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NCT07801079

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

Sponsor: National Institute of Mental Health (NIMH)

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

OBSERVATIONAL

Enrollment

420

Start Date

2026-11-19

Completion Date

2032-08-20

Last Updated

2026-09-03

Healthy Volunteers

Conditions

Depression Anxiety Addiction Emotion Craving Stress

* 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.

Locations (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States