- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04060966
Neural Mechanisms of Cost and Benefit Integration During Decision-Making, Aim 2: Acute & Lifetime Stress
July 21, 2023 updated by: NYU Langone Health
The central aim of this study is to characterize how the costs of acute and lifetime stress affect the neural architecture for decision-making in healthy humans.
Investigators will use behavioral choice paradigms to measure how the costs of stress influence decisions about rewards (e.g., foods, money) as well as decisions about the use of self-control strategies.
They will further examine associations between these stress measures and other decision variables commonly studied in our lab which have well-understood mechanisms, such as risk preferences.
This behavioral work lays the foundation for an fMRI experiment that combines our measures of the behavioral costs of stress with neural measures of brain changes.
Acute stress will be measured using a physiological stressor (cold-pressor task) coupled with saliva sample collection for cortisol analysis.
Lifetime stress will be measured using a computerized life stress survey.
We will study three cohorts: One purely behavioral cohort will be examined on-site (n=60).
In a smaller subset of participants (n=40), investigators will measure neural activity changes in relevant brain areas as measured with MRI during decisions to use self-control in the presence of rewards.
In a larger sample (n=500) the correlation between participants' risk preferences and lifetime stress exposure at scale using Amazon Mechanical Turk subjects will be measured.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
397
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Paul Glimcher, PhD
- Phone Number: 212-263-8169
- Email: paulg@nyu.edu
Study Contact Backup
- Name: Candace Raio, MD
- Phone Number: 570-977-7203
- Email: candace.raio@nyulangone.org
Study Locations
-
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New York
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New York, New York, United States, 10016
- NYU Langone Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Participants will be healthy males and females between ages of 18-64 reflecting the demographics of NYU Washington Square and New York area.
Description
Inclusion Criteria:
- English as a native language
- Corrected-to-normal vision
- Individuals on diets to maintain or lose weight, or those not on a diet
- All races, ethnicities, and cultures
Exclusion Criteria:
- For all fMRI studies we will exclude participants who meet one of the standard CBI MRI exclusion criteria (see attached exclusion questionnaire) prior to participation. This screening questionnaire will be administered prior to scheduling the study, and once again before the scanner session during the second consenting procedure.
- History of and/or medication for neurological or psychiatric disorders
- High blood pressure, heart condition or related medical conditions
- Diabetes, metabolic disorders, history of eating disorders, or food allergies
- Pregnancy
- Handedness (this has been shown be indicative of variations in brain circuitry)
- Since we will measure stress hormones, subjects currently taking corticosteroids or beta-blockers will be ineligible to participate, as these medications have been found to dramatically alter stress hormone levels.
- Furthermore, evidence suggests that fluctuations in bodily hormones (such as that induced through hormonal contraceptives or different stages of menstrual cycle phase) can affect stress hormone levels (Tersman, Collins, & Eneroth, 1991; Kirschbaum et al, 1999; Andreano, Arjomanid, Cahill, 2008). In order to account for hormonal differences, we will ask female participants if they are taking oral contraceptives. Likewise, we propose to use a simple, non-invasive questionnaire to determine cycle phase, as in McCormick & Teillon, 2001. We may need to exclude on the basis of whether or not female participants use hormone-based contraceptives, which, for the reason stated above, could be a potential confound.
- In some cases, we will pre-screen subjects to ensure they are on a diet to maintain or lose weight in order to examine how dietary and health goals influence decisions about self-control and rewards.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cohort 1: Stress Task
Participants in Cohort 1 randomized to the stress task will complete the Cold-Pressor Task (CPT), which requires the continuous submersion of the forearm in ice-water (0-4°C) for 3 minutes in the presence of an experimenter.
After the CPT, participants will complete a decision-making task.
During the decision-making task, participants will do one of the following: evaluate different features of foods/monetary prizes in 'rating trials', choose between pairs or bundles of snack foods in 'choice trials', bid for the chance to win foods/monetary prizes or bid to remove certain foods from their choice menu in 'auction trials', or choose between pairs of monetary lotteries in 'lottery trials'.
|
The CPT involves participants submerging their dominant forearm in ice-water (0-4°C) for 3 minutes.
|
Cohort 1: Control
Participants in Cohort 1 randomized to the Control group will complete a matching control task to the CPT, which involves continuous submersion of the forearm in warm water, ~30°C, for 3 minutes.
