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IIR 18-233 – HSR&D Study

IIR 18-233
A pragmatic trial of brief CBT for anxiety in VA primary care
Terri L. Fletcher, PhD
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, TX
Funding Period: October 2020 - May 2025


Anticipated Impacts on Veteran's Healthcare VA has established strategic goals related to “Access” and "Timely and Integrated Care". The proposed pragmatic trial targets these goals by addressing a significant gap in VA mental health care - namely the treatment of anxiety in the primary care setting using innovative delivery options. Using a partnership approach, the project will examine the effectiveness and implementation potential of a brief psychotherapy program for Veterans with anxiety in primary care. Psychotherapy services will be delivered either in-person or through VA Video Connect-Home (VVC-H). Clinical and implementation outcomes will inform future dissemination efforts to improve access and delivery of high quality anxiety care in VA primary care settings. Background Anxiety disorders are common in VA primary care settings and are associated with substantial functional impairment, poor health-related quality of life, suicide, and high rates of comorbid psychiatric and medical disorders. No brief psychotherapy interventions for anxiety currently exist for VA primary care settings - where many Veterans seek care. Cognitive Behavioral Therapy (CBT) is a first line treatment for anxiety but Primary Care Mental Health Integration (PCMHI) providers need an intervention approach for anxiety disorders that is brief, problem-focused, and fits into their system of care. Objectives The proposed 4-year, multisite trial will use a pragmatic randomized trial design to examine the effectiveness and implementation potential of a brief CBT intervention for anxiety delivered either in-person or via VVC-H, according to patient preference. CBT will be delivered by existing PCMHI providers at three large VAMCs. Aim 1 will examine the clinical effectiveness of the bCBT intervention vs. EUC for anxiety and quality of life at 4-, 8-, and 12-month follow-ups. Aim 2 will determine factors associated with bCBT response and explore Veteran demographic and clinical factors associated with VVC-H engagement. An exploratory aim will use mixed, qualitative and quantitative methods to better understand implementation successes and challenges related to delivery and impact of bCBT anxiety and VVC-H use in the PCMHI setting. Methods The proposed project seeks to embed bCBT into PCMHI programs using existing VHA providers. A total of 225 Veterans diagnosed with an anxiety disorder will be recruited from three VAMCs. Eligible Veteran participants will be randomized to a bCBT or to an Enhanced Usual Care (EUC) condition. A professionally diverse set of PCMHI providers will be invited to deliver bCBT. Providers will receive bCBT training and support to embed treatment into their existing practice setting. Veterans randomized to bCBT will receive 4 – 9 sessions based upon treatment response (50% reduction in GAD-7) by session 4. Veterans will also be offered the choice of receiving bCBT in-person or through VVC-H. EUC participants will receive 4 brief monthly check- in calls from study staff and a note placed in their medical record alerting their provider to the presence of significant anxiety symptoms. BCBT treatment and EUC check-in calls will end at 4 months. Next Steps The proposed project leverages VA stakeholders at all levels to improve alignment of the work with VA and Veteran initiatives. Clinical outcomes will provide justifications or cautions to inform future evidence- based psychotherapy (EBP) programs. If positive, data will be used to assist VA leadership in the expansion of EBPs and VVC-H in PCMHI. For example, should the project produce robust clinical outcomes - next steps would involve a non-research / demonstration project in one or two VISNs where the project team will train and support a wider group of providers in the delivery of brief CBT for anxiety. The project team will use the web- based training program and clinical intervention materials as well as lessons learned from the proposed HSR&D IIR to support and enhance brief CBT delivery in a non-research context.

External Links for this Project

NIH Reporter

Grant Number: I01HX002796-01A1

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None at this time.

DRA: Mental, Cognitive and Behavioral Disorders
DRE: Treatment - Efficacy/Effectiveness Clinical Trial, TRL - Applied/Translational
Keywords: Anxiety Disorders, Cognitive Therapy
MeSH Terms: None at this time.

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