RecruitingNot Applicable

Very Brief Exposure: Development of a Novel Exposure Modality for Social Anxiety Disorder in Transition-Age Youth

United States80 participantsStarted 2024-08-14

Plain-language summary

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.

Who can participate

Age range

16 Years – 22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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+)) a…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean Activation of Frontostriatal and Prefrontal Brain Regions to disgusted facial expression in Social Anxiety

Timeframe: Day 2

Mean activation of regions subserving emotion, emotion regulation, and attention processing. Mean deactivation of the Default Mode Network.

Timeframe: Day 2

Trial details

NCT IDNCT06526260

SponsorChildren's Hospital Los Angeles

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10-30

Contact for this trial

Courtney Marcelino

323-361-6456 cmarcelino@chla.usc.edu

View on ClinicalTrials.gov More Social Anxiety Disorder trials