Stress Tests & Imaging for Self-Discipline

Overseen By Candace Raio

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Corticosteroids, Beta-blockers

Disqualifiers: Neurologic, Psychiatric, Heart, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore why self-control can be difficult and what influences these challenges. Participants will undergo various stress tests, including the Cold-Pressor Task (CPT) and the Trier Social Stress Test (TSST), along with brain scans using Functional Magnetic Resonance Imaging (fMRI) to observe how stress affects decision-making and self-control. The study seeks individuals currently on a diet to maintain or lose weight. Participants should not have a history of mental health issues, high blood pressure, or other specific health conditions. As an unphased trial, this study offers participants a unique opportunity to contribute to groundbreaking research on stress and self-control.

Will I have to stop taking my current medications?

The trial requires that you do not take medications for neurologic or psychiatric diseases, corticosteroids, or beta-blockers. If you are on these medications, you may need to stop taking them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the Cold-Pressor Task (CPT) is generally safe and well-tolerated. Participants place their hand and forearm in cold water, which can cause mild to moderate pain. Some may feel faint or dizzy due to a sudden drop in heart rate and blood pressure, but this is uncommon. Most complete the test without serious problems.

For the Trier Social Stress Test (TSST), studies have found it effectively increases stress levels. This test involves speaking and solving math problems in front of judges, temporarily raising blood pressure, heart rate, and anxiety. These reactions are expected and usually subside quickly.

Both tasks are designed to safely measure stress responses in controlled settings. Most can participate without major issues, but discussing any concerns with the study team is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring how different types of stress—both physiological and social—affect self-discipline and decision-making. Unlike traditional methods that focus on medication or therapy to improve self-control, this study uses stress tasks like the Cold-Pressor Task and the Trier Social Stress Test to simulate real-world stressors. By using fMRI imaging, researchers can observe how these stressors impact brain activity and decision-making processes in real-time. The hope is to gain insights into how stress influences behavior, which could lead to new strategies for managing stress and improving self-control in everyday life.

What evidence suggests that this trial's treatments could be effective for self-control challenges?

This trial compares different stress tests to understand their effects on decision-making and self-control. Participants in the physiological stress group undergo the Cold-Pressor Task (CPT), which involves placing a hand in ice water to raise blood pressure and test self-control under pain. Meanwhile, those in the social stress group complete the Trier Social Stress Test (TSST), which involves speaking and solving math problems in front of judges to increase anxiety and test stress management. These tasks aim to reveal how stress influences decisions and self-control, offering insights into behavior. ^{6 7 8 9 10}

Who Is on the Research Team?

Candace Raio

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Willing and able to follow study procedures and provide informed consent

Must confirm they are on a diet to maintain/lose weight and are implementing/maintaining dietary changes

Exclusion Criteria

Metallic implants or devices contraindicating magnetic resonance imaging

Pregnancy

Diabetes, food allergies, metabolic disorders, or history of eating disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Neuroimaging Study

Participants undergo a single-visit neuroimaging study including demographic and self-report measures, a self-control decision task in an fMRI scanner, and a stress or non-stress task

1 day

1 visit (in-person)

Post-Scan Activity

Participants wait for 1 hour in an adjacent study room and play out one trial of the decision-making task completed in the scanner

1 hour

Follow-up

Participants are monitored for any immediate effects post-study

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Cold-Pressor Task (CPT)
• Functional Magnetic Resonance Imaging (fMRI)
• Modified Non-Stress CPT
• Modified Non-Stress TSST
• Trier Social Stress Test (TSST)

Trial Overview

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.

How Is the Trial Designed?

Group I: Social Stress Experimental Treatment 2 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 Stress Experimental Treatment 2 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-Stress Active Control 2 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-Stress Active Control 2 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.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

The newly developed automated bilateral feet Cold Pressor Test (CPT) effectively eliminates biases associated with traditional hand immersion methods, such as laterality bias and motor response effects, making it a more reliable tool for stress research.

