BACKGROUND/RATIONALE:
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.

OBJECTIVE(S):
The project objectives include: Aim 1 - Clinical Effectiveness: To determine whether depression (PHQ-9 and Beck Depression Inventory) and
quality- of-life (SF-12) differ as a function of bCBT (vs. EUC) at 4-, 8- and 12-month follow-ups. Aim 2 - Implementation: Use a mixed-method formative evaluation to capture information on the clinical and implementation efforts. Data will be used to modify the implementation strategy during the trial. Formative
evaluation will include a developmental assessment to collect data on clinician adoption, intervention fidelity, and individual interviews with stakeholders to obtain a deeper understanding of implementation challenges.

METHODS:
The proposed 4-year, multisite, randomized hybrid effectiveness-implementation trial will focus on the real-world application of bCBT for Veterans with depression, as applied by frontline CBOC practitioners. A total of 232 Veterans will be recruited. Patients that received care at the Houston and Oklahoma City CBOCs will be recruited. The patients will primarily by identified from national VA databases.

Once patients have been identified, a chart review will be conducted to confirm they are not already receiving psychotherapy and that they are not excluded for other serious mental health conditions. Eligible patients will be mailed an opt-out letter. Veterans that don't opt-out will be called and if interested will be screened for eligibility. Eligible participants (those who screen positive for depression on the PHQ-9 will be scheduled for a baseline assessment.

Participant informed consent will be obtained at the baseline appointment. Veterans with clinically significant symptoms of depression (PHQ-9 score of 10 or greater) will be eligible for the study. Eligible Veterans after baseline will be randomized to the bCBT intervention or to an Enhanced Usual Care (EUC) group. Veterans randomized to the bCT intervention will be assigned to work with a trained study clinician and will be eligible to have 3 - 9 sessions over a 4 month period. The EUC participants will receive depression education materials, a note placed in their medical record indicating the presence of depression and encouragement to seek services from their existing providers.

The proposed implementation strategy for provider participants, 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.



FINDINGS/RESULTS:
The project is currently being conducted - there are no findings to report at this time. The projected date for completion of follow up assessments is April 2019.

IMPACT:
The study will provide important clinical data on the effectiveness of a bCBT intervention for Veterans with depression in CBOC settings. Effectiveness data are viewed as critical to our national partners, who are particularly interested in showing the impact of mental health interventions for Veterans.

In addition, the study will augment clinical-effectiveness data by evaluating an implementation strategy and will conduct a comprehensive formative evaluation to identify barriers and facilitators of bCBT use in CBOC settings. The information will allow the study to modify the implementation strategy in real time to improve its usefulness. Also, the study will provide training and support to CBOC clinicians, who frequently desire connectivity to additional mental health training opportunities and resources.

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External Links for this Project

NIH Reporter

Grant Number: I01HX001437-01A1
Link: https://reporter.nih.gov/project-details/8783602

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PUBLICATIONS:

Journal Articles

1. Johnson AL, Ecker AH, Fletcher TL, Hundt N, Kauth MR, Martin LA, Curran GM, Cully JA. Increasing the impact of randomized controlled trials: an example of a hybrid effectiveness-implementation design in psychotherapy research. Translational behavioral medicine. 2020 Aug 7; 10(3):629-636. [view]
2. Brandt CP, Deavers F, Hundt NE, Fletcher TL, Cully JA. The Impact of Integrating Physical Health into a Brief CBT Approach for Medically Ill Veterans. Journal of Clinical Psychology in Medical Settings. 2020 Jun 1; 27(2):285-294. [view]

DRA: Mental, Cognitive and Behavioral Disorders
DRE: Treatment - Efficacy/Effectiveness Clinical Trial, Treatment - Implementation
Keywords: Cognitive Therapy, Depression, Implementation, Rural
MeSH Terms: none