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

NCT ID: NCT00805532

Last Updated: 2018-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2013-07-31

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.

Conditions

Posttraumatic Stress Disorder; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Behavioral Activation

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

Group Type: EXPERIMENTAL

Behavioral Activation treatment

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Other Intervention Names

BA; TAU

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amy W. Wagner, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Medical Center, Portland

Locations

VA Medical Center, Portland

Portland, Oregon, United States

VA Puget Sound Health Care System, Seattle

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31337325 (View on PubMed)

Other Identifiers

PVAMC ID: 1738

Identifier Type: OTHER

Identifier Source: secondary_id

VA PSHCS SUB IRB ID: 33950

Identifier Type: OTHER

Identifier Source: secondary_id

Grant #: 08-0306

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MHBA-019-06F

Identifier Type: -

Identifier Source: org_study_id