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Randomized Controlled Trial
. 2024 Sep 15:361:497-507.
doi: 10.1016/j.jad.2024.05.107. Epub 2024 May 27.

Brief modular anxiety intervention for primary care: Hybrid I pilot randomized controlled trial of feasibility, acceptability, effectiveness, and implementation potential

Robyn L Shepardson  1 , Risa B Weisberg  2 , Michael Wade  3 , Stephen A Maisto  4 , Jennifer S Funderburk  5
Affiliations
Randomized Controlled Trial

Brief modular anxiety intervention for primary care: Hybrid I pilot randomized controlled trial of feasibility, acceptability, effectiveness, and implementation potential

Robyn L Shepardson et al. J Affect Disord. .

Abstract

Background: Anxiety is highly prevalent, but undertreated, in primary care. Brief, non-pharmacological interventions are needed. Modular Anxiety Skills Training (MAST), a cognitive-behavioral anxiety intervention, was developed for primary care and tailored for a Veteran sample (MAST-V). The purpose of this mixed methods pilot study was to evaluate MAST-V's feasibility, acceptability, and implementation potential, and preliminarily examine its effectiveness compared to Primary Care Behavioral Health (PCBH) usual care.

Methods: This hybrid I randomized controlled trial (conducted 2019-2021) assigned 35 primary care patients (Mage = 47, 17 % female, 27 % racial/ethnic minority) with clinically significant anxiety symptoms to receive MAST-V or PCBH usual care. Participants completed validated measures of anxiety symptoms and functional impairment at 0, 4, 8, 12, and 16 weeks.

Results: Participants attended more sessions in MAST-V than usual care. After necessary adjustments to reduce session duration, MAST-V will likely fit within PCBH practice parameters. Participants in both conditions valued treatment, but treatment satisfaction, credibility, and therapeutic alliance were higher for MAST-V. Study therapists achieved high treatment fidelity and rated MAST-V as highly feasible, acceptable, and appropriate for PCBH. They identified ways to address potential barriers to implementation. MAST-V was more effective than usual care in reducing anxiety symptoms and impairment.

Limitations: This was a small pilot study at a single site using study therapists. Results should be considered preliminary until replicated in a full-scale clinical trial.

Conclusions: This brief modular anxiety intervention, which was designed with implementation in mind, may help to address the anxiety treatment gap in primary care.

Keywords: Anxiety; Cognitive-behavioral therapy; Integrated behavioral healthcare; Intervention; Primary care; Veterans.

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Conflict of interest statement

Declaration of competing interest During the period of work, Risa B. Weisberg received an honorarium from Almatica Pharma. Dr. Weisberg is now Chief Clinical Officer at RealizedCare, a digital mental health start-up that produces digital versions of evidence-based cognitive-behavioral therapy for anxiety and other mental health disorders. The remaining authors declare that they have no conflicts of interest.

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