Recruiting

Restoring Efficient Sleep

Sponsor:

VA Eastern Colorado Health Care System

Code:

NCT05683145

Conditions

Insomnia

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Computerized Cognitive Behavioral Therapy for Insomnia

Study Details

Brief 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). 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.

Conditions

Insomnia

Traumatic Brain Injury

Study ID

NCT05683145

Start date

Jul 1, 2022

Status verified date

Feb, 2026

Completion date

May 1, 2026

Anticipated

Primary completion date

May 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Computerized Cognitive Behavioral Therapy for Insomnia

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

no intervention: Enhanced Treatment as Usual

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

Interventions

Computerized Cognitive Behavioral Therapy for Insomnia

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.

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). ]

Central Contacts and Locations

Central contacts

Emerald Saldyt

720-723-6554EMERALD.SALDYT@UCDENVER.EDU

Locations

Rocky Mountain Regional VAMC

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Emerald Saldyt

720-723-6554EMERALD.SALDYT@UCDENVER.EDU

More Information

Sponsor

VA Eastern Colorado Health Care System

Last update posted

Feb 18, 2026

Last verified

Feb, 2026

Keywords

  • computerized intervention
  • insomnia
  • traumatic brain injury
  • clinician guided

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Eastern Colorado Health Care System on 2026-02-18.