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

NCT07801079 | Not Yet Recruiting

• 2 other identifiers: 10002728002728-M
• Study Type: observational
• Target: 420
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Making decisions during daily life is a complicated behavior. Even simple choices can be affected by a range of emotions, stresses, and moods. Mental health issues such as depression and anxiety can lead people to make decisions that have negative effects on their lives. Learning how changes in feeling affect a person's decisions may help researchers find ways to help them make more positive choices. Objective: To learn how changes in a person's feelings and emotions affect their decisions. Eligibility: People aged 18 to 55 years who are healthy or who have some level of depressive, anxiety, substance-related, or addictive disorders. Design: All study activities can be done remotely; participants may use a smartphone app, a website, or telehealth. Participants will have a baseline visit. They will complete tasks that require decisions; these tasks are like games they play on their phone. They will also answer questions about their habits, how they feel, their sleep quality, and any problem behaviors. They may wear a smartwatch during the study; it will record data such as their movements and heart rate. For 12 weeks, a study app will prompt participants to respond. They will be asked to answer questions about how they are feeling, any problematic behaviors, or big life events; they will be asked to complete tasks that require making decisions. They may record a video or audio clip describing their day and how they feel. For 3 of the 12 weeks, participants will get prompts up to 6 times per day. For 9 weeks, they will get up to 3 prompts per day. They will have an end-of-study visit to discuss their experiences.

Conditions

Depression; Anxiety; Addiction; Emotion; Craving; Stress

Keywords

Smartphone; Feelings; Mental Health; Decision-Making; Meta-Cognition; Ecological Momentary Assessment; EMA; Emotion; Craving; Stress

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• To inform key elements of a just-in-time adaptive intervention (JITAI)

  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

  Throughout the study, physiological signals collected from biosensors, speech and facial features from audiovisual recording, and lexical and semantical features derived from free responses.

Study Arms (1)

Transdiagnostic Dimensional Cohort

Individuals with varying degrees of depression, anxiety and addiction symptom severity, including those who have none of the symptoms (healthy volunteer).

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• 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.
• Currently resides in the United States.
• Aged 18-55.
• 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.
• Agreement to adhere to Lifestyle Considerations throughout study duration.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation:
• 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).
• 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.
• Self-reported acute intoxication, withdrawal, or another medically compromised condition at Enrollment / Baseline Visit.
• 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

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Depression; Anxiety Disorders; Behavior, Addictive; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Personal Satisfaction

Study Officials

• Silvia Lopez Guzman, M.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvia Lopez Guzman, M.D.

CONTACT

(301) 451-7822; NIMHCDN@mail.nih.gov

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 3, 2026
• Study Start (Estimated): December 5, 2026
• Primary Completion (Estimated): August 19, 2031
• Study Completion (Estimated): August 20, 2032
• Last Updated: September 21, 2026

Record last verified: 2026-09-17

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Data sharing will be completed at least 5 years after the end of recruitment.
• 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.

Locations

US (1)