StressNCT05666726
State-dependent Interoception, Value-based Decision-making, and Introspection
A study testing Pain, Stress and Craving in people with Stress and Pain, run by National Institute of Mental Health (NIMH) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- What is being tested?
- Pain, Stress and Craving
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2023to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject selections will be equitable among those individuals who meet the inclusion criteria. Every effort will be made to balance sex and race. In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- 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.
Who cannot join
- 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 self-reported current psychiatric diagnosis (based on self-reported medical history)
Show all 31Show fewer
- Scores >=29 on Beck Depression Inventory II or >=26 on Beck Anxiety Inventory
- Endorses any kind of problematic substance-related, gambling, or other addictive behavior disorder (such as videogames, social-networking, online shopping, etc.) as indicated by scores >=6 on the Generalized Problematic Behavior Severity Index
- 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
- 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.
- For craving induction:
- 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.
- For MRI experiments:
- Individuals with conditions that could pose a risk relating to the safety of the MRI 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 Behavioral Sub-study. 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 MRI sub-study and if thermal pain stimulation is involved)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Official title: State-Dependent Interoception, Value-Based Decision Making, and Introspection
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.
Read more
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.
...
Read the detailed 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. 7) Explore how psychological stress and negative affect alter self-reported enjoyment in value-based actions.
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 MRI: 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. Behavior and neural activations in an enjoyable goal-progress task and pleasure reports: 1) local goal progress, 2) pleasure experience. For MRI: 1) OFC BOLD, 2) vmPFC BOLD, 3) ACC BOLD, 4) VS BOLD, 5) network
connectivity.
- Conditions
- Stress, Pain, Emotions, Craving, Frustration
- Being tested
- Pain, Stress, Craving, Frustration, Negative valence emotion
- Keywords
- Decision-Making, Interoception, Metacognition, Stress, Pain, Negative Emotion
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PainOther
Thermal pain
StressOther
Stress state induction
CravingBehavioural
Snack craving induction
FrustrationBehavioural
Real effort task
Negative valence emotionBehavioural
Passive video watching with emotional valence
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: 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). Receives: 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). Receives: Behavioral: Craving |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Right after intervention
BOLD signal in decision-making areas ROI
BOLD signal related to decision making tasks
Measured: Right after intervention
Secondary outcomes (2)
Confidence
Level of confidence on the accuracy or optimality of their behavior.
Measured: Right after intervention
Interoceptive accuracy
Interoceptive accuracy is a measure of an individual's ability to report on bodily sensations with precision.
Measured: Right after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start25 Jul 2023
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Silvia Lopez Guzman, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666726
- Sponsor's protocol ID
- 10000978
- Other IDs
- 000978-M
- Status last verified
- 25 Sep 2026
- First submitted
- 27 Dec 2022
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed journals. @@@@@@@@@@@@All individual participant data that underlie results in a publication will be made publicly available. No Personal Identifiable Information will be shared, all data submitted to repositories will be deidentified.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- State-Dependent Interoception, Value-Based Decision Making, and Introspection
- ClinicalTrials.gov ID
- NCT05666726
- Acronym / sponsor ID
- 10000978
- Conditions
- Stress, Pain, Emotions, Craving, Frustration
- Keywords
- Decision-Making, Interoception, Metacognition, Stress, Pain, Negative Emotion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 25 Jul 2023 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 28 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
...
Detailed 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. 7) Explore how psychological stress and negative affect alter self-reported enjoyment in value-based actions.
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 MRI: 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. Behavior and neural activations in an enjoyable goal-progress task and pleasure reports: 1) local goal progress, 2) pleasure experience. For MRI: 1) OFC BOLD, 2) vmPFC BOLD, 3) ACC BOLD, 4) VS BOLD, 5) network
connectivity.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Negative valence emotionwithin-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). |
| 2 | Experimental | Behavioral: Frustrationwithin-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). |
| 3 | Experimental | Other: Painwithin-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). |
| 4 | Experimental | Other: Stresswithin-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). |
| 5 | Experimental | Behavioral: Cravingwithin-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). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subject selections will be equitable among those individuals who meet the inclusion criteria. Every effort will be made to balance sex and race. In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- 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.
Key exclusion criteria (31 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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 self-reported current psychiatric diagnosis (based on self-reported medical history)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PainThermal pain | Other | 3 |
| StressStress state induction | Other | 4 |
| CravingSnack craving induction | Behavioural | 5 |
| FrustrationReal effort task | Behavioural | 2 |
| Negative valence emotionPassive video watching with emotional valence | Behavioural | 1 |
Primary outcome
Value-based decision-making metrics
Time frame: Right after intervention
Value-based metrics such as delay discounting, which is a measure of an individual's preference for small immediate rewards over larger later rewards.
BOLD signal in decision-making areas ROI
Time frame: Right after intervention
BOLD signal related to decision making tasks
2 secondary outcomes
Confidence
Time frame: Right after intervention
Interoceptive accuracy
Time frame: Right after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed journals. @@@@@@@@@@@@All individual participant data that underlie results in a publication will be made publicly available. No Personal Identifiable Information will be shared, all data submitted to repositories will be deidentified.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Silvia Lopez Guzman, M.D. principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain, Stress and Craving in people with Stress and Pain, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silvia Lopez Guzman, M.D. ((301) 451-7822, nimhcdn@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Value-based decision-making metrics (time frame: Right after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.