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Researchers are evaluating the effectiveness of two telemedicine-delivered treatments, cognitive behavioral therapy for insomnia (CBT-I) and mindfulness-based treatment for insomnia (MBTI), in adults with mild to moderate traumatic brain injury (TBI) who also have insomnia and post-traumatic stress symptoms. This prospective, single-blind randomized controlled trial will include 360 participants and aims to improve insomnia symptoms and reduce depressive symptoms. The study focuses on understanding how these therapies impact sleep severity and other related outcomes in this population. Participants will be randomly assigned to receive either a standardized 6-session CBT-I program or a 6-week MBTI program. CBT-I uses behavioral techniques to reduce arousal and improve sleep quality, while MBTI incorporates mindfulness meditation and behavioral strategies such as stimulus control and sleep restriction therapy. Both treatments are delivered remotely via telemedicine. Throughout the study, participants will wear an actigraph wrist monitor and complete electronic sleep diaries to track sleep patterns. Participants will undergo assessments including psychosocial questionnaires, neurocognitive testing, sleep diaries, actigraphy, and ambulatory EEG sleep monitoring at baseline, immediately after treatment, and at 2, 6, and 12 weeks post-treatment. The main outcome measured is the severity of insomnia using the Insomnia Severity Index (ISI). Secondary outcomes include pre-sleep arousal and depressive symptoms. The study also explores neurocognitive function and pre-sleep arousal changes, with safety and adherence monitored throughout the trial.

Age: 18Years +All GendersPhase Not Applicable
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