Identifying Decision Making Parameters in Healthy Volunteers and Anxiety Patients

Identifying Decision Making Parameters in Healthy Volunteers (HV) and Anxiety Patients (AD)

Background:

Research has shown that anxiety affects more than feelings. It also affects behavior. Researchers want to learn how the brain and body respond to unexpected threats. They want to see if probable pleasant or unpleasant events change decisions.

Objective:

To better understand how changes in anxiety are associated with changes in decision-making.

Eligibility:

Adults aged 18-50 with generalized anxiety disorder, seasonal affective disorder, or panic disorder. Healthy volunteers are also needed.

Design:

Participants will be screened under protocol #01-M-0254.

Participants will complete surveys about their anxiety, risk-taking, and curiosity.

Participants will complete a computer task. They will be given different choices. They will make a choice. They will receive an unpleasant or pleasant stimulus based on their choice. They will repeat this task many times.

Most participants will do the task in the clinic. The unpleasant stimulus will be electric shock and acoustic startle. They will receive electric shocks through electrodes placed on their arm or fingers. They may hear loud noises through headphones. Their eyeblinks will be recorded with electrodes placed under their eye. Their heart rate and skin conductance activity will be collected with electrodes as well.

Some healthy volunteers will do the task during a functional magnetic resonance imaging scan. They will lie on a table that slides in and out of a scanner. A coil will be placed over their head. The unpleasant stimulus will be electric shock, given as stated above. The scanner will record their brain activity. Their breathing and pulse rate will be recorded as well.

Participation will last for 3-4 hours.

Study Overview

• Status: Completed
• Conditions: Anxiety; Healthy Volunteers
• Intervention / Treatment: Device: Shock or startle device

Detailed Description

Study Description:

This study s goal is to identify parameters of interest in decision making in the context of anxiety disorders, using theoretical models in healthy volunteers (HV) and anxiety patients (AD). Participants are asked to complete a decision-making task, namely the Multi-armed Bandit Task.

The study will be conducted in the clinic. Participants (HV and AD) are asked to fill out questionnaires and complete the Multi-armed Bandit Task. An electric shock is used as the aversive stimulus. Monetary reward is used as the reward stimulus. Additionally, physiological signals (Heart rate, skin conductance activity, startle) are collected during the course of the task. In addition, in a pilot study, participants startle responses for varying shock parameters are recorded and analyzed.

Objectives:

The primary objective of this study is to use theoretical models in healthy volunteers (HV) and patients with an anxiety disorder (AD) to better understand how changes in anxiety are associated with changes in decision making. In addition, this study will ascertain whether decision making parameters correlate with certain behavioral measures such as trait and state anxiety using (i) questionnaires, (ii) physiological measures.

Endpoints:

The primary endpoint of this study is a significant difference in model derived parameters between experimental manipulations (conditions) and/or population groups. The parameters of interest include: 1) Learning Rate, 2) Exploration parameter, 3) Discount rate, 4) Loss aversion, 5) Inverse Temperature.

The secondary endpoints are a significant correlation between functions of model derived parameters and behavioral and/or physiological measures of anxiety including:

1. Questionnaire scores
2. Startle
3. Skin conductance

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institutes of Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

• INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Provision of signed and dated informed consent form
2. Male or female, aged 18-50, inclusive
3. Patients only: Primary Diagnostic and Statistical Manual (DSM) 5 diagnoses of an anxiety disorder (GAD, social anxiety disorder (SAD), panic disorder)

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Non-English speaking individual
2. Pregnancy or positive pregnancy test
3. Any significant medical or neurological problems as determined by investigators (e.g.cardiovascular illness, respiratory illness, neurological illness, seizure, etc.)
4. Current or past serious mental disorders (e.g., bipolar or psychotic disorders) (except for anxiety and depressive disorders in patients)
5. Current alcohol or substance use disorder
6. History of moderate or severe alcohol or substance use disorder within one year prior to screening
7. Current or past significant organic central nervous system disorders as determined by investigators, including but not limited to seizure disorder or neurological symptoms of the wrist and arm (e.g., carpal tunnel syndrome) for shocks to be delivered on affected arm.
8. Positive urine toxicology screen at screening visit under 01-M-0254
9. Employees of National Institute of Mental Health (NIMH) or an immediate family member of a NIMH employee.
10. Healthy volunteers only: Current DSM-5 disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anxiety patient; Participants with anxiety completed computer tasks. They were given different choices and had to make choice(s). The objective was to find the optimal choice by sampling through the choices. They received an unpleasant or pleasant stimulus based on their choice(s). They repeated these tasks many times.	Device: Shock or startle device; Shock and startle devices were used as aversive stimulus (shock and startle)
Experimental: Healthy volunteer; Healthy volunteers completed computer tasks. They were given different choices and had to make choice(s). The objective was to find the optimal choice by sampling through the choices. They received an unpleasant or pleasant stimulus based on their choice(s). They repeated these tasks many times.	Device: Shock or startle device; Shock and startle devices were used as aversive stimulus (shock and startle)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Learning Rate	Learning rate is a hyperparameter that quantifies the degree to which subjects update their beliefs in response to feedback. The outcome examined the difference in learning rate between experimental manipulation (condition) and population (healthy and anxiety subjects). During the multi-arm bandit task, participants choose from a set of choices and update their belief of the value of the choices based on prior choices with some choices having a higher probability of shock (punishment) than reward. The changes in learning rate were measured using the learning rate algorithm. The difference in learning rate was analyzed using a 2-way ANOVA with condition and population. The learning rate (α) range between 0 and 1. The higher the value, the faster rate of learning. However, a higher learning rate may also result in lower generalization capability.	End of experiment (3-4 hours in a single day visit)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Startle	The secondary endpoints are a significant correlation between functions of model derived parameters and behavioral and/or physiological measures of anxiety including:	End of study
STAI questionnaire	The secondary endpoints are a significant correlation between functions of model derived parameters and behavioral and/or physiological measures of anxiety including:	End of study
Skin conductance	The secondary endpoints are a significant correlation between functions of model derived parameters and behavioral and/or physiological measures of anxiety including:	End of study
MASQ	The secondary endpoints are a significant correlation between functions of model derived parameters and behavioral and/or physiological measures of anxiety including:	End of study
BIS/BAS	The secondary endpoints are a significant correlation between functions of model derived parameters and behavioral and/or physiological measures of anxiety including:	End of study

Collaborators and Investigators

• Sponsor: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Maryland Pao, M.D., National Institute of Mental Health (NIMH)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2022
• Primary Completion (Actual): July 28, 2022
• Study Completion (Actual): July 28, 2022

Study Registration Dates

• First Submitted: October 23, 2021
• First Submitted That Met QC Criteria: October 23, 2021
• First Posted (Actual): October 26, 2021

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: July 28, 2022

More Information

Terms related to this study

• Keywords: Healthy Volunteers; multi-arm bandit task; anxiety volunteers; functional magnetic resonance imaging (fMRI)
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 10000378; 000378-M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified data will be shared to a repository. Identified individual participant data will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No