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).
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.
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.
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
Location
Facility |
Status |
Contact |
|
The University of Texas at Austin Austin Texas 78705 United States |
Recruiting |
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.
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.