NCT06526260 · Children's Hospital Los Angeles
Very Brief Exposure: Development of a Novel Exposure Modality for Social Anxiety Disorder in Transition-Age Youth
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Very Brief Exposure to Facial Expressions
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.
Primary outcome measures
Mean Activation of Frontostriatal and Prefrontal Brain Regions to disgusted facial expression in Social Anxiety
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.
Mean activation of regions subserving emotion, emotion regulation, and attention processing. Mean deactivation of the Default Mode Network.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patient Population
- Males and females aged 16-22. This age range corresponds with our prior studies of very brief exposure (VBE) in Specific Phobia and will include older adolescents while minimizing potential developmental effects on circuit activation.
- Youth with a Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of Social Anxiety Disorder (SAD) on Kiddie Schedule for Affective Disorders and Schizophrenia for School-Aged Children, Computerized version (K-SADS-COMP) for youth ages 16-17, or the computerized version of Structured Clinical Interview for the DSM-5 (NetSCID) for youth ages 18+.
- Healthy Population • Male and female youth aged 16-22.
- Parents • Parent/caregiver of all ages, no restrictions who are fluent in either English or Spanish.
Exclusion criteria
- Patient Population
- Primary language other than English or Spanish.
- Active suicidality on the Colombia-Suicide Severity Scale (plan, intent, or behavior)
- Ferromagnetic implants (e.g., pacemaker), metal braces, retainers, tattoos or permanent make-up with metallic content, transdermal medicinal patches that cannot be removed.
- Current psychoactive medication.
- Lifetime diagnosis of: obsessive-compulsive disorder (OCD), psychotic, bipolar, autism spectrum disorder, intellectual disability on the KSADS-COMP or NetSCID.
- Any serious neurological or medical conditions (e.g., Lupus, cancer, human immunodeficiency virus positive (HIV+)) as reported by potential participants.
- Current Post-Traumatic Stress Disorder (PTSD) diagnosis.
- Current severe substance abuse (except tobacco/nicotine).
- Pregnancy, as determined by the participant's self-report prior to the magnetic resonance imaging (MRI) scan.
- Healthy Population
- Primary language other than English or Spanish.
- Lifetime disorders: any anxiety disorders, OCD, psychotic, bipolar, autism spectrum disorder, intellectual disability; any psychiatric disorder in the past 2 years
- Current depression disorder.
- Active psychiatric disorder in the past 2 years.
- Serious neurological or medical conditions.
- Current psychoactive medication.
- Ferromagnetic implants (e.g., pacemaker), metal braces, retainers, tattoos or permanent make-up with metallic content, transdermal medicinal patches that cannot be removed.
- Active suicidality on the Colombia-Suicide Severity Scale (plan, intent, or behavior).
- Pregnancy, as determined by the participant's self-report prior to the MRI scan.
- Parents • Primary language other than English or Spanish.
Where
- Los Angeles, California
Collaborators
National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 16, 2025 · Source of record for eligibility and locations