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Behavioral Intervention

Fear Conditioning for Anxiety and Post-Traumatic Stress Disorder

N/A
Recruiting
Research Sponsored by University of Texas at Austin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
MRI exclusions: Claustrophobia; tattoos above the shoulders; permanent eyeliner or permanent; artificial eyebrows; cardiac pacemaker; metal fragments in eye, skin, or body, including shrapnel; heart valve replacement; brain clips; venous umbrella; being a sheet-metal worker or welder; lifetime history of aneurysm surgery; intracranial bypass, renal, or aortic clips; prosthetic devices such as middle ear, eye, joint, or penile implants; joint replacements; non-removable hearing aid, neurostimulator, or insulin pump; shunts/stents; metal mesh/coil implants; metal plate/pin/screws/wires; or any other metal implants
Volunteers with a major medical illness or a neurological disorder (e.g., Parkinson's Disease), or neurological abnormality including significant head trauma (loss of consciousness > 5 min)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 month.
Awards & highlights

Study Summary

This trial uses fMRI to study how the brain makes connections between neutral and negative things. The goal is to learn how the brain deals with fear.

Who is the study for?
This trial is for individuals with PTSD and those without any psychiatric disorders. Participants should not have major medical or neurological issues, significant head trauma, a history of substance abuse, or be at immediate suicide risk. Pregnant women and people with certain metal implants that affect MRI safety are also excluded.Check my eligibility
What is being tested?
The study uses fMRI to explore how the human brain forms memories associated with fear and safety. It aims to understand the neural mechanisms involved in emotional response regulation when encountering fearful stimuli.See study design
What are the potential side effects?
Since this trial involves neuroimaging rather than medication or invasive procedures, there are no direct side effects from interventions like drugs. However, participants may experience discomfort from being in an MRI machine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have metal implants or conditions that prevent me from undergoing an MRI.
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I do not have a major illness, Parkinson's, or significant head trauma.
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I have been diagnosed with PTSD by a healthcare professional.
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My urine test for benzodiazepines was negative.
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I have PTSD diagnosed by specific symptom severity and criteria.
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I have not used psychiatric drugs for more than a month.
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I have never been hospitalized for psychiatric reasons nor diagnosed with PTSD or any psychiatric disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 month.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 month. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in functional MRI data in fear-learning circuitry throughout the experimental phases, compared between healthy controls and PTSD participants
Change in physiological arousal throughout the experimental phases, compared between healthy controls and PTSD participants
Secondary outcome measures
Individual differences in brain-behavior responses

Trial Design

2Treatment groups
Experimental Treatment
Group I: PTSD groupExperimental Treatment1 Intervention
Participants will be screened and diagnosed using typical screening procedures and diagnostic criteria (e.g., the clinically administered PTSD scale). Participants also screened for contraindications for MRI. The learning paradigm inside the MRI scanner occurs over 3 days. The first two days are consecutive (back-to-back) and the third MRI visit is 1 month later. Participants are asked to look at a screen and listen to simple tones over headphones, while the experimenter measures brain activity and physiological measures of arousal (e.g., sweating from sensors on the hand). These visits will be scheduled within two weeks from the baseline and assessment visit.
Group II: Healthy control groupExperimental Treatment1 Intervention
Participants will be healthy adults without a history of psychiatric illness. Participants also screened for contraindications for MRI. The learning paradigm inside the MRI scanner occurs over 3 days. The first two days are consecutive (back-to-back) and the third MRI visit is 1 month later. Participants are asked to look at a screen and listen to simple tones over headphones, while the experimenter measures brain activity and physiological measures of arousal (e.g., sweating from sensors on the hand). These visits will be scheduled within two weeks from the baseline and assessment visit.

Find a Location

Who is running the clinical trial?

University of Texas at AustinLead Sponsor
348 Previous Clinical Trials
80,132 Total Patients Enrolled

Media Library

Fear conditioning (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04975009 — N/A
Post-Traumatic Stress Disorder Clinical Trial 2023: Fear conditioning Highlights & Side Effects. Trial Name: NCT04975009 — N/A
Fear conditioning (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04975009 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open slots available for this research endeavor?

"Affirmative. Clinicaltrials.gov's data shows that this clinical trial, which was initial posted on July 12th 2021, is actively searching for participants. 240 individuals need to be enlisted from two different medical centres."

Answered by AI

What is the aggregate figure of participants in this medical study?

"Affirmative. Clinicaltrials.gov's information attests to the fact that this research endeavour, which was initially announced on July 12th 2021, is actively recruiting trial participants. Two medical centres need 240 individuals for the study."

Answered by AI

Who is eligible to enroll in this research experiment?

"This trial seeks 240 individuals aged 18 to 50 with anxiety as its primary focus. In order for participants to qualify, they must fulfill a variety of criteria: possess no major medical illness or neurological disorder/abnormality (including significant head trauma), not be pregnant, have no benzodiazepines in their urine tox screen, and cannot meet the diagnostic requirements of PTSD nor any other psychiatric disorders. Additionally, healthy subjects are excluded if they've used psychotropic medications longer than one month; those diagnosed with PTSD will need specific confirmation that meets F & G standards set by standard instruments. Lastly, patients may also exhibit comorbid mood or additional"

Answered by AI

Is this medical trial open to persons aged 45 and up?

"The age requirements for participation in this clinical trial are set at 18 as the minimum and 50 as the maximum."

Answered by AI

Who else is applying?

What state do they live in?
Louisiana
Texas
What site did they apply to?
The University of Texas at Austin
Biomedical Imaging Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
2
3+

Why did patients apply to this trial?

I have tried so many drugs that just didn’t work.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How long do screening visits last?
PatientReceived 2+ prior treatments
~95 spots leftby Dec 2025