Very Brief Exposure: Development of a Novel Exposure Modality for Social Anxiety Disorder in Transition-Age Youth
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Mean Activation of Frontostriatal and Prefrontal Brain Regions to disgusted facial expression in Social Anxiety
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient Population
- •Males and females aged 16-
- •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-
- •Parents • Parent/caregiver of all ages, no restrictions who are fluent in either English or Spanish.
排除标准
- •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.
研究组 & 干预措施
Image Exposure Arm
Participants will see various images of facial expressions on a computer screen and provide various rating scores about them.
干预措施: Very Brief Exposure to Facial Expressions (Behavioral)
结局指标
主要结局
Mean Activation of Frontostriatal and Prefrontal Brain Regions to disgusted facial expression in Social Anxiety
时间窗: 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.
时间窗: 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.
次要结局
- Fear induced by exposure to disgusted facial expression in youth with social anxiety as measured by fear scale(Day 2)
- Fear induced by exposure to disgusted facial expression in healthy participants as measured by fear scale(Day 2)
研究者
Bradley Peterson
Chief, Division of Child & Adolescent Psychiatry
Children's Hospital Los Angeles