CompletedNot Applicable

Brief Anxiety Skills Training Intervention for Veterans in Primary Care

United States213 participantsStarted 2021-08-17

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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, defi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Overall Anxiety Severity and Impairment Scale Change

Timeframe: Baseline, Post-assessment (16 weeks), Follow-up assessment (28 weeks)

Trial details

NCT IDNCT04829240

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2025-05-31

Results submitted2026-05-08

View on ClinicalTrials.gov More Anxiety trials