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Study details
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CBT-I vs. MBTI for TBI-Related Insomnia and Post-Traumatic Stress Symptoms

Johns Hopkins University
NCT IDNCT05663034ClinicalTrials.gov data as of Apr 2026
Target enrollment

360

Study length

about 2.4 years

Ages

18+

Locations

5 sites in FL, MD, NC +1

What this study is about

This trial is testing whether a treatment (CBT-I) or another treatment (MBTI) helps people with mild to moderate traumatic brain injury (TBI) who also have insomnia and post-traumatic stress symptoms. Participants will be assessed at different points during it, including before, after, and several weeks later, to see how well each treatment works in improving sleep.

Simplified from trial records by PatientMatch.

What you may be asked to do

  • 1.Participate in Cognitive behavioral therapy for insomnia (CBT-I)
  • 2.Participate in Mindfulness-based treatment for insomnia (MBTI)

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
In-person visits

Requires travel to a study site

Physical Intervention
Standard

How treatment is administered

Treatment Assignment
Randomized & Blinded

You may get a placebo/standard care, and you won't know which.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Endpoints

Primary: Change in Insomnia severity as assessed by the insomnia severity index (ISI)

Procedures

therapy

Body systems

Neurology, Psychiatry / Mental Health