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Integrated CBT-I and PE on Sleep and PTSD Outcomes (Impact Study)

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 post treatment, and 3-month follow-ups presented.
Awards & highlights
No Placebo-Only Group

Summary

This trial uses a combination of sleep therapy and trauma therapy to help veterans with PTSD and insomnia. The sleep therapy aims to improve rest, making it easier to handle the trauma therapy, which reduces trauma-related fears. This approach targets veterans because they often experience both issues, which can hinder recovery.

Eligible Conditions
  • Post-Traumatic Stress Disorder
  • Chronic Insomnia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post treatment, and 3-month follow-ups presented.
This trial's timeline: 3 weeks for screening, Varies for treatment, and post treatment, and 3-month follow-ups presented. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in PTSD Symptoms
Change in Sleep Efficiency
Secondary study objectives
Change in Insomnia Severity
Change in Quality of Life
Other study objectives
Brief Pain Inventory
The Client Satisfaction Questionnaire (CSQ)

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: 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
1,664 Previous Clinical Trials
3,765,572 Total Patients Enrolled
Peter Colvonen, PhDPrincipal InvestigatorVA San Diego Healthcare System, San Diego, CA
1 Previous Clinical Trials
194 Total Patients Enrolled
~10 spots leftby Dec 2025
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