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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
- Recruiting
Rocky Mountain Regional VAMC
Aurora, Colorado, 80045
Emerald Saldyt, 720-723-6554, EMERALD.SALDYT@UCDENVER.EDU
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.
- Conditions
- Insomnia, Traumatic Brain Injury
- 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 group | Role | What they receive |
|---|---|---|
| Computerized Cognitive Behavioral Therapy for Insomnia | Experimental | Self-guided computerized CBT-I program with assistance from a licensed mental health professional. Receives: Behavioral: Computerized Cognitive Behavioral Therapy for Insomnia |
| Enhanced Treatment as Usual | No intervention | ETU 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.
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.
- First posted12 Jan 2023
- Study start1 Jul 2022
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- VA Eastern Colorado Health Care System
- Sponsor type
- US federal agency
- Collaborators
- Colorado Traumatic Brain Injury Trust Fund, University of Colorado, Denver
- Responsible party
- Sponsor
- Investigators
- Lisa A Brenner, PhD, Principal investigator, Rocky Mountain VA Mental Illness, Research, and Education Center
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- University of Colorado - Restoring Efficient Sleep After TBI (CU-REST)
- ClinicalTrials.gov ID
- NCT05683145
- Acronym / sponsor ID
- CU-REST / COMIRB 22-1169
- Conditions
- Insomnia, Traumatic Brain Injury
- Keywords
- computerized intervention, insomnia, traumatic brain injury, clinician guided
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- VA Eastern Colorado Health Care SystemUS federal agency
- Collaborators
- Colorado Traumatic Brain Injury Trust Fund, University of Colorado, Denver
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 12 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- parallel, two-arm, randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Computerized Cognitive Behavioral Therapy for Insomnia | Experimental | Behavioral: Computerized Cognitive Behavioral Therapy for InsomniaSelf-guided computerized CBT-I program with assistance from a licensed mental health professional. |
| Enhanced Treatment as Usual | No intervention | –ETU is defined as treatment per usual which is enhanced by participating in data collection related to study participation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized Cognitive Behavioral Therapy for InsomniaThis 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. | Behavioural | Computerized Cognitive Behavioral Therapy for Insomnia |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa A Brenner, PhD principal investigator
Rocky Mountain VA Mental Illness, Research, and Education Center
1 site in 1 country: see every site and its status.
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.