Recruiting

Observational Study

Sponsor:

NYU Langone Health

Code:

NCT07252947

Conditions

Reward Value Level

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Socially Evaluated Cold Pressor Task (SECPT)

Non-Stressful Control Task

Study Details

Brief summary:

The purpose of this study is to understand how stress, anxiety, and negative affect change learning and decision-making processes. The primary objective is to assess two forms of decision-making-reward adaptation and emotion prediction errors-differ as a function of stress and anxiety. The secondary objectives are to assess how individual differences measured in our studies relate to these decision variables.

Conditions

Reward Value Level

Study ID

NCT07252947

Start date

Dec 18, 2025

Status verified date

Dec, 2025

Completion date

Nov 7, 2028

Anticipated

Primary completion date

Nov 7, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

Aims 1-3: To be eligible for participation in this study, an individual must meet all of the following criteria:

  • 18-65 years of age
  • Able to speak, read, and write fluently in English
  • Be willing and able to follow study procedures and provide informed consent.

Aim 4: To be eligible for participation in this study, an individual must meet all of the following criteria:

  • 18-65 years of age
  • Diagnosis of GAD
  • Able to speak, read, and write fluently in English
  • Be willing and able to follow study procedures and provide informed consent.

Exclusion Criteria:

Aims 1-3: Individuals will be excluded from participation if any of the following criteria are met:

  • History of or medication for neurologic or psychiatric disease
  • High-blood pressure or heart condition
  • Diabetes, food allergies, metabolic disorders or history of eating disorder
  • Use of corticosteroids or beta-blockers
  • Pregnancy

Aim 4: Individuals will be excluded from participation if any of the following criteria are met:

  • High-blood pressure or heart condition
  • Diabetes, food allergies, metabolic disorders or history of eating disorder
  • Use of corticosteroids or beta-blockers
  • Lifetime history of bipolar disorder or any psychotic disorder; substance use disorder in past 3 months; eating disorder in past 6 months; current major depressive disorder (past is allowed)
  • Active suicidal ideation with plan and intent (indicated by score >=4 on the Columbia Suicide Severity Scale)
  • Not on stable dose of psychiatric medication for at least 4 weeks prior to study participation
  • Pregnancy

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Aim 1: Socially Evaluated Cold Pressor Task (SECPT)

Participants will be randomly assigned to complete the Socially Evaluated Cold Pressor Task (SECPT). Cortisol samples will be collected throughout the study session. All participants will then complete a Food Value Task, during which they will view a series of reward stimuli (snack foods) over alternating task blocks.

active comparator: Aim 1: Non-Stressful Control Task

Participants will be randomly assigned to complete a non-stressful control task. Cortisol samples will be collected throughout the study session. All participants will then complete a Food Value Task, during which they will view a series of reward stimuli (snack foods) over alternating task blocks.

experimental: Aim 2: Socially Evaluated Cold Pressor Task (SECPT)

Participants will be randomly assigned to complete the SECPT. Cortisol samples will be collected throughout the study session. Participants will then complete the Image Value Task, during which they will view a series of positive, negative or neutral images over alternating task blocks.

active comparator: Aim 2: Non-Stressful Control Task

Participants will be randomly assigned to complete a non-stressful control task. Cortisol samples will be collected throughout the study session. Participants will then complete the Image Value Task, during which they will view a series of positive, negative or neutral images over alternating task blocks.

experimental: Aim 3: Socially Evaluated Cold Pressor Task (SECPT)

Participants will first complete demographic and self-report measures, followed by random assignment to complete the SECPT. Cortisol samples will be collected throughout the study session to measure neuroendocrine response to the stress/control task. Participants will then complete the Affective Prediction Error Task.

active comparator: Aim 3: Non-Stressful Control Task

Participants will be randomly assigned to complete a non-stressful control task. Cortisol samples will be collected throughout the study session. Participants will then complete the Affective Prediction Task.

no intervention: Aim 4: Behavioral Task

Participants with a diagnosis of generalized anxiety disorder (GAD) will complete a two-session behavioral task examining how clinical anxiety affects value and affective predictions.

Interventions

Socially Evaluated Cold Pressor Task (SECPT)

The SECPT is a validated laboratory stressor that combines physiological stress with social evaluative components; it is widely used to elicit acute stress responses in controlled settings. Participants are asked to submerge their nondominant hand into an ice-cold water (0-4°C) for 3 minutes, while videotaped and observed by one neutral-faced experimenter.

Non-Stressful Control Task

Participants assigned to the warm water control condition will perform a non-evaluative task with warm water.

Primary outcome measure

  • Subjective Value Assigned to Food Stimuli [ Time Frame: Study Visit (Day 1 - Approx. 2 Hours) ]
  • Valence Rating Score of OASIS Images [ Time Frame: Study Visit (Day 1 - Approx. 2 Hours) ]
  • Pleasantness Rating Score of OASIS Images [ Time Frame: Study Visit (Day 1 - Approx. 2 Hours) ]
  • Intensity Rating Score of OASIS Images [ Time Frame: Study Visit (Day 1 - Approx. 2 Hours) ]
  • Emotion Predictions - Valence [ Time Frame: Study Visit (Day 1 - Approx. 2 Hours) ]
  • Emotion Predictions - Pleasantness [ Time Frame: Study Visit (Day 1 - Approx. 2 Hours) ]

Central Contacts and Locations

Central contacts

Candace Raio, PhD

212-404-4223Candace.Raio@nyulangone.org

Ariana Wahab

212-404-3850Ariana.Wahab@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Dec 22, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2025-12-22.