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OpenTrials
Completed

NCT Number: NCT00373698

Re-Engineering Systems for the Primary Care Treatment for PTSD

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX, Dallas, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Three Component Model of Collaborative Care

Behavioral

Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.

Primary outcomes

  1. PTSD Symptom Severity

    Time frame: 3 and 6 months after initial assessment

    PTSD Symptom Severity was measured using the Postraumatic Diagnostic Scale (PDS)

Secondary outcomes

  1. Depression

    Time frame: 3 and 6 months after initial assessment

    Measure using the Hopkins Symptom Checklist-20

  2. SF-36 Mental Component

    Time frame: 3 and 6 months after initial assessment

  3. SF-36 Physical Component

    Time frame: 3 and 6 months after initial assessment

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Official study title

Reengineering Systems for the Primary Care Treatment of PTSD

Acronym: RESPECT-PTSD

Important dates

Study start
2008
Primary completion
2010
Study completion
2012
First posted
Sep 8, 2006
Registry last updated
Apr 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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