University of Colorado - Restoring Efficient Sleep After TBI

Recruiting now · Not applicable

Conditions studied: Insomnia, Traumatic Brain Injury

In brief

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.

Key facts

Study ID

NCT05683145

Run by

VA Eastern Colorado Health Care System

People needed

80

Starts

2022-07-01

Expected to finish

2026-05-01

Last updated by the study team

2026-02-18

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Rocky Mountain Regional VAMC — Aurora, Colorado, United States (enrolling)

Full record on ClinicalTrials.gov

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