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

COVID-19 Clinical Trial

Official title:

SUNLIGHT Study: Online Support Groups for Multiple Sclerosis (MS) to Address COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04379661
• Other study ID #: AAAS9939
• Status: Completed
• Phase: N/A
• Start date: May 7, 2020
• Est. completion date: August 31, 2020

Study information

• Verified date: January 2021
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 31, 2020
• Est. primary completion date: July 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• MS Diagnosis

• 18 years or older

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• COVID-19
• MS (Multiple Sclerosis)
• Multiple Sclerosis
• Sclerosis
• Support Groups

Intervention

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.

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Score on the Personal Health Questionnaire Depression Scale (PHQ-8)	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).	Up to 12 weeks
Primary	Rate of completion	Acceptable rate is defined as at least 66% of participants who complete follow-up surveys.	Up to 12 weeks
Primary	Rate of adherence	Acceptable rate is defined as at least 66% of sessions being attended.	Up to 12 weeks
Secondary	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).	Up to 12 weeks