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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorU.S. Army Medical Research and Development Command

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

950 Participants
are divided into 4 treatment groups
Group A: Cohort 11 intervention
Group B: Cohort 21 intervention
Group C: Cohort 32 interventions
Group D: Cohort 42 interventions

Trial outcomes

Primary outcomes

1

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)

Time frame
7 days (+/- 2) between measurements
2

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)

Time frame
7 days (+/- 2) between measurements
3

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

Time frame
Up to 39 days from the eligibility screen for Cohorts 1-4
4

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)

Time frame
Up to 6 weeks for Group 1-B

Secondary outcomes

1

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)

Time frame
7 days (+/- 2) between measurements

Other outcomes

Sponsors and contacts

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