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

Phase

N/A

Condition

Post-traumatic Stress Disorders

Treatment

PSSI-5

CAPS-5

CAPS-IV

Clinical Study ID

NCT04180930

2017-7745

Ages > 18
All Genders
Accepts Healthy Volunteers

Study Summary

Given the high prevalence of post-traumatic stress disorder (PTSD) in veterans and active duty military, the focus of this research study is to test the reliability of two new PTSD assessments, the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) and the PTSD Symptom Scale Interview for DSM-5 (PSSI-5) and compare the results between the two new assessments and the previous "gold standard", the Clinician Administered PTSD Scale for DSM-IV (CAPS-IV). Biomarkers believed to be related to PTSD (e.g., biofluid biomarkers, cognitive and physiological markers, and neural activity as measured by EEG) will be collected to inform targeted interventions in specific groups of patients and other large-scale biomarker discovery efforts in the field. Participants will be 950 male and female active duty military and veterans ages 18 or older who have been exposed to at least one traumatic event.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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 LifeEvents Checklist for DSM-5 (LEC-5)
Score a 3 or above on the Primary Care-Post Traumatic Stress Disorder Screen (PC-PTSD-5)

Exclusion

Exclusion Criteria:

Current suicidal or homicidal ideation with a plan, and substance use disorderrequiring detoxification currently or in the past month as assessed using the SCIDand Suicidal Ideation/Homicidal Ideation screening tool (SI/HI screen)
Assessment using CAPS or PSSI in the previous 1 year
Currently receiving psychotherapy or counseling for PTSD
Moderate to sever cognitive impairment as measured by the Montreal CognitiveAssessment (MoCA)
Meet criteria for unmedicated Bipolar I, Bipolar II, Schizophrenia, or otherpsychotic disorders in the last month

Study Design

PSSI-5

April 15, 2019

June 30, 2025

Study Description

This is a randomized, observational study where participants will be randomized into one of the four study cohorts. The primary goals of this study are to establish the test-retest reliability of the CAPS-5 and the PSSI-5 and to compare these with each other (Cohorts 1 and 2), to test the convergent validity of the CAPS-5 against the PSSI (Cohort 3) and against the CAPS-IV (Cohort 4), and finally to investigate the consistency of response over 12 weeks on CAPS-5 (Cohort 1) and on the PSSI-5 (Cohort 2). In addition, on an exploratory level, possible biomarkers of PTSD and their relationship to each other and to diagnosis of PTSD will be evaluated.

Participants will be 950 males and females recruited from the Cincinnati VA Medical Center (Cincinnati, OH), Trauma Recovery Center, and Tripler Army Medical Center (Honolulu, HI).

the investigators anticipate that understanding the validity and reliability of the PSSI-5 and the CAPS-5 and the biomarkers related to PTSD will provide necessary information for care provided to active duty military and veterans suffering from PTSD. It will also directly inform trial designs and increase the likelihood of technical and regulatory success for new treatments for PTSD.

Connect with a study center

Tripler Army Medical Center
Honolulu, Hawaii 96859
United States
Active - Recruiting
Cincinnati VA Medical Center - Trauma Recovery Center
Fort Thomas, Kentucky 41075
United States
Active - Recruiting
Walter Reed National Military Medical Center
Bethesda, Maryland 20814
United States
Active - Recruiting

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