Original Query: ALL
Previous Study | Return to List | Next Study

Enhancing Equitable and Effective (E-3) Post Traumatic Stress Disorder (PTSD) Disability Assessment (E-3PTSD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00699660
Recruitment Status : Completed
First Posted : June 18, 2008
Results First Posted : October 16, 2014
Last Update Posted : April 28, 2015
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
This project evaluated the impact of semi-structured, standardized interviews on the initial PTSD C&P on the examination.

Condition or disease Intervention/treatment
Post-Traumatic Stress Disorder Behavioral: CAPS/WHODAS Behavioral: Nonstructured Interview

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 406 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Enhancing Equitable and Effective PTSD Disability Assessment
Study Start Date : May 2009
Primary Completion Date : September 2010
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: CAPS/WHODAS
PTSD assessed using Clinical Assessment of PTSD Symptoms (CAPS) and WHODAS functional impairment structured evidence-based interview
Behavioral: CAPS/WHODAS
CAPS/WHODAS structured clinical PTSD interview
Active Comparator: Nonstructured Interview
Usual clinical interview to assess PTSD, without CAPS or WHODAS
Behavioral: Nonstructured Interview
Usual PTSD clinical PTSD interview, not CAPS or SCID
Other Name: Usual Clinical Interview

Primary Outcome Measures :
  1. Completeness and Quality of PTSD Interview [ Time Frame: Post-exam, same day ]
    total completeness of diagnostic assessment score, range from 0 to 100% and completeness of functional assessment

Secondary Outcome Measures :
  1. PTSD Diagnosis [ Time Frame: post-exam, same day ]
    Number of participants who were unable to receive a conclusive clinician PTSD diagnosis for positive or negative PTSD symptoms(unable to determine accuracy of clinician diagnosis).

  2. PTSD Diagnosis [ Time Frame: Post-exam, same day ]
    Number of participants who were unable to receive a conclusive clinician PTSD diagnosis for positive or negative PTSD symptoms (unable to determine clinician diagnosis).

  3. Patient Satisfaction [ Time Frame: post-exam, same day ]
    Mean score on satisfaction survey rating scale from 1 to 5 (higher)

  4. Resource Utilization [ Time Frame: same day ]
    time spent administering the exam

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Veterans referred to VHA for an Initial PTSD Compensation and Pension Examination
  2. Informed consent

Exclusion Criteria:

  1. Mentally impaired, not able to give informed consent
  2. English speaking

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00699660

United States, Arkansas
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
No. Little Rock, Arkansas, United States, 72114-1706
United States, California
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1290
United States, Connecticut
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, United States, 06516
United States, Louisiana
Southeast Louisiana Veterans Health Care System, New Orleans, LA
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130
United States, Michigan
John D. Dingell VA Medical Center, Detroit, MI
Detroit, Michigan, United States, 48201
United States, Minnesota
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States, 55417
United States, New Mexico
New Mexico VA Health Care System, Albuquerque, NM
Albuquerque, New Mexico, United States, 87108-5153
United States, Tennessee
Memphis VA Medical Center, Memphis, TN
Memphis, Tennessee, United States, 38104
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, United States, 37212-2637
United States, Wisconsin
Clement J. Zablocki VA Medical Center, Milwaukee, WI
Milwaukee, Wisconsin, United States, 53295-1000
Sponsors and Collaborators
VA Office of Research and Development
Principal Investigator: Theodore Speroff, PhD Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Publications of Results:
Marx BP, Jackson JC, Schnuff PP, Murdoch M, Sayer NA, Keane TM, Friedman MJ, Greevy RA, Owen RR, Sinnott PL, Speroff T. The reality of malingered PTSD among Veterans: Reply to McNally and Frueh. Journal of traumatic stress. 2012 Aug 1; 25(4):457-60.

Responsible Party: VA Office of Research and Development Identifier: NCT00699660     History of Changes
Other Study ID Numbers: SDR 06-331
First Posted: June 18, 2008    Key Record Dates
Results First Posted: October 16, 2014
Last Update Posted: April 28, 2015
Last Verified: September 2014

Keywords provided by VA Office of Research and Development:
Disability Examination
Clinician Administered PTSD Scale
Quality of Care

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders