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Behavioral Intervention

Cognitive Behavioral Therapy for Insomnia after TBI (CU-REST Trial)

N/A
Recruiting
Led By Lisa A Brenner, PhD
Research Sponsored by VA Eastern Colorado Health Care System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two collection periods: one week prior to the start of the intervention and for the week immediately following completion of the intervention
Awards & highlights
No Placebo-Only Group

Summary

This trial will evaluate a computer-guided therapy for sleep disturbances caused by TBI, to see if it's more effective than existing treatments for those who may not have access to providers.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since the intervention involves non-pharmaceutical therapy (computerized cognitive behavioral therapy), typical drug-related side effects are not expected. However, participants may experience frustration or stress if they find the technology challenging or if there's no immediate improvement in their sleep.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two timepoints: one week prior to the start of the intervention and for the week immediately following completion of the intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and two timepoints: one week prior to the start of the intervention and for the week immediately following completion of the intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Insomnia Severity Index (ISI)
Other study objectives
Nature and duration of guidance needed to compete intervention
Sleep efficiency - discrepancy between sleep diary and actigraphy
Sleep onset latency - discrepancy between sleep diary and actigraphy
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computerized Cognitive Behavioral Therapy for Insomnia
2018
N/A
~350

Find a Location

Who is running the clinical trial?

Colorado Traumatic Brain Injury Trust FundOTHER
3 Previous Clinical Trials
2,018 Total Patients Enrolled
VA Eastern Colorado Health Care SystemLead Sponsor
54 Previous Clinical Trials
26,138 Total Patients Enrolled
University of Colorado, DenverOTHER
1,810 Previous Clinical Trials
2,920,020 Total Patients Enrolled
Lisa A Brenner, PhDPrincipal InvestigatorRocky Mountain VA Mental Illness, Research, and Education Center
6 Previous Clinical Trials
2,524 Total Patients Enrolled

Media Library

Computerized Cognitive Behavioral Therapy for Insomnia (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05683145 — N/A
Traumatic Brain Injury Research Study Groups: Enhanced Treatment as Usual, Computerized Cognitive Behavioral Therapy for Insomnia
Traumatic Brain Injury Clinical Trial 2023: Computerized Cognitive Behavioral Therapy for Insomnia Highlights & Side Effects. Trial Name: NCT05683145 — N/A
Computerized Cognitive Behavioral Therapy for Insomnia (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05683145 — N/A
~23 spots leftby Dec 2025
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