Comparing two therapies for insomnia in veterans with traumatic brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.