Very Brief Exposure: Development of a Novel Exposure Modality for Social Anxiety Disorder in Transition-Age Youth
- Conditions
- Social Anxiety Disorder
- Interventions
- Behavioral: Very Brief Exposure to Facial Expressions
- Registration Number
- NCT06526260
- Lead Sponsor
- Children's Hospital Los Angeles
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
-
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.
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Image Exposure Arm Very Brief Exposure to Facial Expressions Participants will see various images of facial expressions on a computer screen and provide various rating scores about them.
- Primary Outcome Measures
Name Time Method Mean Activation of Frontostriatal and Prefrontal Brain Regions to disgusted facial expression in Social Anxiety 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. 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.
- Secondary Outcome Measures
Name Time Method Fear induced by exposure to disgusted facial expression in youth with social anxiety as measured by fear scale Day 2 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".
Fear induced by exposure to disgusted facial expression in healthy participants as measured by fear scale Day 2 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".
Trial Locations
- Locations (1)
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States