U01MH136535
Cooperative Agreement
Overview
Grant Description
Phenotypes reimagined to define clinical treatment and outcome research (PREDICTOR) - Project summary
Psychiatry faces a significant challenge in the absence of objective measures to assess behavior.
Clinicians form clinical opinions based largely on their impressions from interviewing and what they read in the electronic health record.
As a result, we are currently unable to provide reliable prognoses on an individual basis.
One untapped source of behavioral information for clinical decision-making is the clinical interview itself, which forms the foundation of the electronic health record (EHR).
Every clinical visit provides a wealth of behavioral information comprising spoken language, eye contact, and facial expressions from both the patient and the clinician.
Another source of behavioral data, which is ecologically valid, comes from smartphones, which provide physical activity metrics (e.g., step count, distance traveled), geolocation, social interactions (e.g., SMS messages and phone calls made and received), sleep patterns, and audio data from diaries.
By analyzing these rich behavioral datasets from routine clinical visits and smartphones, we can develop clinical signatures for particularly clinically relevant outcomes in young help-seeking people, namely treatment disengagement, ER visits, and hospitalizations.
These individualized clinical signatures are important for the real-life situation that confronts both clinician and patient at the first visit to a mental health clinic.
This proposal includes all new patients (N = 2100), ages 15 to 30, who seek treatment for the first time at one of six outpatient mental health clinics in the Mount Sinai Health System.
Aim 1 is to create a baseline clinical signature for outcomes using deep neural network modeling of legacy EHR data and baseline behavior, which includes audiovisual recordings of intake interviews, ratings of working alliance, and brief surveys and tests of cognition.
Aim 2 is to use contextual bandit to create a longitudinal clinical signature for outcomes based on subsequent behavioral data from clinical interviews (and their accompanying notes), and smartphone passive data and audio diary data.
Contextual bandit is a model that keeps updating probabilities and odds over time as it is given new data.
Aim 3 is to create clinical signatures based on EHR data alone, such that the added value of behavioral data for aims 1 and 2 can be quantified.
Study assessments are standard, low-cost, and easy to administer, with good variance, validity, reliability, and attention to bias.
Across all aims, fusion will be used for behavioral feature extraction and natural language processing (NLP) for analysis of both written language (clinical text) and spoken language (clinical visits and audio diaries).
Data science methods have been optimized for partnership with the DCC.
Health equity, community engagement, and ethical issues re privacy, informed consent, and fairness have been prioritized.
Psychiatry faces a significant challenge in the absence of objective measures to assess behavior.
Clinicians form clinical opinions based largely on their impressions from interviewing and what they read in the electronic health record.
As a result, we are currently unable to provide reliable prognoses on an individual basis.
One untapped source of behavioral information for clinical decision-making is the clinical interview itself, which forms the foundation of the electronic health record (EHR).
Every clinical visit provides a wealth of behavioral information comprising spoken language, eye contact, and facial expressions from both the patient and the clinician.
Another source of behavioral data, which is ecologically valid, comes from smartphones, which provide physical activity metrics (e.g., step count, distance traveled), geolocation, social interactions (e.g., SMS messages and phone calls made and received), sleep patterns, and audio data from diaries.
By analyzing these rich behavioral datasets from routine clinical visits and smartphones, we can develop clinical signatures for particularly clinically relevant outcomes in young help-seeking people, namely treatment disengagement, ER visits, and hospitalizations.
These individualized clinical signatures are important for the real-life situation that confronts both clinician and patient at the first visit to a mental health clinic.
This proposal includes all new patients (N = 2100), ages 15 to 30, who seek treatment for the first time at one of six outpatient mental health clinics in the Mount Sinai Health System.
Aim 1 is to create a baseline clinical signature for outcomes using deep neural network modeling of legacy EHR data and baseline behavior, which includes audiovisual recordings of intake interviews, ratings of working alliance, and brief surveys and tests of cognition.
Aim 2 is to use contextual bandit to create a longitudinal clinical signature for outcomes based on subsequent behavioral data from clinical interviews (and their accompanying notes), and smartphone passive data and audio diary data.
Contextual bandit is a model that keeps updating probabilities and odds over time as it is given new data.
Aim 3 is to create clinical signatures based on EHR data alone, such that the added value of behavioral data for aims 1 and 2 can be quantified.
Study assessments are standard, low-cost, and easy to administer, with good variance, validity, reliability, and attention to bias.
Across all aims, fusion will be used for behavioral feature extraction and natural language processing (NLP) for analysis of both written language (clinical text) and spoken language (clinical visits and audio diaries).
Data science methods have been optimized for partnership with the DCC.
Health equity, community engagement, and ethical issues re privacy, informed consent, and fairness have been prioritized.
