Post Traumatic Stress DisorderNCT03498599
Neuroimaging of Pavlovian Fear Conditioning Processes in Patients With Pathological Anxiety
A study testing Novelty facilitated extinction and Standard Extinction in people with Post Traumatic Stress Disorder and Anxiety Disorders, run by University of Texas at Austin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Post Traumatic Stress Disorder, Anxiety Disorders, Panic Disorder
- What is being tested?
- Novelty facilitated extinction and Standard Extinction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The University of Texas at Austin
Austin, Texas, 78705
Joseph Dunsmoor, PhD, 512-495-5114, joseph.dunsmoor@austin.utexas.edu
About this study
Official title: Improving the Control of Fear: Healthy Adults to Pathological Anxiety
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.
- Being tested
- Novelty facilitated extinction, Standard Extinction
- Keywords
- neuroimaging, fear conditioning
- Medical subject headings
- Stress Disorders, Post-Traumatic, Anxiety Disorders, Panic Disorder, Phobia, Social, Phobic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novelty facilitated extinctionBehavioural
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.
Standard ExtinctionBehavioural
During standard fear extinction the expected aversive outcome is omitted.
| Study group | Role | What they receive |
|---|---|---|
| Novelty facilitated extinction | Experimental | Behavioral intervention. After Pavlovian fear conditioning, the shock is omitted and replaced by a novel, surprising, and neutral auditory tone. Receives: Behavioral: Novelty facilitated extinction |
| Standard extinction | Other | The shock is omitted during standard extinction Receives: Behavioral: Standard Extinction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Only on the day of the experiment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start1 Aug 2017
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03498599
- Sponsor's protocol ID
- UTfearconditioning
- Status last verified
- Apr 2018
- First submitted
- 15 Feb 2018
- Last updated
- 13 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: NIMH Data Archive
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Control of Fear: Healthy Adults to Pathological Anxiety
- ClinicalTrials.gov ID
- NCT03498599
- Acronym / sponsor ID
- UTfearconditioning
- Keywords
- neuroimaging, fear conditioning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 13 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novelty facilitated extinction | Experimental | Behavioral: Novelty facilitated extinctionBehavioral intervention. After Pavlovian fear conditioning, the shock is omitted and replaced by a novel, surprising, and neutral auditory tone. |
| Standard extinction | Other | Behavioral: Standard ExtinctionThe shock is omitted during standard extinction |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novelty facilitated extinctionIn the novelty-facilitated extinction design, the aversive outcome (i.e., mild unpleasant electrical pulse) is omitted and replaced by a low volume auditory tone. | Behavioural | Novelty facilitated extinction |
| Standard ExtinctionDuring standard fear extinction the expected aversive outcome is omitted. | Behavioural | Standard extinction |
Primary outcome
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
Time frame: Only on the day of the experiment
We are measuring increases in the BOLD signal in response to visual stimuli during a Pavlovian conditioning task in humans.
1 secondary outcome
Skin conductance responses evoked during a Pavlovian fear conditioning task in humans as an index of physiological arousal.
Time frame: Only on the day of the experiment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2018.
- Individual participant dataSharing planned: Yes. NIMH Data Archive
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novelty facilitated extinction and Standard Extinction in people with Post Traumatic Stress Disorder and Anxiety Disorders, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joseph Dunsmoor, PhD (5124955114, joseph.dunsmoor@austin.utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Only on the day of the experiment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2018.