Effects of Therapeutic Mobile Game on Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The Liebowitz Social Anxiety Scale (LSAS)
研究概览
简要总结
Participants with Social Anxiety Disorder (SAD) will use a digital therapeutic for 30 days, and will complete assessments measuring a broad range of anxiety and mood-related symptoms, with a focus on SAD symptoms, and metrics of functional impairment during this time. After the treatment period, participants will be followed at 6 month and 12 month after the completion of the study.
详细描述
This study aims to assess the feasibility and efficacy of the digital therapeutic ABM-01 in adults ages 22-65 with SAD. Participants access ABM-01 on their mobile smart phone and complete treatment over a period of 30 days. Enrolled participants will be randomly assigned to one of two groups (Experimental Group and Placebo Control) and be assessed over five periods of time (Baseline Session, 30-Day Treatment Phase, Post-Treatment Session, 6-Month Follow Up Session, 12-Month Follow Up Session).
Participants will complete the 30-Day Treatment Phase as well as the five assessments remotely. During the treatment period, participants complete assessments social anxiety and generalized anxiety symptoms, as well as safety and medication use questionnaires.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 22-65 at the time of screening
- •Meets DSM-5 diagnostic criteria for Social Anxiety Disorder
- •Access to and willingness to use computer equipment/smartphone compatible with the product platform over a functional network for the study duration.
- •Currently residing in the United States
排除标准
- •Risk of suicide or has attempted suicide within 24 months of the screening visit
- •Moderate to severe substance use disorder
- •Current co-morbid psychiatric diagnosis including PTSD, Schizophrenia, Bipolar Disorder I or II, Autism Spectrum Disorder, or Borderline Personality Disorder
- •Currently pregnant or planning to become pregnant during the treatment period
研究组 & 干预措施
Experimental group
Participants receive active ABM-01 for the study
干预措施: ABM-01 (Device)
Placebo Control
Participants receive a digital control for the study
干预措施: Digital Control (Device)
结局指标
主要结局
The Liebowitz Social Anxiety Scale (LSAS)
时间窗: Baseline to Treatment End (30 days)
A 24-item, self-rated scale to assess social anxiety in situations as well as the level of avoidance of those situations. Each question is rated on a 4-point scale, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe. Greater scores indicate greater symptom severity.
次要结局
- State-Trait Anxiety Scale (STAI)(Baseline to Treatment End (30 days))
- The Liebowitz Social Anxiety Scale (LSAS)(Bi-weekly time point and at the 6 and 12 month follow-ups)
- Depression, Anxiety, and Stress Scale (DASS-21)(Baseline to Treatment End (30 days))
- Hamilton Anxiety Rating Scale (HAM-A)(Baseline to Treatment End (30 days))
- Generalized Anxiety Disorder-7 (GAD-7)(Baseline to Treatment End (30 days))
- Generalized Anxiety Disorder - 7 (GAD-7)(Bi-weekly time point and at the 6 and 12 month follow-ups)
- Beck Anxiety Inventory (BAI)(Baseline to Treatment End (30 days))
研究者
Tracy Dennis
Professor
Hunter College of City University of New York