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

Conditions

• Stress Disorders, Post-Traumatic

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• 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

Study Details

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.

Key Dates

Start date

Apr 15, 2019

Status verified

Jan 2025

Primary completion

Jun 30, 2025

Completion

Jun 30, 2025

Study Design

Enrollment

950 participants (estimated)

Arms

• Arm: Cohort 1
  Individuals randomized to Cohort 1 will be assigned to the CAPS-5 and will complete between two and seven research visits. Participants will be administered the CAPS-5 during visit 2, and then will be randomized a second time into groups 1-A and 1-B. Group 1-A will end participation after visit 2. Group 1-B will complete visits 3-7 and will be administered the CAPS-5 at each of these visits along with other measures of cognitive and behavioral functioning, and will provide biofluid samples.
• Arm: Cohort 2
  Individuals randomized to Cohort 2 will be assigned to the PSSI-5 and will complete between two and seven research visits. Participants will be administered the PSSI-5 during visit 2, and then will be randomized a second time into groups 2-A and 2-B. Group 2-A will end participation after visit 2. Group 2-B will complete visits 3-7 and will be administered the PSSI-5 at each of these visits along with other measures of cognitive and behavioral functioning, and will provide biofluid samples.
• Arm: Cohort 3
  Individuals randomized to Cohort 3 will have three office visits and will complete the CAPS-5 and the PSSI-5 in a counter-balanced order during visits 2 and 3, along with other measures of cognitive and behavioral functioning, and will provide biofluid samples.
• Arm: Cohort 4
  Individuals randomized to Cohort 4 will have three office visits and will complete the CAPS-IV and the CAPS-5 in a counter-balanced order during visits 2 and 3, along with other measures of cognitive and behavioral functioning, and will provide biofluid samples.

Primary Outcome Measure

Test-Retest reliability of Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Total Score [ Time Frame: 7 days (+/- 2) between measurements ]

Central Contacts

• Savannah Noppert
  513-861-3100
  [email protected]
• Derrell Anderson, MS
  513-861-3100
  [email protected]

Locations (3)

Find similar trials in Honolulu, HI

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