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Re-Engineering Systems for the Primary Care Treatment for PTSD (RESPECT-PTSD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00373698
First received: September 6, 2006
Last updated: September 19, 2012
Last verified: September 2012
History of Changes
  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
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reengineering Systems for the Primary Care Treatment of PTSD

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 195
Study Start Date: March 2008
Study Completion Date: April 2012
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
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.
No Intervention: Arm 2
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

Locations
United States, Texas
VA North Texas Health Care System, Dallas
Dallas, Texas, United States, 75216
Central Texas Veterans Health Care System
Temple, Texas, United States, 76504
Central Texas Veterans Health Care System - Waco
Waco, Texas, United States, 76711
United States, Vermont
VA Medical & Regional Office Center
White River Junction, Vermont, United States, 05009-0001
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: Paula P. Schnurr, PhD VA Medical & Regional Office Center, White River
  More Information

No publications provided by Department of Veterans Affairs

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00373698     History of Changes
Other Study ID Numbers: IAC 06-073
Study First Received: September 6, 2006
Last Updated: September 19, 2012
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

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

ClinicalTrials.gov processed this record on May 19, 2013