Comparing Telemedicine Cognitive Behavioral Therapy and Mindfulness Treatment for Insomnia and Post-Traumatic Stress in Adults with Mild to Moderate Traumatic Brain Injury

What this Trial Is About

Researchers are investigating the effectiveness of two telemedicine-delivered treatmentscognitive behavioral therapy for insomnia CBT-I and mindfulness-based treatment for insomnia MBTIin adults with mild to moderate traumatic brain injury TBI who also have symptoms of post-traumatic stress and insomnia. The study is a prospective, randomized, single-blind controlled trial including 360 participants, aiming to compare how these treatments reduce insomnia severity and depressive symptoms. Participants are randomly assigned to receive either CBT-I or MBTI, each delivered in six standardized sessions via telemedicine. CBT-I focuses on education about sleep, stimulus control, sleep restriction, relaxation training, and cognitive restructuring over six weeks. MBTI integrates mindfulness meditation practices with behavioral sleep strategies during the same 6-week period. Throughout the study, participants wear an actigraph wrist monitor and keep electronic sleep diaries to track sleep patterns and treatment adherence. Participants will complete assessments including psychosocial questionnaires, neurocognitive testing, sleep diaries, actigraphy, and ambulatory EEG sleep monitoring at baseline, end of treatment, and at 2, 6, and 12 weeks post-treatment. The main outcome measured is insomnia severity using the Insomnia Severity Index. Secondary outcomes include pre-sleep arousal and depressive symptoms. The study monitors participants for a total of 24 weeks after randomization to evaluate treatment effects and safety.

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