Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum

September 2, 2026 updated by: National Institute of Mental Health (NIMH)

Background:

Life experiences could impact how one feel, and in turn alter how decisions are made. For example, an argument with a loved one might lead to frustration that drives one to seek alcohol or engage in other riskier decision-making. By tracking not only how life experiences might change feelings but also the decision-making tendencies assessed by behavioral tasks, researcher aimed to better understand naturalistically how life experiences might shape behaviors through feelings. This could lead to a better understanding, identification and treatment for people with mental disorders.

Objective:

Naturalistically track how life experiences change self-reported mental states, such as emotions or mood, as well as decision-making tendencies.

Eligibility:

Individuals aged 18 to 55 years, who are either healthy or with varying degrees of depressive, anxious or addictive symptom severity.

Design:

Participants in the study will complete the following activities: 1) complete an initial assessment of their medical, mental health and personal history; 2) complete a set of behavior tasks; 3) for 12 weeks, complete surveys, tasks and audiovisual diary on a smart phone while they go about their life; 4) for 12 weeks, continuously wear an smartwatch-like device to track physiological signals; 5) every 2 weeks for 12 weeks, complete a set of surveys on mental health conditions; and 6) complete an end-of-study debriefing session to discuss their experience in the study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Study Description:

This observational study employs an Ecological Momentary Assessment (EMA) methodology to investigate how naturalistic changes in internal states (ranging from emotional to physiological and interoceptive states) lead to changes in value-based decision-making. The study will include a "dimensional cohort" of participants that range from healthy to subclinical to clinical levels of psychopathology, with a focus on substance use, depression, and anxiety. Using a mobile application, participants will remotely respond to multiple daily prompts for a total participation time of 12 weeks. In addition to this, the study will incorporate multimodal biosensor recording collected from wearable technology to capture passive physiological metrics. It aims to understand the dynamics of decision making, metacognition, and how their variability may be causally related to changes in emotional internal states, captured in real-world settings.

Objectives:

Primary Objective:

To measure the influence of naturally occurring fluctuations in emotional internal states on value-based decision-making.

Secondary Objectives:

  1. To estimate the temporal profile of internal state; the lag between changes in internal state and measurable changes in decision-making and if different aspects of decision-makings might be sensitive to whether a change in internal state is acute or sustained (state dynamic).
  2. To identify how individual differences in metacognition might moderate the influence of internal states on decision-making.
  3. To establish the relationship between psychiatric symptom severity and the reactivity of decision-making to changes in internal state.

Endpoints:

Primary Endpoint:

Through EMA, repeated measures of self-reported internal states, significant life events, and behaviors in established and novel cognitive-behavioral decision-making tasks.

Secondary Endpoints:

  1. Time of recording of ratings, responses, and completed tasks; repeated measures of self-reported internal states at different temporal scales (hours, days or weeks); repeated measures on internal states followed by reporting of significant life events (Microbursts); and repeated reports on the time of occurrence, description, and characteristics of significant life events.
  2. Measures of metacognition derived from questionnaires and confidence ratings in decision-making tasks, such as confidence bias and confidence sensitivity.
  3. Transdiagnostic dimensional measures of individual-level and state-level symptom severity, collected throughout the study; clinical diagnosis on psychopathology as determined by Structured Clinical Interview for DSM Disorders (SCID).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
420

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center
        • Contact:
          • NIH Clinical Center Office of Patient Recruitment (OPR)
          • Phone Number: TTY dial 711 800-411-1222
          • Email: ccopr@nih.gov

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Study population will consists of health volunteers as well as dimensional cohort with varying degree of depressive, anxious and addiction symptom severity. They will be recruited nationawide and locally. The primary sources of recruitment are: online / physical study recruitment materials, social media, ClinicalTrial.gov, Clinical Center Search the Studies, online recruitment platform (e.g. Prolific / MTurk).

Description

  • INCLUSION CRITERIA

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  1. Understands study procedures as well as the risks and benefits associated with them. Is willing to comply with study procedures and is available for the duration of the study.
  2. Currently resides in the United States.
  3. Aged 18-55.
  4. Individuals in good general health as evidenced by medical and psychiatric history, or individuals who endorsed current or lifetime clinical or subclinical symptoms related to Depressive Disorders, Anxiety Disorders, Substance-Related and Addictive Disorders.
  5. Agreement to adhere to Lifestyle Considerations throughout study duration.

EXCLUSION CRITERIA

An individual who meets any of the following criteria will be excluded from participation:

  1. Any unstable medical conditions (not well-controlled or are subject to frequent exacerbations, including uncontrolled hypertension, recent myocardial infarction, or unstable diabetes), severe chronic (long-term medical conditions that are either progressive or require ongoing medical treatment, including advanced cardiovascular disease, chronic obstructive pulmonary disease (COPD), or end-stage renal disease), or significantly impairing medical condition that could limit cognitive, mobility, and physiological measures (conditions that severely limit mobility or daily functioning, such as severe arthritis, advanced Parkinson's disease, or major neurocognitive disorders).
  2. Any Traumatic Brain Injury (TBI), loss of consciousness, brain lesion, epileptic seizure, or any other conditions that are indicative of abnormal function or structure of the brain.
  3. Self-reported acute intoxication, withdrawal, or another medically compromised condition at Enrollment / Baseline Visit.

  4. Following psychiatric symptoms and disorder diagnosis:

    • Any current serious ideation, intention or plan for homicide or intentional harm towards others as determined by SCID-V and the clinical judgement of qualified clinical team member.
    • Imminent / High risk of self-harm or suicide as determined by SCID-V and the clinical judgement of qualified clinical team member.
    • Current manic episode as determined by SCID-V and self-report questionnaires.
    • Currently under inpatient care.

