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Psychotherapy Treatment of Deployment-Related PTSD in Primary Care Settings

Primary Purpose

Post-Traumatic Stress Disorders, Stress Disorders, Combat Disorders

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cognitive Behavioral Therapy

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorders focused on measuring 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, OIF, Prolonged Exposure Therapy, Psychiatric, Psychiatric medication, Psychological distress, Psychotherapy, Reserve, Retired, Sadness, Separated, Sleeplessness, Soldier, Stress, Stress disorder, Stress management, STRONG STAR, Suicidal, Suicide, Therapy, Trauma, Traumatic Event, Trouble Sleeping, Veteran, Veterans, War, WHMC, Wilford Hall Medical Center, PTSD, Posttraumatic Stress Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

South Texas Veterans Health Care System (STVHCS)
Brooke Army Medical Center (BAMC)
Wilford Hall Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with PTSD Symptoms

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT00974402

First Posted

September 9, 2009

Last Updated

September 16, 2014

Sponsor

The University of Texas Health Science Center at San Antonio

Collaborators

Brooke Army Medical Center, 59th Medical Wing, South Texas Veterans Health Care System

1. Study Identification

Unique Protocol Identification Number

NCT00974402

Brief Title

Psychotherapy Treatment of Deployment-Related PTSD in Primary Care Settings

Official Title

Psychotherapy Treatment of Deployment-related PTSD in Primary Care Settings

Study Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The University of Texas Health Science Center at San Antonio

Collaborators

Brooke Army Medical Center, 59th Medical Wing, South Texas Veterans Health Care System

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post-Traumatic Stress Disorders, Stress Disorders, Combat Disorders

Keywords

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, OIF, Prolonged Exposure Therapy, Psychiatric, Psychiatric medication, Psychological distress, Psychotherapy, Reserve, Retired, Sadness, Separated, Sleeplessness, Soldier, Stress, Stress disorder, Stress management, STRONG STAR, Suicidal, Suicide, Therapy, Trauma, Traumatic Event, Trouble Sleeping, Veteran, Veterans, War, WHMC, Wilford Hall Medical Center, PTSD, Posttraumatic Stress Disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patients with PTSD Symptoms

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Cognitive Behavioral Therapy

Other Intervention Name(s)

brief cognitive-behavioral therapy (CBT)

Intervention Description

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.

Primary Outcome Measure Information:

Title

PTSD symptomatology

Description

PTSD symptoms as assessed by an evaluator-administered interview (PTSD Symptom Scale Interview - PSSI) and self-report form (PTSD Checklist - Military Version - PCL-M).

Time Frame

Baseline, post-treatment, 6-month and 12-month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials: