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

May 16, 2023 updated by: U.S. Army Medical Research and Development Command

Psychometric Evaluation of the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) and the PTSD Symptom Scale Interview for DSM-5 (PSSI-5) in an Active Duty and Military Veteran Sample

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

950

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Hawaii
    • Kentucky
      • Fort Thomas, Kentucky, United States, 41075
        • Recruiting
        • Cincinnati VA Medical Center - Trauma Recovery Center
        • Principal Investigator:
          • Kathleen M Chard, PhD
        • Contact:
        • Contact:
          • Savannah Noppert
          • Phone Number: 313309 513-861-3100
    • Maryland
      • Bethesda, Maryland, United States, 20814
        • Recruiting
        • Walter Reed National Military Medical Center
        • Principal Investigator:
          • Treven C Pickett, PsyD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Active duty military personnel and veterans who satisfy the enrollment criteria. Study participants will be active duty personnel or veterans with PTSD symptoms, who may or may not meet diagnostic criteria for PTSD, recruit from up to two military treatment facilities (MTFs) and one VA facility.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Diagnostic test: CAPS-5
Clinician Administered PTSD Scale for DMS-5
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.
Diagnostic test: PSSI-5
PTSD Symptom Scale Interview for DSM-5
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.
Diagnostic test: CAPS-5
Clinician Administered PTSD Scale for DMS-5
Diagnostic test: PSSI-5
PTSD Symptom Scale Interview for DSM-5
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.
Diagnostic test: CAPS-5
Clinician Administered PTSD Scale for DMS-5
Diagnostic test: CAPS-IV
Clinician Administered PTSD Scale for DSM-IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test-Retest reliability of Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Total Score
Time Frame: 7 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)
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
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)
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
Correlation coefficient among the totals scores for 3 different PTSD symptom scales
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
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)
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
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)
Up to 6 weeks for Group 2-B

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance rate between diagnostic tests
Time Frame: 7 days (+/- 2) between measurements
To determine the concordance rate between diagnosis of PTSD using the CAPS-IV and CAPS-5, and the CAPS-5 and PSSI-5. The severity of diagnosed PTSD is determined by the total score. (minimum score of 0 = absent to a maximum score of 80 = extreme)
7 days (+/- 2) between measurements

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

U.S. Army Medical Research and Development Command

Investigators

  • Principal Investigator: Kathleen M Chard, PhD, Cincinnati VA Medical Center, University of Cincinnati
  • Principal Investigator: Brian Marx, PhD, National Center for PTSD at VA Boston Healthcare System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2019

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

June 25, 2019

First Submitted That Met QC Criteria

November 25, 2019

First Posted (Actual)

November 29, 2019

Study Record Updates

Last Update Posted (Actual)

May 18, 2023

Last Update Submitted That Met QC Criteria

May 16, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-7745

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Final data sets resulting from this study will be shared outside the study team in de-identified format only. Data will be shared with study collaborators from the following institutions: VA Boston healthcare System, Stanford University, Palo Alto VA Health Care System, Auburn University, and the University of Pennsylvania. Research proposals from other institutions will be reviewed by a group of experienced scientists who will judge each request for its scientific merit, its potential contribution to the understanding of the disease, and for the qualifications of the research team. All data will be identified by a code number.

IPD Sharing Time Frame

Starting in March 2020

IPD Sharing Access Criteria

De-identified, anonymized databases will be shared electronically through the VA network and secure messaging. Only de-identified data will be made available outside the VA. The optional biofluid collection for future exploratory research will only be made available to investigators in a de-identified format with the permission of the sponsor, proper protocol approval, and human participants' protection in place.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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