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Singula Phase 0.1 Primary Care Pilot

Validation of an Artificial Intelligence (AI)-Powered Clinical Decision Support System for Anxiety and Depression in Primary Care Settings

Who can join

Ages 18 and older · All sexes · Healthy volunteers welcome

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.

About the study

This prospective, single-arm, observational pilot study evaluates a clinical decision support system developed by Singula Health for use in primary care. Adult patients complete a self-report assessment before a routine primary care visit. The system uses the responses to generate a clinician-facing Companion Brief that summarizes relevant information for the treating clinician. Each Companion Brief is reviewed by the Principal Investigator before it is provided to the clinician. The study will evaluate whether the system can reliably generate and deliver the Companion Briefs, whether clinicians find the Briefs useful and acceptable, and whether patients can successfully complete and accept the pre-visit assessment.

Sponsor: Singula Health, Inc. · Participants: 100 · Started: Jul 13, 2026

Contact the study team

• Marc S Lener, MD · Phone: (240) 389-2381

Official record on ClinicalTrials.gov — NCT07834684

Locations in the U.S.

Conditions

• Anxiety

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.