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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00805532 |
The present study is a randomized, controlled trial that compares Behavioral Activation (BA), to Usual VA Care (UC) as early psychotherapeutic interventions for OIF/OEF veterans with posttraumatic stress disorder (PTSD), or PTSD and major depressive disorder (PTSD/MDD).
Condition | Intervention |
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Posttraumatic Stress Disorder Depression |
Behavioral: Behavioral Activation treatment Other: Usual VA Treatment for PTSD |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Behavioral Activation for PTSD, Depression Treatment in OIF/OEF Veterans |
Estimated Enrollment: | 60 |
Study Start Date: | May 2009 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Behavioral Activation (BA)- modified to be delivered in 6-8, 60 minute sessions in a primary care setting. BA has also been modified to better address PTSD concerns
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Behavioral: Behavioral Activation treatment
Behavioral Activation (BA)- modified to be delivered in 6-8, 60 minute sessions in a primary care setting. BA has also been modified to better address PTSD concerns
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2: Active Comparator
usual care for PTSD and depression Usual Care (UC)-that is provided in the VA primary health clinics particular to this study. Actual clinical practice varies between sites and between providers within sites, as is typical of the VA health care system. Subjects assigned to Usual Care will be permitted to receive medical intervention (i.e., pharmacotherapy) within the primary care settings of PVAMC and VA PSHCS and will be provided a referral to the PTSD Clinical Team for specialty mental health services (psychotherapy or specialty pharmacotherapy). They will also be offered a minimum of 6 sessions of individual therapy.
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Other: Usual VA Treatment for PTSD
Usual Care for PTSD and depression Usual Care (UC)-that is provided in the VA primary health clinics particular to this study. Actual clinical practice varies between sites and between providers within sites, as is typical of the VA health care system. Subjects assigned to Usual Care will be permitted to receive medical intervention (i.e., pharmacotherapy) within the primary care settings of PVAMC and VA PSHCS and will be provided a referral to the PTSD Clinical Team for specialty mental health services (psychotherapy or specialty pharmacotherapy). They will also be offered a minimum of 6 sessions of individual therapy.
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A sizable proportion of soldiers involved in the Iraq and Afghanistan conflicts are experiencing mental health and adjustment problems on their return, including posttraumatic stress disorder and depression (Hoge et al., 2004). Both PTSD and depression can be chronic and debilitating disorders, associated with impairments in social, occupational, and physical functioning, as well as high health care utilization (Katon, Unutzer, & Simon, 2004; Stein et al., 2005). Although empirically supported treatments exist for established PTSD and depression, much less is known about effective early interventions for these conditions. Exploration of early intervention options is necessary, particularly in the case of the new veteran population, as such interventions could address social, occupational and physical impairments before they become too intractable. Also, successful early interventions could curtail high health care utilization dramatically across time. The development of such early interventions for PTSD and depression must also take into account any specifications of accessibility and acceptability that are particular to the OIF/OEF veteran population.
The present study is a randomized, controlled trial that compares Behavioral Activation (BA), to Usual VA Care (UC) as early interventions for OIF/OEF veterans with posttraumatic stress disorder (PTSD), or PTSD and major depressive disorder (PTSD/MDD). BA will be delivered in the primary health care setting (to increase acceptability and accessibility to the veteran population). Both BA and UC treatment groups will be administered by psychotherapists who specialize in the treatment of PTSD. Both groups will be assessed at pre-, mid- and several post-treatment time points to determine maintenance of diagnostic change over time, health care utilization and treatment satisfaction. This is a dual-site study that will be carried out at both the Portland VA Medical Center (PVAMC) and the VA Puget Sound Health Care Center (VA PSHCS) and coordinated at the PVAMC.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Amy L Johnson | (503) 220-8262 ext 31794 | amy.johnson2@va.gov |
Contact: Amy W Wagner, PhD | (503) 220-8262 | Amy.Wagner@va.gov |
United States, Oregon | |
VA Medical Center, Portland | |
Portland, Oregon, United States, 97201 |
Principal Investigator: | Amy W. Wagner, PhD | VA Medical Center, Portland |
Responsible Party: | Department of Veterans Affairs ( Wagner, Amy - Principal Investigator ) |
Study ID Numbers: | MHBA-019-06F, PVAMC ID: 1738, VA PSHCS SUB IRB ID: 33950, Grant #: 08-0306 |
Study First Received: | December 5, 2008 |
Last Updated: | April 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00805532 History of Changes |
Health Authority: | United States: Federal Government |
PTSD depression behavior therapy |
veterans behavioral activation usual care |
Depression Anxiety Disorders Mental Disorders Mood Disorders Stress Disorders, Post-Traumatic |
Stress Depressive Disorder Stress Disorders, Traumatic Behavioral Symptoms |
Pathologic Processes Disease Depression Anxiety Disorders Mental Disorders Mood Disorders |
Stress Disorders, Post-Traumatic Stress Depressive Disorder Stress Disorders, Traumatic Behavioral Symptoms |