Ignite Creation Date:
2024-05-06 @ 2:01 PM
Last Modification Date:
2024-10-26 @ 1:23 PM
Study NCT ID:
NCT04180930
Status:
RECRUITING
Last Update Posted:
2023-05-18
First Post:
2019-06-25
Brief Title:
An Evaluation of Two PTSD Assessments in an Active Duty and Military Veteran Sample
Sponsor:
US Army Medical Research and Development Command
Organization:
US Army Medical Research and Development Command
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None