Psychotherapy Treatment of Deployment-Related PTSD in Primary Care Settings

Sponsor

The University of Texas Health Science Center at San Antonio (Other)

Overall Status

Completed

CT.gov ID

NCT00974402

Collaborator

Brooke Army Medical Center (U.S. Fed), 59th Medical Wing (U.S. Fed), South Texas Veterans Health Care System (U.S. Fed)

Enrollment

Locations

Arm

Duration (Months)

11.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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	Phase
Post-Traumatic Stress Disorders Stress Disorders Combat Disorders	Behavioral: Cognitive Behavioral Therapy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

N/A

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 :

Mar 1, 2008

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Jun 1, 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 Names: brief cognitive-behavioral therapy (CBT)

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)

Outcome Measures

Primary Outcome Measures

PTSD symptomatology [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	South Texas Veterans Health Care System (STVHCS)	San Antonio	Texas	United States	78229
2	Brooke Army Medical Center (BAMC)	San Antonio	Texas	United States	78234-6200
3	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
59th Medical Wing
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