Very Brief Exposure: Development of a Novel Exposure Modality for Social Anxiety Disorder in Transition-Age Youth
NCT Number: NCT06526260
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Social Anxiety Disorder
Interventions: BEHAVIORAL: Very Brief Exposure to Facial Expressions
Sponsor: Children's Hospital Los Angeles
Collaborators: National Institute of Mental Health (NIMH)
Sex: ALL
Age: CHILD, ADULT
Enrollment: 80
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-14
Completion Date: 2026-01-01
Locations: Children's Hospital Los Angeles, Los Angeles, California, 90027, United States

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.

Primary Outcome Measures: Mean Activation of Frontostriatal and Prefrontal Brain Regions to disgusted facial expression in Social Anxiety, 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., Day 2|Mean activation of regions subserving emotion, emotion regulation, and attention processing. Mean deactivation of the Default Mode Network., 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., Day 2
Secondary Outcome Measures: Fear induced by exposure to disgusted facial expression in youth with social anxiety as measured by fear scale, 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"., Day 2|Fear induced by exposure to disgusted facial expression in healthy participants as measured by fear scale, 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"., Day 2