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Neuroimaging of Pavlovian Fear Conditioning Processes in Patients With Pathological Anxiety

Primary Purpose

Post Traumatic Stress Disorder, Anxiety Disorders, Panic Disorder

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Novelty facilitated extinction
Standard Extinction
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Post Traumatic Stress Disorder focused on measuring neuroimaging, fear conditioning

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female volunteer aged 18-50 years old
  2. Able to understand procedures and agree to participate in the study by giving written informed consent.
  3. Speaks fluent English.
  4. Not taking illicit drugs.
  5. No history of neurological problems.
  6. Eligible for MRI, including no metal in the body or body piercings that cannot be removed.

Exclusion Criteria:

  1. Current comorbid Axis 1 psychiatric disorder
  2. Women who are current pregnant or breastfeeding
  3. Lifetime diagnosis of any psychotic disorder, cognitive suicidal ideation, substance abuse or alcohol dependence, hoarding.
  4. Medications that act on the central nervous system that interfere with interpretation of the findings (e.g., painkillers, Adderall)
  5. Claustrophobia
  6. Patients who are unable to comply with procedures or assessments.

Sites / Locations

  • The University of Texas at AustinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Novelty facilitated extinction

Standard extinction

Arm Description

Behavioral intervention. After Pavlovian fear conditioning, the shock is omitted and replaced by a novel, surprising, and neutral auditory tone.

The shock is omitted during standard extinction

Outcomes

Primary Outcome Measures

Changes in functional magnetic resonance imaging (fMRI)-BOLD (blood-oxygen-level dependent) signal in sensory, prefrontal, and limbic regions during a study on the neurobiology of Pavlovian fear conditioning in humans
We are measuring increases in the BOLD signal in response to visual stimuli during a Pavlovian conditioning task in humans.

Secondary Outcome Measures

Skin conductance responses evoked during a Pavlovian fear conditioning task in humans as an index of physiological arousal.
Electrodermal activity collected from the hand that measures increases in sweating, taken as an indicator of Pavlovian fear conditioning

Full Information

First Posted
February 15, 2018
Last Updated
April 12, 2018
Sponsor
University of Texas at Austin
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1. Study Identification

Unique Protocol Identification Number
NCT03498599
Brief Title
Neuroimaging of Pavlovian Fear Conditioning Processes in Patients With Pathological Anxiety
Official Title
Improving the Control of Fear: Healthy Adults to Pathological Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas at Austin

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to use functional magnetic resonance imaging to investigate how the human brain learns to form associations between neutral and emotional stimuli. The study is based on the basic principles of Pavlovian conditioning. When someone learns that a neutral stimulus (such as the sound of a bell) predicts an unpleasant stimulus (such as a mild electrical shock), the neutral stimulus takes on the properties of an emotional stimulus. The investigators are interested in the neural processes involved in this learning in people with a clinical anxiety disorder and posttraumatic stress disorder (PTSD).
Detailed Description
This study uses functional MRI in people with anxiety and stress-related disorders to evaluate the neural correlates of fear conditioning and extinction. During fear conditioning participants see a picture of a face that predicts a mild electrical shock to the wrist. Participants then return the next day to the scanner for a test of fear expression 24-hours after fear conditioning. The investigators are simultaneously measuring autonomic arousal in the scanner using measures of skin conductance responses (i.e., sweating). The primary objective of this study is to evaluate different forms of Pavlovian fear extinction in patients who suffer from pathological anxiety. The investigators are interested in the effects of extinction and extinction retention over a delay in regions that are known to show abnormalities in anxiety populations. This includes the amygdala, ventromedial prefrontal cortex, and the hippocampus. The study is testing behavioral strategies and does not include any pharmacological manipulations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder, Anxiety Disorders, Panic Disorder, Social Phobia, Phobia
Keywords
neuroimaging, fear conditioning

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Novelty facilitated extinction
Arm Type
Experimental
Arm Description
Behavioral intervention. After Pavlovian fear conditioning, the shock is omitted and replaced by a novel, surprising, and neutral auditory tone.
Arm Title
Standard extinction
Arm Type
Other
Arm Description
The shock is omitted during standard extinction
Intervention Type
Behavioral
Intervention Name(s)
Novelty facilitated extinction
Intervention Description
In the novelty-facilitated extinction design, the aversive outcome (i.e., mild unpleasant electrical pulse) is omitted and replaced by a low volume auditory tone.
Intervention Type
Behavioral
Intervention Name(s)
Standard Extinction
Intervention Description
During standard fear extinction the expected aversive outcome is omitted.
Primary Outcome Measure Information:
Title
Changes in functional magnetic resonance imaging (fMRI)-BOLD (blood-oxygen-level dependent) signal in sensory, prefrontal, and limbic regions during a study on the neurobiology of Pavlovian fear conditioning in humans
Description
We are measuring increases in the BOLD signal in response to visual stimuli during a Pavlovian conditioning task in humans.
Time Frame
Only on the day of the experiment
Secondary Outcome Measure Information:
Title
Skin conductance responses evoked during a Pavlovian fear conditioning task in humans as an index of physiological arousal.
Description
Electrodermal activity collected from the hand that measures increases in sweating, taken as an indicator of Pavlovian fear conditioning
Time Frame
Only on the day of the experiment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female volunteer aged 18-50 years old Able to understand procedures and agree to participate in the study by giving written informed consent. Speaks fluent English. Not taking illicit drugs. No history of neurological problems. Eligible for MRI, including no metal in the body or body piercings that cannot be removed. Exclusion Criteria: Current comorbid Axis 1 psychiatric disorder Women who are current pregnant or breastfeeding Lifetime diagnosis of any psychotic disorder, cognitive suicidal ideation, substance abuse or alcohol dependence, hoarding. Medications that act on the central nervous system that interfere with interpretation of the findings (e.g., painkillers, Adderall) Claustrophobia Patients who are unable to comply with procedures or assessments.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joseph Dunsmoor, PhD
Phone
5124955114
Email
joseph.dunsmoor@austin.utexas.edu
Facility Information:
Facility Name
The University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Dunsmoor, PhD
Phone
512-495-5114
Email
joseph.dunsmoor@austin.utexas.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
NIMH Data Archive
IPD Sharing Time Frame
Less than 6 months after data is collected.
IPD Sharing Access Criteria
We will upload data to the NIMH Data Archive and data will be accessible per their policy.

Learn more about this trial

Neuroimaging of Pavlovian Fear Conditioning Processes in Patients With Pathological Anxiety

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