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OpenTrials
Completed

NCT Number: NCT04379661

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • MS Diagnosis
  • 18 years or older

Exclusion criteria

  • None

Treatment and study plan

Online support group

Behavioral

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 7, 2020
Registry last updated
Jan 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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