CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms
Trial Parameters
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Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: 1. Current or former member of the uniform services 2. Meet the Veterans Affairs Medical Center (VAMC) Department of Defense (DoD) criteria for TBI; 3. Time duration since traumatic brain injury (TBI) injury \>90 days 4. Insomnia symptom duration \>90 days 5. Endorse insomnia symptoms (Insomnia Severity Index \[ISI\] score \> 10) 6. Display sufficient cognitive capacity to provide informed consent (Montreal Cognitive Assessment (MoCA) Z-score \> -2) 7. \>18 years of age 8. Access to and ability and to use computer. Exclusion Criteria: 1. History of neurological diseases other than TBI and not attributable to TBI 2. Sleep apnea \[apnea hypopnea index (AHI) \>15; individuals with mild apnea (AHI \> 5 and \<15) will be informed, but allowed to participate\]. Participants 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 de