Recruiting

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

ClinicalTrials.gov IDNCT05663034

PhaseNA

Enrollment360

SponsorJohns Hopkins University

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

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

About this study

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).

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.

Primary outcomes

Change in Insomnia severity as assessed by the insomnia severity index (ISI) (At the end of treatment, and 2-, 6- and 12-weeks post treatment)

Eligibility information

Inclusion Criteria: 1. Current or former member of the uniform services 2. Meet the Veterans Affairs Medical Center (VAMC) Department of Defense (DoD) criteria for TBI; 3. Time duration since traumatic brain injury (TBI) injury \>90 days 4. Insomnia symptom duration \>90 days 5. Endorse insomnia symptoms (Insomnia Severity Index \[ISI\] score \> 10) 6. Display sufficient cognitive capacity to provide informed consent (Montreal Cognitive Assessment (MoCA) Z-score \> -2) 7. \>18 years of age 8. Access to and ability and to use computer. Exclusion Criteria: 1. History of neurological diseases other than TBI and not attributable to TBI 2. Sleep apnea \[apnea hypopnea index (AHI) \>15; individuals with mild apnea (AHI \> 5 and \<15) will be informed, but allowed to participate\]. Participants who use a continuous positive airway pressure (CPAP) device for sleep apnea will be eligible for participation if they are below the apnea/hypopnea cutoff while using CPAP, are adherent to using the device (\> 4 hours/night 21/30 consecutive days) and agree to continue using the device during study participation. 3. Lastly, people using psychotropic medications may be included if they are on a stable dosage for the last three weeks prior to the study.

Study locations

Intrepid Spirit Center - Eglin Air Force Base, Eglin Air Force Base, Florida 32542 United States
Naval School Explosive Ordance Disposal - Eglin Air Force Base, Eglin Air Force Base, Florida 32542 United States
Walter Reed National Medical Military Center, Bethesda, Maryland 20814 United States
Womack Army Medical Center, Fort Bragg, North Carolina 28310 United States
Madigan Army Medical Center, Fort Lewis, Washington 98431 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-28.