Improving sleep for individuals with traumatic brain injury
University of Colorado - Restoring Efficient Sleep After TBI (CU-REST)
This study tests a new online therapy program to help people with moderate to severe traumatic brain injury improve their sleep quality compared to standard treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | VA Eastern Colorado Health Care System Federal |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT05683145 on ClinicalTrials.gov |
What this trial studies
This study evaluates a guided computerized cognitive behavioral therapy for insomnia (cCBT-I) against enhanced treatment as usual (ETU) for individuals with moderate to severe traumatic brain injury (TBI). It addresses the high prevalence of insomnia in this population, which significantly impacts recovery and quality of life. The intervention aims to improve sleep quality through cognitive therapy, behavioral techniques, and psychoeducation, while being accessible and low-cost. Participants must have reliable internet access and a history of insomnia following their TBI.
Who should consider this trial
Good fit: Ideal candidates are individuals with a history of moderate to severe TBI who are currently experiencing insomnia.
Not a fit: Patients with active substance dependence, current psychosis, or other sleep disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve sleep quality and overall rehabilitation outcomes for patients with traumatic brain injury.
How similar studies have performed: Previous studies have shown success with cognitive behavioral therapy for insomnia in the general population, but this approach for individuals with moderate to severe TBI is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * Pregnancy * Currently involved in another research interventional trial targeting insomnia
Where this trial is running
Aurora, Colorado
- Rocky Mountain Regional VAMC — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Lisa A Brenner, PhD — Rocky Mountain VA Mental Illness, Research, and Education Center
- Study coordinator: Emerald Saldyt
- Email: EMERALD.SALDYT@UCDENVER.EDU
- Phone: 720-723-6554
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.