NCT06434571

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis
• Insomnia

Interventions

Type	Name	Description
BEHAVIORAL	Telehealth cognitive behavioral therapy for insomnia (tCBT-I)	The general sessions outlines are as follows with each session: Session 1: determine treatment plan, set up sleep schedule and stimulus control, discuss strategies for how to stay awake to prescribed hour and what to do if wake up in middle of night, sleep hygiene education Session 2: continue upward titration of total sleep time, review sleep hygiene; introduce diaphragmatic breathing Session 3: continue upward titration of total sleep time, introduce mindfulness Session 4: continue upward titration of total sleep time, introduce progressive muscle relaxation Session 5: continue upward titration of total sleep time, discuss negative sleep beliefs Session 6: assess global treatment gains, discuss relapse prevention
BEHAVIORAL	Web-based cognitive behavioral therapy for insomnia (wCBT-I)	Participants receive a daily e-mail reminder to access the program and to complete a sleep log for the prior night's sleep. After completing the sleep log, the daily lesson is made available. Each participant will be provided with a unique password to access the online program.
BEHAVIORAL	Treatment as usual (TAU)	They will be encouraged to avoid starting any new treatment for their sleep unless recommended by their physician. They will be offered access to the web-based CBT-I program following the 6-month reassessment to complete if they wish.

Timeline

• Start date: 2024-10-11
• Primary completion: 2028-07-31
• Completion: 2028-07-31
• First posted: 2024-05-30
• Last updated: 2025-10-09

Locations

1 site across 1 country: United States