University of Alabama at Birmingham
Birmingham, Alabama, 35243, United States
NCT Number: NCT04768777
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.
Trial opening soon.
Get Notified18 year–45 year
Female
Interventional
Not applicable
Birmingham, Alabama, 35243, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-
Exclusion criteria
-
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.
Time frame: Baseline, week 16
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
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
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
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
Fatigue Severity Scale (FSS); scores range between 1 (min) and 7 (max), higher scores reflect greater fatigue severity.
Time frame: Baseline, week 16
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
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
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
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
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
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
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).
Contact information is provided by the study sponsor or research team.
Ashlie Ithurburn
CONTACT
Donald Lein, PhD
CONTACT
University of Alabama at Birmingham
Other
Acronym: BIPAMS-SD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06129019
Anxiety Disorders, Autoimmune Diseases
Elâzığ, Turkey (Türkiye)
View Trial DetailsNCT03561402
Autoimmune Diseases, Autoimmune Diseases of the Nervous System
Montreal, Quebec, Canada
View Trial DetailsNCT01420055
Anxiety Disorders, Autoimmune Diseases
Angers, France
View Trial DetailsNCT07280871
Autoimmune Diseases, Autoimmune Diseases of the Nervous System
Luxembourg
View Trial Details