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.
CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms
At a glance
Conditions
Where it's being run
5 sites across 4 statesStudy leadership
- Luis Buenaver, PhD · PRINCIPAL_INVESTIGATOR · Johns Hopkins School of Medicine
Who to contact
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What this trial measures
- 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