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Recruiting
NCT05683145
University of Colorado - Restoring Efficient Sleep After TBI
Conditions: Insomnia, Traumatic Brain Injury
Sex: All
Ages: 18 Years – 60 Years
Phase: NA
Enrollment: 80
Sponsor: VA Eastern Colorado Health Care System
Location: United States
Summary
Sleep disturbance is a common condition following traumatic brain injury (TBI) and impairs recovery and quality of life.
While efficacious interventions exist many are not accessible to all patients due to a variety of factors (e.g., rurality, access to providers).
Further, many of the available treatments have not been validated for individuals with moderate/severe TBI.
The proposed study will evaluate a guided computerized version of cognitive behavioral therapy for insomnia (cCBT-I) against enhanced treatment as usual (ETU) in individuals with moderate/severe TBI.
Eligibility Criteria
Inclusion Criteria:History of post-acute (i.e., at least one year after injury) moderate to severe traumatic brain injuryCurrent insomniaReliable access to the internetAbility to provide informed consentExclusion Criteria:Active substance dependence, excluding cannabisCurrent psychosisBipolar disorderCurrent sleep disorders other than insomnia, including sleep apneaIrregular work schedule, shift work, and/or life changes (e.g., newborn) interfering with regular sleep patterns.Currently receiving psychological treatment for insomniaPregnancyCurrently involved in another research interventional trial targeting insomnia
Source: ClinicalTrials.gov (NCT05683145). StuddyBuddy aggregates publicly available trial information.