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Restoring Efficient Sleep After Traumatic Brain Injury

This study is looking for people aged 18-60 who have had a moderate to severe traumatic brain injury (TBI) at least one year ago and are currently experiencing insomnia. The study is testing a guided computerized version of cognitive behavioral therapy for insomnia (cCBT-I) against an enhanced usual care approach (ETU). cCBT-I is a computer program that helps you learn new ways to improve your sleep, with support from a mental health professional. Researchers want to see if cCBT-I can improve your insomnia symptoms, measured by the Insomnia Severity Index (ISI), compared to ETU. The study plans to enroll 80 participants and is currently unclear about its recruitment status. You must have reliable internet access and be able to give informed consent to participate.

Study design
This interventional study plans to enroll 80 participants. It compares a guided computerized therapy to an enhanced usual care approach.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your insomnia symptoms will be measured at the end of the intervention or 9 weeks after you are randomly assigned to a group.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05683145

University of Colorado - Restoring Efficient Sleep After TBI

Recruiting
NAAges 18–60InterventionalTreatment
VA Eastern Colorado Health Care System
~80 participants
Updated 2026-02-18 on ClinicalTrials.gov
What's tested:Computerized Cognitive Behavioral Therapy for Insomnia

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Insomnia Severity Index (ISI)
Measured over Change from baseline to post-intervention (CCBT-I arm) or 9 weeks following randomization (ETU arm).

Conditions

Insomnia
Traumatic Brain Injury

Explore related trials

InsomniaTraumatic Encephalopathy

Where it's being run

1 sites across 1 states
Colorado1

Study leadership

  • Lisa A Brenner, PhD · PRINCIPAL_INVESTIGATOR · Rocky Mountain VA Mental Illness, Research, and Education Center

Who to contact

Emerald Saldyt
[email protected]
720-723-6554
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Insomnia Severity Index (ISI)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.