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Stress Tests & Imaging for Self-Discipline
N/A
Recruiting
Led By Candace Raio
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (up to 1.5 hours)
Awards & highlights
Study Summary
This trial examines the cognitive, neural & affective mechanisms behind self-control failure to understand why people give in to temptations. They will use a decision-making task to measure the cost of restricting access to those temptations.
Who is the study for?
This trial is for adults aged 18-70 who are currently dieting to lose or maintain weight and can communicate in English. Participants must be willing to follow the study's procedures. Those with metal implants, high blood pressure, heart conditions, diabetes, food allergies, eating disorders, or on certain medications cannot join.Check my eligibility
What is being tested?
The study tests how stress affects self-control using tasks like the Cold-Pressor and Trier Social Stress Tests under normal and modified conditions. It also uses fMRI scans to see what happens in the brain during these tasks.See study design
What are the potential side effects?
Possible side effects include discomfort from cold exposure during the Cold-Pressor Task and stress from social evaluation in the Trier Test. The fMRI is non-invasive but requires lying still in a loud machine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 (up to 1.5 hours)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (up to 1.5 hours)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Average Self-Control Cost
Change in fMRI BOLD Signal During Self-Control Decisions
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Social StressExperimental Treatment2 Interventions
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.
Group II: Physiological StressExperimental Treatment2 Interventions
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.
Group III: Physiological Non-StressActive Control2 Interventions
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.
Group IV: Social Non-StressActive Control2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cold-Pressor Task (CPT)
2019
N/A
~400
Trier Social Stress Test (TSST)
2020
N/A
~210
Functional Magnetic Resonance Imaging (fMRI)
2010
Completed Phase 4
~520
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,369 Previous Clinical Trials
840,298 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,409 Total Patients Enrolled
Candace RaioPrincipal InvestigatorNYU Langone Health
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking corticosteroids or beta-blockers.I am between 18 and 70 years old and fluent in English.I have a history of or am on medication for a brain or mental health condition.I have high blood pressure or a heart condition.
Research Study Groups:
This trial has the following groups:- Group 1: Physiological Stress
- Group 2: Social Stress
- Group 3: Physiological Non-Stress
- Group 4: Social Non-Stress
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this trialing process accept elderly participants aged 80 and above?
"This clinical trial's enrollment criteria stipulates that participants must be aged between 18 and 70 to take part."
Answered by AI
Might I be a suitable candidate for this experiment?
"The eligibility criteria for this trial necessitates self-control and an age between 18 to 70 years old. This clinical study is currently recruiting approximately 600 participants."
Answered by AI
Is enrolment for this clinical experiment still ongoing?
"As noted on clinicaltrials.gov, this particular trail is no longer in the recruitment phase; having been initially posted on August 1st 2024 and last updated March 21st 2023. Yet there are two other trials currently enrolling patients for participation."
Answered by AI
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