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Recruiting NCT05795179

Stress & Self-Control Costs

No phase Interventional Self-Control

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cold-Pressor Task (CPT), Trier Social Stress Test (TSST), Modified Non-Stress CPT, Modified Non-Stress TSST.
Who it may be relevant to
Registry conditions: Self-Control. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Neural and Affective Mechanisms Underlying Prospective Self-control Costs

Overview

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.

Interventions

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

Primary outcome measures

  • Average Self-Control Cost [Time frame: Day 1]
  • Change in fMRI BOLD Signal During Self-Control Decisions [Time frame: Day 1 (Up to 1.5 Hours)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT05795179 · 22-01630

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