80 Participants Needed

Cognitive Behavioral Therapy for Insomnia after TBI

(CU-REST Trial)

ES
Overseen ByEmerald Saldyt
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: VA Eastern Colorado Health Care System
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Research Team

LA

Lisa A Brenner, PhD

Principal Investigator

Rocky Mountain VA Mental Illness, Research, and Education Center

Eligibility Criteria

This trial is for individuals who have had a moderate to severe traumatic brain injury at least one year ago and are now experiencing insomnia. Participants must have reliable internet access and be able to consent. They can't join if they're dependent on substances (except cannabis), pregnant, dealing with psychosis or bipolar disorder, in another sleep study, getting psychological treatment for insomnia, or have irregular sleep patterns due to work or life changes.

Inclusion Criteria

Ability to provide informed consent
Reliable access to the internet

Exclusion Criteria

Irregular work schedule, shift work, and/or life changes (e.g., newborn) interfering with regular sleep patterns
Active substance dependence, excluding cannabis
Pregnancy
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a guided computerized version of cognitive behavioral therapy for insomnia (cCBT-I) with assistance from a licensed mental health professional

9 weeks
Remote participation

Follow-up

Participants are monitored for changes in sleep metrics and insomnia severity after treatment

1 week

Treatment Details

Interventions

  • Computerized Cognitive Behavioral Therapy for Insomnia
Trial Overview The study is testing a guided computerized cognitive behavioral therapy program for insomnia (cCBT-I) against an enhanced usual care approach in people with past traumatic brain injuries. It aims to see if this online therapy can improve sleep quality when traditional treatments aren't accessible.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Computerized Cognitive Behavioral Therapy for InsomniaExperimental Treatment1 Intervention
Self-guided computerized CBT-I program with assistance from a licensed mental health professional.
Group II: Enhanced Treatment as UsualActive Control1 Intervention
ETU is defined as treatment per usual which is enhanced by participating in data collection related to study participation.

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Eastern Colorado Health Care System

Lead Sponsor

Trials
55
Recruited
26,200+

Colorado Traumatic Brain Injury Trust Fund

Collaborator

Trials
4
Recruited
2,100+

University of Colorado, Denver

Collaborator

Trials
1,842
Recruited
3,028,000+