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

Sponsored by:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00805532

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

MedlinePlus related topics: Depression Post-Traumatic Stress Disorder

U.S. FDA Resources

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

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, 3-month follow-up and 9-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 and 9-month follow-up ] [ Designated as safety issue: Yes ]
Posttraumatic Cognitions Inventory (PTCI) (Foa, Ehlers, Clark, Tolin, & Orsillo, 1999) [ Time Frame: Pre-treatment, post-treatment, 3-month follow-up and 9-month follow-up ] [ Designated as safety issue: No ]
The Life Event Checklist (LEC) (Kaloupek, Charney, Blake, Newman, Weathers, Nagy, Schnurr & Keane, 2004) [ Time Frame: Pre-treatment ] [ Designated as safety issue: No ]
Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) (First et al., 1997) [ Time Frame: Pre-treatment ] [ Designated as safety issue: Yes ]
Modified Hamilton Rating Scale for Depression (HRSD) (Hamilton, 1960) [ Time Frame: Pre-treatment, post-treatment, 3-month follow-up and 9-month follow-up ] [ Designated as safety issue: No ]
Beck Depression Inventory-II (BDI-II) (Beck, Steer, & Brown, 1996) [ Time Frame: Pre-treatment, mid-treatment, post-treatment, 3-month follow-up and 9-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 and 9-month follow-up ] [ Designated as safety issue: No ]
Sheehan Disability Scale (SDS) (Sheehan, 2000) [ Time Frame: Pre-treatment, post-treatment, 3-month follow-up and 9-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 and 9-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 and 9-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 and 9-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 and 9-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 and 9-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 and 9-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 and 9-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 ]
The Test of Self-Conscious Affect-3 (TOSCA-3; Tangney, Dearing, Wagner & Gramzow, 2000) [ Time Frame: Pre-treatment, post-treatment, 3-month follow-up and 9-month follow-up ] [ Designated as safety issue: No ]
The Narcissistic Personality Inventory (NPI; Raskin and Terry, 1988) [ Time Frame: Pre-treatment, post-treatment, 3-month follow-up and 9-month follow-up ] [ 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
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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	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
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.	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.

Arms

Assigned Interventions

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

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

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.

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.

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). 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.

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) or PTSD (related to trauma experienced during the military) and major depressive disorder (MDD). PTSD will be assessed using the Clinician-Administered PTSD Scale for DSM-IV (CAPS; Blake, Weathers, Nagy, Kaloupek, Charney & Keane, 2003). Major Depressive Disorder (MDD) will be assessed using the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I; First, Spitzer, Gibbon & Williams, 2002).

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

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

Contacts

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

Locations

United States, Oregon
VA Medical Center, Portland
Portland, Oregon, United States, 97201

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Principal Investigator:

Amy W. Wagner, PhD

VA Medical Center, Portland

More Information

No publications provided

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

Keywords provided by Department of Veterans Affairs:

PTSD
depression
behavior therapy

veterans
behavioral activation
usual care

Study placed in the following topic categories:

Depression
Anxiety Disorders
Mental Disorders
Mood Disorders
Stress Disorders, Post-Traumatic

Stress
Depressive Disorder
Stress Disorders, Traumatic
Behavioral Symptoms

Additional relevant MeSH terms:

Pathologic Processes
Disease
Depression
Anxiety Disorders
Mental Disorders
Mood Disorders

Stress Disorders, Post-Traumatic
Stress
Depressive Disorder
Stress Disorders, Traumatic
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 07, 2009