Clinical Trials Late Breaking Abstracts

LB1200 - The SUNLIGHT Study: A telehealth intervention to address mental health in persons with MS during COVID-19  (ID 2034)

Speakers
  • V. Leavitt
Authors
  • V. Leavitt
  • A. Kever
  • I. Aguerre
  • C. Riley
  • P. De Jager
  • K. Fong
  • L. Levine
  • R. Straus Farber
  • W. Vargas
  • M. Vasquez
Presentation Number
LB1200
Presentation Topic
Clinical Trials

Abstract

Background

The arrival of the Covid-19 pandemic in the United States brought a heightened level of anxiety to the general population. Individuals with chronic diseases such as multiple sclerosis (MS) were expected to be particularly affected. To address mental health needs safely and immediately, we conducted a trial of a group-based telehealth treatment of professional online support groups to reduce anxiety in persons with MS, the SUNLIGHT study.

Objectives

To determine feasibility and initial efficacy of a pilot trial of online structured, moderated professional support groups to reduce anxiety in persons with MS during the US outbreak of Covid-19. Trial was registered at clinicaltrials.gov (NCT04379661).

Methods

All procedures were conducted remotely. Thirty-two patients with MS were recruited in March-April 2020 at an MS Center in New York City. Consent was obtained via eConsent. 21 received active treatment: 1 hour/week online structured group therapy; 11 served as an inactive control group (i.e., treatment as usual, TAU). Baseline measures were collected from all participants: anxiety (Stait-Trait Anxiety Inventory, primary efficacy outcome), stress (Perceived Stress Scale), distress (Impact of Event Scale), mood (Patient Health Questionnaire), loneliness (UCLA Loneliness Scale), self-efficacy (General Self-Efficacy Scale), quality of life (Functional Assessment of Multiple Sclerosis).

Results

Sample was diverse: 83% female; 23.3% Hispanic / Latino, 10% Black, 3.3% Asian; age range: 24-72 years; disease duration: .25 -38 years. 30% Major Depressive Disorder, 30% anxiety disorder. At baseline, 36.6% had an anxiety attack within past 4 weeks.

Feasibility: Completion and adherence for treatment group were high; 80.9% completed the intervention; average adherence was 75%.

Efficacy results: Anxiety decreased in the treatment group after 12-weeks (STAI mean change = -2.7 points; p=.09).

Qualitative results: 100% responded YES to 'did you find the SUNLIGHT study to be worth your time,' and 'would you recommend SUNLIGHT study to a friend with MS;' 95% responded YES to 'if it were possible to continue your participation in the SUNLIGHT study, would you choose to do so;' 53% responded YES to 'do you think participation in the SUNLIGHT study contributed to a decrease in any of your MS symptoms?'

Conclusions

Telehealth provides an acceptable, accessible, safe vehicle for delivering mental health treatment to chronic disease populations during Covid-19. High adherence and completion, and initial evidence showing reduced anxiety bolster professional support groups as a promising treatment option for individuals with MS. Low cost, high return solutions such as online support groups should be further explored in future large-scale trials. Rigorous clinical trail evidence is needed to elevate the priority given to telehealth behavioral treatments.

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