Funding Goals
THE MISSION OF THE NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH) IS TO TRANSFORM THE UNDERSTANDING AND TREATMENT OF MENTAL ILLNESSES THROUGH BASIC AND CLINICAL RESEARCH, PAVING THE WAY FOR PREVENTION, RECOVERY, AND CURE. IN MAY 2020, NIMH RELEASED ITS NEW STRATEGIC PLAN FOR RESEARCH. THE NEW STRATEGIC PLAN BUILDS ON THE SUCCESSES OF PREVIOUS NIMH STRATEGIC PLANS BY PROVIDING A FRAMEWORK FOR SCIENTIFIC RESEARCH AND EXPLORATION, AND ADDRESSING NEW CHALLENGES IN MENTAL HEALTH. THE NEW STRATEGIC PLAN OUTLINES FOUR HIGH-LEVEL GOALS: GOAL 1: DEFINE THE BRAIN MECHANISMS UNDERLYING COMPLEX BEHAVIORS GOAL 2: EXAMINE MENTAL ILLNESS TRAJECTORIES ACROSS THE LIFESPAN GOAL 3: STRIVE FOR PREVENTION AND CURES GOAL 4: STRENGTHEN THE PUBLIC HEALTH IMPACT OF NIMH-SUPPORTED RESEARCH THESE FOUR GOALS FORM A BROAD ROADMAP FOR THE INSTITUTE'S RESEARCH PRIORITIES OVER THE NEXT FIVE YEARS, BEGINNING WITH THE FUNDAMENTAL SCIENCE OF THE BRAIN AND BEHAVIOR, AND EXTENDING THROUGH EVIDENCE-BASED SERVICES THAT IMPROVE PUBLIC HEALTH OUTCOMES. THE INSTITUTE'S OVERALL FUNDING STRATEGY IS TO SUPPORT A BROAD SPECTRUM OF INVESTIGATOR-INITIATED RESEARCH IN FUNDAMENTAL SCIENCE, WITH INCREASING USE OF INSTITUTE-SOLICITED INITIATIVES FOR APPLIED RESEARCH WHERE PUBLIC HEALTH IMPACT IS A SHORT-TERM MEASURE OF SUCCESS. THE NEW STRATEGIC PLAN ALSO ADDRESSES A NUMBER OF CROSS-CUTTING THEMES THAT ARE RELEVANT TO ALL RESEARCH SUPPORTED BY NIMH, THESE THEMES HIGHLIGHT AREAS WHERE NIMH-FUNDED SCIENCE MAY HAVE THE GREATEST IMPACT, BRIDGE GAPS, AND OFFER NOVEL APPROACHES TO ACCELERATE ADVANCES IN MENTAL HEALTH RESEARCH. FOR EXAMPLE, NIMH VALUES A COMPREHENSIVE RESEARCH AGENDA THAT TAKES AN INCLUSIVE APPROACH THAT ENSURES RESEARCH INTERESTS ARE VARIED, MAINTAIN DIVERSE PARTICIPATION AND PARTNERSHIPS, AND ACHIEVE RESEARCH GOALS ACROSS MULTIPLE TIMEFRAMES. THIS INCLUDES DIVERSE METHODOLOGIES, TOOLS, AND MODELS, RESEARCH ADDRESSING COMPLEX BASIC, TRANSLATIONAL, AND APPLIED QUESTIONS, RESEARCH INCLUDING BOTH SEXES AND, AS APPROPRIATE, GENETIC BACKGROUND, AND, PARTICIPANTS FROM DIVERSE RACIAL AND ETHNIC BACKGROUNDS, AND ACROSS GENDER IDENTITIES, GEOGRAPHICAL CONTEXT, SOCIOECONOMIC STATUS, NEUROTYPE, AND AGE OFFERING THE BEST POSSIBLE REPRESENTATION, FOR THE BROADEST NUMBER OF INDIVIDUALS WHO MAY ULTIMATELY BENEFIT FROM THESE SCIENTIFIC ADVANCES. TO ACCOMPLISH THE GOALS OUTLINED IN THE NEW STRATEGIC PLAN, NIMH WILL SUPPORT RESEARCH THAT AIMS: TO CHARACTERIZE THE GENOMIC, MOLECULAR, CELLULAR, AND CIRCUIT COMPONENTS CONTRIBUTING TO BRAIN ORGANIZATION AND FUNCTION, TO IDENTIFY THE DEVELOPMENTAL, FUNCTIONAL, AND REGULATORY MECHANISMS RELEVANT TO COGNITIVE, AFFECTIVE, AND SOCIAL DOMAINS, ACROSS UNITS OF ANALYSIS, AND, TO GENERATE AND VALIDATE NOVEL TOOLS, TECHNIQUES, AND MEASURES TO QUANTIFY CHANGES IN THE ACTIVITY OF MOLECULES, CELLS, CIRCUITS, AND CONNECTOMES. TO DISCOVER GENE VARIANTS AND OTHER GENOMIC ELEMENTS THAT CONTRIBUTE TO THE