NCT00373698

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
195

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2008

Typical duration for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2006

Completed
1.5 years until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

November 7, 2014

Completed
Last Updated

April 24, 2015

Status Verified

June 1, 2014

Enrollment Period

2.1 years

First QC Date

September 6, 2006

Results QC Date

July 31, 2014

Last Update Submit

April 6, 2015

Conditions

Stress Disorders, PosttraumaticDepression

Keywords

Stress Disorders, PosttraumaticDelivery of Health Care, IntegratedPrimary Health CareVeteransDepression

Outcome Measures

Primary Outcomes (1)

  • PTSD Symptom Severity

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

    3 and 6 months after initial assessment

Secondary Outcomes (3)

  • Depression

    3 and 6 months after initial assessment

  • SF-36 Mental Component

    3 and 6 months after initial assessment

  • SF-36 Physical Component

    3 and 6 months after initial assessment

Study Arms (2)

Three Component Model

EXPERIMENTAL

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

Behavioral: Three Component Model of Collaborative Care

Usual Care

NO INTERVENTION

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

Interventions

Three Component Model of Collaborative CareBEHAVIORAL

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

Three Component Model

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Cognitive impairment
  • A history of psychosis or mania
  • Prominent current suicidal ideation
  • Current substance dependence
  • Current engagement in mental health treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

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

Dallas, Texas, 75216, United States

Location

Central Texas Veterans Health Care System, Temple, TX

Temple, Texas, 76504, United States

Location

Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX

Waco, Texas, 76711, United States

Location

White River Junction VA Medical Center, White River Junction, VT

White River Junction, Vermont, 05009-0001, United States

Location

Related Publications (1)

  • 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.

    PMID: 22865017RESULT

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticDepression

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehavior

Results Point of Contact

Title
Dr. Paula Schnurr and Dr. Mathew Friedman
Organization
VA Medical Center, White River Junction, VT
Paula.Schnurr@va.gov; Matthew.Friedman@va.gov
802-296-5132

Study Officials

  • Paula P Schnurr, PhD

    White River Junction VA Medical Center, White River Junction, VT

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2006

First Posted

September 8, 2006

Study Start

March 1, 2008

Primary Completion

April 1, 2010

Study Completion

April 1, 2012

Last Updated

April 24, 2015

Results First Posted

November 7, 2014

Record last verified: 2014-06

Locations

US(4)