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Behavioral Activation for Posttraumatic Stress Disorder (PTSD)/ Depression Treatment in Operations Iraqi Freedom and Enduring Freedom (OIF/OEF) Veterans

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00805532
First received: December 5, 2008
Last updated: September 6, 2013
Last verified: September 2013
  Purpose

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
Posttraumatic Stress Disorder
Depression
Behavioral: Behavioral Activation treatment
Other: Usual VA Treatment for PTSD

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Behavioral Activation for PTSD, Depression Treatment in OIF/OEF Veterans

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Clinician Administered PTSD Scale (CAPS-IV) (Blake et al., 1990; Blake et al., 1995, Kaloupek, Charney, Blake, Newman, Weathers, Nagy, Schnurr & Keane, 2004) [ Time Frame: Pre-treatment, post-treatment, and 3-month follow-up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Posttraumatic Stress Disorder Checklist-Military Version (PCL-M) (Blanchard, Jones-Alexander, Buckley, & Forneris, 1996; Weathers, Litz, Herman, Huska, & Keane, 1994) [ Time Frame: Pre-treatment, mid-treatment, post-treatment, 3-month follow-up ] [ Designated as safety issue: Yes ]
  • Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) (First et al., 1997) [ Time Frame: Pre-treatment ] [ Designated as safety issue: Yes ]
  • Beck Depression Inventory-II (BDI-II) (Beck, Steer, & Brown, 1996) [ Time Frame: Pre-treatment, mid-treatment, post-treatment, 3-month follow-up ] [ Designated as safety issue: Yes ]
  • Quality of Life Inventory (QOLI) (Frisch, Cornell, & Villanueva, 1992) [ Time Frame: Pre-treatment, post-treatment, 3-month follow-up ] [ Designated as safety issue: No ]
  • Sheehan Disability Scale (SDS) (Sheehan, 2000) [ Time Frame: Pre-treatment, post-treatment, 3-month follow-up ] [ Designated as safety issue: No ]
  • Medical Outcomes Study 12-Item Short-Form Health Survey (SF-12) (Ware, Snow, Kosinski, & et. al., 1993) [ Time Frame: Pre-treatment, post-treatment, 3-month follow-up ] [ Designated as safety issue: No ]
  • Overall health care utilization (Zatzick et al, 2004) [ Time Frame: Pre-treatment, post-treatment, 3-month follow-up ] [ Designated as safety issue: No ]
  • Credibility/Expectation Scales (Borkovec & Nau, 1972) [ Time Frame: Pre-treatment ] [ Designated as safety issue: No ]
  • Client Satisfaction Questionnaire (CSQ) [ Time Frame: post-treatment, 3-month follow-up ] [ Designated as safety issue: No ]
  • Social Support Questionnaire (SSQ) (Sarason, Levine, Basham, & Sarason, 1983) [ Time Frame: Pre-treatment, post-treatment, 3-month follow-up ] [ Designated as safety issue: No ]
  • Behavioral Activation Scale (BAS) (Kanter, Mulick, & Martell, 2004) [ Time Frame: Pre-treatment, mid-treatment, post-treatment, 3-month follow-up ] [ Designated as safety issue: No ]
  • Cognitive-Behavioral Avoidance Scale (CBAS) (Ottenbreit & Dobson, 2004) [ Time Frame: Pre-treatment, mid-treatment, post-treatment, 3-month follow-up ] [ Designated as safety issue: No ]
  • Action and Acceptance Questionnaire (AAQ) (Hayes et al., 2004) [ Time Frame: Pre-treatment, mid-treatment, post-treatment, 3-month follow-up ] [ Designated as safety issue: No ]
  • The Male Role Norms Scale (MRNS) (Thompson & Pleck, 1986) [ Time Frame: Pre-treatment ] [ Designated as safety issue: No ]
  • Deployment Risk and Resilience Inventory (DRRI) (King, King & Vogt, 2003). [ Time Frame: pre-treatment ] [ Designated as safety issue: No ]
  • Defense and Veteran Brain Injury Center Traumatic Brain Injury Screening Tool (DVBIC) (Schwab, Baker, Ivins, Sluss-Tiller, Lux & Warden, 2006). [ Time Frame: pre-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2009
Study Completion Date: July 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Behavioral Activation (BA)- modified to be delivered in 6-8, 60 minute sessions in a primary care setting by skilled psychotherapists. BA has also been modified to better address PTSD concerns.
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
Other Name: BA
Active Comparator: Arm 2
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: Usual VA Treatment for PTSD
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: UC

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 Usual VA Care (UC) as early interventions for OIF/OEF veterans with posttraumatic stress disorder (PTSD), or PTSD and major depressive disorder (PTSD/MDD). Participants will be recruited from 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 two 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00805532

Locations
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
Investigators
Principal Investigator: Amy W. Wagner, PhD VA Medical Center, Portland
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00805532     History of Changes
Other 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: September 6, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
PTSD
depression
behavior therapy
veterans
behavioral activation
usual care

Additional relevant MeSH terms:
Depression
Depressive Disorder
Disease
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 19, 2014