SUNLIGHT Study: Online Support Groups for MS to Address COVID-19
1 other identifier
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2020
CompletedFirst Posted
Study publicly available on registry
May 7, 2020
CompletedStudy Start
First participant enrolled
May 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 7, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2020
CompletedJanuary 8, 2021
January 1, 2021
2 months
May 5, 2020
January 7, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Rate of completion
Acceptable rate is defined as at least 66% of participants who complete follow-up surveys.
Up to 12 weeks
Rate of adherence
Acceptable rate is defined as at least 66% of sessions being attended.
Up to 12 weeks
Secondary Outcomes (1)
Score on the State Trait Anxiety Inventory (STAI)
Up to 12 weeks
Other Outcomes (1)
Score on the Personal Health Questionnaire Depression Scale (PHQ-8)
Up to 12 weeks
Study Arms (2)
Online support group
EXPERIMENTALOnline weekly 1-hour moderated support group sessions for 12-weeks; participants complete surveys at baseline and 12-week follow-up
Treatment as usual
NO INTERVENTIONInactive control group of participants who complete surveys at baseline and 12-weeks later
Interventions
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.
Eligibility Criteria
You may qualify if:
- MS Diagnosis
- years or older
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Columbia University Medical Center
New York, New York, 10032, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Victoria Leavitt, PhD
Columbia University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Neuropsychology
Study Record Dates
First Submitted
May 5, 2020
First Posted
May 7, 2020
Study Start
May 7, 2020
Primary Completion
July 7, 2020
Study Completion
August 31, 2020
Last Updated
January 8, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share