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

Conditions

• Insomnia
• Multiple Sclerosis

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Telehealth cognitive behavioral therapy for insomnia (tCBT-I) — BEHAVIORAL
  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
• Web-based cognitive behavioral therapy for insomnia (wCBT-I) — BEHAVIORAL
  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.
• Treatment as usual (TAU) — BEHAVIORAL
  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.

Study Details

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.

Key Dates

Start date

Oct 11, 2024

Status verified

Oct 2025

Primary completion

Jul 31, 2028

Completion

Jul 31, 2028

Study Design

Enrollment

90 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Insomnia Severity Index (ISI) [ Time Frame: baseline, Week 6, Week 12 ]

Central Contacts

• Eryen Nelson, MPH
  913-945-7349
  [email protected]
• Catherine Siengsukon, PhD
  913-588-6913
  [email protected]

Locations (1)

Find similar trials in Kansas City, KS

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