Singula Phase 0.1 Primary Care Pilot

NCT07834684 | Recruiting

• 1 other identifier: SINGULA-CDSS-PCP-0.1
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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

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)

Outcome Measures

Primary Outcomes (2)

• Successful Production and Delivery of the Companion Brief

  Proportion of enrolled patient cases for which an Artificial Intelligence (AI)-generated Companion Brief is successfully produced, reviewed by the Principal Investigator, and delivered to the treating clinician prior to the patient's scheduled visit.

  Up to 7 days

• Clinician-Rated Overall Clinical Utility of the Companion Brief

  Clinician-rated overall clinical utility of the Companion Brief, captured on the periodic batched feedback survey using a 5-point Likert scale. Target: ≥70% of feedback batches indicating overall utility of "useful" or "very useful" across the cases covered in each batch.

  Periodic feedback during active enrollment, approximately 30 to 90 days

Secondary Outcomes (9)

• Survey 0.1 Completion Rate

  Up to 7 days

• Pipeline End-to-End Latency

  Up to 72 hours

• Principal Investigator Corrections to Large Language Model (LLM)-Generated Reports

  Up to 7 days

• Number of Safety-Flag Triggers Generated by the Clinical Decision Support System

  Up to 8 days

• Number of Safety-Flag Triggers by Documented Disposition

  Up to 8 days

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged 18 years or older presenting for a routine, non-urgent primary care visit at a participating independent primary care practice. Eligible patients complete a pre-visit electronic informed consent and self-report assessment (Survey 0.1) on a personal device prior to their scheduled visit.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Singula Health, Inc.: lead

Study Sites (2)

Morris Medical Office

Brentwood, New York, 11717, United States

COMPLETED

WestDocs Concierge

Mount Kisco, New York, 10549, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Marc S Lener, MD

  Singula Health, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc S Lener, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 22, 2026
• Study Start: July 13, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)