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

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).

• INCLUSION CRITERIA

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.

Exclusion criteria

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
• 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.