About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial 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.
Trial design
Other
Prospective
Treatments tested in this trial
CAPS-5
Diagnostic testClinician Administered PTSD Scale for DMS-5
PSSI-5
Diagnostic testPTSD Symptom Scale Interview for DSM-5
CAPS-IV
Diagnostic testClinician Administered PTSD Scale for DSM-IV
Treatment groups
Trial outcomes
Primary outcomes
Test-Retest reliability of Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Total Score
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 Score
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)
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 weeks
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)
Secondary outcomes
Concordance rate between diagnostic tests
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)
Sponsors and contacts
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