DepressionNCT07801079
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
An observational study of Depression and Anxiety, run by National Institute of Mental Health (NIMH) at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Depression, Anxiety, Addiction
- How many people
- 420 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Dec 2026to 20 Aug 2032
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 21Show fewer
- 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.
- Self-reported pregnancy or lactation.
- Any disrespectful or unprofessional behavior towards any study team member.
- Familial or any close personal relationship with a study team member.
- Any condition or general impairment that might interfere with or limit individual's ability to engage in informed consent and study procedures.
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
National Institute of Mental Health (NIMH)
Bethesda, Maryland, 20892
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
NIH Clinical Center Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
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.
Read more
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.
Read the 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:
- 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).
- To identify how individual differences in metacognition might moderate the influence of internal states on decision-making.
- 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:
- 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.
- Measures of metacognition derived from questionnaires and confidence ratings in decision-making tasks, such as confidence bias and confidence sensitivity.
- 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).
- Keywords
- Smartphone, Feelings, Mental Health, Decision-Making, Meta-Cognition, Ecological Momentary Assessment, EMA, Emotion, Craving, Stress
- Medical subject headings
- Depression, Anxiety Disorders, Behavior, Addictive, Psychological Well-Being
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 |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
EMA data and analysis will aid in identifying some of the key elements for a future JITAI study aimed at reducing emotional reactivity.
Measured: 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.
Measured: Throughout the study, physiological signals collected from biosensors, speech and facial features from audiovisual recording, and lexical and semantical features derived from free responses.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start5 Dec 2026 (estimated)
- Primary completion19 Aug 2031 (estimated)
- Study completion20 Aug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Silvia Lopez Guzman, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801079
- Sponsor's protocol ID
- 10002728
- Other IDs
- 002728-M
- Status last verified
- 28 Oct 2026
- First submitted
- 2 Sep 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Per NIMH guideline, all data collected in the protocol will be de-identifieid and shared after data collection is completed
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
- ClinicalTrials.gov ID
- NCT07801079
- Acronym / sponsor ID
- 10002728
- Keywords
- Smartphone, Feelings, Mental Health, Decision-Making, Meta-Cognition, Ecological Momentary Assessment, EMA, Emotion
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 5 Dec 2026 (estimated)
- Primary completion
- 19 Aug 2031 (estimated)
- Study completion
- 20 Aug 2032 (estimated)
- First posted
- 3 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.
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.
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:
- 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).
- To identify how individual differences in metacognition might moderate the influence of internal states on decision-making.
- 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:
- 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.
- Measures of metacognition derived from questionnaires and confidence ratings in decision-making tasks, such as confidence bias and confidence sensitivity.
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transdiagnostic Dimensional Cohort | – | –Individuals with varying degrees of depression, anxiety and addiction symptom severity, including those who have none of the symptoms (healthy volunteer). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (21 listed)
- 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:
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
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.
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.
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.
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.
2 secondary outcomes
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.
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.
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 30 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Per NIMH guideline, all data collected in the protocol will be de-identifieid and shared after data collection is completed
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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.
Silvia Lopez Guzman, M.D. principal investigator
National Institute of Mental Health (NIMH)
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 and Anxiety, run by National Institute of Mental Health (NIMH) 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 6 inclusion and 21 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: opening soon, as of the sponsor's last update on 30 Oct 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 Silvia Lopez Guzman, M.D. ((301) 451-7822, NIMHCDN@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 4 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 30 Oct 2026.