Self-ControlNCT05795179
Stress & Self-Control Costs
A study testing Cold-Pressor Task (CPT), Trier Social Stress Test (TSST) and Modified Non-Stress CPT in people with Self-Control, run by NYU Langone Health at 1 site in United States.
Trial summary
Self-control failures are a universal challenge for healthy and clinical populations. Recent work suggests these failures may arise from excessive cognitive costs associated with exercising self-control, yet the mechanisms underlying these costs are unknown. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Self-Control
- What is being tested?
- Cold-Pressor Task (CPT), Trier Social Stress Test (TSST) and Modified Non-Stress CPT
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 1 Apr 2028
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-70 years of age, able to speak, read, and write fluently in English
- be willing and able to follow study procedures and provide informed consent.
- Must additionally confirm they are on a diet to maintain/lose weight and are implementing/maintaining dietary changes.
Who cannot join
- History of or medication for neurologic or psychiatric disease
- High-blood pressure or heart condition
- Diabetes, food allergies, metabolic disorders or history of eating disorder
- Use of corticosteroids or beta-blockers
- Metallic implants or devices contraindicating magnetic resonance imaging.
- Pregnancy is considered an exclusion criteria due to all stress and scanning procedures, thus pregnant participants will not be permitted to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Candace Raio contact
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: Neural and Affective Mechanisms Underlying Prospective Self-control Costs
Self-control failures are a universal challenge for healthy and clinical populations. Recent work suggests these failures may arise from excessive cognitive costs associated with exercising self-control, yet the mechanisms underlying these costs are unknown. To address this, the investigators will use a validated decision-making task that measures how much individuals will pay (from a study endowment) to restrict access to tempting rewards that may lead to self-control failures. The investigators will examine these costs to identify their cognitive, neural and affective mechanisms. First, the investigators will identify the cognitive and computational mechanism that gives rise to self-control costs. Second, the investigators will characterize the neural correlates of self-control costs and identify neural mediators and connectivity patterns stemming from these costs. Finally, the investigators will examine how different classes of stressors (physical, social, or lifetime stress) shape the behavioral and neural representations of self-control costs.
- Conditions
- Self-Control
- Being tested
- Cold-Pressor Task (CPT), Trier Social Stress Test (TSST), Modified Non-Stress CPT, Modified Non-Stress TSST, Functional Magnetic Resonance Imaging (fMRI)
- Medical subject headings
- Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold-Pressor Task (CPT)Behavioural
CPT is a physiological stress task in which participants continuously submerge their hand and forearm in ice-water (0-4°C) for 3 minutes.
Trier Social Stress Test (TSST)Behavioural
The TSST is a psychosocial stressor that requires participants perform a short speech and solve math problems in front of 2 evaluative judges.
Modified Non-Stress CPTBehavioural
The modified non-stress CPT involves participants continuously submerging their hand and forearm in warm water for 3 minutes.
Modified Non-Stress TSSTBehavioural
For the modified non-stress TSST, participants are asked to prepare for a speech that they will practice alone to themselves and complete math problems alone on a piece of scrap paper.
Functional Magnetic Resonance Imaging (fMRI)Device
Participants will complete the self-control task in the fMRI scanner.
