Comparing two therapies for insomnia in veterans with traumatic brain injury
CoMBat Insomnia: A Randomized Controlled Trial of Cognitive-Behavioral vs. Mindfulness-Based Treatment for TBI-Related Insomnia and Post-Traumatic Stress Symptoms
This study is testing whether online therapy for insomnia or mindfulness techniques can help veterans with brain injuries sleep better and feel less depressed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 5 sites (Eglin Air Force Base, Florida and 4 other locations) |
| Trial ID | NCT05663034 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of telemedicine-delivered cognitive behavioral therapy for insomnia (CBT-I) and mindfulness-based treatment for insomnia (MBTI) in treating insomnia and depressive symptoms in adults with mild to moderate traumatic brain injury (TBI) and comorbid post-traumatic stress symptoms. A total of 360 participants will be randomized to receive either CBT-I or MBTI over six sessions, with assessments conducted at baseline, post-treatment, and at 2, 6, and 12 weeks after treatment. The primary outcome will be measured using the Insomnia Severity Index (ISI), while secondary outcomes will include pre-sleep arousal and depressive symptoms. Participants will also wear actigraph monitors and complete electronic sleep diaries throughout the study.
Who should consider this trial
Good fit: Ideal candidates are current or former members of the uniform services with mild to moderate TBI and chronic insomnia symptoms.
Not a fit: Patients with significant neurological diseases other than TBI or severe sleep apnea may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective non-pharmacological treatments for insomnia and related symptoms in veterans with TBI.
How similar studies have performed: Previous studies have shown promising results for both CBT-I and mindfulness-based interventions in treating insomnia, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Eglin Air Force Base, Florida and 4 other locations
- Intrepid Spirit Center - Eglin Air Force Base — Eglin Air Force Base, Florida, United States (Recruiting)
- Naval School Explosive Ordance Disposal - Eglin Air Force Base — Eglin Air Force Base, Florida, United States (Recruiting)
- Walter Reed National Medical Military Center — Bethesda, Maryland, United States (Recruiting)
- Womack Army Medical Center — Fort Bragg, North Carolina, United States (Recruiting)
- Madigan Army Medical Center — Fort Lewis, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Luis Buenaver, PhD — Johns Hopkins School of Medicine
- Study coordinator: Luis Buenaver, PHD
- Email: lbuenav1@jhmi.edu
- Phone: 4105507986
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.