Evaluating PTSD Assessments in Military Personnel and Veterans

This study is evaluating two new tools for diagnosing Post-Traumatic Stress Disorder (PTSD): the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) and the PTSD Symptom Scale Interview for DSM-5 (PSSI-5). Researchers want to see how reliable these new tools are and how they compare to an older, widely used tool called the Clinician Administered PTSD Scale for DSM-IV (CAPS-IV). You may be able to join if you are an active duty service member or military veteran, 18 years or older, have experienced a traumatic event, and screen positive for PTSD. The study aims to understand the best ways to assess PTSD, which could lead to better care for military personnel and veterans. The current recruitment status is unclear.

Study design
This is an observational study involving 950 participants who will be randomly assigned to one of four groups.
What's involved
Participants will have assessments to test the reliability of the CAPS-5 and PSSI-5 over 7 days, and comparisons between the different PTSD scales will occur over up to 39 days. Some participants will also have their responses tracked over 12 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 39 days for some comparisons, and for 12 weeks for consistency of response on certain assessments.

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NCT04180930

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

Recruiting
Not specifiedAges 18+Observational
U.S. Army Medical Research and Development Command
~950 participants
Updated 2025-01-23 on ClinicalTrials.gov
What's tested:CAPS-5PSSI-5CAPS-IV

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Test-Retest reliability of Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Total Score
Measured over 7 days (+/- 2) between measurements
+4 more outcomes measured
Stress Disorders, Post-Traumatic
3 sites across 3 states
Hawaii1
Kentucky1
Maryland1
  • Kathleen M Chard, PhD · PRINCIPAL_INVESTIGATOR · Cincinnati VA Medical Center, University of Cincinnati
  • Brian Marx, PhD · PRINCIPAL_INVESTIGATOR · National Center for PTSD at VA Boston Healthcare System

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Eligibility criteria

Inclusion

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

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
  • Test-Retest reliability of Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Total Score7 days (+/- 2) between measurements

    Concordance of the Clinician Administered PTSD Scale Total Score of at 2 visits. The severity of diagnosed PTSD is determined by the total score. (minimum score of 0 = absent to a maximum score of 80 = extreme)

  • Test-retest reliability of PTSD Symptom Scale - Interview for DSM-5 (PSSI-5) Total Score7 days (+/- 2) between measurements

    To determine the test-retest reliability of Posttraumatic Stress Disorder Symptom Scale Interview-5 within Visits 2-3 for Groups 1-B and 2-B. The severity of diagnosed PTSD is determined by the total score. (minimum score of 0 = absent to a maximum score of 80 = extreme)

  • Correlation among the total scores of the CAPS-5, PSSI-5, and Clinician Administered PTSD Scale for DSM-IV (CAPS-IV)Up to 39 days from the eligibility screen for Cohorts 1-4

    Correlation coefficient among the totals scores for 3 different PTSD symptom scales

  • Stability of the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) item-level scores over 6 weeksUp to 6 weeks for Group 1-B

    Change in the DSM-5 Clinician Administered PTSD Scale item-level scores over 6 weeks. The severity of diagnosed PTSD is determined by the total score. (minimum score of 0 = absent to a maximum score of 80 = extreme)

  • Stability of PTSD Symptom Scale - Interview for DSM-5 (PSSI-5) item-level scores over 6 weeksUp to 6 weeks for Group 2-B

    Change in PTSD Symptom Scale for DSM-5 Posttraumatic Stress Disorder Symptom Scale Interview item-level scores over 6 weeks. The severity of diagnosed PTSD is determined by the total score. (minimum score of 0 = absent to a maximum score of 80 = extreme)