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Psychotherapy Treatment of Deployment-Related PTSD in Primary Care Settings

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ClinicalTrials.gov Identifier: NCT00974402
Recruitment Status : Completed
First Posted : September 10, 2009
Last Update Posted : September 18, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Post-Traumatic Stress Disorders Stress Disorders Combat Disorders Behavioral: Cognitive Behavioral Therapy

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Psychotherapy Treatment of Deployment-related PTSD in Primary Care Settings
Study Start Date : March 2008
Primary Completion Date : June 2012
Study Completion Date : June 2012
Arms and Interventions

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 Name: brief cognitive-behavioral therapy (CBT)

Outcome Measures

Primary Outcome Measures :
  1. 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).

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00974402

United States, Texas
South Texas Veterans Health Care System (STVHCS)
San Antonio, Texas, United States, 78229
Brooke Army Medical Center (BAMC)
San Antonio, Texas, United States, 78234-6200
Wilford Hall Medical Center
San Antonio, Texas, United States, 78236-5300
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Brooke Army Medical Center
Wilford Hall Medical Center
South Texas Veterans Health Care System
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
More Information

Additional Information:
Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00974402     History of Changes
Other Study ID Numbers: HSC20090194H
BAMC C.2009.022 ( Other Identifier: Brooke Army Medical Center Institutional Review Board )
W81XWH-08-2-0109 ( Other Grant/Funding Number: Department of Defense )
First Posted: September 10, 2009    Key Record Dates
Last Update Posted: September 18, 2014
Last Verified: September 2014

Keywords provided by The University of Texas Health Science Center at San Antonio:
Active duty
Brooke Army Medical Center
Cognitive Behavioral Therapy
Combat Disorder
Feeling alone
Mental Health
Military member
Military personnel

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Combat Disorders
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders