Clinical Trial

Comparing Telehealth-Delivered CBT-I to Web-Based CBT-I to Enhance Sleep, Reduce Fatigue, and Promote Neuroprotection

Study acronym: CLEAR
Recruiting Phase 2
View on ClinicalTrials.gov →
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-05-23; most recent amendment 2025-10-08.
Status change: Not Yet Recruiting → Recruiting 2024-10-15
Trial Details
NCT Number NCT06434571
Lead Sponsor University of Kansas Medical Center
Conditions Multiple Sclerosis, Insomnia
Enrollment 90 participants
Start Date 2024-10-11
Primary Completion 2028-07-31 (estimated)
Study Completion 2028-07-31 (estimated)
Updated on ClinicalTrials.gov 2025-10-09