Improving Anxiety Treatment Engagement and Effectiveness in Primary Care-Mental Health Integration: Multi-site Hybrid I RCT of a Brief Veteran-Centered Anxiety Intervention

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Background: Many Veterans experience impairing symptoms of anxiety and seek treatment in primary care, yet anxiety is highly undertreated in this setting. Primary Care-Mental Health Integration (PCMHI), in which mental health clinicians embedded in primary care provide brief treatment, affords an opportunity to address this treatment gap. However, behavioral interventions that are compatible with the brief PCMHI treatment format and able to accommodate a wide range of anxiety presentations are needed. Accordingly, Veterans Anxiety Skills Training (VAST) was designed to be evidence-based, transdiagnostic, feasible for PCMHI, and Veteran-centered. VAST comprises empirically-supported cognitive-behavioral therapy (CBT) techniques adapted into a manualized modular intervention specifically designed for delivery in PCMHI. As VAST is being piloted at a single site with study therapists, the next scientific step is a multi-site randomized controlled trial (RCT) to evaluate its effectiveness using PCMHI providers in routine care. Significance/Impact: This study addresses Veteran care priorities of mental health and suicide prevention, MISSION Act priorities of increasing access to care and improving patient satisfaction with Veterans Health Administration (VHA) care, and Health Services Research and Development (HSR&D) focus areas of quality, effectiveness, and efficiency as well as implementation science research methods. Improving anxiety treatment in PCMHI will address a major gap in VHA treatment options, given the high prevalence of anxiety in primary care, tendency for patients with anxiety to seek treatment in primary care rather than specialty mental health settings, and absence of Evidence-Based Psychotherapy (EBP) protocols addressing non-trauma related anxiety. Innovation: Modular (vs. standard) intervention designs offer advantages in efficiency, patient and provider satisfaction, efficacy, effectiveness, implementation, and sustainability. Other innovative aspects include the transdiagnostic approach and examination of fidelity to inform future implementation. Specific Aims: The specific aims are to: (1) Compare patient clinical outcomes for VAST vs. PCMHI usual care between baseline and 16 weeks (post) in a multi-site RCT in which PCMHI providers deliver VAST, and examine whether treatment gains are more likely to be maintained for VAST vs. PCMHI usual care at 28 weeks (follow-up); (2) For participants assigned to receive VAST, explore patient-level predictors of (a) early (8 weeks) and (b) overall (16 weeks) treatment response; and (3) Conduct a mixed-methods process evaluation of VAST implementation to examine rates of, barriers to, and facilitators of achieving and sustaining high-fidelity intervention delivery. Methodology: In this multi-site, hybrid type I effectiveness-implementation RCT, 178 adult Veterans with elevated anxiety symptoms will be recruited from primary care at two VHA sites. PCMHI providers will be randomized to deliver either VAST or usual care (routine PCMHI care, meaning whatever care the provider deems appropriate), and participants will be randomized to condition. VAST (up to six biweekly 30-minute sessions) consists of a standard initial and final session as well as up to 4 CBT skills-based modules. The primary outcome (Overall Anxiety Severity and Impairment Scale) and secondary outcomes (anxiety and depressive symptom severity, functioning, quality of life, suicidality) will be assessed at baseline, 4, 8, 12, 16 (post) and 28 weeks (follow-up). Multi-level modeling will be used to evaluate the hypothesis that patient clinical outcomes will improve more from baseline to 16 weeks for participants receiving VAST compared to PCMHI usual care. Multivariate logistic regression will be used to explore predictors of early (8 weeks) and overall (16 weeks) VAST treatment response. A mixed- methods process evaluation will examine the proportion of PCMHI providers who achieve and sustain high- fidelity VAST delivery as well as barriers to and facilitators of high-fidelity delivery. Implementation/Next Steps: VAST will be disseminated to VHA PCMHI leadership and providers nationwide using several strategies, and a follow-up hybrid III trial will facilitate formal implementation in VHA PCMHI.