SUNLIGHT Study: Online Support Groups for MS to Address COVID-19
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|ClinicalTrials.gov Identifier: NCT04379661|
Recruitment Status : Completed
First Posted : May 7, 2020
Last Update Posted : January 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|MS (Multiple Sclerosis) COVID-19 Support Groups||Behavioral: Online support Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||SUNLIGHT Study: Online Support Groups for Multiple Sclerosis (MS) to Address COVID-19|
|Actual Study Start Date :||May 7, 2020|
|Actual Primary Completion Date :||July 7, 2020|
|Actual Study Completion Date :||August 31, 2020|
Experimental: Online support group
Online weekly 1-hour moderated support group sessions for 12-weeks; participants complete surveys at baseline and 12-week follow-up
Behavioral: Online support Group
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.
No Intervention: Treatment as usual
Inactive control group of participants who complete surveys at baseline and 12-weeks later
- Rate of completion [ Time Frame: Up to 12 weeks ]Acceptable rate is defined as at least 66% of participants who complete follow-up surveys.
- Rate of adherence [ Time Frame: Up to 12 weeks ]Acceptable rate is defined as at least 66% of sessions being attended.
- Score on the State Trait Anxiety Inventory (STAI) [ Time Frame: 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).
- Score on the Personal Health Questionnaire Depression Scale (PHQ-8) [ Time Frame: Up to 12 weeks ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04379661
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Victoria Leavitt, PhD||Columbia University|