Stress and Anxiety Effects on Valuation

NYU Langone Health

Status: Enrolling

Conditions: Reward Value Level

Treatments: Behavioral: Non-Stressful Control Task; Behavioral: Socially Evaluated Cold Pressor Task (SECPT)

Study type: Interventional

Funder types: Other

Identifiers

NCT07252947

25-01195

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 7 patient groups

Aim 1: Socially Evaluated Cold Pressor Task (SECPT)

Experimental group

Description:

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.

Treatment:

Behavioral: Socially Evaluated Cold Pressor Task (SECPT)

Aim 1: Non-Stressful Control Task

Active Comparator group

Description:

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.

Treatment:

Behavioral: Non-Stressful Control Task

Aim 2: Socially Evaluated Cold Pressor Task (SECPT)

Experimental group

Description:

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.

Treatment:

Behavioral: Socially Evaluated Cold Pressor Task (SECPT)

Aim 2: Non-Stressful Control Task

Active Comparator group

Description:

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.

Treatment:

Behavioral: Non-Stressful Control Task

Aim 3: Socially Evaluated Cold Pressor Task (SECPT)

Experimental group

Description:

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.

Treatment:

Behavioral: Socially Evaluated Cold Pressor Task (SECPT)

Aim 3: Non-Stressful Control Task

Active Comparator group

Description:

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.

Treatment:

Behavioral: Non-Stressful Control Task

Aim 4: Behavioral Task

No Intervention group

Description:

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.