RECRUITING

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

Conditions

Stress Pain Emotions Craving Frustration Decision-Making Interoception Metacognition Negative Emotion

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. ...

Official Title

State-Dependent Interoception, Value-Based Decision Making, and Introspection

Quick Facts

Study Start:2023-07-25

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05666726

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Ability of subject to understand and the willingness to sign a written informed consent document. * All genders; Age 18 to 55. * Able to read and write in English to guarantee understanding of all written and spoken instructions, which are in English.	* 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 * NIMH employees and staff and their immediate family members * 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) * 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 * Regular and recent use of prescription or over-the-counter medication that has a significant effect on pain or heat perception. These include medications such as centralacting agents such as opiates (morphine, tramadol), antidepressants (amitriptyline, duloxetine, milnacipran), anticonvulsants (gabapentin, pregabalin), anxiolytics (barbiturates, benzodiazepines), hypnotics (zolpidem, sodium oxybate), antipsychotics (valproate, lithium, olanzapine), antimigraine agents (sumatriptan, ergotamine), and muscle relaxants (cyclobenzaprine, carisoprodol). Use of analgesic medications, such as non-steroidal anti-inflammatories, salicylates, and acetaminophen, taken on an as needed basis is acceptable as long as the last dose taken was within 5 half-lives of testing. * Has a condition that in a clinician s assessment could preclude the ability to hold 4-6 hours of fasting or that is associated with a risk of hypoglycemia (such as diabetes, kidney disease, insulinoma, adrenal or pituitary tumors or disorders, or anorexia nervosa) * Is currently engaged in any kind of diet medically- or self-prescribed or endorses a very strong desire to start a diet that involves eliminating or decreasing carbohydrate consumption * Has a history of food allergies such as tree-nut or peanut allergy. * Individuals with conditions that could pose a risk relating to the safety of the fMRI procedure but do not meet specific exclusion criteria for all experiments or for specific inductions will be excluded from the MRI portion of the protocol but may participate in the non-MRI sessions. Such conditions include: * Those with ferromagnetic metal in the cranial cavity or eye (e.g. aneurysm clip, implanted neural stimulator, cochlear implant, ocular foreign body) * Those with an abnormality on a structural MRI * Those with an implanted cardiac pacemaker or auto-defibrillator * Those with an insulin pump * Those with an irremovable body piercing * Pregnancy (based on urine test completed within 24 hours prior to scan) * Left-handed (only for fMRI experiments involving thermal pain stimulation)

Inclusion Criteria

Exclusion Criteria

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

* 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
* NIMH employees and staff and their immediate family members
* 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)
* 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
* Regular and recent use of prescription or over-the-counter medication that has a significant effect on pain or heat perception. These include medications such as centralacting agents such as opiates (morphine, tramadol), antidepressants (amitriptyline, duloxetine, milnacipran), anticonvulsants (gabapentin, pregabalin), anxiolytics (barbiturates, benzodiazepines), hypnotics (zolpidem, sodium oxybate), antipsychotics (valproate, lithium, olanzapine), antimigraine agents (sumatriptan, ergotamine), and muscle relaxants (cyclobenzaprine, carisoprodol). Use of analgesic medications, such as non-steroidal anti-inflammatories, salicylates, and acetaminophen, taken on an as needed basis is acceptable as long as the last dose taken was within 5 half-lives of testing.
* Has a condition that in a clinician s assessment could preclude the ability to hold 4-6 hours of fasting or that is associated with a risk of hypoglycemia (such as diabetes, kidney disease, insulinoma, adrenal or pituitary tumors or disorders, or anorexia nervosa)
* Is currently engaged in any kind of diet medically- or self-prescribed or endorses a very strong desire to start a diet that involves eliminating or decreasing carbohydrate consumption
* Has a history of food allergies such as tree-nut or peanut allergy.
* Individuals with conditions that could pose a risk relating to the safety of the fMRI procedure but do not meet specific exclusion criteria for all experiments or for specific inductions will be excluded from the MRI portion of the protocol but may participate in the non-MRI sessions. Such conditions include:
* Those with ferromagnetic metal in the cranial cavity or eye (e.g. aneurysm clip, implanted neural stimulator, cochlear implant, ocular foreign body)
* Those with an abnormality on a structural MRI
* Those with an implanted cardiac pacemaker or auto-defibrillator
* Those with an insulin pump
* Those with an irremovable body piercing
* Pregnancy (based on urine test completed within 24 hours prior to scan)
* Left-handed (only for fMRI experiments involving thermal pain stimulation)

Contacts and Locations

Study Contact

Silvia Lopez Guzman, M.D.

CONTACT

(301) 451-7822

nimhcdn@mail.nih.gov

Principal Investigator

Silvia Lopez Guzman, M.D.

PRINCIPAL_INVESTIGATOR

National Institute of Mental Health (NIMH)

Study Locations (Sites)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

Collaborators and Investigators

Sponsor: National Institute of Mental Health (NIMH)

Silvia Lopez Guzman, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Mental Health (NIMH)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-25

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2023-07-25

Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

Decision-Making
Interoception
Metacognition
Stress
Pain
Negative Emotion

Additional Relevant MeSH Terms

Stress
Pain
Emotions
Craving
Frustration