| Study group | Role | What they receive |
|---|---|---|
| Physiological Stress | Experimental | Healthy dieters will undergo a single-visit neuroimaging study where they will first complete demographic and self-report measures followed by a self-control decision task in an fMRI scanner. Prior to scanning, participants will be assigned to a physiological stress group and complete the corresponding stress task. For the physiological stress group, this task is the Cold-Pressor Task (CPT), a physiological stress task in which participants continuously submerge their hand and forearm in ice-water (0-4°C) for 3 minutes. After the scan, participants will wait for 1 hour in an adjacent study room where they will play out one trial of the decision-making task completed in the scanner. Receives: Behavioral: Cold-Pressor Task (CPT); Device: Functional Magnetic Resonance Imaging (fMRI) |
| Social Stress | Experimental | Healthy dieters will undergo a single-visit neuroimaging study where they will first complete demographic and self-report measures followed by a self-control decision task in an fMRI scanner. Prior to scanning, participants will be assigned to the social stress group and complete the corresponding stress task. For the social stress group, this task is the Trier Social Stress Test (TSST), a psychosocial stressor that requires participants perform a short speech and solve math problems in front of 2 evaluative judges. After the scan, participants will wait for 1 hour in an adjacent study room where they will play out one trial of the decision-making task completed in the scanner. Receives: Behavioral: Trier Social Stress Test (TSST); Device: Functional Magnetic Resonance Imaging (fMRI) |
| Physiological Non-Stress | Active comparator | Healthy dieters will undergo a single-visit neuroimaging study where they will first complete demographic and self-report measures followed by a self-control decision task in an fMRI scanner. Prior to scanning, participants will be assigned to the physiological non-stress group and complete the corresponding stress task. For the physiological non-stress group, participants will continuously submerge their hand and forearm in warm water for 3 minutes. After the scan, participants will wait for 1 hour in an adjacent study room where they will play out one trial of the decision-making task completed in the scanner. Receives: Behavioral: Modified Non-Stress CPT; Device: Functional Magnetic Resonance Imaging (fMRI) |
| Social Non-Stress | Active comparator | Healthy dieters will undergo a single-visit neuroimaging study where they will first complete demographic and self-report measures followed by a self-control decision task in an fMRI scanner. Prior to scanning, participants will be assigned to the social stress group and complete the corresponding stress task. For the social non-stress group, participants will be asked to prepare for a speech that they will practice alone to themselves and complete math problems alone on a piece of scrap paper. After the scan, participants will wait for 1 hour in an adjacent study room where they will play out one trial of the decision-making task completed in the scanner. Receives: Behavioral: Modified Non-Stress TSST; Device: Functional Magnetic Resonance Imaging (fMRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Self-Control Cost
The self-control cost is the amount that a participant would be willing to pay to avoid temptation. This will be tested in a self-control task in which participants are shown an images of snack food and report how much they would be willing to avoid the different food items.
Measured: Day 1
Change in fMRI BOLD Signal During Self-Control Decisions
Functional MRI (fMRI) data will be analyzed to measure changes in blood-oxygen-level-dependent (BOLD) signal in the Dorsal Anterior Cingulate Cortex (dACC), Frontopolar Cortex (FPC) and Orbitofrontal Cortex (OFC) regions of interest as participants make self-control cost decisions during the self-control activity.
Measured: Day 1 (Up to 1.5 Hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start1 Oct 2024
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-ControlStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Candace Raio, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05795179
- Sponsor's protocol ID
- 22-01630
- Status last verified
- Mar 2026
- First submitted
- 21 Mar 2023
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: candace.raio@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural and Affective Mechanisms Underlying Prospective Self-control Costs
- ClinicalTrials.gov ID
- NCT05795179
- Acronym / sponsor ID
- 22-01630
- Conditions
- Self-Control
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 3 Apr 2023 (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.
Self-control failures are a universal challenge for healthy and clinical populations. Recent work suggests these failures may arise from excessive cognitive costs associated with exercising self-control, yet the mechanisms underlying these costs are unknown. To address this, the investigators will use a validated decision-making task that measures how much individuals will pay (from a study endowment) to restrict access to tempting rewards that may lead to self-control failures. The investigators will examine these costs to identify their cognitive, neural and affective mechanisms. First, the investigators will identify the cognitive and computational mechanism that gives rise to self-control costs. Second, the investigators will characterize the neural correlates of self-control costs and identify neural mediators and connectivity patterns stemming from these costs. Finally, the investigators will examine how different classes of stressors (physical, social, or lifetime stress) shape the behavioral and neural representations of self-control costs.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Physiological Stress | Experimental | Behavioral: Cold-Pressor Task (CPT), Device: Functional Magnetic Resonance Imaging (fMRI)Healthy dieters will undergo a single-visit neuroimaging study where they will first complete demographic and self-report measures followed by a self-control decision task in an fMRI scanner. Prior to scanning, participants will be assigned to a physiological stress group and complete the corresponding stress task. For the physiological stress group, this task is the Cold-Pressor Task (CPT), a physiological stress task in which participants continuously submerge their hand and forearm in ice-water (0-4°C) for 3 minutes. After the scan, participants will wait for 1 hour in an adjacent study room where they will play out one trial of the decision-making task completed in the scanner. |
