A Novel Computer-Based Therapy for Social Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Liebowitz Social Anxiety Scale
研究概览
简要总结
The present study is a double blind trial that seeks to examine the feasibility, acceptability, efficacy, and mechanism of a recently developed eye-tracking-based therapy (GC-MRT) in individuals with social anxiety disorder (SAD)
详细描述
The present study is a double blind trial that seeks to examine the feasibility, acceptability, efficacy, and mechanism of a recently developed eye-tracking-based therapy (GC-MRT) in individuals with social anxiety disorder (SAD). The purpose of this study is to assess whether a brief computer-based research treatment, provided in 30 minutes sessions twice a week for 4 weeks, helps improve social anxiety symptoms, and by what mechanism. The study will also assess the effect of research treatments on brain activity using a scan called magnetic resonance imaging (MRI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females between the ages of 18 and 60
- •Current DSM-V primary diagnosis of SAD
- •Score of at least 50 on the Liebowitz Social Anxiety Scale (Self-rated version)
- •Fluent in English and willing and able to give informed written consent and participate responsibly in the protocol
- •Normal or corrected-to-normal vision
排除标准
- •Present or past psychotic episode, psychotic disorder, schizophrenia, schizoaffective disorder, or bipolar disorder
- •Current severe depression
- •Suicidal ideation or behavior
- •Current diagnosis of PTSD, obsessive-compulsive disorder, bipolar disorder, manic episode or tic disorder
- •Current or past organic mental disorder, seizure disorder, epilepsy or brain injury
- •Current unstable or untreated medical illness
- •Severe alcohol use disorder, severe cannabis use disorder, and any severity of other substance use disorder (except nicotine use disorders allowed)
- •Use of psychiatric medication in the past month other than a stable dose of selective serotonin reuptake inhibitors (SSRIs) for a least 3 months
- •Any concurrent cognitive behavioral therapy; other psychotherapy that was initiated in the past 3 months
- •Pregnancy, or plans to become pregnant during the period of the study - will be assessed by Urine β-HCG
- •Contraindication to MRI scanning:
- •Paramagnetic metallic implants or devices contraindicating magnetic resonance imaging or any other non-removable paramagnetic metal in the body (e.g. pacemaker, paramagnetic metallic prosthesis, surgical clips, shrapnel, necessity for constant medicinal patch, some tattoos)
- •Being unable to tolerate the scanning procedures (i.e., severe obesity, claustrophobia)
研究组 & 干预措施
GC-MRT
Group 1 will receive a 4-week (8-sessions) course of standard GC-MRT
干预措施: GC-MRT (Behavioral)
non-GC-MRT
Group 2 will receive a 4-week (8-sessions) course of non-GC-MRT
干预措施: Non-GC-MRT (Behavioral)
GC-MRT-modified
Group 3 will receive a 4-week (8-sessions) course of modified GC-MRT.
干预措施: modified GC-MRT (Behavioral)
结局指标
主要结局
Liebowitz Social Anxiety Scale
时间窗: 4 months
Total score of the Liebowitz Social Anxiety Scale
次要结局
- Social Phobia Inventory (SPIN)(4 months)
- Revised Social Anhedonia Scale(4 months)
- Snaith Hamilton Pleasure Scale(4 months)
- Quality of Life Enjoyment & Satisfaction Questionnaire(4 months)
- Clinical Global Impression-Change Scale(4 months)
- Hamilton Rating Scale for Depression - 17 item version(4 months)
研究者
Franklin Schneier
Research Scientist
New York State Psychiatric Institute