In a study with 28 healthy male students, the bilateral feet CPT produced significant physiological and subjective stress responses, indicating its validity and feasibility as a stress test that can be used in psychobiological research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of an automated bilateral feet cold pressor test. Bachmann, P., Zhang, X., Larra, MF., et al.[2019]

During the cold pressor test (CPT), a healthy male exhibited a biphasic heart rate response, initially increasing and then dropping significantly, which indicates a complex cardiovascular reaction to cold exposure.

The study revealed that the participant experienced neurocardiogenic syncope, characterized by low blood pressure and heart rate, highlighting the potential risks of the CPT in triggering fainting episodes due to extreme autonomic responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood pressure variability and baroreflex sensitivity of a healthy male during cold pressor test that induced development of neurocardiogenic syncope. Sinha, B., Dubey, DK.[2017]

The cold pressor task (CPT) is a reliable method for measuring pain threshold and pain tolerance, showing excellent test-retest stability over a 2-week period in a study of 61 undergraduate students.

The study found that pain threshold and tolerance were not significantly affected by the temperature of the water (4°C vs. 6°C) or environmental factors, but age was identified as a significant predictor of pain tolerance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-week test-retest stability of the cold pressor task procedure at two different temperatures as a measure of pain threshold and tolerance. Koenig, J., Jarczok, MN., Ellis, RJ., et al.[2014]

The cold pressor task (CPT) is considered an acceptable method for inducing pain in pediatric research, as reported by researchers, children, and parents, with a majority expressing positive experiences.

Adverse events during the CPT were rare and temporary, indicating that with proper safeguards, the method can be ethically employed in studies involving children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The cold pressor task: is it an ethically acceptable pain research method in children? Birnie, KA., Noel, M., Chambers, CT., et al.[2022]

The cold pressor gel test (CPGT) is a new, safe, and reproducible method for inducing pain in experimental settings, specifically designed for use with functional MRI (fMRI) studies.

In a study involving 13 women with chronic pelvic pain, the CPGT maintained a stable low temperature during the pain stimulus, leading to significant brain activation related to chronic pain processing, demonstrating its effectiveness as a pain delivery tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cold pressor gel test: A safe alternative to the cold pressor test in fMRI. Lapotka, M., Ruz, M., Salamanca Ballesteros, A., et al.[2018]

The Trier Social Stress Test (TSST) produced significantly higher levels of ACTH and cortisol compared to the Cold Pressor Test (CPT) in a study of 31 subjects, indicating a stronger activation of the HPA axis during social stress.

While the TSST led to lower mood ratings than the CPT, the CPT may still be useful for assessing stress responses in patients with diverse diagnoses, such as PTSD and alcohol dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stress reactivity: biological and subjective responses to the cold pressor and Trier Social stressors. McRae, AL., Saladin, ME., Brady, KT., et al.[2022]

The cold pressor arm wrap (CPAW) is a practical and effective alternative to the traditional cold pressor test (CPT) for inducing stress, using MRI-safe gel packs instead of water, making it suitable for various research environments.

CPAW successfully activates the sympatho-adrenomedullary (SAM) and hypothalamic-pituitary-adrenal (HPA) axes at levels comparable to CPT, ensuring similar physiological responses while being safer and more convenient for studies involving sensitive equipment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An alternative to the traditional cold pressor test: the cold pressor arm wrap. Porcelli, AJ.[2021]

This study used a 7 Tesla fMRI scanner to detect significant changes in brain activity in response to a cold pressor test (CPT) in 11 healthy participants, highlighting the potential of advanced imaging techniques to study brainstem responses.

The results showed increased BOLD signal intensity in specific brain regions, including the dorsal medulla, indicating that BOLD fMRI can effectively measure brainstem activity related to neurogenic hypertension during cold stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brainstem Correlates of a Cold Pressor Test Measured by Ultra-High Field fMRI. Hendriks-Balk, MC., Megdiche, F., Pezzi, L., et al.[2022]

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The cold pressor test is used clinically to evaluate autonomic and left ventricular function. This activity is easily adapted to an inquiry format that asks ...

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In conclusion, CPTs are generally safe and well tolerated. Because of paradoxical vasovagal reactions, however, venous access and resuscitation equipment should ...

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