An Exploratory Open-Label Potency and Precision Investigation of a Relational Agent Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 203
- 试验地点
- 2
- 主要终点
- Working Alliance Inventory-Short Revised (WAI-SR), Total Scale
研究概览
简要总结
The overarching goal of this study is to establish initial proof of mechanism for precision interventions in an adult population.
详细描述
This exploratory single-arm trial will provide initial learning on the current implementation of precision interventions and generate data and hypotheses to inform the exploration of future interventions by identifying mechanisms and moments in the user journey to target. The DISC-MA app uses a relational agent (Woebot) to engage users in conversations. Eligible participants will be assigned to use DISC-MA, in which Woebot selects from a list of responses based on natural language processing. Participants will receive instructions on downloading and using the DISC-MA app in order to access the intervention. Participants will use the app as instructed and will complete assessments for the primary endpoint as Week 4 (EOT) with additional measures being collected as Baseline, Week 1, and Week 2. Results from this study will provide data on baseline participant clinical and psychological characteristics and their engagement with DISC-MA, and associations between the two.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be 18-75 years of age
- •Must own or have regular access to a smartphone with a recent operating system installed (Android: OS 8.0 or higher, Apple: iOS 13.0 or higher) with reliable Wi-Fi access or sufficient data plan to engage with assigned treatment condition for the duration of the study
- •Must be available and committed to engage with the program and complete assessments for a 4-week duration
- •Must be able to read and write in English
- •Must have primary residence in the United States
- •Must have mild or greater symptoms of depression and/or anxiety at Screening/Baseline, indicated by a score > 4 on the Patient Health Questionnaire (PHQ-8) and/or Generalized Anxiety Disorder (GAD-7)
排除标准
- •Current suicidal ideation with a plan and/or intent or a suicide attempt within the past 12 months
- •Previous Woebot use
- •Involuntary inpatient psychiatric hospitalization any time within the past 30 days
- •Lifetime diagnosis of bipolar disorder
- •Lifetime diagnosis of a psychotic disorder
结局指标
主要结局
Working Alliance Inventory-Short Revised (WAI-SR), Total Scale
时间窗: 1 week and Post-treatment at 4 weeks
Measure of working alliance. A 12-item measure that assesses three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy, and (c) development of an affective bond. For the purposes of the study, the word "therapist" was replaced with "Woebot". Total mean scores range from 1-5, with higher scores indicating greater alliance between the participant and Woebot.
次要结局
未报告次要终点