Psychotherapy Treatment of Deployment-Related PTSD in Primary Care Settings

September 16, 2014 updated by: The University of Texas Health Science Center at San Antonio

Psychotherapy Treatment of Deployment-related PTSD in Primary Care Settings

The purpose of this study is to evaluate Cognitive-behavioral therapy (CBT) for deployment-related post-traumatic stress disorder (PTSD) that can be used by behavioral health consultants working with Service Members in the primary care clinic. CBT is a well-researched, very effective individual (one-to-one) treatment that is designed to help people to directly deal with traumatic events they have suffered in the past, including combat. Many Service Members prefer to see behavioral health providers in primary care rather than the mental health clinic. The researchers hope to learn if a brief treatment for PTSD in primary care can be just as useful as more traditional treatment given in the mental health clinic. This study will enroll approximately 45 participants overall; with approximately 30 participants at Wilford Hall Medical Center or Brooke Army Medical Center, and 15 participants to be enrolled at the South Texas Veterans Health Care System over a period of one year.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • South Texas Veterans Health Care System (STVHCS)
      • San Antonio, Texas, United States, 78234-6200
        • Brooke Army Medical Center (BAMC)
      • San Antonio, Texas, United States, 78236-5300
        • Wilford Hall Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The target population for the study is active duty, reserve, guard, separated, or retired OIF/OEF veterans (minimum age 18 and English speaking) in the primary care population who are symptomatic for deployment-related PTSD and interested in treatment.
  • Symptomatic for PTSD will be defined as a minimum score of 32 on the PTSD CheckList - Military (PCL-M).

Exclusion Criteria:

  • The exclusion criteria are those that would normally apply for standard of care behavioral health consultation in an integrated primary care clinic.
  • These exclusion criteria are moderate to severe suicide risk, current alcohol dependence, psychotic disorder, significant dissociative disorder, and severe brain injury.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with PTSD Symptoms
Patients with Post-Traumatic Stress Disorder (PTSD) symptoms willing to undergo Cognitive Behavioral Therapy in a primary care setting.
Behavioral: Cognitive Behavioral Therapy
The study investigators have developed a 4-session PTSD treatment plan including a behavioral health consultants (BHC) manual and a patient guide for use in primary care. Therapists will be psychologists who are functioning as behavioral health consultants (BHC) in an integrated primary care clinic. The study will adapt intervention methods for use in the time-constrained primary care environment from Cognitive Behavioral Therapy(ies) that have proven effective for PTSD in specialty mental health care settings. Study participants will receive four 30-minute treatment sessions over six weeks.
Other Names:
  • brief cognitive-behavioral therapy (CBT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTSD symptomatology
Time Frame: Baseline, post-treatment, 6-month and 12-month
PTSD symptoms as assessed by an evaluator-administered interview (PTSD Symptom Scale Interview - PSSI) and self-report form (PTSD Checklist - Military Version - PCL-M).
Baseline, post-treatment, 6-month and 12-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at San Antonio

Collaborators

59th Medical Wing
Brooke Army Medical Center
South Texas Veterans Health Care System

Investigators

  • Study Chair: Alan L Peterson, PhD, University of Texas Health Science Center San Antonio (UTHSCSA), STRONG STAR Consortium Director
  • Principal Investigator: Jeffrey Cigrang, Lt Col, U.S. Air Force, 5MDG, Minot Air Force Base
  • Principal Investigator: Lisa Kearney, PhD, South Texas Veterans Health Care System (STVHCS)
  • Principal Investigator: Diana Dolan, Capt, U.S. Air Force, Wilford Hall Medical Center (WHMC)
  • Principal Investigator: Laura Avila, PhD, Brooke Army Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

September 9, 2009

First Submitted That Met QC Criteria

September 9, 2009

First Posted (Estimate)

September 10, 2009

Study Record Updates

Last Update Posted (Estimate)

September 18, 2014

Last Update Submitted That Met QC Criteria

September 16, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC20090194H
  • W81XWH-08-2-0109 (Other Grant/Funding Number: Department of Defense)
  • BAMC C.2009.022 (Other Identifier: Brooke Army Medical Center Institutional Review Board)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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