An Exploratory Randomized Controlled Trial of Participant Satisfaction With the BUILD Mobile Application
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 175
- 试验地点
- 2
- 主要终点
- User Satisfaction as Measured by the Client Satisfaction Questionnaire (CSQ-8)
研究概览
简要总结
This study explores user satisfaction with the BUILD mobile application.
详细描述
This exploratory randomized, double-blind, controlled trial explores user satisfaction with the BUILD mobile application. The BUILD app uses a relational agent (Woebot) to engage users in therapeutic conversations. Eligible participants will be randomized to one of two treatment conditions: (1) an experimental condition in which Woebot uses large language models to understand user sentiment, and based on this understanding of natural language generate responses through a controlled process or (2) a digital control condition in which Woebot selects from a list of responses based on natural language processing. Participants will receive instructions on downloading and using the BUILD app in order to access the intervention to which they were assigned. Participants will use the app as instructed and will complete assessments for the primary endpoint at Week 2 (EOT) with additional measures being collected at Baseline, Day 3, and Week 2. Results from this study will provide preliminary data on user satisfaction and feasibility and inform product development iteration for inclusion in a statistically powered clinical randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be 18+ years of age and older
- •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 2-week duration
- •Must be able to read and write in English
- •Must have primary residence in the United States
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
结局指标
主要结局
User Satisfaction as Measured by the Client Satisfaction Questionnaire (CSQ-8)
时间窗: Post-intervention at Week 2
The CSQ-8 is an 8-item measure used to assess client's satisfaction with treatment.Total scores range from 8-32, with high scores indicating greater satisfaction with the treatment.
次要结局
- User Satisfaction Amongst a Sub-sample of Adults With at Least Mild Symptoms of Depression and/or Anxiety.(Post-intervention at Week 2)