Psychotherapy Treatment of Deployment-Related PTSD in Primary Care Settings

Post-Traumatic Stress Disorders Clinical Trial

Official title:

Psychotherapy Treatment of Deployment-related PTSD in Primary Care Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00974402
• Other study ID #: HSC20090194H
• Secondary ID: BAMC C.2009.022W
• Status: Completed
• Phase: N/A
• First received: September 9, 2009
• Last updated: September 16, 2014
• Start date: March 2008
• Est. completion date: June 2012

Study information

• Verified date: September 2014
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Combat Disorders
• Disease
• Post-Traumatic Stress Disorders
• Stress Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.

Locations

Country	Name	City	State
United States	Brooke Army Medical Center (BAMC)	San Antonio	Texas
United States	South Texas Veterans Health Care System (STVHCS)	San Antonio	Texas
United States	Wilford Hall Medical Center	San Antonio	Texas

Sponsors (4)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	Brooke Army Medical Center, South Texas Veterans Health Care System, Wilford Hall Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD symptomatology	PTSD symptoms as assessed by an evaluator-administered interview (PTSD Symptom Scale Interview - PSSI) and self-report form (PTSD Checklist - Military Version - PCL-M).	Baseline, post-treatment, 6-month and 12-month	No

External Links

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