Reward Value LevelNCT07252947
Stress and Anxiety Effects on Valuation
A study testing Socially Evaluated Cold Pressor Task (SECPT) in people with Reward Value Level, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Reward Value Level
- What is being tested?
- Socially Evaluated Cold Pressor Task (SECPT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2025to 7 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- Diagnosis of GAD
- Able to speak, read, and write fluently in English
- Be willing and able to follow study procedures and provide informed consent.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
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
- Being tested
- Socially Evaluated Cold Pressor Task (SECPT), Non-Stressful Control Task
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Socially Evaluated Cold Pressor Task (SECPT)Behavioural
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 TaskBehavioural
Participants assigned to the warm water control condition will perform a non-evaluative task with warm water.
| Study group | Role | What they receive |
|---|---|---|
| Aim 1: Socially Evaluated Cold Pressor Task (SECPT) | Experimental | 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. Receives: Behavioral: Socially Evaluated Cold Pressor Task (SECPT) |
| Aim 1: Non-Stressful Control Task | Active comparator | 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. Receives: Behavioral: Non-Stressful Control Task |
| Aim 2: Socially Evaluated Cold Pressor Task (SECPT) | Experimental | 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. Receives: Behavioral: Socially Evaluated Cold Pressor Task (SECPT) |
| Aim 2: Non-Stressful Control Task | Active comparator | 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. Receives: Behavioral: Non-Stressful Control Task |
| Aim 3: Socially Evaluated Cold Pressor Task (SECPT) | Experimental | 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. Receives: Behavioral: Socially Evaluated Cold Pressor Task (SECPT) |
| Aim 3: Non-Stressful Control Task | Active comparator | 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. Receives: Behavioral: Non-Stressful Control Task |
| Aim 4: Behavioral Task | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Subjective Value Assigned to Food Stimuli
Measured as participants' willingness-to-pay ($) for snack foods across the behavioral task. (Aims 1 and 4).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Study Visit (Day 1 - Approx. 2 Hours)
Emotion Predictions - Valence
Difference in valence ratings before and after trial outcomes. (Aims 3 and 4)
Measured: Study Visit (Day 1 - Approx. 2 Hours)
Emotion Predictions - Pleasantness
Difference in pleasantness ratings before and after trial outcomes. (Aims 3 and 4)
Measured: Study Visit (Day 1 - Approx. 2 Hours)
Secondary outcomes (3)
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)
Measured: 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)
Measured: 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.
Measured: Study Visit (Day 1 - Approx. 2 Hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start18 Dec 2025
- Primary completion7 Nov 2028 (estimated)
- Study completion7 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reward Value LevelStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Candace Raio, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252947
- Sponsor's protocol ID
- 25-01195
- Status last verified
- Oct 2026
- First submitted
- 19 Nov 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress and Anxiety Effects on Valuation
- ClinicalTrials.gov ID
- NCT07252947
- Acronym / sponsor ID
- 25-01195
- Conditions
- Reward Value Level
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 18 Dec 2025 (actual)
- Primary completion
- 7 Nov 2028 (estimated)
- Study completion
- 7 Nov 2028 (estimated)
- First posted
- 28 Nov 2025 (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 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Aim 1: Socially Evaluated Cold Pressor Task (SECPT) | Experimental | Behavioral: 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. |
| Aim 1: Non-Stressful Control Task | Active comparator | Behavioral: Non-Stressful Control TaskParticipants 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. |
| Aim 2: Socially Evaluated Cold Pressor Task (SECPT) | Experimental | Behavioral: 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. |
| Aim 2: Non-Stressful Control Task | Active comparator | Behavioral: Non-Stressful Control TaskParticipants 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. |
| Aim 3: Socially Evaluated Cold Pressor Task (SECPT) | Experimental | Behavioral: 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. |
| Aim 3: Non-Stressful Control Task | Active comparator | Behavioral: Non-Stressful Control TaskParticipants 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. |
| Aim 4: Behavioral Task | No intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| 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. | Behavioural | Aim 1: Socially Evaluated Cold Pressor Task (SECPT), Aim 2: Socially Evaluated Cold Pressor Task (SECPT), Aim 3: Socially Evaluated Cold Pressor Task (SECPT) |
| Non-Stressful Control TaskParticipants assigned to the warm water control condition will perform a non-evaluative task with warm water. | Behavioural | Aim 1: Non-Stressful Control Task, Aim 2: Non-Stressful Control Task, Aim 3: Non-Stressful Control Task |
Primary outcome
Subjective Value Assigned to Food Stimuli
Time frame: Study Visit (Day 1 - Approx. 2 Hours)
Measured as participants' willingness-to-pay ($) for snack foods across the behavioral task. (Aims 1 and 4).
Valence Rating Score of OASIS Images
Time frame: Study Visit (Day 1 - Approx. 2 Hours)
Valence is rated on a scale from 0 (very negative) to 6 (very positive). (Aims 2 and 4)
Pleasantness Rating Score of OASIS Images
Time frame: Study Visit (Day 1 - Approx. 2 Hours)
Pleasantness is rated on a scale from 0 (very unpleasant) to 6 (very pleasant). (Aims 2 and 4)
Intensity Rating Score of OASIS Images
Time frame: Study Visit (Day 1 - Approx. 2 Hours)
Intensity is rated on a scale from 0 (very low) to 6 (very high). (Aims 2 and 4)
Emotion Predictions - Valence
Time frame: Study Visit (Day 1 - Approx. 2 Hours)
Difference in valence ratings before and after trial outcomes. (Aims 3 and 4)
Emotion Predictions - Pleasantness
Time frame: Study Visit (Day 1 - Approx. 2 Hours)
Difference in pleasantness ratings before and after trial outcomes. (Aims 3 and 4)
3 secondary outcomes
Perceived Stress Scale (PSS) Score
Time frame: Study Visit (Day 1 - Approx. 2 Hours)
Holmes-RaHe Life Stress Inventory Score
Time frame: Study Visit (Day 1 - Approx. 2 Hours)
Multidimensional Assessment of Interoceptive Awareness (MAIA-2) Score
Time frame: Study Visit (Day 1 - Approx. 2 Hours)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No. 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.
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.
Candace Raio, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Socially Evaluated Cold Pressor Task (SECPT) in people with Reward Value Level, 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 9 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 30 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Candace Raio, PhD (212-404-4223, Candace.Raio@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Value Assigned to Food Stimuli (time frame: Study Visit (Day 1 - Approx. 2 Hours)). The study lists 6 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 30 Oct 2026.