Neuroimaging of Pavlovian Fear Conditioning Processes in Patients With Pathological Anxiety

NCT03498599 | Unknown

• 1 other identifier: UTfearconditioning
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Post Traumatic Stress Disorder; Anxiety Disorders; Panic Disorder; Social Phobia; Phobia

Keywords

neuroimaging; fear conditioning

Outcome Measures

Primary Outcomes (1)

• 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.

  Only on the day of the experiment

Secondary Outcomes (1)

• 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

Study Arms (2)

Novelty facilitated extinction

EXPERIMENTAL

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

Behavioral: Novelty facilitated extinction

Standard extinction

OTHER

The shock is omitted during standard extinction

Behavioral: Standard Extinction

Interventions

Novelty facilitated extinction BEHAVIORAL

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.

Novelty facilitated extinction

Standard Extinction BEHAVIORAL

During standard fear extinction the expected aversive outcome is omitted.

Standard extinction

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

The University of Texas at Austin

Austin, Texas, 78705, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Anxiety Disorders; Panic Disorder; Phobia, Social; Phobic Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

Joseph Dunsmoor, PhD

CONTACT

5124955114; joseph.dunsmoor@austin.utexas.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: April 13, 2018
• Study Start: August 1, 2017
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: April 13, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Less than 6 months after data is collected.
• Access Criteria: We will upload data to the NIMH Data Archive and data will be accessible per their policy.

Locations

US (1)