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

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 6- and 12-weeks post-treatment. The primary outcome is sleep as measured by the Insomnia Severity Index (ISI).

Inclusion Criteria:Meet the Veterans Affairs Medical Center (VAMC) and Department of Defense (DoD) criteria for TBIMild to moderate TBI severity at time of injury based on review of medical recordsTime duration since injury >3 weeksEndorse insomnia symptoms (Insomnia Severity Index [ISI] score > 9)Display sufficient cognitive capacity to provide informed consent (Montreal Cognitive Assessment (MoCA), Z-score > -2149)18 years of age or greaterAccess to and ability and to use computerExclusion Criteria:History of neurological diseases other than TBI and not attributable to TBIKnown history of intellectual or developmental disabilityCommunication difficulties or inability to speak EnglishSleep apnea [apnea hypopnea index (AHI) >15; individuals with mild apnea (AHI > 5 and <14.9) will be informed, but allowed to participate].Patients who use a continuous positive airway pressure (CPAP) device for sleep apnea will be eligible for participation if they are below the apnea/hypopnea cutoff while using CPAP, are adherent to using the device (> 4 hours/night 21/30 consecutive days) and agree to continue using the device during study participation.Patients using psychotropic medications may be included if they are on a stable dosage for the last three weeks prior to the study.