Comparing Telehealth-Delivered Cognitive Behavioral Therapy for Insomnia to Web-Based to Enhance Sleep, Reduce Fatigue, and Promote Neuroprotection

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

The objective of this RCT is to assess the efficacy of one-on-one telehealth CBT-I (tCBT-I) compared to web-based CBT-I (wCBT-I) and treatment as usual (TAU) to improve sleep outcomes (Aim 1), fatigue and quality of life (Aim 2), and promote neuroprotection (Exploratory Aim 3), and to explore the characteristics of participants that predict improvement in sleep outcomes (Exploratory Aim 4). Reassessment of outcomes will be completed after the 6-week intervention and 6 months following completion of interventions.

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 guidelines21 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 Telephone Interview of Cognitive Status

• 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- Sleep, Health and Wellness Laboratory
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: 2024-10-11
Estimated Completion Date: 2028-07-31
Participants
Target number of participants: 90
Treatments
Experimental: Telehealth cognitive behavioral therapy for insomnia (tCBT-I)
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.
Experimental: Web-based cognitive behavioral therapy for insomnia (wCBT-I)
The Go!ToSleep online program is a 6-week interactive, web-based program that delivers typical CBT-I treatment techniques of stimulus control, sleep restriction, behavioral modifications, relaxation techniques and cognitive restructuring with daily lessons (41 lessons in total)
Other: Treatment as usual (TAU)
The treatment as usual comparison group will be encouraged to continue with their usual care recommended by their physician and their usual activities and sleep habits during the period between baseline and 6-month reassessment.
Related Therapeutic Areas
Sponsors
Leads: University of Kansas Medical Center

This content was sourced from clinicaltrials.gov