Clinical trial NCT04379661: 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
Overall status: COMPLETED
Phase: NA
Conditions: MS (Multiple Sclerosis)
COVID-19
Support Groups
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* MS Diagnosis
* 18 years or older

Exclusion Criteria:

* None

Primary outcomes:
measure: Rate of completion
timeFrame: Up to 12 weeks
measure: Rate of adherence
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Score on the State Trait Anxiety Inventory (STAI)
timeFrame: Up to 12 weeks
Other outcomes:
measure: Score on the Personal Health Questionnaire Depression Scale (PHQ-8)
timeFrame: Up to 12 weeks
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Victoria Leavitt, PhD
role: PRINCIPAL_INVESTIGATOR
References: