week 16
2

Change from Baseline Depression at 16 weeks

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
3

Change from Baseline Anxiety at 16 weeks

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
4

Change from Baseline Subjective sleep complaints at 16 weeks

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

Sponsors and contacts

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University of Alabama at Birmingham

Lead sponsor

National Multiple Sclerosis Society

Collaborator

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