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| 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: | The University of Texas Health Science Center at San Antonio |
| ClinicalTrials.gov Identifier: | NCT00974402 |
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 |
| Estimated Enrollment: | 45 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 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)
|
The study investigators have developed a 4-session PTSD treatment protocol including a behavioral health consultants (BHC) manual and a patient guide for use in primary care (See Appendix A) The treatment incorporates key elements of effective treatments for PTSD used in specialty settings and has been developed based on the investigators' clinical experience in primary care and a review and editing input from nationally-recognized experts on PTSD treatment Therapists will be psychologists who are functioning as behavioral health consultants (BHC) in an integrated primary care clinic. Study participants will receive four 30-minute treatment sessions over six weeks, and up to two additional sessions if the therapist and participant agree that additional sessions would be beneficial.
At WHMC and BAMC: Potential participants will be active duty, separated, and retired OIF/OEF veterans with PTSD symptoms who are referred by their primary care manager to the behavioral health consultant. Current standard of care for these patients is to provide assessment, psycho-education, and referral to specialty mental health care for a trial of CBT for PTSD. However, many veterans are reluctant to be seen in specialty care and will not accept a referral. The behavioral health consultants (BHC) routinely sees these patients now in primary care for a time-limited consultation (typically two to three 30-minute appointments over 5-6 week period) while the primary care manager retains overall responsibility for their care. Consultation in these cases has consisted of abbreviated elements of effective specialty care treatments. The abbreviated treatments, while usually shown helpful for individual patients, have not been systematically evaluated and the content has varied across provider and time. The purpose of the present research proposal is to develop and evaluate a standardized version of behavioral health consultation for PTSD in primary care.
At the STVHCS: Potential participants will be active duty, separated, or retired OIF/OEF veterans with PTSD symptoms who are referred by their primary care manager to the behavioral health consultant. Current standard of care for these patients is to provide assessment, psycho-education, and referral to specialty mental health care in the PTSD clinic for prolonged exposure, cognitive processing therapy, and/or psychoeducational interventions However, many veterans are reluctant to be seen in specialty care and will not accept a referral. The behavioral health consultants (BHC) routinely sees these patients now in primary care for a time-limited consultation (typically three to four 30-minute individual appointments on a monthly basis or weekly group psychotherapy using CBT and psycho-education on a weekly basis for 4 weeks) while the primary care manager retains overall responsibility for their care. Consultation in these cases has consisted of abbreviated elements of effective specialty care treatments. The abbreviated treatments, while usually shown helpful for individual patients, have not been systematically evaluated and the content has varied across provider and time. The purpose of the present research proposal is to develop and evaluate a standardized version of behavioral health consultation for PTSD in primary care.
The study will employ a quasi-experimental design in which we will measure within subject changes in a series of clinical cases. This design is sometimes referred to as a clinical replication series (Morin, Stone, McDonald, & Jones, 1994). This design will be used because it will allow us to evaluate the general effectiveness of this treatment approach when used in clinical practice in military primary care settings. It will also provide the valuable pilot data that may lead to a larger randomized clinical trial in the future.
Effectiveness of behavioral health consultation in primary care will be assessed based on degree of reduction in PTSD symptoms at post-treatment and at 6 and 12 month follow-up periods. The effect of consultation on symptoms of depression will be examined as depressive symptoms often co-exist with PTSD symptoms and are responsive to CBT treatments for PTSD. A general measure of global mental health functioning will also be included in the outcome measures.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |
| 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
| Responsible Party: | Lt Col Jeffery A Cigrang/ Overall Principal Investigator, STRONG STAR- South Tx Research Org Net Guiding Studies on Trauma & Resilience |
| ClinicalTrials.gov Identifier: | NCT00974402 History of Changes |
| Other Study ID Numbers: | HSC20090194H, BAMC C.2009.022, CIRO 2009096, A-15083.a, W81XWH-08-2-0117 |
| Study First Received: | September 9, 2009 |
| Last Updated: | July 12, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
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 |
|
Combat Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Anxiety Disorders Mental Disorders |