    • Diagnosis (current and lifetime) and / or treatment for the following psychiatric disorders as defined in the DSM-5:

      • Any symptoms compatible with Psychosis
      • Neurodevelopmental Disorders (e.g. with learning or intellectual disability) impacting understanding of Decision-Making Tasks
      • Schizophrenia Spectrum and Other Psychotic Disorders
      • Dissociative Disorders
      • Sleep-Wake Disorders, except for Breathing-Related Sleep Disorders
      • Neurocognitive Disorders (e.g., dementia or cognitive decline) impacting understanding of Decision-Making Tasks
    • Any significantly impairing psychiatric disorder, symptom or behavior, as determined by comprehensive clinical assessments, including severity scales, clinician judgment, and self-report measures.
  5. Self-reported pregnancy or lactation.
  6. Any disrespectful or unprofessional behavior towards any study team member.
  7. Familial or any close personal relationship with a study team member.
  8. Any condition or general impairment that might interfere with or limit individual's ability to engage in informed consent and study procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Transdiagnostic Dimensional Cohort
Individuals with varying degrees of depression, anxiety and addiction symptom severity, including those who have none of the symptoms (healthy volunteer).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To establish the relationship between psychiatric symptom severity and the reactivity of decision-making to changes in internal state.
Time Frame: Throughout the study, transdiagnostic measures of trait- and state-level symptom severity and clinical diagnosis determined by Structured Clinical Interview for DSM Disorders (SCID).
Dimensional approach allows for examination of the moderation effect of symptom-level severity across psychiatric diagnosis. The state-level symptom severity can also be used to infer the state dynamic.However, clinical diagnosis still serves an important role in understanding how decision making and internal state dynamics might be different for patients with psychopathology. Further, collecting clinical diagnosis can better connect knowledge gained from this protocol to existing literature.
Throughout the study, transdiagnostic measures of trait- and state-level symptom severity and clinical diagnosis determined by Structured Clinical Interview for DSM Disorders (SCID).
To identify how individual differences in metacognition might moderate the influence of internal states on decision-making.
Time Frame: In 12 weeks of EMA, measure of metacognition derived from questionnaires and confidence ratings in decision-making tasks.
Confidence is a standard proxy measure of metacognitive ability.
In 12 weeks of EMA, measure of metacognition derived from questionnaires and confidence ratings in decision-making tasks.
To estimate the temporal profile of internal state; the lag between changes in internal state and measurable changes in decision-making and to assess whether different aspects of decision-makings are sensitive to acute versus sustained changes i...
Time Frame: In 12 weeks of EMA, self-report of internal states in different time scale and following significant life event.
Time difference between a measurable change in decision-making characteristics and the most recent change in internal state can be calculated. State dynamics (acute versus sustained changes in internal state) can be identified by analyzing internal state fluctuation measures collected at different time scales and temporal proximity to significant life events.Life events of different types or characteristics might be more likely to elicit acute versus sustained changes and vice versa.
In 12 weeks of EMA, self-report of internal states in different time scale and following significant life event.
To assess the influence of naturally occurring fluctuations in internal states on value-based decision-making.
Time Frame: In 12 weeks of EMA, self-report of internal states and significant life events as well as behaviors in established and novel cognitive-behavioral decision-making tasks.
EMA allows for measures of changes in naturalistic settings. Collecting self-reported internal states and significant life events can establish an internal state timeline for modeling naturally occurring fluctuations in internal states.Cognitive-behavioral decision-making tasks are informative of value-based decision-making processes.Behaviors in these tasks can also be used for computational modeling of the (sub)processes and mechanisms of value-based decision-making, such as risk tolerance, ambiguity tolerance, impulsive choice, approach/avoidance behavior, planning, learning, goal progress, pleasure related to goal progress, and decision confidence.
In 12 weeks of EMA, self-report of internal states and significant life events as well as behaviors in established and novel cognitive-behavioral decision-making tasks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To inform key elements of a just-in-time adaptive intervention (JITAI)
Time Frame: Possible decision points jointly estimated with self-reported internal state, model predicted internal states, decision-making behavior, and symptom severity.
EMA data and analysis will aid in identifying some of the key elements for a future JITAI study aimed at reducing emotional reactivity.
Possible decision points jointly estimated with self-reported internal state, model predicted internal states, decision-making behavior, and symptom severity.
To predict the presence of emotional state changes using multimodal feature data
Time Frame: Throughout the study, physiological signals collected from biosensors, speech and facial features from audiovisual recording, and lexical and semantical features derived from free responses.
Physiological signals such as heart rate and electrodermal activity is linked to dimensions of internal state, such as arousal. Speech and facial features are used to infer internal states such as emotions (voice intonation and facial expression).Language use features, lexicon and semantic content, are sensitive to internal states.
Throughout the study, physiological signals collected from biosensors, speech and facial features from audiovisual recording, and lexical and semantical features derived from free responses.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Silvia Lopez Guzman, M.D., National Institute of Mental Health (NIMH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 19, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 19, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 20, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 25, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10002728
  • 002728-M

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Per NIMH guideline, all data collected in the protocol will be de-identifieid and shared after data collection is completed

IPD Sharing Time Frame

Data sharing will be completed at least 5 years after the end of recruitment.

IPD Sharing Access Criteria

Participants in the study will be registered in the NIMH Data Archive (NDA) and all data collected will be de-identified and upload to the NDA database.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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