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

Pain Clinical Trial

Official title: State-Dependent Interoception, Value-Based Decision Making, and Introspection

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Study Description:

This study involves a series of experiments consisting of within-subject experimental manipulations of state. In separate sub-studies, we will induce 5 types of negative valence states (negative emotion, loss, pain, stress, and craving) compared to a neutral state to test the hypothesis that negative valence states impact value-based decision-making and the neural mechanisms involved in decision-making.

Objectives:

Primary Objective: Determine the effect of induced negative valence states on value-based decision-making and examine how brain value representation during decision-making is affected by negative valence states.

Secondary Objectives: 1) Determine the role of interoception and metacognition as moderators of the effect of negative valence states on value-based decision-making. 2) Characterize state-specific effects on value-based decision-making. 3) Establish whether states can affect stable features of interoception and metacognition. 4) Build a classification model for state-specific detection using multimodal feature data. 5) Compare interoception across modalities (cardiac, respiratory, pain). 6) Characterize state-specific neuroendocrine profiles for gonadal, stress, and appetitive hormones.

Endpoints:

Primary Endpoints: Choice behavior and brain activations in decision-making tasks: 1) willingness-to-pay, 2) risk aversion, 3) ambiguity

aversion, and 4) delay discounting. For fMRI: 1) VMPFC BOLD, 2) VS BOLD, and 3) AI BOLD signal.

Secondary Endpoints: Behavior and neural activations in an interoceptive task and confidence reports: 1) interoceptive accuracy, 2) confidence bias, and 3) confidence sensitivity. ;

Related Conditions & MeSH terms

• Craving
• Emotions
• Pain
• Stress

• NCT number: NCT05666726
• Study type: Interventional
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Silvia Lopez Guzman, M.D.
• Phone: (301) 451-7822
• Email: nimhcdn@mail.nih.gov
• Status: Recruiting
• Phase: N/A
• Start date: July 25, 2023
• Completion date: December 31, 2026