Depression - Major Depressive DisorderNCT07834684
Singula Phase 0.1 Primary Care Pilot
An observational study of Depression - Major Depressive Disorder and Anxiety, run by Singula Health, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression - Major Depressive Disorder, Anxiety
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Jul 2026to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Completed
Morris Medical Office
Brentwood, New York, 11717
- Recruiting
WestDocs Concierge
Mount Kisco, New York, 10549
Lisa Youkeles, MD, 914-218-3838, general@westdocsconcierge.com
About this study
Official title: Validation of an Artificial Intelligence (AI)-Powered Clinical Decision Support System for Anxiety and Depression in Primary Care Settings
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.
Read the detailed description
The Singula clinical decision support system is designed to organize information collected from a patient before a routine primary care visit into a structured Companion Brief for the treating clinician. The pre-visit assessment includes validated screening measures and structured questions addressing behavioral health symptoms and other factors relevant to the patient's clinical context. After a patient completes the assessment, an automated software pipeline processes the responses and generates a draft Companion Brief. The Principal Investigator reviews each Artificial Intelligence (AI)-generated Brief for clinical accuracy, appropriate safety language, and potential errors before it is released to the treating clinician. The treating clinician receives the reviewed Brief before the patient's routine primary care visit and retains full independent authority over clinical assessment and decision-making. The Companion Brief is informational and does not direct treatment. This Phase 0.1 pilot is intended primarily to characterize the feasibility and operational performance of this workflow in real-world primary care. The study will examine successful generation and delivery of Companion Briefs, pipeline performance, clinician feedback regarding the utility and acceptability of the Briefs, patient completion of the pre-visit assessment, and errors or other operational issues identified during the pilot. Findings from this study are intended to inform subsequent technical, operational, and clinical development of the system.
- 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)
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Periodic feedback during active enrollment, approximately 30 to 90 days
Secondary outcomes (9)
Survey 0.1 Completion Rate
Completion rate of Survey 0.1 among consented patient participants
Measured: Up to 7 days
Pipeline End-to-End Latency
End-to-end latency from Survey 0.1 submission to availability of the generated Companion Brief in storage.
Measured: Up to 72 hours
Principal Investigator Corrections to Large Language Model (LLM)-Generated Reports
Number and category of Principal Investigator corrections to Large Language Model (LLM)-Generated Companion Briefs, categorized as clinical accuracy, safety language, formatting, or hallucination.
Measured: Up to 7 days
Number of Safety-Flag Triggers Generated by the Clinical Decision Support System
Total number of safety-flag triggers generated by the clinical decision support system during the study period. Safety-flag triggers will be classified by risk level (Critical or High) for descriptive reporting.
Measured: Up to 8 days
Number of Safety-Flag Triggers by Documented Disposition
Number of safety-flag triggers by documented disposition category following Principal Investigator review and clinician notification.
Measured: Up to 8 days
Clinician-Rated Most Useful Companion Brief Section
Clinician identification of the most useful Companion Brief section across cases included in each feedback batch.
Measured: Periodic feedback during active enrollment, approximately 30 to 90 days
Number of Feedback Batches With Clinician-Reported Influence on Clinical Decision-Making, Measured by the Singula Clinician Feedback Survey
Clinician-reported influence of Companion Briefs on clinical decision-making will be assessed using the Singula Clinician Feedback Survey. For each feedback batch, clinicians will indicate whether any Companion Brief in the batch period influenced a clinical decision. The outcome will be reported as the number of feedback batches in which an influence on clinical decision-making was reported.
Measured: Periodic feedback during active enrollment, approximately 30 to 90 days
Clinician-Reported Willingness to Continue Using the Companion Brief, Measured by the Singula Clinician Feedback Survey
Clinician-reported willingness to continue using the Companion Brief system will be assessed using the Singula Clinician Feedback Survey. Responses will be summarized across clinician feedback collected during the study period.