DEVELOPMENT OF MENTAL ILLNESSES IN DIVERSE POPULATIONS, TO ADVANCE OUR UNDERSTANDING OF THE COMPLEX ETIOLOGY OF MENTAL ILLNESSES USING MOLECULAR EPIDEMIOLOGIC APPROACHES THAT INCORPORATE INDIVIDUAL GENETIC INFORMATION IN LARGE COHORTS, TO ELUCIDATE HOW HUMAN GENETIC VARIATION AFFECTS THE COORDINATION OF MOLECULAR, CELLULAR, AND PHYSIOLOGICAL NETWORKS SUPPORTING HIGHER-ORDER FUNCTIONS AND EMERGENT PROPERTIES OF NEUROBIOLOGICAL SYSTEMS, AND, TO DEVELOP NOVEL TOOLS AND TECHNIQUES FOR THE ANALYSIS OF LARGE-SCALE GENETIC, MULTI-OMIC DATA AS IT APPLIES TO MENTAL HEALTH. TO UTILIZE CONNECTOMIC APPROACHES TO IDENTIFY BRAIN NETWORKS AND CIRCUIT COMPONENTS THAT CONTRIBUTE TO VARIOUS ASPECTS OF MENTAL FUNCTION AND DYSFUNCTION, TO DETERMINE THROUGH BRAIN-WIDE ANALYSIS HOW CHANGES IN THE PHYSIOLOGICAL PROPERTIES OF MOLECULES, CELLS, AND CIRCUITS CONTRIBUTE TO MENTAL ILLNESSES, TO DEVELOP MOLECULAR, CELLULAR, AND CIRCUIT-LEVEL BIOMARKERS OF IMPAIRED NEURAL FUNCTION IN HUMANS, AND, TO DEVELOP INNOVATIVE TECHNOLOGIES, INCLUDING NEW IMAGING, COMPUTATIONAL, PHARMACOLOGICAL, AND GENETIC TOOLS TO INTERROGATE AND MODULATE CIRCUIT ACTIVITY AND STRUCTURE ALTERED IN MENTAL ILLNESSES. TO ELUCIDATE THE MECHANISMS CONTRIBUTING TO THE TRAJECTORIES OF BRAIN DEVELOPMENT AND BEHAVIOR, AND, TO CHARACTERIZE THE EMERGENCE AND PROGRESSION OF MENTAL ILLNESSES, AND IDENTIFYING SENSITIVE PERIODS FOR OPTIMAL INTERVENTION. TO DETERMINE EARLY RISK AND PROTECTIVE FACTORS, AND RELATED MECHANISMS, TO SERVE AS NOVEL INTERVENTION GROUPS, AND, TO DEVELOP RELIABLE AND ROBUST BIOMARKERS AND ASSESSMENT TOOLS TO PREDICT ILLNESS ONSET, COURSE, AND ACROSS DIVERSE POPULATIONS. TO DEVELOP NOVEL INTERVENTIONS USING A MECHANISM-INFORMED, EXPERIMENTAL THERAPEUTICS APPROACH, AND, TO DEVELOP AND IMPLEMENT MEASUREMENT STRATEGIES TO FACILITATE MECHANISM-BASED INTERVENTION DEVELOPMENT AND TESTING. TO INVESTIGATE PERSONALIZED INTERVENTION STRATEGIES ACROSS DISEASE PROGRESSION AND DEVELOPMENT, AND, TO DEVELOP AND REFINE COMPUTATIONAL APPROACHES AND RESEARCH DESIGNS THAT CAN BE USED TO INFORM AND TEST PERSONALIZED INTERVENTIONS. TO DEVELOP AND TEST APPROACHES FOR ADAPTING, COMBINING, AND SEQUENCING INTERVENTIONS TO ACHIEVE THE GREATEST IMPACT ON THE LIVES AND FUNCTIONING OF PERSONS SEEKING CARE, TO CONDUCT EFFICIENT PRAGMATIC TRIALS THAT EMPLOY NEW TOOLS TO RAPIDLY IDENTIFY, ENGAGE, ASSESS, AND FOLLOW PARTICIPANTS IN THE CONTEXT OF ROUTINE CARE, AND, TO ENHANCE THE PRACTICAL RELEVANCE OF EFFECTIVENESS RESEARCH VIA DEPLOYMENT-FOCUSED, HYBRID, EFFECTIVENESS-IMPLEMENTATION STUDIES. TO EMPLOY ASSESSMENT PLATFORMS WITHIN HEALTHCARE SYSTEMS TO ACCURATELY ASSESS THE DISTRIBUTION AND DETERMINANTS OF MENTAL ILLNESSES AND TO INFORM STRATEGIES FOR IMPROVED SERVICES, TO OPTIMIZE REAL-WORLD DATA COLLECTION SYSTEMS TO IDENTIFY STRATEGIES FOR IMPROVING ACCESS, QUALITY, EFFECTIVENESS, AND CONTINUITY OF MENTAL HEALTH SERVICES, AND, TO COMPARE ALTERNATIVE FINANCING MODELS TO PROMOTE EFFECTIVE