- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02818114
Peer Enhanced Prolonged Exposure (PEET)
June 25, 2019 updated by: VA Office of Research and Development
Peer Enhanced Exposure Therapy (PEET)
The investigators plan to develop and test an intervention using peer specialists (Veterans who have managed PTSD and completed PE) to provide support services for Veterans using prolonged exposure therapy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The investigators will use qualitative data from Veterans and PE providers to revise the investigators' manualized intervention for peer support services, then complete a feasibility trial to assess the feasibility and acceptability of Peer Enhanced Prolonged Exposure
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55417
- Minneapolis VA Health Care System, Minneapolis, MN
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Veteran participants will be individuals appropriate for PE, i.e., :
- Veterans who are currently seeking PE
- meet DSM-5 criteria for PTSD or subthreshold PTSD
- are competent to consent to research
Exclusion Criteria:
- Veteran participants do not have levels of other types of psychopathology that would prevent successful participation in the intervention
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PEET
Peer support interventions as an adjunct to prolonged exposure
|
Peer support interventions as adjunct to prolonged exposure
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PE Sessions Attended
Time Frame: 10 weeks
|
Number of PE Sessions attended during 10 weeks of participation in study.
10 is the maximum, 0 is the minimum.
Higher numbers of sessions attended are an indication of better engagement in treatment.
|
10 weeks
|
|
Posttraumatic Stress Disorder (PTSD) Checklist-5
Time Frame: 10 weeks
|
Self-report measure of PTSD symptoms; score range is 0-80, with higher scores indicating more PTSD symptoms.
|
10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jeanette I. Harris, PhD, Minneapolis VA Health Care System, Minneapolis, MN
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 16, 2016
Primary Completion (Actual)
June 16, 2018
Study Completion (Actual)
October 30, 2018
Study Registration Dates
First Submitted
June 27, 2016
First Submitted That Met QC Criteria
June 27, 2016
First Posted (Estimate)
June 29, 2016
Study Record Updates
Last Update Posted (Actual)
July 2, 2019
Last Update Submitted That Met QC Criteria
June 25, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- D2188-P
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.