NCT05683145 · VA Eastern Colorado Health Care System
University of Colorado - Restoring Efficient Sleep After TBI
(CU-REST)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Computerized Cognitive Behavioral Therapy for Insomnia
This 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.
Primary outcome measures
Insomnia Severity Index (ISI)
Time frame: Change from baseline to post-intervention (CCBT-I arm) or 9 weeks following randomization (ETU arm).
The change in the total score of the ISI, compared across study arms, will be used as the outcome.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- Active substance dependence, excluding cannabis
- Current psychosis
- Bipolar disorder
- Current sleep disorders other than insomnia, including sleep apnea
- Irregular work schedule, shift work, and/or life changes (e.g., newborn) interfering with regular sleep patterns.
- Currently receiving psychological treatment for insomnia
- Currently involved in another research interventional trial targeting insomnia
Where
- Aurora, Colorado
Collaborators
Colorado Traumatic Brain Injury Trust Fund, University of Colorado, Denver
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 18, 2026 · Source of record for eligibility and locations