Stress and Anxiety Effects on Valuation

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.

Study Overview

• Status: Recruiting
• Conditions: Reward Value Level
• Intervention / Treatment: Behavioral: Socially Evaluated Cold Pressor Task (SECPT); Behavioral: Non-Stressful Control Task

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Candace Raio, PhD; Phone Number: 212-404-4223; Email: Candace.Raio@nyulangone.org
• Study Contact Backup: Name: Ariana Wahab; Phone Number: 212-404-3850; Email: Ariana.Wahab@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: 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.
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.	Behavioral: 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.
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.	Behavioral: Non-Stressful Control Task; Participants assigned to the warm water control condition will perform a non-evaluative task with warm water.
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.	Behavioral: 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.
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.	Behavioral: Non-Stressful Control Task; Participants assigned to the warm water control condition will perform a non-evaluative task with warm water.
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.	Behavioral: Non-Stressful Control Task; Participants assigned to the warm water control condition will perform a non-evaluative task with warm water.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Value Assigned to Food Stimuli	Measured as participants' willingness-to-pay ($) for snack foods across the behavioral task. (Aims 1 and 4).	Study Visit (Day 1 - Approx. 2 Hours)
Valence Rating Score of OASIS Images	Valence is rated on a scale from 0 (very negative) to 6 (very positive). (Aims 2 and 4)	Study Visit (Day 1 - Approx. 2 Hours)
Pleasantness Rating Score of OASIS Images	Pleasantness is rated on a scale from 0 (very unpleasant) to 6 (very pleasant). (Aims 2 and 4)	Study Visit (Day 1 - Approx. 2 Hours)
Intensity Rating Score of OASIS Images	Intensity is rated on a scale from 0 (very low) to 6 (very high). (Aims 2 and 4)	Study Visit (Day 1 - Approx. 2 Hours)
Emotion Predictions - Valence	Difference in valence ratings before and after trial outcomes. (Aims 3 and 4)	Study Visit (Day 1 - Approx. 2 Hours)
Emotion Predictions - Pleasantness	Difference in pleasantness ratings before and after trial outcomes. (Aims 3 and 4)	Study Visit (Day 1 - Approx. 2 Hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Stress Scale (PSS) Score	The PSS is a 10-item assessment of stressful feelings and thoughts over the past month; each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (fairly often). The total score is the sum of responses and ranges from 0-20. Higher scores indicate greater levels of perceived stress. (Aims 3 and 4)	Study Visit (Day 1 - Approx. 2 Hours)
Holmes-RaHe Life Stress Inventory Score	Measurement of lifetime stress; comprises 43 items, each item represents a stressful event that may have occurred over the course of the participant's lifetime. The total score is the total number of stressful events that have occured; the total score ranges from 0-43; higher scores indicate greater lifetime stress. (Aims 3 and 4)	Study Visit (Day 1 - Approx. 2 Hours)
Multidimensional Assessment of Interoceptive Awareness (MAIA-2) Score	The MAIA-2 is a 37-item assessment of interoceptive awareness. Each item is rated on a 6-point Likert scale from 0 (never) to 5 (always); the total score is the average of responses and ranges from 0 to 5; higher scores indicate greater equates to more awareness of bodily sensation.	Study Visit (Day 1 - Approx. 2 Hours)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Candace Raio, PhD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2025
• Primary Completion (Estimated): November 7, 2028
• Study Completion (Estimated): November 7, 2028

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Estimated): November 28, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 25-01195

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data collected in this study will be used for upcoming grant submissions and not publication. We do not intend to share unpublished pilot data that goes into our grant proposals. The data collected in this study are used to acquire funding for a fully powered version of this pilot study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No