Clinical trial NCT04180930: An Evaluation of Two PTSD Assessments in an Active Duty and Military Veteran Sample
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stress Disorders, Post-Traumatic
Keywords: Assessment
Post-Traumatic Stress Disorder
PTSD
Veterans
Military
Lead sponsor: U.S. Army Medical Research and Development Command
Sponsor class: FED
First posted: 2019-11-29
Enrollment: 950
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

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

Primary outcomes:
measure: Test-Retest reliability of Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Total Score
timeFrame: 7 days (+/- 2) between measurements
measure: Test-retest reliability of PTSD Symptom Scale - Interview for DSM-5 (PSSI-5) Total Score
timeFrame: 7 days (+/- 2) between measurements
measure: Correlation among the total scores of the CAPS-5, PSSI-5, and Clinician Administered PTSD Scale for DSM-IV (CAPS-IV)
timeFrame: Up to 39 days from the eligibility screen for Cohorts 1-4
measure: Stability of the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) item-level scores over 6 weeks
timeFrame: Up to 6 weeks for Group 1-B
measure: Stability of PTSD Symptom Scale - Interview for DSM-5 (PSSI-5) item-level scores over 6 weeks
timeFrame: Up to 6 weeks for Group 2-B
Secondary outcomes:
measure: Concordance rate between diagnostic tests
timeFrame: 7 days (+/- 2) between measurements
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Tripler Army Medical Center
state: Hawaii
city: Fort Thomas
country: United States
facility: Cincinnati VA Medical Center - Trauma Recovery Center
state: Kentucky
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
Study officials:
affiliation: Cincinnati VA Medical Center, University of Cincinnati
name: Kathleen M Chard, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Center for PTSD at VA Boston Healthcare System
name: Brian Marx, PhD
role: PRINCIPAL_INVESTIGATOR
References: