Actively Recruiting
Psychometric Evaluation of the CAPS-5 and PSSI-5 for PTSD in Active Duty Military and Veterans
Led by U.S. Army Medical Research and Development Command · Updated on 2025-01-23
950
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the reliability and validity of two new PTSD assessment tools, the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) and the PTSD Symptom Scale Interview for DSM-5 (PSSI-5), in active duty military personnel and veterans aged 18 or older who have experienced traumatic events. The study also compares these new tools to the previous standard, the CAPS-IV, while exploring biomarkers related to PTSD such as biofluid markers, cognitive and physiological indicators, and brain activity measured by EEG. This research aims to improve diagnosis and treatment approaches for PTSD in this population. Participants are randomly assigned to one of four cohorts. Cohorts 1 and 2 focus on test-retest reliability of CAPS-5 and PSSI-5 respectively, with participants completing between two and seven visits; some continue with additional visits including cognitive, behavioral assessments, and biofluid sample collection. Cohort 3 compares CAPS-5 and PSSI-5 through three visits, while Cohort 4 compares CAPS-IV and CAPS-5 over three visits, including similar assessments and sample collections. The study uses multiple visits and assessments to thoroughly evaluate the consistency and validity of these diagnostic tools. During the study, participants undergo multiple office visits where they complete PTSD assessments, cognitive and behavioral tests, and provide biofluid samples. Researchers measure test-retest reliability over intervals of about one week and six weeks, and correlations among the different PTSD assessments. Safety and mental health status are monitored throughout. The total involvement may range from two to seven visits depending on cohort and group assignment. The study collects detailed data to better understand PTSD diagnosis and related biomarkers in veterans and active duty military members.
CONDITIONS
Brief Title
An Evaluation of Two PTSD Assessments in an Active Duty and Military Veteran Sample
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female active duty personnel or military veterans, 18 years of age or older
- Competent to give informed consent
- Have experienced any Criterion A qualifying traumatic event as defined by the Life Events Checklist for DSM-5 (LEC-5)
- Score a 3 or above on the Primary Care-Post Traumatic Stress Disorder Screen (PC-PTSD-5)
You will not qualify if you...
- Current suicidal or homicidal ideation with a plan
- Substance use disorder requiring detoxification currently or in the past month
- Assessment using CAPS or PSSI in the previous 1 year
- Currently receiving psychotherapy or counseling for PTSD
- Moderate to severe cognitive impairment as measured by the Montreal Cognitive Assessment (MoCA)
- Meet criteria for unmedicated Bipolar I, Bipolar II, Schizophrenia, or other psychotic disorders in the last month
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 39 days from the eligibility screen
Participants complete diagnostic assessments including CAPS-5, PSSI-5, or CAPS-IV depending on cohort assignment, along with other cognitive and behavioral measures and biofluid sample collection.
Between 2 and 7 visits depending on cohort and group assignment
Duration - Up to 6 weeks
Participants in some groups undergo repeated diagnostic assessments with CAPS-5 or PSSI-5 over up to 6 weeks to evaluate test-retest reliability and stability of symptom scores.
Up to 5 additional visits after initial assessments
Trial Site Locations
Total: 3 locations
1
Tripler Army Medical Center
Honolulu, Hawaii, United States, 96859
Actively Recruiting
2
Cincinnati VA Medical Center - Trauma Recovery Center
Fort Thomas, Kentucky, United States, 41075
Actively Recruiting
3
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20814
Actively Recruiting
Research Team
S
Savannah Noppert
D
Derrell Anderson, MS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here