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

Sponsor:	Department of Veterans Affairs
Information provided by (Responsible Party):	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00699660

Purpose

This project will evaluate variations of the initial PTSD C&P interview on the examination process..

Condition	Intervention
Post-Traumatic Stress Disorder	Behavioral: Clinician Assessment of PTSD Symptoms (CAPS) Behavioral: Nonstructured Interview

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Enhancing Equitable and Effective PTSD Disability Assessment

Resource links provided by NLM:

MedlinePlus related topics: Post-Traumatic Stress Disorder

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

completeness and quality of PTSD interview [ Time Frame: Post-exam, same day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

PTSD diagnosis [ Time Frame: post-exam, same day ] [ Designated as safety issue: No ]
PTSD diagnosis [ Time Frame: Post-exam, same day ] [ Designated as safety issue: No ]
Patient Satisfaction [ Time Frame: post-exam, same day ] [ Designated as safety issue: No ]
resource utilization [ Time Frame: same day ] [ Designated as safety issue: No ]

Estimated Enrollment:	370
Study Start Date:	May 2009
Estimated Study Completion Date:	September 2011
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 PTSD interview using CAPS and WHODAS	Behavioral: Clinician Assessment of PTSD Symptoms (CAPS) CAPS/WHODAS structured clinical PTSD interview
Active Comparator: 2 Usual PTSD interview, without CAPS or WHODAS	Behavioral: Nonstructured Interview Usual PTSD clinical PTSD interview, not CAPS or SCID

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Mentally impaired, not able to give informed consent
English speaking

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699660

Locations

United States, Arkansas
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
No. Little Rock, Arkansas, United States, 72114-1706
United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304-1290
United States, Connecticut
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, United States, 06516
United States, Louisiana
Southeast Veterans Healthcare System, New Orleans
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
VA Medical Center
Boston, Massachusetts, United States, 02130
United States, Michigan
John D. Dingell VA Medical Center, Detroit
Detroit, Michigan, United States, 48201
United States, Minnesota
VA Medical Center
Minneapolis, Minnesota, United States, 55417
United States, New Mexico
New Mexico VA Health Care System, Albuquerque
Albuquerque, New Mexico, United States, 87108-5153
United States, Tennessee
VA Medical Center, Memphis
Memphis, Tennessee, United States, 38104
VA Medical Center, Nashville
Nashville, Tennessee, United States, 37212-2637
United States, Wisconsin
Zablocki VA Medical Center, Milwaukee
Milwaukee, Wisconsin, United States, 53295-1000

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Principal Investigator:

Theodore Speroff, PhD

Department of Veterans Affairs

More Information

Publications:

Marx BP, Marshall PJ, Castro F. The moderating effects of stimulus valence and arousal on memory suppression. Emotion. 2008 Apr;8(2):199-207.

Sloan DM, Marx BP, Epstein EM, Dobbs JL. Expressive writing buffers against maladaptive rumination. Emotion. 2008 Apr;8(2):302-6.

Responsible Party:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00699660 History of Changes
Other Study ID Numbers:	SDR 06-331
Study First Received:	June 12, 2008
Last Updated:	September 16, 2011
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

Disability Examination
Clinician Administered PTSD Scale
Quality of Care

Additional relevant MeSH terms:

Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on February 09, 2012