AzTrials
AzTrials

InsomniaCU-RESTNCT05683145

University of Colorado - Restoring Efficient Sleep After TBI

A study testing Computerized Cognitive Behavioral Therapy for Insomnia in people with Insomnia and Traumatic Brain Injury, run by VA Eastern Colorado Health Care System at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Insomnia, Traumatic Brain Injury
What is being tested?
Computerized Cognitive Behavioral Therapy for Insomnia
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
1 Jul 2022to 1 May 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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 join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • Rocky Mountain Regional VAMC

    Aurora, Colorado, 80045

    Emerald Saldyt, 720-723-6554, EMERALD.SALDYT@UCDENVER.EDU

    Recruiting

Other trials in United States

About this study

Official title: University of Colorado - Restoring Efficient Sleep After TBI (CU-REST)

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.

Read the detailed description

Individuals with a history of moderate to severe TBI experience multi-faceted sleep problems, including greater daytime sleepiness, lesser total sleep time, and difficulties with initiating, maintaining, and self-monitoring sleep. Such sleep complaints may reflect underlying sleep conditions such as insomnia, the prevalence of which is significantly greater among individuals with TBI (29%) compared to members of the general population (10%). As such, treatment of insomnia among individuals with moderate to severe TBI is expected to produce wide-ranging benefits in regards to short- and long-term rehabilitation. Among members of the general population, cognitive behavioral therapy for insomnia (CBT-I) is considered the gold standard for treating insomnia. CBT-I focuses on improving sleep quality via cognitive therapy, behavioral techniques, and psychoeducation. However, access to in-person treatment has been limited by cost, insufficient numbers of adequately trained healthcare providers, and patient perceptions regarding the efficacy of the intervention, as well as additional barriers that may be particularly pertinent for those living with moderate to severe TBI (e.g., limited transportation). Optimally, an intervention for those with TBI and insomnia would show efficacy at reversing sleep inefficiency, and be able to be used with minimal stigma. In addition, the intervention should be highly accessible, low cost, self-sustaining (e.g., portable), and with minimal side effects.

Computerized versions of CBT-I assist in reducing barriers to access and have been found to be acceptable and efficacious in a variety of populations, including those with mild TBI. To date, research among those with moderate to severe TBI has been limited. This study will address this gap by examining the efficacy of a guided computerized CBT-I (CCBT-I) intervention for those with moderate to severe TBI and insomnia. That is, we will implement a free, computerized version of CBT-I, provided in conjunction with guidance (e.g., prompts or reminders to complete modules, help or support using the program and/or completing the modules) by a licensed mental health professional (Study Clinician). As participants will be recruited from the community at-large across the State of Colorado, it is believed that findings will be highly generalizable.

Moreover, both geography (where an individual resides) and challenges with transportation create barriers to treatment access and research participation among those living with moderate to severe TBI. As such, all study procedures will be completed remotely. During the Coronavirus Disease 2019 (COVID-19) pandemic, members of this study team explored and implemented multiple methods to facilitate remote research participation (e.g., video conferencing, data collection via Research Electronic Data Capture [REDCap], mailing study data collection devices). Employing such methods will allow individuals in both rural and urban areas across Colorado to participate.

Being tested
Computerized Cognitive Behavioral Therapy for Insomnia
Keywords
computerized intervention, insomnia, traumatic brain injury, clinician guided
Medical subject headings
Sleep Initiation and Maintenance Disorders, Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computerized Cognitive Behavioral Therapy for InsomniaBehavioural

    This is a computerized version of cognitive behavioral therapy for insomnia that is augmented by support from a licensed mental health professional. The intervention consists of 6 modules designed to provide education regarding sleep and insomnia, establish behavioral modifications to reduce insomnia symptoms, and monitor progress. Participants will be able to complete these intervention at their own pace, which will take between 6-9 weeks.

Study groups in NCT05683145
Study groupRoleWhat they receive
Computerized Cognitive Behavioral Therapy for InsomniaExperimentalSelf-guided computerized CBT-I program with assistance from a licensed mental health professional.
Receives: Behavioral: Computerized Cognitive Behavioral Therapy for Insomnia
Enhanced Treatment as UsualNo interventionETU is defined as treatment per usual which is enhanced by participating in data collection related to study participation.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Insomnia Severity Index (ISI)

    The change in the total score of the ISI, compared across study arms, will be used as the outcome.

    Measured: Change from baseline to post-intervention (CCBT-I arm) or 9 weeks following randomization (ETU arm).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2023
  2. Study start1 Jul 2022
  3. Primary completion1 May 2026 (estimated)
  4. Study completion1 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
parallel, two-arm, randomized control trial
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05683145
Sponsor's protocol ID
COMIRB 22-1169
Acronym
CU-REST
Status last verified
Feb 2026
First submitted
14 Dec 2022
Last updated
18 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Computerized Cognitive Behavioral Therapy for Insomnia in people with Insomnia and Traumatic Brain Injury, run by VA Eastern Colorado Health Care System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Emerald Saldyt (720-723-6554, EMERALD.SALDYT@UCDENVER.EDU), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Insomnia Severity Index (ISI) (time frame: Change from baseline to post-intervention (CCBT-I arm) or 9 weeks following randomization (ETU arm).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in