Novel exposure method for social anxiety in youth

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

This study is testing a new way to help young people with social anxiety by showing them brief images of facial expressions to see how their brains react and if it can lead to better treatments.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 16 Years to 22 Years
• Sex: All
• Sponsor: Children's Hospital Los Angeles (other)
• Locations: 1 site (Los Angeles, California)
• Trial ID: NCT06526260 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to explore the brain circuit activations in youth with social anxiety disorder (SAD) through a technique called very brief exposure (VBE) to facial expressions. By utilizing functional magnetic resonance imaging (fMRI), the study will measure the brain's response to these stimuli, focusing on specific regions associated with emotion regulation and attention. The trial will also assess participants' subjective fear ratings and their awareness and tolerance of the exposure stimuli. The findings could lead to the development of new interventions for managing SAD in young individuals.

Who should consider this trial

Good fit: Ideal candidates for this study are youth aged 16-22 diagnosed with social anxiety disorder.

Not a fit: Patients with active suicidality or those whose primary language is not English or Spanish may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a novel therapeutic approach for treating social anxiety disorder in youth.

How similar studies have performed: While this approach is innovative, previous studies have shown promise with brief exposure techniques in related anxiety disorders.

Eligibility criteria

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 this trial is running

Los Angeles, California

• Children's Hospital Los Angeles — Los Angeles, California, United States (RECRUITING)

Study contacts

• Principal investigator: Bradley S Peterson, MD — Children's Hospital Los Angeles
• Study coordinator: Courtney Marcelino

Conditions: Social Anxiety Disorder, Youth, Very Brief Exposure