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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Cold-Pressor Task (CPT) and related stress tests?

Research shows that the Cold Pressor Task (CPT) is effective in measuring stress responses, as it significantly affects physiological and subjective stress indicators like heart rate and pain perception. The automated bilateral feet CPT is validated as a reliable stress test, indicating its potential usefulness in stress-related research. ^{1 2 3 4 5}

Is the Cold Pressor Test (CPT) and related stress tests safe for humans?

The Cold Pressor Test (CPT) and related stress tests like the Trier Social Stress Test (TSST) are generally considered safe for humans, as they have been used in various studies to measure stress and pain responses. However, they can cause temporary discomfort, such as increased stress hormones and mood changes, and ethical concerns exist regarding their use in children due to the nontherapeutic induction of pain. ^{2 4 5 6 7}

How does the treatment in the 'Stress Tests & Imaging for Self-Discipline' trial differ from other treatments for stress management?

The treatment in this trial likely involves the Cold Pressor Test (CPT), which is unique because it uses cold-induced pain to measure stress responses, unlike other stress management treatments that may not involve such a physiological stressor. This method can provide insights into both biological and subjective stress responses, making it a novel approach compared to traditional stress management techniques. ^{1 2 5 6 8}

Research Team

Candace Raio

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

I am currently taking corticosteroids or beta-blockers.

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

Metallic implants or devices contraindicating magnetic resonance imaging

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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 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 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 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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Brainstem Correlates of a Cold Pressor Test Measured by Ultra-High Field fMRI. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Validation of an automated bilateral feet cold pressor test. [2019]

3. Germany 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. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Cold pressor gel test: A safe alternative to the cold pressor test in fMRI. [2018]

5. United States 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. [2014]

6. England pubmed.ncbi.nlm.nih.gov

Stress reactivity: biological and subjective responses to the cold pressor and Trier Social stressors. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The cold pressor task: is it an ethically acceptable pain research method in children? [2022]

8. United States pubmed.ncbi.nlm.nih.gov

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