Viewing Study NCT00699660


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Study NCT ID: NCT00699660
Status: COMPLETED
Last Update Posted: 2018-08-16
First Post: 2008-06-12
Is NOT Gene Therapy: False
Has Adverse Events: True

Brief Title: Enhancing Equitable and Effective (E-3) Post Traumatic Stress Disorder (PTSD) Disability Assessment
Sponsor: VA Office of Research and Development
Organization:

Study Overview

Official Title: Enhancing Equitable and Effective PTSD Disability Assessment
Status: COMPLETED
Status Verified Date: 2018-07
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: E-3PTSD
Brief Summary: This project evaluated the impact of semi-structured, standardized interviews on the initial PTSD C\&P on the examination.
Detailed Description: Our objective is to compare the process and outcomes of C\&P exams for PTSD conducted with CAPS and WHODAS-II interviews versus the PTSD exams conducted without the CAPS and WHODAS-II interviews. This project will conduct a randomized controlled trial on 688 veterans to evaluate the effects of the CAPS/WHODAS instruments on the initial PTSD C\&P examination process. Study outcomes include variation in assessing the DSM-IV components of PTSD, diagnostic accuracy, veteran perception of the exam process, VBA rater utility and resource utilization. This project will 1) demonstrate the feasibility of conducting program evaluation and intervention studies on the PTSD C\&P examination process, 2) develop research tools, instruments and methods for C\&P evaluation, 3) provide data on the value-added contribution of CAPS and WHODAS-II to the PTSD assessment process and examination report, and 4) inform the business case of utilizing the CAPS and WHODAS-II in the PTSD C\&P process. The ultimate aim is to improve the reproducibility, consistency and validity of the PTSD examination process while maintaining a level of efficiency and cost restraint that provides veterans with an exam process that is fair, accurate and equitable across VHA.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: