SUNLIGHT Study: Online Support Groups for MS to Address COVID-19
Primary Purpose
MS (Multiple Sclerosis), COVID-19, Support Groups
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Online support Group
Sponsored by

About this trial
This is an interventional supportive care trial for MS (Multiple Sclerosis)
Eligibility Criteria
Inclusion Criteria:
- MS Diagnosis
- 18 years or older
Exclusion Criteria:
- None
Sites / Locations
- Columbia University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Online support group
Treatment as usual
Arm Description
Online weekly 1-hour moderated support group sessions for 12-weeks; participants complete surveys at baseline and 12-week follow-up
Inactive control group of participants who complete surveys at baseline and 12-weeks later
Outcomes
Primary Outcome Measures
Rate of completion
Acceptable rate is defined as at least 66% of participants who complete follow-up surveys.
Rate of adherence
Acceptable rate is defined as at least 66% of sessions being attended.
Secondary Outcome Measures
Score on the State Trait Anxiety Inventory (STAI)
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04379661
Brief Title
SUNLIGHT Study: Online Support Groups for MS to Address COVID-19
Official Title
SUNLIGHT Study: Online Support Groups for Multiple Sclerosis (MS) to Address COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 7, 2020 (Actual)
Primary Completion Date
July 7, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MS (Multiple Sclerosis), COVID-19, Support Groups
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Online support group
Arm Type
Experimental
Arm Description
Online weekly 1-hour moderated support group sessions for 12-weeks; participants complete surveys at baseline and 12-week follow-up
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Inactive control group of participants who complete surveys at baseline and 12-weeks later
Intervention Type
Behavioral
Intervention Name(s)
Online support Group
Intervention Description
12 one-hour, once-weekly online support groups for people with Multiple Sclerosis to address anxiety related to the COVID-19 outbreak and its effects on them.
Primary Outcome Measure Information:
Title
Rate of completion
Description
Acceptable rate is defined as at least 66% of participants who complete follow-up surveys.
Time Frame
Up to 12 weeks
Title
Rate of adherence
Description
Acceptable rate is defined as at least 66% of sessions being attended.
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Score on the State Trait Anxiety Inventory (STAI)
Description
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).
Time Frame
Up to 12 weeks
Other Pre-specified Outcome Measures:
Title
Score on the Personal Health Questionnaire Depression Scale (PHQ-8)
Description
Mood as measured by change in depression or depressive symptoms will be measured with the 8-item PHQ-8 which is scored from 0 (minimum score) to 24 (maximum score), in which higher scores indicate higher depression or depressive symptoms (worse outcome).
Time Frame
Up to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
MS Diagnosis
18 years or older
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria Leavitt, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
SUNLIGHT Study: Online Support Groups for MS to Address COVID-19
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