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Recruiting NCT07252947

Stress and Anxiety Effects on Valuation

No phase Interventional Reward Value Level

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Socially Evaluated Cold Pressor Task (SECPT), Non-Stressful Control Task.
Who it may be relevant to
Registry conditions: Reward Value Level. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.
  • Behavioral Non-Stressful Control Task
    Participants assigned to the warm water control condition will perform a non-evaluative task with warm water.

Primary outcome measures

  • 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)]
Secondary outcome measures (3)
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT07252947 · 25-01195

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