Multiple Sclerosis Clinical Trial
Official title:
A Social Emotion Regulation Intervention in MS
Verified date | May 2021 |
Source | Kessler Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The current project will examine effectiveness of an intervention based on the concept of the social regulation of emotion. The intervention is designed to improve well-being in individuals with MS by leveraging participants' existing social support. Effectiveness will be tested on a sample of 42 individuals with MS, half of whom will receive the intervention and half of which will receive an inactive control. Investigators will document changes resulting from treatment on self-reported levels of stress, depression, and quality of life. Intervention evaluation will expand scientific knowledge of emotion regulation disruption in MS, and potentially identify a novel and highly efficient means of treatment.
Status | Enrolling by invitation |
Enrollment | 42 |
Est. completion date | July 9, 2021 |
Est. primary completion date | July 9, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Multiple Sclerosis diagnosis - English language fluency Exclusion Criteria: - currently taking steroids or benzodiazepines - within 30 days of an exacerbation - history of substance abuse - diagnosis of bipolar, schizophrenia, epilepsy, stroke |
Country | Name | City | State |
---|---|---|---|
United States | Kessler Foundation | East Hanover | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Kessler Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Well-being: Depression | Change in scores on a self-report questionnaire of depression (the Center for Epidemiologic Studies Depression Scale, a 20-item scale with higher scores indicating greater depression) | Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 6) | |
Primary | Well-being: Stress | Change in scores on a self-report questionnaire of stress (the Perceived Stress Scale, a 10-item scale with higher scores reflecting higher stress) | Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 6) | |
Primary | Well-being: Quality of life | Change in scores on a self-report questionnaire of quality of life (the Satisfaction with Life Scale, a five item scale where higher scores reflect higher satisfaction) | Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 6) | |
Secondary | Perceived social support | Change in scores on a self-report questionnaire of perceived social support (the Multidimensional Scale of Perceived Social Support, a 12-item scale where higher scores reflect greater support) | Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 6) |
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