University of Colorado - Restoring Efficient Sleep After TBI

NCT05683145 | Recruiting

• 1 other identifier: COMIRB 22-1169
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

computerized intervention; insomnia; traumatic brain injury; clinician guided

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index (ISI)

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

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

Other Outcomes (5)

• Total sleep time - discrepancy between sleep diary and actigraphy

  Two timepoints: One week prior to the start of the intervention and for the week immediately following completion of the intervention

• Sleep onset latency - discrepancy between sleep diary and actigraphy

  Two collection periods: One week prior to the start of the intervention and for the week immediately following completion of the intervention

• Wake after sleep onset - discrepancy between sleep diary and actigraphy

  Two collection periods: One week prior to the start of the intervention and for the week immediately following completion of the intervention

Study Arms (2)

Computerized Cognitive Behavioral Therapy for Insomnia

EXPERIMENTAL

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

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.

Interventions

Computerized Cognitive Behavioral Therapy for Insomnia BEHAVIORAL

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.

Computerized Cognitive Behavioral Therapy for Insomnia

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Eastern Colorado Health Care System: lead
• Colorado Traumatic Brain Injury Trust Fund: collaborator
• University of Colorado, Denver: collaborator

Study Sites (1)

Rocky Mountain Regional VAMC

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Lisa A Brenner, PhD

  Rocky Mountain VA Mental Illness, Research, and Education Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emerald Saldyt

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: parallel, two-arm, randomized control trial

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: January 12, 2023
• Study Start: July 1, 2022
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

US (1)