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

Primary Purpose

Stress Disorders, Posttraumatic, Depression

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Three Component Model of Collaborative Care
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Posttraumatic focused on measuring Stress Disorders, Posttraumatic, Delivery of Health Care, Integrated, Primary Health Care, Veterans, Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
  • Central Texas Veterans Health Care System, Temple, TX
  • Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX
  • White River Junction VA Medical Center, White River Junction, VT

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Three Component Model

Usual Care

Arm Description

Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.

Patients randomized to "Usual Care" will receive care as usual by VA clinicians.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Depression
Measure using the Hopkins Symptom Checklist-20
SF-36 Mental Component
SF-36 Physical Component

Full Information

First Posted
September 6, 2006
Last Updated
April 6, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00373698
Brief Title
Re-Engineering Systems for the Primary Care Treatment for PTSD
Acronym
RESPECT-PTSD
Official Title
Reengineering Systems for the Primary Care Treatment of PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Posttraumatic, Depression
Keywords
Stress Disorders, Posttraumatic, Delivery of Health Care, Integrated, Primary Health Care, Veterans, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
195 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Three Component Model
Arm Type
Experimental
Arm Description
Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Patients randomized to "Usual Care" will receive care as usual by VA clinicians.
Intervention Type
Behavioral
Intervention Name(s)
Three Component Model of Collaborative Care
Intervention Description
Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
Primary Outcome Measure Information:
Title
PTSD Symptom Severity
Description
PTSD Symptom Severity was measured using the Postraumatic Diagnostic Scale (PDS)
Time Frame
3 and 6 months after initial assessment
Secondary Outcome Measure Information:
Title
Depression
Description
Measure using the Hopkins Symptom Checklist-20
Time Frame
3 and 6 months after initial assessment
Title
SF-36 Mental Component
Time Frame
3 and 6 months after initial assessment
Title
SF-36 Physical Component
Time Frame
3 and 6 months after initial assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula P Schnurr, PhD
Organizational Affiliation
White River Junction VA Medical Center, White River Junction, VT
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
Central Texas Veterans Health Care System, Temple, TX
City
Temple
State/Province
Texas
ZIP/Postal Code
76504
Country
United States
Facility Name
Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX
City
Waco
State/Province
Texas
ZIP/Postal Code
76711
Country
United States
Facility Name
White River Junction VA Medical Center, White River Junction, VT
City
White River Junction
State/Province
Vermont
ZIP/Postal Code
05009-0001
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22865017
Citation
Schnurr PP, Friedman MJ, Oxman TE, Dietrich AJ, Smith MW, Shiner B, Forshay E, Gui J, Thurston V. RESPECT-PTSD: re-engineering systems for the primary care treatment of PTSD, a randomized controlled trial. J Gen Intern Med. 2013 Jan;28(1):32-40. doi: 10.1007/s11606-012-2166-6. Epub 2012 Aug 3.
Results Reference
result

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Re-Engineering Systems for the Primary Care Treatment for PTSD

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