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| Sponsored by: |
Department of Veterans Affairs |
| Information provided by: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00699660 |
Purpose
This project will evaluate variations of the inital PTSD C&P interview on the examination process..
| Condition | Intervention |
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Post Traumatic Stress Disorder |
Behavioral: Clinician Assessment of PTSD Symptoms (CAPS) Behavioral: Nonstructured Interview |
| MedlinePlus related topics: | Post-Traumatic Stress Disorder Stress |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Enhancing Equitable and Effective PTSD Disability Assessment |
| Estimated Enrollment: | 644 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | August 2009 |
| Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Experimental
PTSD interview using CAPS and WHODAS
|
Behavioral: Clinician Assessment of PTSD Symptoms (CAPS)
CAPS/WHODAS structured clinical PTSD interview
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2: Active Comparator
Usual PTSD interview, without CAPS or WHODAS
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Behavioral: Nonstructured Interview
Usual PTSD clinical PTSD interview, not CAPS or SCID
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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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Theodore Speroff, PhD MS PhD | (615) 340-2357 | ted.speroff@va.gov |
| Contact: Heather J Davis-Underwood, MPH MBA BA | (615) 340-2354 | heather.davis-underwood@va.gov |
| United States, Arkansas | |||||
| Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock | Not yet recruiting | ||||
| No. Little Rock, Arkansas, United States, 72114-1706 | |||||
| Contact: Richard R Owen, MD 501-257-1710 owenrichardr@uams.edu | |||||
| Contact: Jeffrey L Smith, BS (501) 257-1066 jeffrey.smith6@med.va.gov | |||||
| Sub-Investigator: Richard R. Owen, MD | |||||
| Sub-Investigator: Jeffrey L. Smith, BS | |||||
| United States, Connecticut | |||||
| VA Connecticut Health Care System (West Haven) | Not yet recruiting | ||||
| West Haven, Connecticut, United States, 06516 | |||||
| Contact: Marc Rosen, MD 203-932-5711 ext 2112 marc.rosen@va.gov | |||||
| United States, Louisiana | |||||
| Southeast Veterans Healthcare System, New Orleans | Not yet recruiting | ||||
| New Orleans, Louisiana, United States, 70112 | |||||
| Contact: Madeline Uddo, PhD 504-571-8107 madeline./uddo@va.gov | |||||
| United States, Massachusetts | |||||
| VA Medical Center | Not yet recruiting | ||||
| Boston, Massachusetts, United States, 02130 | |||||
| Contact: Brian P Marx, PhD (857) 364-6071 brian.marx@va.gov | |||||
| Contact: Terence M Keane, PhD (857) 364-4551 terry.keane@va.gov | |||||
| Sub-Investigator: Brian Paul Marx, PhD | |||||
| United States, Michigan | |||||
| John D. Dingell VA Medical Center, Detroit | Not yet recruiting | ||||
| Detroit, Michigan, United States, 48201 | |||||
| Contact: Lad J Vidergar, PhD 313-576-1000 lad.vidergar@va.gov | |||||
| United States, Minnesota | |||||
| VA Medical Center | Not yet recruiting | ||||
| Minneapolis, Minnesota, United States, 55417 | |||||
| Contact: Maureen Murdoch, MD MPH 612-467-2688 maureen.murdoch@med.va.gov | |||||
| Contact: Nina A Sayer, PhD (612) 467-4623 nina.sayer@med.va.gov | |||||
| Sub-Investigator: Nina A. Sayer, PhD | |||||
| Sub-Investigator: Maureen Murdoch, MD MPH | |||||
| United States, New Mexico | |||||
| New Mexico VA Health Care System, Albuquerque | Not yet recruiting | ||||
| Albuquerque, New Mexico, United States, 87108-5153 | |||||
| Contact: Janet CdeBaca, PhD 505-265-1711 ext 5856 janet.cdebaca@va.gov | |||||
| United States, Tennessee | |||||
| VA Medical Center | Not yet recruiting | ||||
| Nashville, Tennessee, United States, 37212-2637 | |||||
| Contact: Theodore Speroff, PhD MS PhD (615) 340-2357 ted.speroff@va.gov | |||||
| Principal Investigator: Theodore Speroff, PhD MS PhD | |||||
| Sub-Investigator: Steven Holloway Brown, AB MD MS | |||||
| Sub-Investigator: James C Jackson, PSYD MA BA | |||||
| Sub-Investigator: Elliot Fielstein, BA PhD | |||||
| VA Medical Center, Memphis | Not yet recruiting | ||||
| Memphis, Tennessee, United States, 38104 | |||||
| Contact: Karin Thompson, PhD 901-523-8990 ext 5762 karin.thompson@va.gov | |||||
| United States, Texas | |||||
| VA South Texas Health Care System, San Antonio | Not yet recruiting | ||||
| San Antonio, Texas, United States, 78229 | |||||
| Contact: Twila J Thompson, PhD 210-617-5300 twila.thompson@va.gov | |||||
| Michael E. DeBakey VA Medical Center (152) | Not yet recruiting | ||||
| Houston, Texas, United States, 77030 | |||||
| Contact: Thomas Anderson, PhD 713-141-1414 ext 6741 thomas.anderson@va.gov | |||||
| United States, Wisconsin | |||||
| Zablocki VA Medical Center, Milwaukee | Not yet recruiting | ||||
| Milwaukee, Wisconsin, United States, 53295-1000 | |||||
| Contact: Michelle Cornette, PhD 414-384-2000 ext 46229 michelle.cornette@va.gov | |||||
| Principal Investigator: | Theodore Speroff, PhD MS PhD | Department of Veterans Affairs |
More Information
| Responsible Party: | Department of Veterans Affairs ( Speroff, Theodore - Principal Investigator ) |
| Study ID Numbers: | SDR 06-331 |
| First Received: | June 12, 2008 |
| Last Updated: | June 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00699660 |
| Health Authority: | United States: Federal Government |
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