A Novel and Adaptive Software for Automated Delivery of Cognitive Behavioral Therapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Change in Patient Health Questionnaire-9 score
研究概览
简要总结
TreadWill is a fully automated digital intervention that provides a multi-modal treatment for depressive symptoms. It includes:
- Slides and interactive text-based conversations based on Cognitive Behavioral Therapy (CBT);
- Mindfulness videos;
- Game-based Cognitive Bias Modification paradigms;
- An empathetic chatbot. This study's primary aim is to test the differential effectiveness of this full-featured version of TreadWill compared to a text-based CBT program.
详细描述
TreadWill is an online tool to deliver automated intervention for depressive symptoms. TreadWill helps the participants learn the concepts of Cognitive Behavioral Therapy (CBT), and practice mindfulness in an interactive manner. It also has games based on Cognitive Bias Modification (CBM) and an empathetic chatbot. We hypothesize that participants using TreadWill will show a significant reduction in depressive symptoms and will show engagement with the program. To test this hypothesis, we are conducting a randomized controlled trial. We will randomize participants into three groups: experimental, active control, and waitlist. Participants randomized to the experimental group will get access to the full-featured version of TreadWill as described above. Participants randomized to the active control group will have access to a limited version of TreadWill designed to deliver basic CBT in plain text format. The waitlisted participants will be put on a waitlist for 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The participant is masked to the intervention assigned to them. All outcome measures are self-reported by the participants through a computer program without any involvement of the experimenters.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fluent in English
- •PHQ-9 Score from 5 to 19
- •Access to an internet-enabled Android smartphone
- •Plan to use TreadWill in Google Chrome browser
- •Agree to allow notifications from TreadWill
- •Agree to add TreadWill to Home screen
- •Have email on one of the HTML-enabled platforms including Gmail, Outlook, Yahoo, Rediffmail, AOL, Hotmail.
排除标准
- •Suicide ideation (score greater than 0 on the 9th question of PHQ-9 and score greater than 4 on SIQ)
- •Unemployed
- •Current or previous diagnosis of bipolar disorder/manic-depressive disorder or psychosis
- •Prospective participants who say they only want to check out the program and do not plan to complete it are excluded.
- •Used an earlier version of TreadWill
结局指标
主要结局
Change in Patient Health Questionnaire-9 score
时间窗: change from baseline to program completion or last usage (upto 90 days).
Standard questionnaire for depressive symptoms. Total score is used; lower score indicates better outcome.
次要结局
- Time spent with the program(from beginning till study completion date (expected within 1 year from the trial start date))
- Follow-up Patient Health Questionnaire-9 score(90-120 days after program completion)
- Change in Generalized Anxiety Disorder 7 score(baseline, post-completion or last usage (upto 90 days), 90 day follow-up after completion)
研究者
Nitin Gupta
Associate Professor
Indian Institute of Technology Kanpur