Stress & Self-Control Costs

Self-Control Clinical Trial

Official title:

Neural and Affective Mechanisms Underlying Prospective Self-control Costs

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05795179
• Other study ID #: 22-01630
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2024
• Est. completion date: April 1, 2028

Study information

• Verified date: February 2024
• Source: NYU Langone Health
• Contact: Candace Raio
• Email: candace.raio[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 1, 2028
• Est. primary completion date: December 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Self-Control

Intervention

Behavioral:
• 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.
• 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.
• Modified Non-Stress CPT
The modified non-stress CPT involves participants continuously submerging their hand and forearm in warm water for 3 minutes.
• Modified Non-Stress TSST
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.

Device:
• Functional Magnetic Resonance Imaging (fMRI)
Participants will complete the self-control task in the fMRI scanner.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)