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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

CU-REST Trial 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.Check my eligibility
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.See study design
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.

CU-REST Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 9 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 9 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Insomnia Severity Index (ISI)
Other outcome measures
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

CU-REST 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
53 Previous Clinical Trials
26,098 Total Patients Enrolled
University of Colorado, DenverOTHER
1,736 Previous Clinical Trials
2,149,115 Total Patients Enrolled
5 Trials studying Insomnia
927 Patients Enrolled for Insomnia

Media Library

Computerized Cognitive Behavioral Therapy for Insomnia (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05683145 — N/A
Insomnia Research Study Groups: Enhanced Treatment as Usual, Computerized Cognitive Behavioral Therapy for Insomnia
Insomnia 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial permit those aged 35 and above to participate?

"This clinical trial requires participants to be between 18 - 60 years old, in accordance with the set eligibility criteria."

Answered by AI

Are there any openings available to join this clinical endeavor?

"Clinicaltrials.gov specifies that this medical trial is currently enrolling subjects. The initial post was made on the 1st of July 2022 and recent modifications were applied on May 1st, 2023."

Answered by AI

How many people are being recruited for this study?

"Affirmative, the clinicaltrials.gov registry shows that this research is actively seeking to enroll participants. The trial was initially posted on July 1st 2022 and has been newly updated as of May 1st 2023. Specifically, 80 individuals need to be recruited from a single medical centre."

Answered by AI

Who meets the selection criteria for this research endeavor?

"80 individuals aged 18 to 60 with insomnia are eligible for this trial. To be considered, applicants must have experienced moderate or severe traumatic brain injury at least one year prior and possess the capabilities of accessing the web reliably, giving informed consent and dealing with current bouts of sleeplessness."

Answered by AI

Who else is applying?

What site did they apply to?
Rocky Mountain Regional VAMC
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

I have taken ambiam n some other medications.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
University of Colorado - Restoring Efficient Sleep After TBI
2022. "University of Colorado - Restoring Efficient Sleep After TBI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05683145.
All > Tbi > Traumatic Brain Injury
~7 spots leftby Jun 2024
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