RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2019-04-15
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04180930

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female active duty personnel or military veterans, 18 years of age or older
  2. * Competent to give informed consent
  3. * Have experienced any Criterion A qualifying traumatic event as defined by the Life Events Checklist for DSM-5 (LEC-5)
  4. * Score a 3 or above on the Primary Care-Post Traumatic Stress Disorder Screen (PC-PTSD-5)
  1. * 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)
  2. * Assessment using CAPS or PSSI in the previous 1 year
  3. * Currently receiving psychotherapy or counseling for PTSD
  4. * Moderate to sever cognitive impairment as measured by the Montreal Cognitive Assessment (MoCA)
  5. * Meet criteria for unmedicated Bipolar I, Bipolar II, Schizophrenia, or other psychotic disorders in the last month

Contacts and Locations

Study Contact

Savannah Noppert
CONTACT
513-861-3100
savannah.noppert@va.gov
Derrell Anderson, MS
CONTACT
513-861-3100
derrell.anderson@va.gov

Principal Investigator

Kathleen M Chard, PhD
PRINCIPAL_INVESTIGATOR
Cincinnati VA Medical Center, University of Cincinnati
Brian Marx, PhD
PRINCIPAL_INVESTIGATOR
National Center for PTSD at VA Boston Healthcare System

Study Locations (Sites)

Tripler Army Medical Center
Honolulu, Hawaii, 96859
United States
Cincinnati VA Medical Center - Trauma Recovery Center
Fort Thomas, Kentucky, 41075
United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20814
United States

Collaborators and Investigators

Sponsor: U.S. Army Medical Research and Development Command

  • Kathleen M Chard, PhD, PRINCIPAL_INVESTIGATOR, Cincinnati VA Medical Center, University of Cincinnati
  • Brian Marx, PhD, PRINCIPAL_INVESTIGATOR, National Center for PTSD at VA Boston Healthcare System

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-04-15
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2019-04-15
Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

  • Assessment
  • Post-Traumatic Stress Disorder
  • PTSD
  • Veterans
  • Military

Additional Relevant MeSH Terms

  • Stress Disorders, Post-Traumatic