AND EFFICIENT CARE FOR INDIVIDUALS WITH SERIOUS EMOTIONAL DISTURBANCES AND SERIOUS MENTAL ILLNESSES. TO STRENGTHEN PARTNERSHIPS WITH KEY STAKEHOLDERS TO DEVELOP AND VALIDATE STRATEGIES FOR IMPLEMENTING, SUSTAINING, AND CONTINUOUSLY IMPROVE EVIDENCE-BASED PRACTICES, TO BUILD MODELS TO SCALE-UP EVIDENCE-BASED PRACTICES FOR USE IN PUBLIC AND PRIVATE PRIMARY CARE, SPECIALTY CARE AND OTHER SETTINGS, AND, TO DEVELOP DECISION-SUPPORT TOOLS AND TECHNOLOGIES THAT INCREASE THE EFFECTIVENESS AND CONTINUOUS IMPROVEMENT OF MENTAL HEALTH INTERVENTIONS IN PUBLIC AND PRIVATE PRIMARY CARE, SPECIALTY CARE, AND OTHER SETTINGS. TO ADAPT, VALIDATE, AND SCALE-UP PROGRAMS CURRENTLY IN USE THAT IMPROVE MENTAL HEALTH SERVICES FOR UNDERSERVED POPULATIONS, TO DEVELOP AND VALIDATE SERVICE DELIVERY MODELS THAT PROVIDE EVIDENCE-BASED CARE FOR INDIVIDUALS THROUGHOUT THE COURSE OF MENTAL ILLNESS, TO DEVELOP AND VALIDATE SYSTEMS-LEVEL STRATEGIES USING TECHNOLOGY AND OTHER APPROACHES, TO IDENTIFY, SUPPORT, AND MONITOR THE EFFECTIVENESS OF EVIDENCE-BASED CARE THROUGHOUT THE COURSE OF ILLNESS, AND, TO DEVELOP AND VALIDATE DECISION-MAKING MODELS THAT BRIDGE MENTAL HEALTH, MEDICAL, AND OTHER CARE SETTINGS TO INTEGRATE THE APPROPRIATE CARE FOR PEOPLE WITH SERIOUS MENTAL ILLNESSES AND COMORBID MEDICAL CONDITIONS.
Grant Program (CFDA)
Awarding / Funding Agency
Place of Performance
New York,
New York
100296504
United States
Geographic Scope
Single Zip Code
Related Opportunity
Analysis Notes
Amendment Since initial award the total obligations have increased 96% from $4,170,401 to $8,166,955.
Icahn School Of Medicine At Mount Sinai was awarded
Behavioral Data Analysis Clinical Prognosis in Young Mental Health Patients
Cooperative Agreement U01MH136535
worth $8,166,955
from the National Institute of Mental Health in July 2024 with work to be completed primarily in New York New York United States.
The grant
has a duration of 4 years 9 months and
was awarded through assistance program 93.242 Mental Health Research Grants.
The Cooperative Agreement was awarded through grant opportunity Individually Measured Phenotypes to Advance Computational Translation in Mental Health (IMPACT-MH) (U01 Clinical Trial Optional).
Status
(Ongoing)
Last Modified 9/24/25
Period of Performance
7/11/24
Start Date
4/30/29
End Date
Funding Split
$8.2M
Federal Obligation
$0.0
Non-Federal Obligation
$8.2M
Total Obligated
Activity Timeline
Subgrant Awards
Disclosed subgrants for U01MH136535
Transaction History
Modifications to U01MH136535
Additional Detail
Award ID FAIN
U01MH136535
SAI Number
U01MH136535-3856739053
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Private Institution Of Higher Education
Awarding Office
75N700 NIH National Institute of Mental Health
Funding Office
75N700 NIH National Institute of Mental Health
Awardee UEI
C8H9CNG1VBD9
Awardee CAGE
1QSQ9
Performance District
NY-13
Senators
Kirsten Gillibrand
Charles Schumer
Charles Schumer
Modified: 9/24/25