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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
Sponsor:
Information provided by (Responsible Party):
Victoria M. Leavitt, 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.

Condition or disease Intervention/treatment Phase
MS (Multiple Sclerosis) COVID-19 Support Groups Behavioral: Online support Group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Rate of completion [ Time Frame: Up to 12 weeks ]
    Acceptable rate is defined as at least 66% of participants who complete follow-up surveys.

  2. Rate of adherence [ Time Frame: Up to 12 weeks ]
    Acceptable rate is defined as at least 66% of sessions being attended.


Secondary Outcome Measures :
  1. 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).


Other Outcome Measures:
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • MS Diagnosis
  • 18 years or older

Exclusion Criteria:

  • None

Information from the National Library of Medicine

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


Locations
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United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Victoria Leavitt, PhD Columbia University
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Responsible Party: Victoria M. Leavitt, Assistant Professor of Neuropsychology, Columbia University
ClinicalTrials.gov Identifier: NCT04379661    
Other Study ID Numbers: AAAS9939
First Posted: May 7, 2020    Key Record Dates
Last Update Posted: January 8, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases