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Psychotherapy Treatment of Deployment-Related PTSD in Primary Care Settings

This study has been completed.
Sponsor:
Collaborators:
Brooke Army Medical Center
Wilford Hall Medical Center
South Texas Veterans Health Care System
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00974402
First received: September 9, 2009
Last updated: September 16, 2014
Last verified: September 2014
  Purpose

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 Intervention
Post-Traumatic Stress Disorders
Stress Disorders
Combat Disorders
Behavioral: Cognitive Behavioral Therapy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Psychotherapy Treatment of Deployment-related PTSD in Primary Care Settings

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • PTSD symptomatology [ Time Frame: Baseline, post-treatment, 6-month and 12-month ] [ Designated as safety issue: No ]
    PTSD symptoms as assessed by an evaluator-administered interview (PTSD Symptom Scale Interview - PSSI) and self-report form (PTSD Checklist - Military Version - PCL-M).


Enrollment: 35
Study Start Date: March 2008
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00974402

Locations
United States, Texas
Brooke Army Medical Center (BAMC)
San Antonio, Texas, United States, 78234-6200
South Texas Veterans Health Care System (STVHCS)
San Antonio, Texas, United States, 78229
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
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
  More Information

Additional Information:
No publications provided

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, W81XWH-08-2-0109
Study First Received: September 9, 2009
Last Updated: September 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center at San Antonio:
Active duty
Afghanistan
Anger
Anxiety
Avoidance
BAMC
Brooke Army Medical Center
Cognitive Behavioral Therapy
Combat
Combat Disorder
Coping
Counseling
Counselor
Deployment
Depression
Exposure
Fear
Feeling alone
Flashbacks
Guard
Guilt
Hospitalization
Iraq
Mental Health
Military
Military member
Military personnel
Neuroses
Nightmares
OEF

Additional relevant MeSH terms:
Combat Disorders
Disease
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014