C04 – Brief Transdiagnostic Modular CBT Intervention for Anxiety in Primary Care: Effectiveness and Implementation Results from a Pilot Hybrid I Randomized Controlled Trial

Summary

Anxiety is prevalent, but undertreated, among primary care patients. We developed Modular Anxiety Skills Training (MAST), an evidence-based, transdiagnostic intervention for use in Primary Care Behavioral Health (PCBH) settings, to help address this treatment gap. MAST includes 9 modules that provide psychoeducation and teach cognitive-behavioral coping skills to improve self-management. We conducted a pilot hybrid I randomized controlled trial within the Veterans Health Administration (using MAST for Veterans or MAST-V) to (1) assess feasibility and acceptability, (2) preliminarily evaluate effectiveness compared to PCBH usual care, and (3) identify potential barriers and facilitators to future implementation of the intervention. Participants (N=36, 17% women, 28% non-White or Latinx, age M=47 [16] years, range: 23-77) reporting current anxiety symptoms (GAD7≥8) were recruited from primary care at a VA medical center and completed assessments every 4 weeks for 16 weeks. 35 patients were randomized to MAST-V (n=17), which was delivered by 5 study therapists (39% of sessions via telehealth), or PCBH usual care (n=18), which was delivered by 6 clinic providers. The COVID-19 pandemic began approximately two-thirds through the trial thus necessitating a switch to telehealth modalities. We will report data on feasibility (engagement, retention, number and duration of sessions), acceptability (treatment satisfaction and credibility, therapeutic alliance, qualitative patient perceptions), effectiveness (functional impairment and anxiety, depression, and stress symptoms), and implementation (validated scales, MAST-V fidelity, qualitative provider perceptions). The primary effectiveness outcome is a validated measure of anxiety symptom severity and impairment that will be at evaluated using multi-level modeling. This study illustrates how data related to effectiveness and implementation can be collected within hybrid trials. We will examine the impact of the switch to telehealth on trial outcomes. Promising data from this pilot trial would demonstrate the utility of continued research and evaluation of brief transdiagnostic modular interventions, which can be delivered feasibly in-person and via telehealth, to improve engagement and effectiveness of anxiety treatment in primary care.