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

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ClinicalTrials.gov Identifier: NCT00805532
Recruitment Status : Completed
First Posted : December 9, 2008
Results First Posted : November 5, 2018
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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).

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Depression Behavioral: Behavioral Activation treatment Other: Treatment as Usual Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Behavioral Activation for PTSD, Depression Treatment in OIF/OEF Veterans
Study Start Date : May 2009
Actual Primary Completion Date : June 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Behavioral Activation
Behavioral Activation (BA), modified to be delivered in 6-8, 60 minute sessions to address PTSD-related problems.
Behavioral: Behavioral Activation treatment
Behavioral Activation (BA) is a present-focused psychotherapy based on behavioral theory and principles of change, that aims to re-engage individuals with meaningful and pleasurable life activities by targeting and problem-solving patterns of avoidance. It is well-established as a treatment for depression and has been modified for the current study to address PTSD-related problems.
Other Name: BA

Active Comparator: Treatment as Usual
Treatment As Usual for PTSD (TAU) within VA PTSD specialty clinics. Actual clinical practice varies between sites and between providers within sites, as is typical of the VA health care system.
Other: Treatment as Usual
Usual Care for PTSD (UC)-that is provided in the VA PTSD Specialty clinics. 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) and any additional psychotherapy deemed appropriate by the provider. They will also be offered a minimum of 6 sessions of individual therapy.
Other Name: TAU




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Posttraumatic Stress Disorder Checklist-Military Version (PCL-M) [ Time Frame: Pre-treatment, post-treatment (12 weeks after first therapy appointment), 3-month follow-up (24 weeks after first therapy appointment) ]
    The PCL-M is a 17 item self-report scale that assesses the presence of DSM-IV PTSD symptoms. Items are rated on a 5-point Likert scale (1= not at all to 5=extremely) according to how much the symptom bothered the respondent over the past month. Scores range from 17-85 with higher scores representing greater symptom severity.

  2. Beck Depression Inventory-II (BDI-II) [ Time Frame: Pre-treatment, post-treatment (12 weeks after first therapy appointment), 3-month follow-up (24 weeks after first therapy appointment) ]
    The Beck Depression Inventory-II (BDI-II) (Beck, Steer, & Brown, 1996) is a 21-item measure of subjective levels of depression. Items are rated on Likert-scales from 0-3 (individual descriptions are provided for each number ranging from the absence of the symptom to the severe manifestation of the symptom). Scores can range from 0-63 with higher scores representing higher levels of depression. This widely used measure of depression is commonly included in outcome studies in order to determine treatment effects on severity of depressive symptoms and has excellent psychometric properties.

  3. Sheehan Disability Scale (SDS) [ Time Frame: Pre-treatment, post-treatment (12 weeks after first psychotherapy session), 3-month follow-up (24 weeks after first psychotherapy appointment) ]
    The Sheehan Disability Scale (SDS) (Sheehan, 2000) is a three item self-rated scale of impairment that is widely used in psychopharmacology studies (allowing comparison with these studies). The items ask the respondent to rate (on a Likert scale of 0-10, unimpaired to highly impaired) to what extent their symptoms interfere with their functioning in the areas of: work, social, and family life; a summary score can be obtained by summing the three items (range 0-30, unimpaired to highly impaired). The scale's reliability and concurrent validity have been demonstrated in individuals with anxiety disorders and depression.

  4. Behavioral Activation Scale (BAS) [ Time Frame: Pre-treatment, post-treatment (12 weeks after 1st therapy appointment), 3-month follow-up (24 weeks after first therapy appointment) ]
    The BAS is a 25-item self-report measure that assesses overall degree of behavioral activation as well as indicators of inactivation across three subscales: avoidance/rumination, work/school impairment, and social impairment. Items are rated on 7-point Likert scales (0=not at all to 6=completely). The total BAS score reflects overall level of activation with high scores reflecting higher activation (range 0 - 150).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00805532


Locations
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United States, Oregon
VA Medical Center, Portland
Portland, Oregon, United States, 97201
United States, Washington
VA Puget Sound Health Care System, Seattle
Seattle, Washington, United States, 98108
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Amy W. Wagner, PhD VA Medical Center, Portland

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00805532     History of Changes
Other Study ID Numbers: MHBA-019-06F
PVAMC ID: 1738 ( Other Identifier: PVAMC R&D )
VA PSHCS SUB IRB ID: 33950 ( Other Identifier: VA PSHCS R&D )
Grant #: 08-0306 ( Other Grant/Funding Number: VA Clinical Science R&D )
First Posted: December 9, 2008    Key Record Dates
Results First Posted: November 5, 2018
Last Update Posted: November 5, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all IPD that underlie results in the publications
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 6 months after publication of the manuscript(s)
Access Criteria: The PIs will review requests and consult with the R&D offices and privacy officers at both sites prior to release of data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by VA Office of Research and Development:
PTSD
depression
behavior therapy
veterans
behavioral activation
usual care

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Stress Disorders, Post-Traumatic
Behavioral Symptoms
Mood Disorders
Mental Disorders
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders