NCT05683145 University of Colorado - Restoring Efficient Sleep After TBI
| NCT ID | NCT05683145 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Eastern Colorado Health Care System |
| Condition | Insomnia |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2022-07-01 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2022-07-01 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Lisa A Brenner, PhD
PRINCIPAL INVESTIGATOR
Rocky Mountain VA Mental Illness, Research, and Education Center
Frequently Asked Questions
Who can join the NCT05683145 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Insomnia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05683145 currently recruiting?
Yes, NCT05683145 is actively recruiting participants. Contact the research team at EMERALD.SALDYT@UCDENVER.EDU for enrollment information.
Where is the NCT05683145 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT05683145 clinical trial?
NCT05683145 is sponsored by VA Eastern Colorado Health Care System. The principal investigator is Lisa A Brenner, PhD at Rocky Mountain VA Mental Illness, Research, and Education Center. The trial plans to enroll 80 participants.
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