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RECRUITING
NCT05663034
NA

CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms

Sponsor: Johns Hopkins University

View on ClinicalTrials.gov

Summary

This study is a prospective two-arm, single blind randomized controlled trial design to compare the clinical effectiveness of telemedicine-delivered, 6-session, standardized cognitive behavioral therapy for insomnia (CBT-I) and mindfulness-based treatment for insomnia (MBTI) in treating insomnia symptoms and ameliorating depressive symptoms in persons with mild to moderate TBI and comorbid Post-Traumatic Stress Symptoms (PTSS) and insomnia symptoms in a 360 patients. Participants will undergo assessment (psychosocial questionnaires, neurocognitive testing, sleep monitoring) at baseline, at the end of treatment, and at 2-, 6- and 12-weeks post-treatment. The primary outcome is sleep as measured by the Insomnia Severity Index (ISI).

Official title: CoMBat Insomnia: A Randomized Controlled Trial of Cognitive-Behavioral vs. Mindfulness-Based Treatment for TBI-Related Insomnia and Post-Traumatic Stress Symptoms

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

360

Start Date

2024-05-10

Completion Date

2026-09

Last Updated

2025-12-18

Healthy Volunteers

No

Interventions

BEHAVIORAL

Mindfulness-based treatment for insomnia (MBTI)

A 6-week intervention that uses the principles and practices of mindfulness meditation along with behavioral strategies (stimulus control, sleep restriction therapy) to reduce symptoms of insomnia

BEHAVIORAL

Cognitive behavioral therapy for insomnia (CBT-I)

Standard of care for adults with chronic insomnia. 6-week program that uses behavioral techniques to decrease psychophysiological arousal and increase sleep propensity to deepen and consolidate sleep.

Locations (5)

Intrepid Spirit Center - Eglin Air Force Base

Eglin Air Force Base, Florida, United States

Naval School Explosive Ordance Disposal - Eglin Air Force Base

Eglin Air Force Base, Florida, United States

Walter Reed National Medical Military Center

Bethesda, Maryland, United States

Womack Army Medical Center

Fort Bragg, North Carolina, United States

Madigan Army Medical Center

Fort Lewis, Washington, United States