Efficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms and Fatigue in Individuals With Multiple Sclerosis

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The incidence of insomnia is estimated to be as high as 90% in individuals with MS due to insomnia being underdiagnosed. Sleep disturbances in people with MS have been associated with reduced cognitive performance, physical function, psychological well-being, quality of life, and occupational function, as well as increased prevalence of fatigue, pain, depression, and anxiety. The objective of the proposed study is to determine the efficacy of cognitive behavioral therapy for insomnia (CBT-I) to improve insomnia symptoms (Aim 1) fatigue, and health-related quality of life (Aim 2) in individuals with multiple sclerosis compared to an active control group, and to determine the characteristics of participants that predict improvement in sleep outcomes (Exploratory Aim 3).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 18-65 years old

• Diagnosis of relapsing-remitting or secondary progressive MS based on established guidelines20 and verified by their neurologist

• Mild-to-moderately severe disability (≤ 6 on Patient Determined Disability Steps (PDDS) scale)

• Report of difficulty falling asleep, maintaining sleep, or waking up too early at least 3 nights/week for the past 3 months with significant distress and impact on function despite adequate opportunity for sleep and not due to other sleep disorders as indicated in the DSM-5

• ≥10 on Insomnia Severity Index

• English speaking

• ≥31 on modified Telephone Interview of Cognitive Status23

• Has a high school diploma or equivalent to serve as a proxy measurement of reading ability to ensure adequate reading ability to participate in the study

• Report having access to internet service or a data plan and access to a computer, tablet, or smart phone

Locations
United States
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Contact Information
Primary
Eryen Nelson, MPH
enelson5@kumc.edu
913-945-7349
Backup
Catherine Siengsukon, PhD
csiengsukon@kumc.edu
913-588-6913
Time Frame
Start Date: 2024-07-30
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 70
Treatments
Experimental: Cognitive behavioral therapy for insomnia
1x/week, 6-week 45-60 min one-one-one manualized program via video conferencing (HIPAA-compliant Zoom) with a trained research assistant that includes time in bed restriction, stimulus control, relaxation strategies, cognitive restructuring, and sleep health promotion education.
Active_comparator: Sleep and lifestyle education
1x/week, 6 weekly 45-60 min one-on-one program via video conferencing (HIPAA-compliant Zoom) with a trained research assistant that includes gentle stretching activities for major muscle groups accompanied by sleep and lifestyle education.
Related Therapeutic Areas
Sponsors
Leads: University of Kansas Medical Center

This content was sourced from clinicaltrials.gov