SUNLIGHT Study: Online Support Groups for MS to Address COVID-19

Not Applicable

Completed

• Conditions: COVID-19; MS (Multiple Sclerosis); Support Groups
• Interventions: Behavioral: Online support Group

• Registration Number: NCT04379661
• Lead Sponsor: Columbia University

Brief Summary

Stress and anxiety can have an adverse impact on health, and the experience of many around the 2020 outbreak of COVID-19 is affecting health and well-being. Individuals with chronic disease such as multiple sclerosis may be particularly vulnerable in some ways, but also particularly resilient in others. This study evaluates the effects of belonging to online support groups that meet weekly for 12 weeks to address the stress and anxiety felt by individuals with Multiple Sclerosis (MS). This study will also measure and explore the effects of online support groups.

Detailed Description

Anxiety is a pervasive and debilitating symptom for individuals with MS, who are at much greater risk for anxiety than the general population. The lifetime prevalence of anxiety in MS is estimated at 48.9%, compared to 37.9% in the general population. The negative consequences of anxiety for individuals with MS include impairment of work function and workplace attrition, increased healthcare usage and healthcare costs, increased physical disability (i.e., higher Expanded Disability Status Scale (EDSS) score), and reduced overall quality of life. And while anxiety has been shown to be acutely elevated both before and in the first years after diagnosis, individuals with longstanding MS also exhibit anxiety at higher rates than the general population. Of note, women are at heightened risk for both anxiety and MS, and lower socioeconomic status (SES) is associated with increased prevalence of anxiety in MS. In the SUNLIGHT study, participants join a structured meeting in which they receive content specifically focused on anxiety, its detrimental impact on individuals with MS, and an emphasis on techniques to reduce anxiety. Over the 12-week period of the intervention, participants learn techniques for stress reduction that can be self-administered, such that the benefits of participation outlive the active period of the intervention.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-05-05
• Study First Submitted QC: 2020-05-06
• Study Start: 2020-05-07
• Study First Posted: 2020-05-07
• Primary Completion: 2020-07-07
• Study Completion: 2020-08-31
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-07
• Last Update Posted: 2021-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• MS Diagnosis
• 18 years or older

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Exclusion Criteria

• None

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Online support group	Online support Group	Online weekly 1-hour moderated support group sessions for 12-weeks; participants complete surveys at baseline and 12-week follow-up

Primary Outcome Measures

Name	Time	Method
Rate of completion	Up to 12 weeks	Acceptable rate is defined as at least 66% of participants who complete follow-up surveys.
Rate of adherence	Up to 12 weeks	Acceptable rate is defined as at least 66% of sessions being attended.

Secondary Outcome Measures

Name	Time	Method
Score on the State Trait Anxiety Inventory (STAI)	Up to 12 weeks	The STAI is a commonly used measure of trait and state anxiety that is scored from 20 (minimum score) to 80 (maximum score), with a higher scores indicating higher anxiety (worse outcome).

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States