Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
Location status: Recruiting
NCT Number: NCT06526260
The goal of this clinical trial is to identify the circuit activations by very brief exposure (VBE) among youth with social anxiety disorder (SAD) in order to develop a novel intervention for those with SAD. The secondary objectives of this study are to measure the effect of VBE on subjective fear ratings, and participants' awareness and tolerance of the exposure stimuli.
* The primary outcome of this study is the mean activation of frontostriatal and prefrontal brain regions to facial stimuli, as measured by Blood Oxygen Level Dependent (BOLD) response, in 4 regions of interest during the magnetic resonance imaging (MRI). * Another primary outcome of the study is to identify networks of regions subserving emotion regulation and attention, as measured by BOLD response of corresponding brain regions.
Secondary Outcomes
-The secondary outcome of this study is the fear induced by exposure to facial expression stimuli as measured by a 4-point fear scale during the functional magnetic resonance imaging (fMRI) after each block of 10 facial expression stimuli trials.
Participants will participate in an interview where they will answer questions both inside and outside of the MRI scan. Participants will be asked to rate on a scale the imagines they see while undergoing MRI scan.
Interested in participating?
Request Info16 year–22 year
All sexes
Interventional
Not applicable
Los Angeles, California, 90027, United States
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In Very Brief Exposure (VBE): a series of rapid micro- exposures to images depicting feared stimuli (e.g., for SAD, judgmental faces). Each image is followed by a masking stimulus to prevent its conscious recognition. This sequence of image-mask stimuli is repeated many times in an exposure session.
Time frame: Day 2
A hypothesis-driven, group-level analysis will test brain activity, measured as Blood Oxygen Level Dependent (BOLD) response, in 4 regions of interest while minimizing Type II error.
Time frame: Day 2
To identify networks of regions subserving information processing functions, we will employ a voxel-wise, linear mixed model with random- and fixed-effects in group-level analyses. The use of a mixed model with random effects will account for highly discrepant variances between and within participants. We will use Statistical Parametric Mapping 12 Software's (SPM12) implementation of Random Field Theory (RFT) at a voxel-wise level to control for false positives. We will assess the cluster-level statistical significance of task-related brain activity using nonparametric, permutation-based statistical techniques.
Time frame: Day 2
After each block of 10 disgusted facial expressions, participants rate levels of fear on a 4-point, 1-4 visual analogue scale with these anchor point: "1 - Minimal fear", "2 - Moderate Fear", "3- Much Fear" and "4 - extreme fear".
Time frame: Day 2
After each block of 10 disgusted facial expressions, participants rate levels of fear on a 4-point, 1-4 visual analogue scale with these anchor point: "1 - Minimal fear", "2 - Moderate Fear", "3- Much Fear" and "4 - extreme fear".
Contact information is provided by the study sponsor or research team.
Bradley S Peterson, MD
CONTACT
Courtney Marcelino
CONTACT
Children's Hospital Los Angeles
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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