A Novel Computer-Based Treatment for Social Anxiety: Target Engagement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Change in Percent Dwell Time on Threat Faces
研究概览
简要总结
The present study is an open trial that seeks to examine the feasibility, acceptability, mechanism, and efficacy of a recently developed computer-based therapy in individuals with social anxiety disorder (SAD)
详细描述
This randomized clinical trial examines the feasibility, acceptability, mechanism, and relative efficacy of two "doses" (standard 4-week/8 session vs. extended 8-week/12-session) of a recently developed computer-based therapy 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, helps improve social anxiety symptoms, and by what mechanism. The study will also assess the effect of research treatments on brain activity using 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
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes assessor will not be informed as to whether a participant is randomized to 4 or 8 weeks of treatment.
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 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 posttraumatic stress disorder, 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
- •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)
结局指标
主要结局
Change in Percent Dwell Time on Threat Faces
时间窗: baseline to week 8
Percent dwell time on threat faces was computed as the ratio of gaze dwell time on threat faces to total dwell time on all faces as measured by eye tracking during treatment sessions. Change in percent dwell time is the value at week 8 minus value at baseline.
Change in Total Score of Liebowitz Social Anxiety Scale (LSAS)
时间窗: Baseline to week 8
Clinician-rated scale scoring anxiety (0, none to 3, severe) and avoidance (0,none to 3, severe) in 24 social situations for a total score of 0 to 144. Higher scores indicate greater social anxiety.
次要结局
- Change in Total Score of the Revised Social Anhedonia Scale(baseline to week 8)
- Change in Total Score of Quality of Life Enjoyment & Satisfaction Questionnaire(baseline to week 8)
- Clinical Global Impression-Change Scale(week 8)
- Change in Total Score of the Snaith Hamilton Pleasure Scale(baseline to week 8)
- Change in Total Score of the Hamilton Rating Scale for Depression - 17 Item Version(baseline to week 8)
- Change in Total Score of Social Phobia Inventory (SPIN)(baseline to week 8)
研究者
Franklin Schneier
Research Psychiatrist
New York State Psychiatric Institute