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临床试验/NCT07252947
NCT07252947招募中不适用

Stress and Anxiety Effects on Valuation

NYU Langone Health2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年12月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
2
主要终点
Subjective Value Assigned to Food Stimuli

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Socially Evaluated Cold Pressor Task (SECPT) (Behavioral)

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.

干预措施: Non-Stressful Control Task (Behavioral)

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.

干预措施: Socially Evaluated Cold Pressor Task (SECPT) (Behavioral)

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.

干预措施: Non-Stressful Control Task (Behavioral)

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.

干预措施: Socially Evaluated Cold Pressor Task (SECPT) (Behavioral)

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.

干预措施: Non-Stressful Control Task (Behavioral)

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.

结局指标

主要结局

Subjective Value Assigned to Food Stimuli

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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)

Subjective Value Assigned to Food Stimuli

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: Study Visit (Day 1 - Approx. 2 Hours)

Difference in valence ratings before and after trial outcomes. (Aims 3 and 4)

Emotion Predictions - Pleasantness

时间窗: Study Visit (Day 1 - Approx. 2 Hours)

Difference in pleasantness ratings before and after trial outcomes. (Aims 3 and 4)

次要结局

  • Perceived Stress Scale (PSS) Score(Study Visit (Day 1 - Approx. 2 Hours))
  • Holmes-RaHe Life Stress Inventory Score(Study Visit (Day 1 - Approx. 2 Hours))
  • Multidimensional Assessment of Interoceptive Awareness (MAIA-2) Score(Study Visit (Day 1 - Approx. 2 Hours))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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