Clinical trial NCT06526260: Very Brief Exposure: Development of a Novel Exposure Modality for Social Anxiety Disorder in Transition-Age Youth
Official title: Very Brief Exposure: Development of a Novel Exposure Modality for Social Anxiety Disorder in Transition-Age Youth
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Social Anxiety Disorder
Keywords: Youth
Very Brief Exposure
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-07-29
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.


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.

Primary outcomes:
measure: Mean Activation of Frontostriatal and Prefrontal Brain Regions to disgusted facial expression in Social Anxiety
timeFrame: Day 2
measure: Mean activation of regions subserving emotion, emotion regulation, and attention processing. Mean deactivation of the Default Mode Network.
timeFrame: Day 2
Secondary outcomes:
measure: Fear induced by exposure to disgusted facial expression in youth with social anxiety as measured by fear scale
timeFrame: Day 2
measure: Fear induced by exposure to disgusted facial expression in healthy participants as measured by fear scale
timeFrame: Day 2
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: Bradley S Peterson, MD
role: PRINCIPAL_INVESTIGATOR
References: