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Computer-guided therapy for insomnia after a moderate or severe brain injury

Tests computer-based insomnia therapy in adults with moderate or severe traumatic brain injury.

Key facts

Who runs it
VA Eastern Colorado Health Care System
Where
Aurora, United StatesSee the site
Trial code
Registry title
University of Colorado - Restoring Efficient Sleep After TBI
Status
Recruiting
People taking part
80 people, planned
Started
1 Jul 2022
Planned end
1 May 2026
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Computerized Cognitive Behavioral Therapy for Insomnia
Record updated
18 February 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with insomnia who had a moderate to severe traumatic brain injury at least one year ago. It compares a guided computer program for insomnia therapy with usual care.

Age
18 Years to 60 Years
Sex
All
Disease stage
Moderate to severe traumatic brain injury, at least one year after the injury, with current insomnia.
Earlier treatment
People currently getting psychological treatment for insomnia cannot join.

Main reasons for not taking part

  • Active substance dependence (cannabis use is allowed)
  • Current psychosis or bipolar disorder
  • Other current sleep disorders, such as sleep apnea
  • Shift work, irregular work hours or life changes (such as a newborn) that disturb sleep
  • Pregnancy, or being in another trial that treats insomnia

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Currently receiving psychological treatment for insomnia
  • Bipolar disorder
  • Current sleep disorders other than insomnia, including sleep apnea
  • Active substance dependence, excluding cannabis
  • Current psychosis
  • Irregular work schedule, shift work, and/or life changes (e.g., newborn) interfering with regular sleep patterns
  • Pregnancy
  • Currently involved in another research interventional trial targeting insomnia

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 60 years old?

Where in United States

  • Rocky Mountain Regional VAMCAurora, United StatesContact: Emerald SaldytTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Computerized Cognitive Behavioral Therapy for InsomniaTreatment being tested

    Self-guided computerized CBT-I program with assistance from a licensed mental health professional.

  • Enhanced Treatment as UsualNo study treatment, for comparison

    ETU is defined as treatment per usual which is enhanced by participating in data collection related to study participation.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
University of Colorado - Restoring Efficient Sleep After TBI (CU-REST)
Plain-language title
Computer-guided therapy for insomnia after a moderate or severe brain injuryGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT05683145, who can take part
Record updated
18 February 2026