CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms (NCT05663034) | Clinical Trial Compass
RecruitingNot Applicable
CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms
United States360 participantsStarted 2024-05-10
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Current or former member of the uniform services
✓. Meet the Veterans Affairs Medical Center (VAMC) Department of Defense (DoD) criteria for TBI;
✓. Time duration since traumatic brain injury (TBI) injury \>90 days
✓. Display sufficient cognitive capacity to provide informed consent (Montreal Cognitive Assessment (MoCA) Z-score \> -2)
✓. \>18 years of age
✓. Access to and ability and to use computer.
Exclusion criteria
✕. History of neurological diseases other than TBI and not attributable to TBI
✕. 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 device (\> 4 hours/night 21/30 consecutive days) and agree to continue using the device during study participation.
What they're measuring
1
Change in Insomnia severity as assessed by the insomnia severity index (ISI)
Timeframe: At the end of treatment, and 2-, 6- and 12-weeks post treatment