Comparing Telehealth-Delivered CBT-I to Web-Based CBT-I to Enhance Sleep, Reduce Fatigue, and Promote Neuroprotection
Eligible age
18–65 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: University of Kansas Medical Center
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ Known untreated sleep disorder (such as sleep apnea or restless legs syndrome)
- ✕ \>3 on STOP BANG indicating increased risk of sleep apnea
- ✕ Restless legs syndrome as determined by RLS-Diagnosis Index
- ✕ Circadian rhythm sleep-wake disorder as determined by the Sleep Disorders-Revised
- ✕ Parasomnia as determined by the Sleep Disorders-Revised
- ✕ If taking benzodiazepines, non-benzodiazepines, or melatonin supplements or agonists for insomnia, taking \< 3 months or dose has changed in past 3 months
- ✕ Score of ≥20 on the Patient Health Questionnaire (PHQ-9) indicating severe depression or endorsement of suicidal ideation (answer 1, 2 or 3 on #9 of the PHQ-9)
- ✕ Score of ≥15 on the Generalized Anxiety Disorder (GAD-7) indicating severe anxiety
Where it's recruiting
Kansas City
Source: ClinicalTrials.gov · NCT06434571 · last updated 2025-10-09