Actively Recruiting
Comparing Telehealth-Delivered CBT-I to Web-Based CBT-I to Enhance Sleep, Reduce Fatigue, and Promote Neuroprotection
Led by University of Kansas Medical Center · Updated on 2025-10-09
90
Participants Needed
1
Research Sites
198 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparing Telehealth-Delivered CBT-I to Web-Based CBT-I to Enhance Sleep, Reduce Fatigue, and Promote Neuroprotection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years
- Diagnosis of relapsing-remitting or secondary progressive multiple sclerosis confirmed by a neurologist
- Mild to moderately severe disability (6 or less on Patient Determined Disability Steps scale)
- Difficulty falling asleep, staying asleep, or waking too early at least 3 nights per week for past 3 months causing distress and impacting function
- Insomnia Severity Index score of 10 or higher
- English speaking
- Telephone Interview of Cognitive Status score of 31 or higher
- High school diploma or equivalent for reading ability
- Access to internet and a computer, tablet, or smartphone
You will not qualify if you...
- Untreated sleep disorders such as sleep apnea or restless legs syndrome
- STOP BANG score greater than 3 indicating higher sleep apnea risk
- Restless legs syndrome by RLS-Diagnosis Index
- Circadian rhythm sleep-wake disorder or parasomnia by Sleep Disorders-Revised
- Use of benzodiazepines, non-benzodiazepines, or melatonin supplements for insomnia for less than 3 months or dose changed in past 3 months
- Severe depression (PHQ-9 score 20 or higher) or suicidal thoughts
- Severe anxiety (GAD-7 score 15 or higher)
- Current or recent (last 2 years) alcohol or drug abuse
- History of other nervous system disorders like stroke or Parkinson's disease
- Pregnant or planning pregnancy in next 6 months
- Severe mental illness such as schizophrenia or bipolar disorder
- Severe neurological or sensory impairments affecting testing
- Relapse or corticosteroid use in past 8 weeks
- History of or current overnight shift work in past 5 years
- Currently receiving behavioral sleep health treatment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Kansas Medical Center- Sleep, Health and Wellness Laboratory
Kansas City, Kansas, United States, 66160
Actively Recruiting
Research Team
E
Eryen Nelson, MPH
CONTACT
C
Catherine Siengsukon, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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