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

Recruiting in Palo Alto (17 mi)

Overseen by Peter Colvonen, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: VA Office of Research and Development

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Peter Colvonen, PhD

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Eligibility Criteria

Inclusion Criteria

English literacy

Over the age of 19 years old

Diagnosis of PTSD

Treatment Details

Interventions

• CBTI-PE (Behavioral Intervention)
• Hygiene-PE (Behavioral Intervention)

Participant Groups

Group I: CBTI-PE Experimental Treatment 1 Intervention

Integrates the core components of CBT-I and PE in 14 90-minute weekly sessions.

Group II: Hygiene-PE Active Control 1 Intervention

Uses non-active sleep hygiene to account for the dose response of experimental condition before starting PE. Uses 14 90-minute weekly sessions.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine