Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID04180930

Evaluation of Two PTSD Assessments, CAPS-5 and PSSI-5, Compared to CAPS-IV 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

324 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the reliability and validity of two new assessments for post-traumatic stress disorder (PTSD) called the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) and the PTSD Symptom Scale Interview for DSM-5 (PSSI-5). They are comparing these new tools to the previous standard, the Clinician Administered PTSD Scale for DSM-IV (CAPS-IV), in a study involving 950 active duty military personnel and veterans who have experienced traumatic events. The study also explores potential PTSD-related biomarkers, including biofluid, cognitive, physiological markers, and neural activity measured by EEG, to better understand and target treatments for PTSD. Participants will be randomly assigned to one of four study groups to test different aspects of the assessments. Groups 1 and 2 focus on test-retest reliability and response consistency over 12 weeks for CAPS-5 and PSSI-5. Group 3 tests the convergent validity of CAPS-5 against PSSI-5, and Group 4 compares CAPS-5 with CAPS-IV. The study uses these diagnostic interviews conducted at various times over up to 12 weeks to measure reliability and validity. During the study, participants will undergo interviews using the CAPS-5, PSSI-5, and CAPS-IV tools, with repeated assessments to check consistency and reliability. Researchers will collect data on PTSD symptoms and related biomarkers, and participants will complete screening for traumatic event exposure and PTSD symptoms. Outcomes measured include test-retest reliability scores, correlation of assessment results, and stability of symptom scores over time. The study aims to improve PTSD diagnosis and support future treatment development for military and veteran populations.

CONDITIONS

Official Title

An Evaluation of Two PTSD Assessments in an Active Duty and Military Veteran Sample

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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)
Not Eligible

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

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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

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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

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