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NCT04829240

Brief Anxiety Skills Training Intervention for Veterans in Primary Care

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

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 170 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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

213

Start Date

2021-08-17

Completion Date

2025-08-31

Last Updated

2026-08-07

Healthy Volunteers

Conditions

Anxiety

Interventions

BEHAVIORAL

Veterans Anxiety Skills Training Intervention

Modular anxiety intervention designed for Primary Care-Mental Health Integration settings, including up to six 30-minute sessions occurring approximately every 2 weeks, in which Veterans select modules of interest to them to complete, with an emphasis on psychoeducation and cognitive-behavioral coping strategies for self management of anxiety symptoms

BEHAVIORAL

PCMHI Usual Care

Appointment with Primary Care-Mental Health Integration provider at local primary care clinic for anxiety treatment; provider delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PCMHI care

Patient Inclusion Criteria: * Veteran, * Age \>=18 years, * Seen in the Syracuse or Western New York VAMC or CBOC primary care clinic in the past 12 months, * Screen positive for current (past 2 weeks) clinically significant anxiety symptoms (\>= 8 on GAD7) Provider Inclusion Criteria: * Current behavioral health provider working in Primary Care-Mental Health Integration (PCMHI) at the VA Syracuse or VA Western New York healthcare system, including full-time, part-time, and trainee status Patient Exclusion Criteria: * Inability to communicate in English (as assessed by study staff); * Hearing impairment that precludes completion of telephone eligibility screening (as assessed by study staff); * Cognitive impairment that precludes informed consent, defined as any of the following: * not able to comprehend the study description or eligibility screening as assessed by study staff, * diagnosis of dementia or severe cognitive impairment per self-report, primary care provider, or Problem List, or * screen positive for cognitive impairment (\>= 3 errors on screener); * Diagnosis of Obsessive-Compulsive Disorder (OCD) or serious mental illness (SMI, i.e., psychotic disorders, bipolar disorder) in Problem List; * Encounter diagnosis of Posttraumatic Stress Disorder (PTSD) within the past 2 years or screen positive for PTSD (\>= 4 for men or \>= 5 for women on the Primary Care PTSD Screen for DSM-5; * Currently in psychotherapy/counseling for anxiety and/or depression, defined as any of the following within the past 30 days: * attending \>= 1 non-intake specialty mental health session, * attending \>= 2 PCMHI sessions, or * being hospitalized for mental health treatment; * Current (past 2 weeks) severe depressive symptoms (\>= 20 on PHQ9); * At imminent risk of suicide, defined as being in need of intensive treatment (e.g., hospitalization) to ensure safety, based on study staff's suicide risk assessment (verified by the PI); * Started or had dosage change in psychotropic medication for anxiety or depression in the past 30 days Provider Exclusion Criteria: * None

Locations (2)

VA Western New York Healthcare System, Buffalo, NY

Buffalo, New York, United States

Syracuse VA Medical Center, Syracuse, NY

Syracuse, New York, United States