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Re-Engineering Systems for the Primary Care Treatment for PTSD (RESPECT-P)
This study is currently recruiting participants.
Verified by Department of Veterans Affairs, February 2009
First Received: September 6, 2006   Last Updated: February 18, 2009   History of Changes
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00373698
  Purpose

The study is an evaluation of a systemic intervention to enhance the delivery of care according to practice guidelines for posttraumatic stress disorder (PTSD). The immediate objectives are to (1) implement three component model (3CM) in VA primary care clinics; and (2) evaluate the effects of 3CM on clinician behavior and patient outcomes. The long-term objectives are to generate information to support implementation research on the RESPECT model for treating PTSD in primary care and ultimately, the implementation of the model in VHA to provide care to veterans with PTSD.


Condition Intervention Phase
Stress Disorders, Posttraumatic
Depression
Behavioral: Three Component Model of Collaborative Care
Behavioral: Usual Care
Phase III

MedlinePlus related topics: Choosing a Doctor or Health Care Service Depression Post-Traumatic Stress Disorder
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title: Reengineering Systems for the Primary Care Treatment of PTSD

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • PTSD Severity at 3 and 6 months [ Time Frame: 3 months and 6 months after initial assessment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Depression, functioning, types and amount of mental health treatment received, and cost of care at 3 and 6 months [ Time Frame: 3 months and 6 months after initial assessment ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: March 2008
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
Behavioral: Three Component Model of Collaborative Care
Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
2: No Intervention
Patients randomized to "Usual Care" will recieve care as usual by VA clinicians.
Behavioral: Usual Care
Patients randomized to "Usual Care" will receive care as usual by VA clinicians.

Detailed Description:

3CM consists of (1) a prepared practice, (2) care management, and (3) enhanced mental health support. A prepared practice refers to education for primary care clinicians and office staff about practice guidelines and evidence-based care, the skills needed for use of assessment measures, and the use of communication forms and routines. The education plan consists of predisposing activities, including active teaching and learning, and enabling and reinforcing activities in order to help clinicians use newly acquired skills and to reinforce the continued use of these skills in practice. Care management is accomplished by telephone, usually by a centrally located care manager during acute phase treatment and follow up to answer patient questions, promote adherence to the clinician's management plan, and help patients overcome barriers to adherence. Enhanced mental health support is provided by a psychiatrist who supervises care managers by telephone, provides informal consultation to primary care clinicians, and helps to increase the quantity or quality of mental health referral resources.

  Eligibility

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

Inclusion Criteria:

  • Military Veterans in Primary Care Clinics who meet diagnostic criteria for PTSD in one of the 5 sites in Texas where this study is being conducted.
  • Must have regular access to a telephone and speak English.

Exclusion Criteria:

  • Cognitive impairment
  • A history of psychosis or mania
  • Prominent current suicidal ideation
  • Current substance dependence
  • Current engagement in mental health treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00373698

Contacts
Contact: Liz Forshay, MSW MS (802) 291-6218 elizabeth.forshay@va.gov
Contact: Veronica Thurston, MBA veronica.thurston@va.gov

Locations
United States, Texas
VA North Texas Health Care System, Dallas Recruiting
Dallas, Texas, United States, 75216
Contact: Guna Raj     214-857-1588     Guna.Raj@va.gov    
Contact: Dzung V Le, DO     (817) 882-6004     Dzung.Le2@va.gov    
Sub-Investigator: Guna Raj            
VA North Texas Health Care System, Dallas Recruiting
Fort Worth, Texas, United States, 76104
Contact: Guna Raj     214-857-1588     Guna.Raj@va.gov    
Contact: Dzung V Le, DO     (817) 882-6004     Dzung.Le2@va.gov    
Sub-Investigator: Dzung V. Le, DO            
VA South Texas Health Care System, San Antonio Terminated
San Antonio, Texas, United States, 78229
Central Texas Veterans Health Care System - Waco Recruiting
Waco, Texas, United States, 76711
Contact: Immanuel Thamban, MD     254-297-3735     Immanuel.Thamban@va.gov    
United States, Vermont
VA Medical & Regional Office Center Not yet recruiting
White River Junction, Vermont, United States, 05009-0001
Contact: Liz Forshay, MSW MS     802-291-6218     elizabeth.forshay@va.gov    
Contact: Veronica Thurston, MBA         veronica.thurston@va.gov    
Sub-Investigator: Matthew J. Friedman, MD PhD            
Principal Investigator: Paula P. Schnurr, PhD            
Sponsors and Collaborators
Investigators
Principal Investigator: Paula P. Schnurr, PhD VA Medical & Regional Office Center, White River
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs ( Schnurr, Paula - Principal Investigator )
Study ID Numbers: IAC 06-073
Study First Received: September 6, 2006
Last Updated: February 18, 2009
ClinicalTrials.gov Identifier: NCT00373698     History of Changes
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Stress Disorders, Posttraumatic
Delivery of Health Care, Integrated
Primary Health Care
Veterans
Depression

Study placed in the following topic categories:
Depression
Anxiety Disorders
Mental Disorders
Mood Disorders
Stress Disorders, Post-Traumatic
Stress
Depressive Disorder
Stress Disorders, Traumatic
Behavioral Symptoms

Additional relevant MeSH terms:
Depression
Anxiety Disorders
Mental Disorders
Mood Disorders
Stress Disorders, Post-Traumatic
Depressive Disorder
Stress Disorders, Traumatic
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 06, 2009