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Identifying Decision Making Parameters in Healthy Volunteers and Anxiety Patients

Primary Purpose

Anxiety, Healthy Volunteers

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multi-arm bandit tasks
Multi-arm bandit tasks
Sponsored by
National Institute of Mental Health (NIMH)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Anxiety focused on measuring fMRI, multi-arm bandit task, anxiety volunteers, Healthy Volunteers

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers
  • 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 DSM5 diagnoses of an anxiety disorder (GAD, 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 NIMH or an immediate family member of a NIMH employee.
  10. Healthy volunteers only: Current DSM-5 disorders.

Sites / Locations

  • National Institutes of Health Clinical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Clinic

fMRI

Arm Description

Tasks to be completed in OP4 clinic

Tasks to be completed in fMRI

Outcomes

Primary Outcome Measures

Learning rate
The primary endpoint of this study is a significant difference in model derived parameters between experimental manipulations (conditions) and/or population groups.
Risk-taking (vs. risk aversion)
The primary endpoint of this study is a significant difference in model derived parameters between experimental manipulations (conditions) and/or population groups.
Discount rate
The primary endpoint of this study is a significant difference in model derived parameters between experimental manipulations (conditions) and/or population groups.
Inverse temperature
The primary endpoint of this study is a significant difference in model derived parameters between experimental manipulations (conditions) and/or population groups.
Loss aversion
The primary endpoint of this study is a significant difference in model derived parameters between experimental manipulations (conditions) and/or population groups.
Exploration parameter
The primary endpoint of this study is a significant difference in model derived parameters between experimental manipulations (conditions) and/or population groups.

Secondary Outcome Measures

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

Full Information

First Posted
October 23, 2021
Last Updated
August 11, 2022
Sponsor
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05092971
Brief Title
Identifying Decision Making Parameters in Healthy Volunteers and Anxiety Patients
Official Title
Identifying Decision Making Parameters in Healthy Volunteers (HV) and Anxiety Patients (AD)
Study Type
Interventional

2. Study Status

Record Verification Date
July 28, 2022
Overall Recruitment Status
Completed
Study Start Date
March 3, 2022 (Actual)
Primary Completion Date
July 28, 2022 (Actual)
Study Completion Date
July 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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: Questionnaire scores Startle Skin conductance

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Healthy Volunteers
Keywords
fMRI, multi-arm bandit task, anxiety volunteers, Healthy Volunteers

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clinic
Arm Type
Other
Arm Description
Tasks to be completed in OP4 clinic
Arm Title
fMRI
Arm Type
Other
Arm Description
Tasks to be completed in fMRI
Intervention Type
Behavioral
Intervention Name(s)
Multi-arm bandit tasks
Intervention Description
Part 1 to be completed in the clinic. Subject participation is for one part and is pseudo-randomly.
Intervention Type
Device
Intervention Name(s)
Multi-arm bandit tasks
Intervention Description
Part 2 to be completed in the scanner. Subject participation is for one part and is pseudo-randomly.
Primary Outcome Measure Information:
Title
Learning rate
Description
The primary endpoint of this study is a significant difference in model derived parameters between experimental manipulations (conditions) and/or population groups.
Time Frame
End of study
Title
Risk-taking (vs. risk aversion)
Description
The primary endpoint of this study is a significant difference in model derived parameters between experimental manipulations (conditions) and/or population groups.
Time Frame
End of study
Title
Discount rate
Description
The primary endpoint of this study is a significant difference in model derived parameters between experimental manipulations (conditions) and/or population groups.
Time Frame
End of study
Title
Inverse temperature
Description
The primary endpoint of this study is a significant difference in model derived parameters between experimental manipulations (conditions) and/or population groups.
Time Frame
End of study
Title
Loss aversion
Description
The primary endpoint of this study is a significant difference in model derived parameters between experimental manipulations (conditions) and/or population groups.
Time Frame
End of study
Title
Exploration parameter
Description
The primary endpoint of this study is a significant difference in model derived parameters between experimental manipulations (conditions) and/or population groups.
Time Frame
End of study
Secondary Outcome Measure Information:
Title
Startle
Description
The secondary endpoints are a significant correlation between functions of model derived parameters and behavioral and/or physiological measures of anxiety including:
Time Frame
End of study
Title
STAI questionnaire
Description
The secondary endpoints are a significant correlation between functions of model derived parameters and behavioral and/or physiological measures of anxiety including:
Time Frame
End of study
Title
Skin conductance
Description
The secondary endpoints are a significant correlation between functions of model derived parameters and behavioral and/or physiological measures of anxiety including:
Time Frame
End of study
Title
MASQ
Description
The secondary endpoints are a significant correlation between functions of model derived parameters and behavioral and/or physiological measures of anxiety including:
Time Frame
End of study
Title
BIS/BAS
Description
The secondary endpoints are a significant correlation between functions of model derived parameters and behavioral and/or physiological measures of anxiety including:
Time Frame
End of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: Provision of signed and dated informed consent form Male or female, aged 18-50, inclusive Patients only: Primary DSM5 diagnoses of an anxiety disorder (GAD, SAD, panic disorder) EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: Non-English speaking individual Pregnancy or positive pregnancy test Any significant medical or neurological problems as determined by investigators (e.g.cardiovascular illness, respiratory illness, neurological illness, seizure, etc.) Current or past serious mental disorders (e.g., bipolar or psychotic disorders) (except for anxiety and depressive disorders in patients) Current alcohol or substance use disorder History of moderate or severe alcohol or substance use disorder within one year prior to screening 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. Positive urine toxicology screen at screening visit under 01-M-0254 Employees of NIMH or an immediate family member of a NIMH employee. Healthy volunteers only: Current DSM-5 disorders.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monique Ernst, M.D.
Organizational Affiliation
National Institute of Mental Health (NIMH)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institutes of Health Clinical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
.De-identified data will be shared to a repository. Identified individual participant data will not be shared.
Links:
URL
https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_000378-M.html
Description
NIH Clinical Center Detailed Web Page

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Identifying Decision Making Parameters in Healthy Volunteers and Anxiety Patients

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