Using Smartphone Sensors to Assess Symptom Relief in Patients With Social Anxiety Disorder Undergoing Gaze Contingent Music Reward Therapy (GC-MRT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The Liebowitz Social Anxiety Scale (LSAS)
研究概览
简要总结
The goal of this study is to examine if a digital behavior-based framework, utilizing the BHQ app, can effectively monitor social anxiety symptoms and evaluate the symptom-reducing impact of attentional training for adults (18-65) with social anxiety disorder (SAD), compared to traditional clinical questionnaires and self-reports.
The main questions it aims to answer are:
- Can the BHQ app provide a reliable digital measure of social anxiety symptoms?
- Does GC-MRT significantly reduce symptoms of social anxiety as measured through BHQ app monitoring and standard assessment tools?
Researchers will compare the digital BHQ measurements to traditional clinical assessments to see if the app-based measurements is effective in monitoring symptoms relief.
Participants will:
- Complete an initial clinical interview and self-report questionnaires.
- Engage in a computer-based "free-viewing" task for baseline attention assessment using eye tracking.
- Connect to the BHQ app for continuous monitoring throughout the study.
- Undergo attentional training, GC-MRT.
- Complete weekly SPIN assessments.
- Undergo Final evaluation two weeks post-treatment including repeated clinical interviews, self-reports, and the computer-based task to assess changes in attention patterns and symptom reduction.
详细描述
Research Design The study is a multiple baseline open trial with one active treatment arm and comprises three stages. The interval between the first and second stages varies across groups (one, two, or three weeks) to create a mixed baseline structure. Continuous monitoring via the smartphone App takes place from the first meeting until the final assessment in the third stage.
Stage 1 - Baseline Assessment:
Participants are recruited through social media advertisements (e.g., Google, Facebook) offering participation in a study on a treatment shown to be effective for social anxiety disorder. Potential participants who express interest are invited to an initial clinical assessment following a brief phone screening. Before the assessment, participants are informed of the study process and are asked to provide a written informed consent. A structured clinical interview is then conducted by a trained clinician to evaluate symptom severity and diagnosis and determine eligibility based on the inclusion and exclusion criteria of the study. The evaluation session lasts about two hours and includes:
- Clinical Interview:
1.1. MINI (Mini International Neuropsychiatric Interview): A short clinical interview to diagnose major psychiatric disorders in Axis 1 as per DSM-IV and ICD-10 criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Normal or corrected vision, without color blindness.
- •A primary diagnosis of social anxiety disorder (based on clinician assessment (LSAS), a MINI interview, and an LSAS score above 50).
- •Age range of 18-
- •Ownership of a smartphone that supports the digital monitoring App.
排除标准
- •Prior experience with GC-MRT.
- •A current diagnosis of post-traumatic stress disorder (PTSD).
- •A current or past diagnosis of psychosis or bipolar disorder.
- •Neurological disorder (e.g., epilepsy, brain injury).
- •Severe suicidal ideation.
- •Substance or alcohol addiction.
- •Concurrent treatment (pharmacological or psychosocial).
- •Pregnancy.
- •Insufficient Hebrew proficiency (unable to complete a clinical interview and/or self-report symptoms and/or perform cognitive tasks).
研究组 & 干预措施
Starting GC-MRT training after randomized allocation of period of time after assesment
Gaze-Contingent Music Reward Therapy (GC-MRT) is a treatment method for adults with social anxiety disorder found to be effective in reducing social anxiety in various RCTs. This method includes a computerized cognitive training to redirect threat-related attention patterns. Time period between Pre assessment and start of GC-MRT is randomly assigned (1 week/ 2 weeks/ 3 weeks) to create a multiple baseline design.
干预措施: Gaze-Contingent Music Reward Therapy (GC-MRT (Behavioral)
结局指标
主要结局
The Liebowitz Social Anxiety Scale (LSAS)
时间窗: From Pre meeting measurements in week 0 to post training measurements in week 10
Clinician-rated severity of social anxiety symptoms
次要结局
- Threat-related attention bias(From Pre meeting measurements in week 0 to post training measurements in week 10)
- The Social Phobia Inventory (SPIN)(From Pre meeting measurements in week 0 to post training measurements in week 10)
研究者
Yair Bar-Haim
Professor
Tel Aviv University