ClinicalTrials.gg
Status unknownNCT03498599Updated Apr 13, 2018

Neuroimaging of Pavlovian Fear Conditioning Processes in Patients With Pathological Anxiety

An interventional study of Novelty facilitated extinction and Standard Extinction in Post Traumatic Stress Disorder, Anxiety Disorders and Panic Disorder, sponsored by University of Texas at Austin. Status unknown at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2018-04-13.

Sponsored by University of Texas at Austin · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Apr 2018), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Aug 2017, registered Feb 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 20 studies in Stress Disorders, Post-Traumatic by University of Texas at Austin — 6 open to participants now, 6 under way, none of them phase 3. Stress Disorders, Post-Traumatic · University of Texas at Austin.

Planned enrollment
14th of 20
40 · median 65
Started
2017
with 1 other
No phase
15 of 20
6 open now
Registered
7th of 20
by date

Among the 20 studies in Stress Disorders, Post-Traumatic by University of Texas at Austin, this one is the 14th largest by planned enrollment, is one of 2 that started in 2017, is one of 15 with no phase, and was the 7th registered.

By phase

20 studies; the count open now beside each. This study's row is marked.

No phasethis study15 · 6 open
Phase 22 · 0 open
Phase 11 · 0 open
Phase 1/21 · 0 open
Phase 31 · 0 open

By the year they started

First in 2005; this study’s year is marked. 2 started in 2017.

What they test

Size and results

Median enrollment 65 across the 20 interventional studies. Of the 9 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 20 studies in Stress Disorders, Post-Traumatic by University of Texas at Austin, or all of them as a file.
02

Study 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).

Read the 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.

03

Conditions studied

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

Keywords

  • neuroimaging
  • fear conditioning
04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .
  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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Novelty facilitated extinction

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

    Behavioral: Novelty facilitated extinction

  • Other
    Standard extinction

    The shock is omitted during standard extinction

    Behavioral: Standard Extinction

Interventions

  • BehavioralNovelty facilitated extinction

    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.

  • BehavioralStandard Extinction

    During standard fear extinction the expected aversive outcome is omitted.

06

What researchers measure

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.

    Time frame: 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.

    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

07

Study locations

1 of 1 sites recruiting
  • The University of Texas at Austin
    Austin, Texas 78705, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — NIMH Data Archive

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2017 (actual). Primary completion is estimated for Jun 2020, 34 months after the start.

Of 1,064 non-industry interventional studies with no phase under Stress Disorders, Post-Traumatic, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 34 months is close to that.

Counting every sponsor, half of 1,092 studies reached it within 34 months; a quarter within 17 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 15, 2018
First posted
Apr 13, 2018
StartActual
Aug 1, 2017
Primary completionEst.
Jun 2020
CompletionEst.
Jun 2020
Last update
Apr 13, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03498599
Responsible party
Sponsor
First posted
Apr 13, 2018
Start date
Aug 1, 2017
Primary completion
Jun 2020 (estimated)
Completion
Jun 2020 (estimated)
Last update
Apr 13, 2018

Study contacts

Joseph Dunsmoor, PhD
Contact
joseph.dunsmoor@austin.utexas.edu
5124955114

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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