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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
397

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Paul Glimcher, PhD
  • Phone Number: 212-263-8169
  • Email: paulg@nyu.edu

Study Contact Backup

Study Locations

  • United States
    • New York
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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'.
Behavioral: Cold-Pressor Task (CPT)
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'.
Behavioral: Control CPT
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.
Behavioral: Cold-Pressor Task (CPT)
The CPT involves participants submerging their dominant forearm in ice-water (0-4°C) for 3 minutes.
Device: fMRI
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.
Behavioral: Control CPT
The control CPT involves participants submerging their dominant forearm in warm water (~30°C) for 3 minutes.
Device: fMRI
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Up to 2 Hours
Stress and Adversity Inventory (STRAIN) Overall Severity Score
Time Frame: 60 Minutes
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NYU Langone Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 16, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 25, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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