- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05795179
Stress & Self-Control Costs
March 9, 2026 updated by: NYU Langone Health
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Candace Raio
- Email: candace.raio@nyulangone.org
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- Recruiting
- NYU Langone Health
-
-
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.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Physiological Stress
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.
|
CPT is a physiological stress task in which participants continuously submerge their hand and forearm in ice-water (0-4°C) for 3 minutes.
Participants will complete the self-control task in the fMRI scanner.
|
|
Experimental: Social Stress
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.
|
Participants will complete the self-control task in the fMRI scanner.
The TSST is a psychosocial stressor that requires participants perform a short speech and solve math problems in front of 2 evaluative judges.
|
|
Active Comparator: Physiological Non-Stress
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.
|
Participants will complete the self-control task in the fMRI scanner.
The modified non-stress CPT involves participants continuously submerging their hand and forearm in warm water for 3 minutes.
|
|
Active Comparator: Social Non-Stress
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.
|
Participants will complete the self-control task in the fMRI scanner.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Day 1
|
|
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.
|
Day 1 (Up to 1.5 Hours)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Candace Raio, NYU Langone Health
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 Major Dates
Study Start (Actual)
October 1, 2024
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
April 1, 2028
Study Registration Dates
First Submitted
March 21, 2023
First Submitted That Met QC Criteria
March 21, 2023
First Posted (Actual)
April 3, 2023
Study Record Updates
Last Update Posted (Actual)
March 11, 2026
Last Update Submitted That Met QC Criteria
March 9, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-01630
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
The investigator who proposed to use the data will be granted access upon reasonable request.
Requests should be directed to candace.raio@nyulangone.org.
To gain access, data requestors will need to sign a data access agreement.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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