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CBTI-PE for Post-Traumatic Stress Disorder
N/A
Waitlist Available
Led By Peter Colvonen, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, post treatment (14-weeks), follow-up (26-weeks)
Awards & highlights
Study Summary
This trial is examining whether adding a treatment for insomnia to standard PTSD treatment will improve sleep, PTSD symptoms, and quality of life for veterans.
Eligible Conditions
- Post-Traumatic Stress Disorder
- Chronic Insomnia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in PTSD Symptoms
Secondary outcome measures
Change in Quality of Life
Change in Sleep Efficiency
Other outcome measures
Medications Use Interview
Nox T3 recorders - Obstructive Sleep Apnea (OSA)
Pain Disability Questionnaire (PDQ)
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: CBTI-PEExperimental Treatment1 Intervention
Integrates the core components of CBT-I and PE in 14 90-minute weekly sessions.
Group II: Hygiene-PEActive Control1 Intervention
Uses non-active sleep hygiene to account for the dose response of experimental condition before starting PE. Uses 14 90-minute weekly sessions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CBTI-PE
2016
N/A
~100
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,361 Total Patients Enrolled
Peter Colvonen, PhDPrincipal InvestigatorVA San Diego Healthcare System, San Diego, CA
1 Previous Clinical Trials
194 Total Patients Enrolled
Frequently Asked Questions
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