| Social Stress | Experimental | Behavioral: Trier Social Stress Test (TSST), Device: Functional Magnetic Resonance Imaging (fMRI)Healthy dieters will undergo a single-visit neuroimaging study where they will first complete demographic and self-report measures followed by a self-control decision task in an fMRI scanner. Prior to scanning, participants will be assigned to the social stress group and complete the corresponding stress task. For the social stress group, this task is the Trier Social Stress Test (TSST), a psychosocial stressor that requires participants perform a short speech and solve math problems in front of 2 evaluative judges. After the scan, participants will wait for 1 hour in an adjacent study room where they will play out one trial of the decision-making task completed in the scanner. |
| Physiological Non-Stress | Active comparator | Behavioral: Modified Non-Stress CPT, Device: Functional Magnetic Resonance Imaging (fMRI)Healthy dieters will undergo a single-visit neuroimaging study where they will first complete demographic and self-report measures followed by a self-control decision task in an fMRI scanner. Prior to scanning, participants will be assigned to the physiological non-stress group and complete the corresponding stress task. For the physiological non-stress group, participants will continuously submerge their hand and forearm in warm water for 3 minutes. After the scan, participants will wait for 1 hour in an adjacent study room where they will play out one trial of the decision-making task completed in the scanner. |
| Social Non-Stress | Active comparator | Behavioral: Modified Non-Stress TSST, Device: Functional Magnetic Resonance Imaging (fMRI)Healthy dieters will undergo a single-visit neuroimaging study where they will first complete demographic and self-report measures followed by a self-control decision task in an fMRI scanner. Prior to scanning, participants will be assigned to the social stress group and complete the corresponding stress task. For the social non-stress group, participants will be asked to prepare for a speech that they will practice alone to themselves and complete math problems alone on a piece of scrap paper. After the scan, participants will wait for 1 hour in an adjacent study room where they will play out one trial of the decision-making task completed in the scanner. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-70 years of age, able to speak, read, and write fluently in English
- be willing and able to follow study procedures and provide informed consent.
- Must additionally confirm they are on a diet to maintain/lose weight and are implementing/maintaining dietary changes.
Key exclusion criteria (6 listed)
- History of or medication for neurologic or psychiatric disease
- High-blood pressure or heart condition
- Diabetes, food allergies, metabolic disorders or history of eating disorder
- Use of corticosteroids or beta-blockers
- Metallic implants or devices contraindicating magnetic resonance imaging.
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 |
|---|---|---|
| Cold-Pressor Task (CPT)CPT is a physiological stress task in which participants continuously submerge their hand and forearm in ice-water (0-4°C) for 3 minutes. | Behavioural | Physiological Stress |
| Trier Social Stress Test (TSST)The TSST is a psychosocial stressor that requires participants perform a short speech and solve math problems in front of 2 evaluative judges. | Behavioural | Social Stress |
| Modified Non-Stress CPTThe modified non-stress CPT involves participants continuously submerging their hand and forearm in warm water for 3 minutes. | Behavioural | Physiological Non-Stress |
| Modified Non-Stress TSSTFor the modified non-stress TSST, participants are asked to prepare for a speech that they will practice alone to themselves and complete math problems alone on a piece of scrap paper. | Behavioural | Social Non-Stress |
| Functional Magnetic Resonance Imaging (fMRI)Participants will complete the self-control task in the fMRI scanner. | Device | Physiological Non-Stress, Physiological Stress, Social Non-Stress, Social Stress |
Primary outcome
Average Self-Control Cost
Time frame: Day 1
The self-control cost is the amount that a participant would be willing to pay to avoid temptation. This will be tested in a self-control task in which participants are shown an images of snack food and report how much they would be willing to avoid the different food items.
Change in fMRI BOLD Signal During Self-Control Decisions
Time frame: Day 1 (Up to 1.5 Hours)
Functional MRI (fMRI) data will be analyzed to measure changes in blood-oxygen-level-dependent (BOLD) signal in the Dorsal Anterior Cingulate Cortex (dACC), Frontopolar Cortex (FPC) and Orbitofrontal Cortex (OFC) regions of interest as participants make self-control cost decisions during the self-control activity.
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 11 Mar 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: candace.raio@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Candace Raio contact
Candace Raio principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold-Pressor Task (CPT), Trier Social Stress Test (TSST) and Modified Non-Stress CPT in people with Self-Control, run by NYU Langone Health 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 3 inclusion and 6 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 11 Mar 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 Candace Raio (candace.raio@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Self-Control Cost (time frame: Day 1). 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 11 Mar 2026.