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Clinical Trials/NCT00805532
NCT00805532
Completed
Not Applicable

Behavioral Activation for PTSD, Depression Treatment in OIF/OEF Veterans

VA Office of Research and Development2 sites in 1 country81 target enrollmentMay 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Posttraumatic Stress Disorder
Sponsor
VA Office of Research and Development
Enrollment
81
Locations
2
Primary Endpoint
Clinician Administered PTSD Scale (CAPS-IV)
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The present study is a randomized, controlled trial that compares Behavioral Activation (BA) to Treatment As Usual (TAU) in PTSD Specialty clinics, as early psychotherapeutic interventions for OIF/OEF veterans with posttraumatic stress disorder (PTSD).

Detailed Description

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 Treatment As Usual (TAU) as early interventions for OIF/OEF veterans with posttraumatic stress disorder (PTSD). Participants will be recruited largely from the primary health care setting (to increase acceptability and accessibility to the veteran population). Both BA and TAU treatment groups will be administered by psychotherapists who specialize in the treatment of PTSD. Both groups will be assessed at pre-, mid- and post-treatment time points to determine 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.

Registry
clinicaltrials.gov
Start Date
May 2009
End Date
July 2013
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Ability to comply with assessment and therapy schedule.
  • Ability to comply with study regulations.
  • English fluency.
  • Must meet diagnostic criteria for PTSD (related to trauma experienced during military service). PTSD will be assessed using the Clinician-Administered PTSD Scale for DSM-IV (CAPS; Blake, Weathers, Nagy, Kaloupek, Charney \& Keane, 2003).

Exclusion Criteria

  • Bipolar disorder.
  • Psychotic disorders.
  • Substance dependence. Because these conditions warrant alternative treatments. Bipolar, psychotic and substance dependence disorders will be assessed using the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I; First, Spitzer, Gibbon \& Williams, 2002).
  • Report active and imminent suicidal intent. If imminent suicidality is present, this would suggest that a treatment specifically targeting this intent is indicated. Suicidal intent will be assessed using The Brief Assessment for Suicidal Ideation or Behavior that was designed for this study.

Outcomes

Primary Outcomes

Clinician Administered PTSD Scale (CAPS-IV)

Time Frame: Pre-treatment, post-treatment (12 weeks after 1st therapy session), and 3-month follow-up (24 weeks after first therapy session)

The CAPS is a clinician-administered scale and is considered the "gold standard" for assessing the presence of PTSD. Items are ranked on Likert scales according to both frequency (0=never to 4=daily or almost every day) and intensity (0=none to 4=extreme) of symptoms, yielding an overall severity score by summing frequency and intensity ratings (range 0 to 136, with higher scores reflecting greater symptomatology). Scale scores corresponding to the 3 subcategories of PTSD symptoms (intrusive symptoms, avoidance symptoms, and hyperarousal symptoms) can be similarly obtained (scores range from 0-40, 0-56, 0-40 for the 3 subscales, respectively). Internal consistency, interrater reliability, and validity of this measure are strong and well-documented.

Secondary Outcomes

  • Beck Depression Inventory-II (BDI-II)(Pre-treatment, post-treatment (12 weeks after first therapy appointment), 3-month follow-up (24 weeks after first therapy appointment))
  • Posttraumatic Stress Disorder Checklist-Military Version (PCL-M)(Pre-treatment, post-treatment (12 weeks after first therapy appointment), 3-month follow-up (24 weeks after first therapy appointment))
  • Sheehan Disability Scale (SDS)(Pre-treatment, post-treatment (12 weeks after first psychotherapy session), 3-month follow-up (24 weeks after first psychotherapy appointment))
  • Behavioral Activation Scale (BAS)(Pre-treatment, post-treatment (12 weeks after 1st therapy appointment), 3-month follow-up (24 weeks after first therapy appointment))

Study Sites (2)

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