Pre-visit Companion Brief: a primary care AI-assisted check for depression and anxiety

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-arm, observational pilot in primary care that examines a clinical decision support system designed to summarize patient-reported mental health information into a Companion Brief for clinicians. After a patient completes a pre-visit, validated screening measures and questions are processed by an automated pipeline to generate a draft Companion Brief, which the Principal Investigator reviews before sharing with the clinician. The goal is to assess feasibility, reliability of brief generation, and clinician and patient acceptance of the workflow in real-world settings. The study refrains from directing treatment and focuses on feasibility, operational performance, and user feedback to inform future development. Findings will guide potential next steps for technical and procedural refinements.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult, aged 18 years or older at the time of consent.
* Scheduled for a routine, non-urgent primary care visit at a participating practice.
* Able to read and understand English at a level sufficient to complete the electronic informed consent and Survey 0.1 independently.
* Has personal-device access to complete the survey (smartphone, tablet, or computer with internet).
* Capable of providing informed consent.

Exclusion Criteria:

* Non-English-speaking, defined as inability to read English at a level sufficient to complete electronic informed consent and the survey independently.
* Visually impaired to a degree that prevents independent reading of an electronic consent form on a personal device, without specialized assistive technology beyond standard mobile-device accessibility features.
* Unable to read for any reason (literacy, cognitive impairment, or other).
* Presenting with an acute psychiatric emergency or in acute crisis at the time of the scheduled visit, as identified by clinic staff during routine check-in.
* Patient is a known minor at the time of scheduling (under 18 years).
* Patient or clinician declines participation.

Where it's running

• WestDocs Concierge
  Mount Kisco, New York, United States Recruiting
• Morris Medical Office
  Brentwood, New York, United States Completed

Study contacts

• Principal investigator: Marc S Lener, MD — Singula Health, Inc.
• Study coordinator: Marc S Lener, MD
• Email: marc.lener@singulahealth.com
• Phone: (240) 389-2381

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.