RECRUITING

University of Colorado - Restoring Efficient Sleep After TBI

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

University of Colorado - Restoring Efficient Sleep After TBI (CU-REST)

Quick Facts

Study Start:2022-07-01
Study Completion:2024-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05683145

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * History of post-acute (i.e., at least one year after injury) moderate to severe traumatic brain injury
  2. * Current insomnia
  3. * Reliable access to the internet
  4. * Ability to provide informed consent
  1. * Active substance dependence, excluding cannabis
  2. * Current psychosis
  3. * Bipolar disorder
  4. * Current sleep disorders other than insomnia, including sleep apnea
  5. * Irregular work schedule, shift work, and/or life changes (e.g., newborn) interfering with regular sleep patterns.
  6. * Currently receiving psychological treatment for insomnia
  7. * Pregnancy
  8. * Currently involved in another research interventional trial targeting insomnia

Contacts and Locations

Study Contact

Emerald Saldyt
CONTACT
720-723-6554
EMERALD.SALDYT@UCDENVER.EDU

Principal Investigator

Lisa A Brenner, PhD
PRINCIPAL_INVESTIGATOR
Rocky Mountain VA Mental Illness, Research, and Education Center

Study Locations (Sites)

Rocky Mountain Regional VAMC
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: VA Eastern Colorado Health Care System

  • Lisa A Brenner, PhD, PRINCIPAL_INVESTIGATOR, Rocky Mountain VA Mental Illness, Research, and Education Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-01
Study Completion Date2024-12-30

Study Record Updates

Study Start Date2022-07-01
Study Completion Date2024-12-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Insomnia
  • Traumatic Brain Injury