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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Current or former member of the uniform services

• Meet the Veterans Affairs Medical Center (VAMC) Department of Defense (DoD) criteria for TBI;

• Time duration since traumatic brain injury (TBI) injury \>90 days

• Insomnia symptom duration \>90 days

• Endorse insomnia symptoms (Insomnia Severity Index \[ISI\] score \> 10)

• Display sufficient cognitive capacity to provide informed consent (Montreal Cognitive Assessment (MoCA) Z-score \> -2)

• \>18 years of age

• Access to and ability and to use computer.

Locations
United States
Florida
Intrepid Spirit Center - Eglin Air Force Base
RECRUITING
Eglin Air Force Base
Naval School Explosive Ordance Disposal - Eglin Air Force Base
RECRUITING
Eglin Air Force Base
Maryland
Walter Reed National Medical Military Center
RECRUITING
Bethesda
North Carolina
Womack Army Medical Center
RECRUITING
Fort Bragg
Washington
Madigan Army Medical Center
RECRUITING
Fort Lewis
Contact Information
Primary
Luis Buenaver, PHD
lbuenav1@jhmi.edu
4105507986
Backup
Elizabeth Wysocki, MS
ewysock2@jhu.edu
Time Frame
Start Date: 2024-05-10
Estimated Completion Date: 2026-09
Participants
Target number of participants: 360
Treatments
Active_comparator: Cognitive behavioral therapy for insomnia (CBT-I)
CBT-I treatment will involve a standardized 6-session blended intervention that combines cognitive and behavioral techniques. The core components include (1) education about sleep and insomnia, stimulus control (SC) and sleep restriction (SRT) (week 1); (2) sleep hygiene education (week 2); and (3) relaxation training, cognitive restructuring (to counter-arousal and address sleep-interfering cognitions), adherence monitoring, and adjusting the recommended sleep-wake schedule (weeks 3 through 6). The final session will also include a review of treatment content and relapse prevention. Common to all sessions is an initial review of participant diary data, charting progress, setting measurable goals, discussing adherence, and reinforcing learned skills.
Active_comparator: Mindfulness-based treatment for insomnia (MBTI)
MBTI treatment will involve a standardized 6-session intervention which integrates the mindfulness training and exercises from mindfulness-based stress reduction (MBSR) with behavioral strategies based on sleep restriction therapy and stimulus control delivered within the context of mindfulness principles. Mindfulness principles include: 1) increase awareness of the mental and physical states that promote sleep (i.e., sleepiness), 2) shift sleep-related metacognitions to reduce hyperarousal, and 3) promote a mindful stance to respond when symptoms of insomnia arise. An overview of the treatment program, sleep education, and an introduction to the principles of mindfulness meditation is given (week 1). Then a combination of mindfulness meditations, sleep restriction, and stimulus control is conducted (week 2-6).
Related Therapeutic Areas
Sponsors
Collaborators: Department of Defense Congressionally Directed Medical Research Program
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov