Condition: Traumatic Brain Injury · Insomnia · Depression · Sponsor: Johns Hopkins University
This study is a prospective two-arm, single blind randomized controlled trial design to compare the clinical effectiveness of telemedicine-delivered, 6-session, standardized cognitive behavioral therapy for insomnia (CBT-I) and mindfulness-based treatment for insomnia (MBTI) in treating insomnia symptoms and ameliorating depressive symptoms in persons with mild to moderate TBI and comorbid Post-Traumatic Stress Symptoms (PTSS) and insomnia symptoms in a 360 patients. Participants will undergo assessment (psychosocial questionnaires, neurocognitive testing, sleep monitoring) at baseline, at the end of treatment, and at 2-, 6- and 12-weeks post-treatment. The primary outcome is sleep as measured by the Insomnia Severity Index (ISI).
This description comes directly from the study's public registry record.
Luis Buenaver, PHD · 4105507986 · lbuenav1@jhmi.edu
Elizabeth Wysocki, MS · ewysock2@jhu.edu
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Source record: clinicaltrials.gov/study/NCT05663034