HealthyNCT04060966
Neural Mechanisms of Cost and Benefit Integration During Decision-Making, Aim 2: Acute & Lifetime Stress
An observational study of Healthy, run by NYU Langone Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cold-Pressor Task (CPT) and fMRI
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 397 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 1 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Healthy
- Being tested
- Cold-Pressor Task (CPT), Control CPT, fMRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold-Pressor Task (CPT)Behavioural
The CPT involves participants submerging their dominant forearm in ice-water (0-4°C) for 3 minutes.
Control CPTBehavioural
The control CPT involves participants submerging their dominant forearm in warm water (~30°C) for 3 minutes.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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'. Receives: 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'. Receives: 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. Receives: 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 $10 study endowment to avoid spending the trial's stated amount of time with the snack food. Receives: Behavioral: Control CPT; Device: fMRI | |
| Cohort 3: M-Turk Survey | Participants in Cohort 3 will access the Amazon Mechanical Turk (M-Turk) platform, where they can search for available surveys ('HITs') to complete for payment on the M-Turk website. After completing the surveys, participants will complete the Stress and Adversity Inventory (STRAIN) questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount in Dollars ($) 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.
Measured: 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.
Measured: 60 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start1 May 2019
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 397 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Paul Glimcher, PhD, Principal investigator, New York Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04060966
- Sponsor's protocol ID
- 18-01945
- Other IDs
- 7R01DA038063-06
- Status last verified
- Jul 2023
- First submitted
- 16 Aug 2019
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Mechanisms of Cost and Benefit Integration During Decision-Making, Aim 2: Acute & Lifetime Stress
- ClinicalTrials.gov ID
- NCT04060966
- Acronym / sponsor ID
- 18-01945
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 397 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 19 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Stress Task | – | Behavioral: Cold-Pressor Task (CPT)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'. |
| Cohort 1: Control | – | Behavioral: Control CPTParticipants 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'. |
| Cohort 2: Stress Task + fMRI | – | Behavioral: Cold-Pressor Task (CPT), Device: fMRIParticipants 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. |
| Cohort 2: Control + fMRI | – | Behavioral: Control CPT, Device: fMRIParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold-Pressor Task (CPT)The CPT involves participants submerging their dominant forearm in ice-water (0-4°C) for 3 minutes. | Behavioural | Cohort 1: Stress Task, Cohort 2: Stress Task + fMRI |
| Control CPTThe control CPT involves participants submerging their dominant forearm in warm water (~30°C) for 3 minutes. | Behavioural | Cohort 1: Control, Cohort 2: Control + fMRI |
| fMRIParticipants 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. | Device | Cohort 2: Control + fMRI, Cohort 2: Stress Task + fMRI |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Glimcher, PhD principal investigator
New York Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount in Dollars ($) Participants are Willing to Allocate to Avoid Use of Self-Control during Decision-Making Task (time frame: Up to 2 Hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.