CBT-I vs. MBTI for TBI-Related Insomnia and PTSD Symptoms

This study is comparing two types of therapy for people who have trouble sleeping (insomnia) and post-traumatic stress symptoms (PTSS) after a traumatic brain injury (TBI). The therapies are Cognitive Behavioral Therapy for Insomnia (CBT-I) and Mindfulness-Based Treatment for Insomnia (MBTI). Both are 6-week programs delivered remotely. Researchers want to see which therapy is more effective at improving sleep and reducing symptoms of depression. You might be able to join if you are a current or former member of the uniform services, had a TBI and insomnia for more than 90 days, and have an Insomnia Severity Index (ISI) score above 10. The study aims to enroll 360 participants.

Study design
This is a randomized controlled trial with two groups, meaning participants will be randomly assigned to receive either CBT-I or MBTI. It is a single-blind study, so you won't know which treatment you're getting. The study plans to enroll 360 participants.
What's involved
You will participate in a 6-week therapy program delivered remotely. You will also complete questionnaires, neurocognitive tests, sleep diaries, and wear a wrist monitor. Assessments will happen at the start, end of treatment, and at 2, 6, and 12 weeks after treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 weeks after treatment (or 24 weeks after randomization) to assess changes in insomnia severity and other symptoms.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05663034

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

Recruiting
NAAges 18+InterventionalTreatment
Johns Hopkins University
~360 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:Mindfulness-based treatment for insomnia (MBTI)Cognitive behavioral therapy for insomnia (CBT-I)

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Insomnia severity as assessed by the insomnia severity index (ISI)
Measured over At the end of treatment, and 2-, 6- and 12-weeks post treatment
Traumatic Brain Injury
Insomnia
Depression
Post-traumatic Stress
Sleep
Memory Impairment
Cognitive Behavioral Therapy
Concussion, Brain
Head Injury
Brain Injury Traumatic Mild
5 sites across 4 states
Florida2
Maryland1
North Carolina1
Washington1
  • Luis Buenaver, PhD · PRINCIPAL_INVESTIGATOR · Johns Hopkins School of Medicine

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  • 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

    Insomnia symptoms and severity measured by insomnia severity index (ISI); score range: 0-28; Higher scores are associated with greater insomnia symptoms