Improving the Control of Fear: Healthy Adults to Pathological Anxiety

Neuroimaging of Pavlovian Fear Conditioning Processes in Patients With Pathological Anxiety



Sponsors


Source

University of Texas at Austin

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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.

Overall Status

Recruiting

Start Date

2017-08-01

Completion Date

2020-06-01

Primary Completion Date

2020-06-01

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

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
Only on the day of the experiment

Secondary Outcome

Measure

Time Frame

Skin conductance responses evoked during a Pavlovian fear conditioning task in humans as an index of physiological arousal.
Only on the day of the experiment

Enrollment

40

Conditions


Intervention

Intervention Type

Behavioral

Intervention Name


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.

Arm Group Label

Novelty facilitated extinction


Intervention Type

Behavioral

Intervention Name


Description

During standard fear extinction the expected aversive outcome is omitted.

Arm Group Label

Standard extinction



Eligibility

Criteria

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.

Gender

All

Minimum Age

18 Years

Maximum Age

50 Years

Healthy Volunteers

No


Overall Contact

Last Name

Joseph Dunsmoor, PhD

Phone

5124955114

Email



Location

Facility

Status

Contact

The University of Texas at Austin
Austin Texas 78705 United States
Recruiting
Last Name: Joseph Dunsmoor, PhD
Phone: 512-495-5114
Email: [email protected]

Location Countries

Country

United States


Verification Date

2018-04-01

Lastchanged Date

2018-04-12

Firstreceived Date

2018-02-15

Responsible Party

Responsible Party Type

Sponsor


Keywords


Has Expanded Access

No

Condition Browse


Number Of Arms

2

Arm Group

Arm Group Label

Novelty facilitated extinction

Arm Group Type

Experimental

Description

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


Arm Group Label

Standard extinction

Arm Group Type

Other

Description

The shock is omitted during standard extinction



Firstreceived Results Date

N/A

Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Basic Science

Masking

Single (Participant)


Study First Submitted

February 15, 2018

Study First Submitted Qc

April 12, 2018

Study First Posted

April 13, 2018

Last Update Submitted

April 12, 2018

Last Update Submitted Qc

April 12, 2018

Last Update Posted

April 13, 2018


ClinicalTrials.gov processed this data on April 13, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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