An Evaluation of Two PTSD Assessments in an Active Duty and Military Veteran Sample
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CAPS-5, PSSI-5, CAPS-IV.
- Who it may be relevant to
- Registry conditions: Stress Disorders, Post-Traumatic. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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.
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.
Interventions
- Diagnostic test CAPS-5
Clinician Administered PTSD Scale for DMS-5 - Diagnostic test PSSI-5
PTSD Symptom Scale Interview for DSM-5 - Diagnostic test CAPS-IV
Clinician Administered PTSD Scale for DSM-IV
Primary outcome measures
- 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]
Secondary outcome measures (1)
- Concordance rate between diagnostic tests [Time frame: 7 days (+/- 2) between measurements]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
United States · 3 centers
- Tripler Army Medical Center — Honolulu
- Cincinnati VA Medical Center - Trauma Recovery Center — Fort Thomas
- Walter Reed National Military Medical Center — Bethesda
Identifiers
NCT: NCT04180930 · 2017-7745