Recruiting

Companion BriefSingula Phase 0.1 Primary Care Pilot

Sponsor:

Singula Health, Inc.

Code:

NCT07834684

Conditions

Depression - Major Depressive Disorder

Anxiety

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief summary:

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.

Conditions

Depression - Major Depressive Disorder

Anxiety

Study ID

NCT07834684

Start date

Jul 13, 2026

Status verified date

Sep, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Primary Care Patient Cohort

Adult primary care patients evaluated during routine clinical care using the Singula Artificial Intelligence (AI)-powered clinical decision support system for assessment of anxiety and depression. Participants are included in a single observational cohort; no study-assigned intervention is administered.

Primary outcome measure

Successful Production and Delivery of the Companion Brief [ Time Frame: Up to 7 days ]
Clinician-Rated Overall Clinical Utility of the Companion Brief [ Time Frame: Periodic feedback during active enrollment, approximately 30 to 90 days ]

Central Contacts and Locations

Central contacts

Marc S Lener, MD

(240) 389-2381 marc.lener@singulahealth.com

Locations

WestDocs Concierge

Recruiting

Mount Kisco, New York, United States, 10549

Contacts

Lisa Youkeles, MD

914-218-3838 general@westdocsconcierge.com

More Information

Sponsor

Singula Health, Inc.

Last update posted

Sep 22, 2026

Last verified

Sep, 2026

Keywords

Clinical Decision Support System
Artificial Intelligence
Primary Care
Mental Health Screening
Companion Brief
Patient Health Questionnaire-9 (PHQ-9)
Generalized Anxiety Disorder-7 (GAD-7)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Singula Health, Inc. on 2026-09-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.