Brief Anxiety Skills Training Intervention for Veterans in Primary Care

Anxiety Clinical Trial

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

Status Recruiting

Clinical Trial Summary

Anxiety symptoms are common among primary care patients, but anxiety is undertreated. Brief behavioral (non-medication) anxiety treatments are needed. The purpose of this study is to evaluate whether a brief anxiety treatment designed for VA primary care is more effective at reducing anxiety symptoms and impairment in Veterans compared to usual care. The brief anxiety treatment, Veterans Anxiety Skills Training (VAST), was designed to be evidence-based (emphasis on cognitive-behavioral skills), transdiagnostic (applicable to a wide range of anxiety symptoms), feasible for integrated primary care (no more than 6 brief [30-minute] sessions), and Veteran-centered (tailored to Veterans and personalized to individual patients). A total of 178 adult Veteran primary care patients from the Syracuse and Western New York VA healthcare systems who are experiencing anxiety symptoms will be recruited and randomly assigned to receive the brief anxiety treatment or usual care. The investigators will compare anxiety symptom severity and functional impairment between the two groups at baseline and at post-assessment (at 16 weeks) and follow-up assessment (at 28 weeks). The investigators will also examine predictors of treatment response among those receiving VAST and whether providers deliver VAST as intended.

Clinical Trial Description

Background/Rationale: Many Veteran primary care patients experience impairing symptoms of anxiety, but rates of behavioral treatment are low. 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 consists of empirically-supported cognitive-behavioral therapy techniques adapted into a manualized modular intervention specifically designed for delivery in PCMHI.

Objectives: The specific aims of this study are to: (1) Compare patient clinical outcomes for VAST vs. PCMHI usual care between baseline and 16 weeks (post), and also examine whether treatment gains are more likely to be maintained for VAST vs. PCMHI usual care at 28 weeks (follow-up); (2) For participants receiving 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.

Methods: In this multi-site, hybrid type I effectiveness-implementation randomized clinical trial, 178 adult Veterans with elevated anxiety symptoms will be recruited from primary care at the Syracuse and Western New York VA Medical Centers (VAMCs) and Community-Based Outpatient Clinics (CBOCs). PCMHI providers will be randomized to deliver either VAST or usual care (routine PCMHI care, meaning whatever care the provider deems appropriate), and Veteran participants will be randomized to condition. VAST (up to six 30-minute sessions) consists of a standard initial and final session as well as up to 4 cognitive-behavioral skills modules. The primary outcome (Overall Anxiety Severity and Impairment Scale [OASIS]) and secondary outcomes (anxiety and depressive symptom severity, functioning, quality of life, suicidality) will be assessed at baseline, 16 weeks (post) and 28 weeks (follow-up). Symptom severity and impairment will also be assessed at 4, 8, and 12 weeks as part of Aim 2. The fidelity of VAST delivery by PCMHI providers will be measured and tracked, and VAST providers will complete semi-structured interviews at the beginning and end of the study.

Analytic plan: Multi-level modeling will be used to evaluate the hypothesis that patient clinical outcomes will improve more from baseline to post (16 weeks) for participants receiving VAST compared to PCMHI usual care. The primary analysis will be conducted using the intention-to-treat approach. Multi-level modeling will also be used to examine group differences in the secondary outcomes at post (16 weeks) and the primary outcomes at follow-up (28 weeks). Multivariate logistic regression will be used to explore predictors of early (8 weeks) and overall (16 weeks) VAST treatment response (defined as a decrease of 4 or more points on the OASIS). 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. ;

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

• NCT number: NCT04829240
• Study type: Interventional
• Source: VA Office of Research and Development
• Contact: Robyn L Shepardson, PhD
• Phone: (315) 425-4400
• Email: Robyn.Shepardson@va.gov
• Status: Recruiting
• Phase: Phase 3
• Start date: August 17, 2021
• Completion date: April 30, 2025