NCT04060966

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
397

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

July 25, 2023

Status Verified

July 1, 2023

Enrollment Period

3.3 years

First QC Date

August 16, 2019

Last Update Submit

July 21, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Amount in Dollars ($) Participants are Willing to Allocate to Avoid Use of Self-Control during Decision-Making Task

    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

    Cumulative lifetime stress will be quantified as a score (Overall Severity Score; OSS) derived from the Stress and Adversity Inventory (STRAIN) questionnaire.

    60 Minutes

Study Arms (5)

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)

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

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)Device: fMRI

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 CPTDevice: fMRI

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.

Interventions

The CPT involves participants submerging their dominant forearm in ice-water (0-4°C) for 3 minutes.

Cohort 1: Stress TaskCohort 2: Stress Task + fMRI
Control CPTBEHAVIORAL

The control CPT involves participants submerging their dominant forearm in warm water (\~30°C) for 3 minutes.

Cohort 1: ControlCohort 2: Control + fMRI
fMRIDEVICE

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 + fMRICohort 2: Stress Task + fMRI

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Paul Glimcher, PhD

    New York Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2019

First Posted

August 19, 2019

Study Start

May 1, 2019

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

July 25, 2023

Record last verified: 2023-07

Locations