Measured: Periodic feedback during active enrollment, approximately 30 to 90 days
Patient Survey Dropout and Skip Patterns
Patient-side dropout and question-skipping patterns during completion of Survey 0.1.
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start13 Jul 2026
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singula Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc S Lener, MD, Principal investigator, Singula Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834684
- Sponsor's protocol ID
- SINGULA-CDSS-PCP-0.1
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers. External use of study findings will be limited to aggregate, de-identified data. Individual participant data, individual Companion Briefs, and individual survey responses will not be used externally. De-identified analytic data may be retained by Singula Health, Inc. for internal product development, regulatory documentation, and internal research and quality improvement.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of an Artificial Intelligence (AI)-Powered Clinical Decision Support System for Anxiety and Depression in Primary Care Settings
- ClinicalTrials.gov ID
- NCT07834684
- Acronym / sponsor ID
- SINGULA-CDSS-PCP-0.1
- 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)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Singula Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Jul 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Singula clinical decision support system is designed to organize information collected from a patient before a routine primary care visit into a structured Companion Brief for the treating clinician. The pre-visit assessment includes validated screening measures and structured questions addressing behavioral health symptoms and other factors relevant to the patient's clinical context. After a patient completes the assessment, an automated software pipeline processes the responses and generates a draft Companion Brief. The Principal Investigator reviews each Artificial Intelligence (AI)-generated Brief for clinical accuracy, appropriate safety language, and potential errors before it is released to the treating clinician. The treating clinician receives the reviewed Brief before the patient's routine primary care visit and retains full independent authority over clinical assessment and decision-making. The Companion Brief is informational and does not direct treatment. This Phase 0.1 pilot is intended primarily to characterize the feasibility and operational performance of this workflow in real-world primary care. The study will examine successful generation and delivery of Companion Briefs, pipeline performance, clinician feedback regarding the utility and acceptability of the Briefs, patient completion of the pre-visit assessment, and errors or other operational issues identified during the pilot. Findings from this study are intended to inform subsequent technical, operational, and clinical development of the system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Successful Production and Delivery of the Companion Brief
Time frame: Up to 7 days
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.
Clinician-Rated Overall Clinical Utility of the Companion Brief
Time frame: Periodic feedback during active enrollment, approximately 30 to 90 days
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.
9 secondary outcomes
Survey 0.1 Completion Rate
Time frame: Up to 7 days
Pipeline End-to-End Latency
Time frame: Up to 72 hours
Principal Investigator Corrections to Large Language Model (LLM)-Generated Reports
Time frame: Up to 7 days
Number of Safety-Flag Triggers Generated by the Clinical Decision Support System
Time frame: Up to 8 days
Number of Safety-Flag Triggers by Documented Disposition
Time frame: Up to 8 days
Clinician-Rated Most Useful Companion Brief Section
Time frame: Periodic feedback during active enrollment, approximately 30 to 90 days
Number of Feedback Batches With Clinician-Reported Influence on Clinical Decision-Making, Measured by the Singula Clinician Feedback Survey
Time frame: Periodic feedback during active enrollment, approximately 30 to 90 days
Clinician-Reported Willingness to Continue Using the Companion Brief, Measured by the Singula Clinician Feedback Survey
Time frame: Periodic feedback during active enrollment, approximately 30 to 90 days
Patient Survey Dropout and Skip Patterns
Time frame: Up to 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers. External use of study findings will be limited to aggregate, de-identified data. Individual participant data, individual Companion Briefs, and individual survey responses will not be used externally. De-identified analytic data may be retained by Singula Health, Inc. for internal product development, regulatory documentation, and internal research and quality improvement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marc S Lener, MD principal investigator
Singula Health, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression - Major Depressive Disorder and Anxiety, run by Singula Health, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc S Lener, MD ((240) 389-2381, marc.lener@singulahealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Production and Delivery of the Companion Brief (time frame: Up to 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.