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

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: Not yet recruiting
• Conditions: Depression; Stress; Anxiety; Addiction; Craving; Emotion

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: Observational
• Enrollment (Estimated): 420

Contacts and Locations

• Study Contact: Name: Silvia Lopez Guzman, M.D.; Phone Number: (301) 451-7822; Email: silvia.lopezguzman@nih.gov

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

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

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.	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.	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 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.	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

Outcome Measure	Measure Description	Time Frame
To inform key elements of a just-in-time adaptive intervention (JITAI)	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	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

• Sponsor: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Silvia Lopez Guzman, M.D., National Institute of Mental Health (NIMH)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Estimated): November 19, 2026
• Primary Completion (Estimated): August 19, 2031
• Study Completion (Estimated): August 20, 2032

Study Registration Dates

• First Submitted: September 2, 2026
• First Submitted That Met QC Criteria: September 2, 2026
• First Posted (Actual): September 3, 2026

Study Record Updates

• Last Update Posted (Actual): September 3, 2026
• Last Update Submitted That Met QC Criteria: September 2, 2026
• Last Verified: August 25, 2026

More Information

Terms related to this study

• Keywords: Mental Health; Stress; Emotion; Smartphone; Craving; Ecological Momentary Assessment; Decision-Making; EMA; Feelings; Meta-Cognition
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Compulsive Behavior; Impulsive Behavior; Behavior; Personal Satisfaction; Anxiety Disorders; Depression; Behavior, Addictive; Psychological Well-Being
• Other Study ID 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