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NCT Number: NCT04180930

An Evaluation of Two PTSD Assessments 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.

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Key information

Conditions

Stress Disorders, Post-Traumatic Mental Disorders Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tripler Army Medical Center, Honolulu, Hawaii, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CAPS-5

Diagnostic Test

Clinician Administered PTSD Scale for DMS-5

PSSI-5

Diagnostic Test

PTSD Symptom Scale Interview for DSM-5

CAPS-IV

Diagnostic Test

Clinician Administered PTSD Scale for DSM-IV

Primary outcomes

  1. 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)

  2. 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)

  3. 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

  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)

  5. 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)

Secondary outcomes

  1. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Derrell Anderson, MS

CONTACT

[email protected]

513-861-3100 ext. 313309

Savannah Noppert

CONTACT

[email protected]

513-861-3100 ext. 313262

Sponsors and collaborators

Lead sponsor

U.S. Army Medical Research and Development Command

Fed

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Nov 29, 2019
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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