Stress & Self-Control Costs
Neural and Affective Mechanisms Underlying Prospective Self-control Costs
1 other identifier
interventional
300
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2023
CompletedFirst Posted
Study publicly available on registry
April 3, 2023
CompletedStudy Start
First participant enrolled
October 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
March 11, 2026
March 1, 2026
3.2 years
March 21, 2023
March 9, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
Day 1 (Up to 1.5 Hours)
Study Arms (4)
Physiological Stress
EXPERIMENTALHealthy 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
EXPERIMENTALHealthy 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 COMPARATORHealthy 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 COMPARATORHealthy 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.
Interventions
CPT is a physiological stress task in which participants continuously submerge their hand and forearm in ice-water (0-4°C) for 3 minutes.
The TSST is a psychosocial stressor that requires participants perform a short speech and solve math problems in front of 2 evaluative judges.
The modified non-stress CPT involves participants continuously submerging their hand and forearm in warm water for 3 minutes.
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.
Participants will complete the self-control task in the fMRI scanner.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NYU Langone Healthlead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Candace Raio
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2023
First Posted
April 3, 2023
Study Start
October 1, 2024
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
April 1, 2028
Last Updated
March 11, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- 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.
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.