State-dependent Interoception, Value-based Decision-making, and Introspection

NCT05666726 | Recruiting

• 2 other identifiers: 10000978000978-M
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Negative emotional states can affect a person s behavior as they make decisions. For example, hunger may make people more impatient; they may then make riskier choices. Other negative emotional states that can change behavior include stress, pain, and sadness. By learning more about how emotions affect thinking and behavior in healthy people, researchers hope to better understand how to identify and treat people with mental disorders. Objective: To learn how negative emotions affect the brain and decision-making behavior. Eligibility: Healthy people aged 18 to 55 years. Design: Participants will have 3 clinic visits in 3 weeks. Participants will fill out questionnaires. They will be asked about their personal history, their personality, and state of mind. For 2 visits, participants will be assigned to different groups. Each group will experience 1 type of emotional stressor: Some participants will watch a video. Some will have to do arithmetic problems. Some will have heat applied to an arm or leg. Some will experience cold by immersing their hand in ice water. For a snack craving test, some will be tempted by food after a 4-hour fast. During these tests, participants will have sensors attached to their bodies. They will be videotaped. Saliva samples will be collected. After the stressors, participants will do tasks on a computer. They will need to make choices. Some participants will perform these decision-making tasks while lying in a brain scanner for functional magnetic resonance imaging. The brain scan involves lying on a table that slides into a cylinder that takes images of the brain. ...

Conditions

Craving; Frustration; Stress; Pain; Emotions

Keywords

Decision-Making; Interoception; Metacognition; Stress; Pain; Negative Emotion

Outcome Measures

Primary Outcomes (2)

• Value-based decision-making metrics

  Value-based metrics such as delay discounting, which is a measure of an individual's preference for small immediate rewards over larger later rewards.

  Right after intervention

• BOLD signal in decision-making areas ROI

  BOLD signal related to decision making tasks

  Right after intervention

Secondary Outcomes (2)

• Confidence

  Right after intervention

• Interoceptive accuracy

  Right after intervention

Study Arms (5)

1

EXPERIMENTAL

within-subjects experimental study, where each subject will receive a neutral state and a negative state induction intervention in a cross-over design (counterbalanced order across participants).

Behavioral: Negative valence emotion

2

EXPERIMENTAL

within-subjects experimental study, where each subject will receive a neutral state and a negative state induction intervention in a cross-over design (counterbalanced order across participants).

Behavioral: Frustration

3

EXPERIMENTAL

within-subjects experimental study, where each subject will receive a neutral state and a negative state induction intervention in a cross-over design (counterbalanced order across participants).

Other: Pain

4

EXPERIMENTAL

within-subjects experimental study, where each subject will receive a neutral state and a negative state induction intervention in a cross-over design (counterbalanced order across participants).

Other: Stress

5

EXPERIMENTAL

within-subjects experimental study, where each subject will receive a neutral state and a negative state induction intervention in a cross-over design (counterbalanced order across participants).

Behavioral: Craving

Interventions

Frustration BEHAVIORAL

Real effort task

2

Negative valence emotion BEHAVIORAL

Passive video watching with emotional valence

1

Pain OTHER

Thermal pain

3

Stress OTHER

Stress state induction

4

Craving BEHAVIORAL

Snack craving induction

5

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ability of subject to understand and the willingness to sign a written informed consent document.
• All sexes; Age 18 to 55.
• Able to read and write in English to guarantee understanding of all written and spoken instructions, which are in English.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• For all experiments:
• Unable to comply with study procedures or follow-up visits
• Has any serious or unstable medical condition or history that in a clinician s assessment implies a cardiovascular, neurological, or physical risk from the study procedures performed to induce negative valence states. This may include chronic systemic disorders that could worsen due to stress (e.g. uncontrolled hypertension, coronary artery disease for example a history of myocardial infarction or stable or unstable angina, or diabetes)
• Has any current psychiatric diagnosis (based on SCID or the MINI Mini International Neuropsychiatric Interview) or no diagnosis but scores \>=29 on Beck Depression Inventory II or \>=26 on Beck Anxiety Inventory
• Meets criteria for diagnosis of any substance-related or addictive disorder, or endorses any kind of problematic gambling behavior or problematic media-based addictive behavior (such as videogames, social-networking, online shopping, etc.)
• Regular use of psychoactive medications or psychoactive substances
• Regular use of corticosteroids
• Is pregnant
• For stress and pain induction:
• Has a major medical condition or medical history that in a clinician s assessment could affect temperature sensitivity, pain thresholds, or ability to comply with study procedures. This may include cardiovascular, autonomic, neurological, psychiatric, or chronic systemic disorders (including but not limited to stroke, blindness, deafness, history of brain damage, neurodegenerative, neurotoxic or demyelinating disorder, or diabetes)
• Has a medical condition that in a clinician s assessment might affect somatosensation (e.g., Raynaud s disease, peripheral neuropathy, or circulatory disorder)
• For pain induction:
• Has a current chronic pain condition or has had chronic pain in the past (painful condition lasting more than six months)
• Has a dermatological condition such as scars or burns, or has had a tattoo in the testing region within the previous 4 weeks that might influence cutaneous sensibility

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Pain

Interventions

Projective Techniques

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Personality Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Silvia Lopez Guzman, M.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvia Lopez Guzman, M.D.

CONTACT

(301) 451-7822; nimhcdn@mail.nih.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2022
• First Posted: December 28, 2022
• Study Start: July 25, 2023
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: January 26, 2026

Record last verified: 2026-01-22

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Data from this study may be requested from other researchers 1 year after the completion of the primary endpoint by contacting the NIMH Data Archive (NDA) for all behavioral data and OpenNeuro (www.openneuro.org) for all fMRI data. It will remain in said repositories indefinitely.
• Access Criteria: All individual participant data that underlie results in a publication will be made public through the IMH Data Archive (NDA) and OpenNeuro (www.openneuro.org) repositories. Access criteria is defined by these repositories and will not be limited by analysis type.

Locations

US (1)