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

NCT00805532 | Completed Results DMC

• 4 other identifiers: MHBA-019-06FPVAMC ID: 1738VA PSHCS SUB IRB ID: 33950Grant #: 08-0306
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 2

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).

Conditions

Posttraumatic Stress Disorder; Depression

Keywords

PTSD; depression; behavior therapy; veterans; behavioral activation; usual care

Outcome Measures

Primary Outcomes (1)

• Clinician Administered PTSD Scale (CAPS-IV)

  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.

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

Secondary Outcomes (4)

• 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)

• 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)

• 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 Arms (2)

Behavioral Activation

EXPERIMENTAL

Behavioral Activation (BA), modified to be delivered in 6-8, 60 minute sessions to address PTSD-related problems.

Behavioral: Behavioral Activation treatment

Treatment as Usual

ACTIVE COMPARATOR

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

Interventions

Behavioral Activation treatment BEHAVIORAL

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.

Also known as: BA

Behavioral Activation

Treatment as Usual OTHER

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.

Also known as: TAU

Treatment as Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

VA Medical Center, Portland

Portland, Oregon, 97201, United States

Location

VA Puget Sound Health Care System, Seattle

Seattle, Washington, 98108, United States

Location

Related Publications (1)

• Wagner AW, Jakupcak M, Kowalski HM, Bittinger JN, Golshan S. Behavioral Activation as a Treatment for Posttraumatic Stress Disorder Among Returning Veterans: A Randomized Trial. Psychiatr Serv. 2019 Oct 1;70(10):867-873. doi: 10.1176/appi.ps.201800572. Epub 2019 Jul 24.

  PMID: 31337325 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Amy W. Wagner, Ph.D.
• Organization: VA Portland Health Care System

amy.wagner@va.gov

(503) 220-8262

Study Officials

• Amy W. Wagner, PhD

  VA Medical Center, Portland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2008
• First Posted: December 9, 2008
• Study Start: May 1, 2009
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: November 5, 2018
• Results First Posted: November 5, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, 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.

Locations

US (2)