After the control CPT, participants will complete a decision-making task.
During the decision-making task, participants will do one of the following: evaluate different features of foods/monetary prizes in 'rating trials', choose between pairs or bundles of snack foods in 'choice trials', bid for the chance to win foods/monetary prizes or bid to remove certain foods from their choice menu in 'auction trials', or choose between pairs of monetary lotteries in 'lottery trials'.
|
The control CPT involves participants submerging their dominant forearm in warm water (~30°C) for 3 minutes.
|
Cohort 2: Stress Task + fMRI
Participants in Cohort 2 randomized to the Stress task will complete the CPT, which requires the continuous submersion of the forearm in ice-water (0-4°C) for 3 minutes in the presence of an experimenter.
After the CPT, participants will complete decision-making tasks while being scanned via functional MRI (fMRI).
The tasks will involve attending to auditory and/or visual stimuli on a computer.
On each trial, different food items and different amounts of time (1-60 minutes) will be presented and participants will be asked to indicate how much they would pay from their $10 study endowment to avoid spending the trial's stated amount of time with the snack food.
|
The CPT involves participants submerging their dominant forearm in ice-water (0-4°C) for 3 minutes.
Participants in the neuroimaging cohort will complete up to two fMRI experimental sessions on different days, with at least a day between sessions, each lasting approximately 2 hours.
Imaging data will be collected with a Prisma 3T head- only scanner equipped with a head coil from Nova Medical.
|
Cohort 2: Control + fMRI
Participants in Cohort 2 randomized to the Control group will complete a matching control task to the CPT, which involves continuous submersion of the forearm in warm water, ~30°C, for 3 minutes.
After the control CPT, participants will complete decision-making tasks while being scanned via functional MRI (fMRI).
The tasks will involve attending to auditory and/or visual stimuli on a computer.
On each trial, different food items and different amounts of time (1-60 minutes) will be presented and participants will be asked to indicate how much they would pay from their $10 study endowment to avoid spending the trial's stated amount of time with the snack food.
|
The control CPT involves participants submerging their dominant forearm in warm water (~30°C) for 3 minutes.
Participants in the neuroimaging cohort will complete up to two fMRI experimental sessions on different days, with at least a day between sessions, each lasting approximately 2 hours.
Imaging data will be collected with a Prisma 3T head- only scanner equipped with a head coil from Nova Medical.
|
Cohort 3: M-Turk Survey
Participants in Cohort 3 will access the Amazon Mechanical Turk (M-Turk) platform, where they can search for available surveys ('HITs') to complete for payment on the M-Turk website.
After completing the surveys, participants will complete the Stress and Adversity Inventory (STRAIN) questionnaire.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Amount in Dollars ($) Participants are Willing to Allocate to Avoid Use of Self-Control during Decision-Making Task
Time Frame: Up to 2 Hours
|
Amount participants would be willing to spend to avoid use of self-control will be evaluated during a decision-making task in Cohorts 1 and 2.
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Up to 2 Hours
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Stress and Adversity Inventory (STRAIN) Overall Severity Score
Time Frame: 60 Minutes
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Cumulative lifetime stress will be quantified as a score (Overall Severity Score; OSS) derived from the Stress and Adversity Inventory (STRAIN) questionnaire.
|
60 Minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Paul Glimcher, PhD, New York Langone Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2019
Primary Completion (Actual)
August 1, 2022
Study Completion (Actual)
August 1, 2022
Study Registration Dates
First Submitted
August 16, 2019
First Submitted That Met QC Criteria
August 16, 2019
First Posted (Actual)
August 19, 2019
Study Record Updates
Last Update Posted (Actual)
July 25, 2023
Last Update Submitted That Met QC Criteria
July 21, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 18-01945
- 7R01DA038063-06 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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