University of Colorado - Restoring Efficient Sleep After TBI

Part of paid clinical trials in Aurora, Colorado.

Sponsor
VA Eastern Colorado Health Care System
Study ID
NCT05683145
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jul 1, 2022
Status verified
Feb 2026
Primary completion
May 1, 2026
Completion
May 1, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Rocky Mountain Regional VAMCAuroraColorado80045
Emerald Saldyt
[email protected]
720-723-6554

Find similar trials in Aurora, CO

By condition
Insomnia
By specialty
Mental healthSleep medicine
By research site
Rocky Mountain Regional VAMC· Aurora, CO

Related Studies