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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: February 20, 2013
Last verified: February 2013
History of Changes

September 9, 2009
February 20, 2013
March 2008
June 2012   (final data collection date for primary outcome measure)
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).
A single group mixed effects repeated measures analysis of variance will be used to examine within-group changes on study measures. [ Time Frame: pre-treatment, 6 and 12 month analyses, post-treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00974402 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Psychotherapy Treatment of Deployment-Related PTSD in Primary Care Settings
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.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Post-Traumatic Stress Disorders
  • Stress Disorders
  • Combat Disorders
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 CBT therapies 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)
Experimental: Patients with PTSD Symptoms
Patients with Post-Traumatic Stress Disorder (PTSD) symptoms willing to undergo treatment in a primary care setting.
Intervention: Behavioral: Cognitive Behavioral Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
June 2012
June 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00974402
HSC20090194H, BAMC C.2009.022, W81XWH-08-2-0109
Yes
The University of Texas Health Science Center at San Antonio
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
The University of Texas Health Science Center at San Antonio
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP