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

2026년 9월 9일 업데이트: National Institute of Mental Health (NIMH)

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.

연구 개요

상태

아직 모집하지 않음

정황

상세 설명

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).

연구 유형

관찰

등록 (추정된)

420

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: Silvia Lopez Guzman, M.D.
전화번호: (301) 451-7822
이메일: silvia.lopezguzman@nih.gov

연구 장소

미국
- Maryland
  - Bethesda, Maryland, 미국, 20892
    - National Institutes of Health Clinical Center
    - 연락하다:
      
      NIH Clinical Center Office of Patient Recruitment (OPR)
      
      전화번호: TTY dial 711 800-411-1222
      
      이메일: ccopr@nih.gov

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

성인

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

확률 샘플

연구 인구

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).

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트 그룹/코호트 생물 의학 또는 건강 결과에 대해 평가되는 관찰 연구의 참가자 그룹 또는 하위 그룹입니다.
Transdiagnostic Dimensional Cohort Individuals with varying degrees of depression, anxiety and addiction symptom severity, including those who have none of the symptoms (healthy volunteer).

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
To establish the relationship between psychiatric symptom severity and the reactivity of decision-making to changes in internal state. 기간: 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.	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. 기간: 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.	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... 기간: 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.	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. 기간: 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.	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.

2차 결과 측정

결과 측정	측정값 설명	기간
To inform key elements of a just-in-time adaptive intervention (JITAI) 기간: Possible decision points jointly estimated with self-reported internal state, model predicted internal states, decision-making behavior, and symptom severity.	EMA data and analysis will aid in identifying some of the key elements for a future JITAI study aimed at reducing emotional reactivity.	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 기간: Throughout the study, physiological signals collected from biosensors, speech and facial features from audiovisual recording, and lexical and semantical features derived from free responses.	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.	Throughout the study, physiological signals collected from biosensors, speech and facial features from audiovisual recording, and lexical and semantical features derived from free responses.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

National Institute of Mental Health (NIMH)

수사관

수석 연구원: Silvia Lopez Guzman, M.D., National Institute of Mental Health (NIMH)

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

NIH Clinical Center Detailed Web Page

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 11월 19일

기본 완료 (추정된)

2031년 8월 19일

연구 완료 (추정된)

2032년 8월 20일

연구 등록 날짜

최초 제출

2026년 9월 2일

QC 기준을 충족하는 최초 제출

2026년 9월 2일

처음 게시됨 (실제)

2026년 9월 3일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 9일

마지막으로 확인됨

2026년 8월 25일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

10002728
002728-M

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Per NIMH guideline, all data collected in the protocol will be de-identifieid and shared after data collection is completed

IPD 공유 기간

Data sharing will be completed at least 5 years after the end of recruitment.

IPD 공유 액세스 기준

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.

IPD 공유 지원 정보 유형

연구_프로토콜
ANALYTIC_CODE

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .