University of Colorado - Restoring Efficient Sleep After TBI
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorVA Eastern Colorado Health Care System
About this trial
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
This trial does not accept healthy volunteersQualifiers
History of post-acute (i.e., at least one year after injury) moderate to severe traumatic brain injury
Current insomnia
Reliable access to the internet
Ability to provide informed consent
Disqualifiers
Active substance dependence, excluding cannabis
Current psychosis
Bipolar disorder
Current sleep disorders other than insomnia, including sleep apnea
Trial design
Design model
Parallel
Treatments tested in this trial
Computerized Cognitive Behavioral Therapy for Insomnia
BehavioralThis is a computerized version of cognitive behavioral therapy for insomnia that is augmented by support from a licensed mental health professional. The intervention consists of 6 modules designed to provide education regarding sleep and insomnia, establish behavioral modifications to reduce insomnia symptoms, and monitor progress. Participants will be able to complete these intervention at their own pace, which will take between 6-9 weeks.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Computerized Cognitive Behavioral Therapy for InsomniaExperimental treatment 1 intervention
Group B: Enhanced Treatment as UsualNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Insomnia Severity Index (ISI)
The change in the total score of the ISI, compared across study arms, will be used as the outcome.
Time frame
Change from baseline to post-intervention (CCBT-I arm) or 9 weeks following randomization (ETU arm).Other outcomes
1
Total sleep time - discrepancy between sleep diary and actigraphy
Change in the discrepancy between sleep diary- and actigraphy-derived total sleep time will be evaluated for the CCBT-I arm.
Time frame
Two timepoints: One week prior to the start of the intervention and for the week immediately following completion of the intervention2
Sleep onset latency - discrepancy between sleep diary and actigraphy
Change in the discrepancy between sleep diary- and actigraphy-derived sleep onset latency will be evaluated for the CCBT-I arm.
Time frame
Two collection periods: One week prior to the start of the intervention and for the week immediately following completion of the intervention3
Wake after sleep onset - discrepancy between sleep diary and actigraphy
Change in the discrepancy between sleep diary- and actigraphy-derived wake after sleep onset will be evaluated for the CCBT-I arm.
Time frame
Two collection periods: One week prior to the start of the intervention and for the week immediately following completion of the intervention4
Sleep efficiency - discrepancy between sleep diary and actigraphy
Change in the discrepancy between sleep diary- and actigraphy-derived sleep efficiency will be evaluated for the CCBT-I arm.
Time frame
Two collection periods: One week prior to the start of the intervention and for the week immediately following completion of the interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
VA Eastern Colorado Health Care System
Lead sponsor
Colorado Traumatic Brain Injury Trust Fund
Collaborator
University of Colorado, Denver
Collaborator
Source ClinicalTrials.gov