Psychotherapy Treatment of Deployment-Related PTSD in Primary Care Settings

NCT ID: NCT00974402

Last Updated: 2014-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Post-Traumatic Stress Disorders Stress Disorders Combat Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients with PTSD Symptoms

Patients with Post-Traumatic Stress Disorder (PTSD) symptoms willing to undergo Cognitive Behavioral Therapy in a primary care setting.

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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brief cognitive-behavioral therapy (CBT)

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brooke Army Medical Center

FED

Sponsor Role collaborator

59th Medical Wing

FED

Sponsor Role collaborator

South Texas Veterans Health Care System

FED

Sponsor Role collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alan L Peterson, PhD

Role: STUDY_CHAIR

University of Texas Health Science Center San Antonio (UTHSCSA), STRONG STAR Consortium Director

Jeffrey Cigrang, Lt Col

Role: PRINCIPAL_INVESTIGATOR

U.S. Air Force, 5MDG, Minot Air Force Base

Lisa Kearney, PhD

Role: PRINCIPAL_INVESTIGATOR

South Texas Veterans Health Care System (STVHCS)

Diana Dolan, Capt

Role: PRINCIPAL_INVESTIGATOR

U.S. Air Force, Wilford Hall Medical Center (WHMC)

Laura Avila, PhD

Role: PRINCIPAL_INVESTIGATOR

Brooke Army Medical Center

Locations

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South Texas Veterans Health Care System (STVHCS)

San Antonio, Texas, United States

Site Status

Brooke Army Medical Center (BAMC)

San Antonio, Texas, United States

Site Status

Wilford Hall Medical Center

San Antonio, Texas, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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BAMC C.2009.022

Identifier Type: OTHER

Identifier Source: secondary_id

W81XWH-08-2-0109

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HSC20090194H

Identifier Type: -

Identifier Source: org_study_id

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