An observational study in Depression, Anxiety and Addiction, sponsored by National Institute of Mental Health (NIMH). Not yet recruiting at 2 sites in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by National Institute of Mental Health (NIMH) · Observational
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.
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:
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:
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 420 is above the median of 175 across 1,257 observational studies indexed under Depression.
Browse Depression studies →National Institute of Mental Health (NIMH) is the lead sponsor of 367 studies on the registry; 45 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 24 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation:
Following psychiatric symptoms and disorder diagnosis:
Diagnosis (current and lifetime) and / or treatment for the following psychiatric disorders as defined in the :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Individuals with varying degrees of depression, anxiety and addiction symptom severity, including those who have none of the symptoms (healthy volunteer).
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.
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).
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.
Time frame: 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.
Time frame: 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.
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.
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.
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
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.
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.
Plan to share: Yes — Per NIMH guideline, all data collected in the protocol will be de-identifieid and shared after data collection is completed
Supporting information: 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.
Start is estimated for Dec 2026; primary completion for Aug 2031, 56 months later.
Of 460 non-industry observational studies under Depression, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 63. This study's planned 56 months is above that.
Counting every sponsor, half of 493 studies reached it within 33 months; a quarter within 13 and three quarters within 62.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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