Recruiting

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

Sponsor:

U.S. Army Medical Research and Development Command

Code:

NCT04180930

Conditions

Stress Disorders, Post-Traumatic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

CAPS-5

PSSI-5

CAPS-IV

Study Details

Brief 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.

Conditions

Stress Disorders, Post-Traumatic

Study ID

NCT04180930

Start date

Apr 15, 2019

Status verified date

Jan, 2025

Completion date

Jun 30, 2025

Anticipated

Primary completion date

Jun 30, 2025

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 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)

Exclusion Criteria:

Current suicidal or homicidal ideation with a plan, and substance use disorder requiring detoxification currently or in the past month as assessed using the SCID and 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 Cognitive Assessment (MoCA)
Meet criteria for unmedicated Bipolar I, Bipolar II, Schizophrenia, or other psychotic disorders in the last month

Study Design

Enrollment

950 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort 1

Individuals randomized to Cohort 1 will be assigned to the CAPS-5 and will complete between two and seven research visits. Participants will be administered the CAPS-5 during visit 2, and then will be randomized a second time into groups 1-A and 1-B. Group 1-A will end participation after visit 2. Group 1-B will complete visits 3-7 and will be administered the CAPS-5 at each of these visits along with other measures of cognitive and behavioral functioning, and will provide biofluid samples.

Cohort 2

Individuals randomized to Cohort 2 will be assigned to the PSSI-5 and will complete between two and seven research visits. Participants will be administered the PSSI-5 during visit 2, and then will be randomized a second time into groups 2-A and 2-B. Group 2-A will end participation after visit 2. Group 2-B will complete visits 3-7 and will be administered the PSSI-5 at each of these visits along with other measures of cognitive and behavioral functioning, and will provide biofluid samples.

Cohort 3

Individuals randomized to Cohort 3 will have three office visits and will complete the CAPS-5 and the PSSI-5 in a counter-balanced order during visits 2 and 3, along with other measures of cognitive and behavioral functioning, and will provide biofluid samples.

Cohort 4

Individuals randomized to Cohort 4 will have three office visits and will complete the CAPS-IV and the CAPS-5 in a counter-balanced order during visits 2 and 3, along with other measures of cognitive and behavioral functioning, and will provide biofluid samples.

Interventions

CAPS-5

Clinician Administered PTSD Scale for DMS-5

PSSI-5

PTSD Symptom Scale Interview for DSM-5

CAPS-IV

Clinician Administered PTSD Scale for DSM-IV

Primary outcome measure

Test-Retest reliability of Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Total Score [ Time Frame: 7 days (+/- 2) between measurements ]
Test-retest reliability of PTSD Symptom Scale - Interview for DSM-5 (PSSI-5) Total Score [ Time Frame: 7 days (+/- 2) between measurements ]
Correlation among the total scores of the CAPS-5, PSSI-5, and Clinician Administered PTSD Scale for DSM-IV (CAPS-IV) [ Time Frame: Up to 39 days from the eligibility screen for Cohorts 1-4 ]
Stability of the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) item-level scores over 6 weeks [ Time Frame: Up to 6 weeks for Group 1-B ]
Stability of PTSD Symptom Scale - Interview for DSM-5 (PSSI-5) item-level scores over 6 weeks [ Time Frame: Up to 6 weeks for Group 2-B ]

Central Contacts and Locations

Central contacts

Savannah Noppert

513-861-3100 savannah.noppert@va.gov

Derrell Anderson, MS

513-861-3100 derrell.anderson@va.gov

Locations

Tripler Army Medical Center

Recruiting

Honolulu, Hawaii, United States, 96859

Contacts

Catherine Uyehara, PhD

808-433-7163 catherine.yamauchi2.civ@health.mil

Monique Weisman, LSW

808-433-5067 monique.s.weisman.ctr@health.mil

Cincinnati VA Medical Center - Trauma Recovery Center

Recruiting

Fort Thomas, Kentucky, United States, 41075

Contacts

Savannah Noppert, MS

513-861-3100 savnnah.noppert@va.gov

Derrell Anderson

513-861-3100 derrell.anderson@va.gov

Principal Investigator:

Kathleen M Chard, PhD

Walter Reed National Military Medical Center

Recruiting

Bethesda, Maryland, United States, 20814

Contacts

Nathalie Jimenez

202-377-9687 nathalie.t.jimenez.ctr@health.mil

Principal Investigator:

Treven C Pickett, PsyD

More Information

Sponsor

U.S. Army Medical Research and Development Command

Last update posted

Jan 23, 2025

Last verified

Jan, 2025

Keywords

Assessment
Post-Traumatic Stress Disorder
PTSD
Veterans
Military

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by U.S. Army Medical Research and Development Command on 2025-01-23.