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

Description

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).

Conditions

Traumatic Brain Injury, Insomnia, Depression, Post-traumatic Stress, Sleep, Memory Impairment, Cognitive Behavioral Therapy, Concussion, Brain, Head Injury, Brain Injury Traumatic Mild

Talk to us

Study Overview

On this page

Study Details

Study overview

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).

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

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

Condition
Traumatic Brain Injury
Intervention / Treatment

-

Contacts and Locations

Eglin Air Force Base

Intrepid Spirit Center - Eglin Air Force Base, Eglin Air Force Base, Florida, United States, 32542

Eglin Air Force Base

Naval School Explosive Ordance Disposal - Eglin Air Force Base, Eglin Air Force Base, Florida, United States, 32542

Bethesda

Walter Reed National Medical Military Center, Bethesda, Maryland, United States, 20814

Fort Bragg

Womack Army Medical Center, Fort Bragg, North Carolina, United States, 28310

Fort Lewis

Madigan Army Medical Center, Fort Lewis, Washington, United States, 98431

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Current or former member of the uniformed services
  • 2. Meet the Veterans Affairs Medical Center (VAMC) and Department of Defense (DoD) criteria for TBI
  • 3. Time duration since injury \> 90 days
  • 4. Insomnia symptom duration \> 90 days
  • 5. Endorse insomnia symptoms (Insomnia Severity Index \[ISI\] score \> 9)
  • 6. Display sufficient cognitive capacity to provide informed consent (Montreal Cognitive Assessment (MoCA), Z-score \> -2)
  • 7. 18 years of age or greater
  • 8. Access to and ability and to use computer
  • 1. History of neurological diseases other than TBI and not attributable to TBI
  • 2. Sleep apnea \[apnea hypopnea index (AHI) \>15; individuals with mild apnea (AHI \> 5 and \<14.9) will be informed, but allowed to participate\].
  • 3. Patients using psychotropic medications may be included if they are on a stable dosage for the last three weeks prior to the study.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Johns Hopkins University,

Luis Buenaver, PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins School of Medicine

Study Record Dates

2026-09