Psychotherapy Treatment of Deployment-Related PTSD in Primary Care Settings
This study has been completed.
Sponsor:
The University of Texas Health Science Center at San Antonio
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
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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: | Allocation: Non-Randomized 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 treatment 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 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)
|
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
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 | |
| Wilford Hall Medical Center | |
| San Antonio, Texas, United States, 78236-5300 | |
| South Texas Veterans Health Care System (STVHCS) | |
| San Antonio, Texas, United States, 78229 | |
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: | February 20, 2013 |
| 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 Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Anxiety Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013