The proposed study will examine the clinical impact and implementation potential of a brief cognitive behavioral therapy (bCBT) for depressed Veterans treated in VA Community-Based Outpatient Clinics (CBOCs). The implications of this study are multifaceted and will provide: 1) clinical data on the effectiveness of bCBT for Veterans in CBOC settings; 2) training and clinical support to existing CBOC clinicians who currently struggle to incorporate evidence-based psychotherapies into their clinical practice; 3) a bCBT intervention that is highly flexible and holds the potential to reach Veterans who might otherwise go untreated; and 4) provide preliminary data on the impact of an implementation strategy to aid CBOC clinicians in the use of a structured bCBT. Depression is a serious health condition that places tremendous burden on patients and healthcare systems and is especially prevalent in Veterans. In 2008, the Veterans Health Administration released the Uniform Mental Health Services Handbook in an effort to expand the availability of mental health services for Veterans with depression, including expansion of services for primary care and CBOC settings. Although the VA remains a national leader in mental health services, the provision of psychotherapy within VA is limited, especially for Veterans cared for in CBOC settings. Currently, efforts are needed to assist CBOC clinicians and other stakeholders to address clinical effectiveness and practice barriers related to the utilization of evidence-based psychotherapy in CBOCs.
Aim 1 will seek to determine whether depression outcomes differ as a function of the intervention (bCBT provided by CBOC clinicians vs. enhanced usual care) at post-treatment (4-month), and 8- and 12-month follow-up.
Aim 2 will use a mixed-method formative evaluation to understand the contextual factors related to bCBT feasibility, adoption, and implementation. Formative evaluation will occur before, during, and after implementation and include a needs assessment, modifications to the clinical and implementation approaches, and collection and interpretation of data. The proposed 4-year multi-site trial seeks to use an effectiveness-implementation hybrid type 2 design to examine a bCBT intervention for Veterans with depression as delivered by existing mental health providers in VA CBOC clinics. Clinical effectiveness will focus on the use of a modular bCBT intervention for depression adapted from the PI's prior and ongoing work with Veterans in the primary care setting. A total of 232 Veterans with clinically elevated symptoms of depression will be recruited from CBOC clinics within the Houston and Oklahoma City VAMC stations (8 CBOCs per station). Eligible Veterans will be randomized to either bCBT or to an Enhanced Usual Care (EUC) arm where participant depression information will be conveyed to the Veteran through a depression tool kit as well as to VA providers through the electronic medical record. The proposed implementation strategy, informed by the PARHis framework and tested in an ongoing VA trial, will be vetted and modified through CBOC and national stakeholders. A comprehensive formative evaluation will seek to understand stakeholder needs, modify the proposed strategies (e.g. treatment materials, online clinician training, audit and feedback, and facilitation) and to assess implementation outcomes. As informed by the RE-AIM and PARHiS frameworks, the second aim will explore evidence, context, and facilitation of bCBT for CBOCs with outcomes related to feasibility, acceptability, and impact on care.

Public Health Relevance

This hybrid type 2 effectiveness-implementation trial will examine the clinical impact of a brief cognitive behavioral therapy (bCBT) intervention for depressed veterans as delivered by VA Community- based Outpatient Clinic (CBOC) mental health providers. The trial will also examine the feasibility, acceptability, and preliminary outcomes of a multifaceted implementation strategy designed to increase bCBT adoption and intervention fidelity. Data from this project will help providers, managers, and policy makers to understand the potential impact, challenges and benefits to of using bCBT in VA CBOC settings.

Agency
National Institute of Health (NIH)
Institute
Veterans Affairs (VA)
Type
Non-HHS Research Projects (I01)
Project #
5I01HX001437-02
Application #
9145504
Study Section
HSR-4 Mental and Behavioral Health (HSR4)
Project Start
2015-05-01
Project End
2019-04-30
Budget Start
2016-05-01
Budget End
2017-04-30
Support Year
2
Fiscal Year
2018
Total Cost
Indirect Cost
Name
Michael E Debakey VA Medical Center
Department
Type
DUNS #
078446044
City
Houston
State
TX
Country
United States
Zip Code
77030