跳至主要内容
临床试验/NCT05758285
NCT05758285已完成不适用

Using Responsible Artificial Intelligence (AI) to Predict Online Therapy Outcome and Engagement

University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 6,671 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
6,671
试验地点
1
主要终点
Change in Patient Health Questionnaire 9-item (PHQ9) (percent change)

研究概览

简要总结

This study is to develop AI-based models for the personalised prediction of treatment engagement and treatment outcomes in patients engaging in digital psychotherapy. A large, real-world dataset of patients in a digital psychotherapy program will be used to train AI algorithms. Responsible AI algorithms will be developed by describing, accounting for, and mitigating bias due to severity of mental disturbances in AI-based models, in addition to considering bias due to other sensitive attributes, such as gender, ethnicity, and socio-demographic status.

详细描述

Mental disorders contribute greatly to the global disease burden, but many people do not have access to mental health care. This treatment gap is partly due to structural (e.g., availability) and attitude-related (e.g. fear of stigma) barriers in health care seeking. Digital therapeutics (DTx) in the form of digital mental health interventions or digital psychotherapy may be the solution to this problem. The integration of Information and Communication Technology (ICT) and mental health care has the potential to increase the efficiency of care delivery and enables personalisation of treatments. Artificial Intelligence (AI)-based analysis of large datasets from digital psychotherapy programs may allow developing and validating personalised prediction models. The prediction of individual engagement and the early identification of untoward engagement patterns may improve personalisation of DTx, which could help reduce nonadherence and improve treatment outcome. The personalised prediction of DTx outcomes and engagement patterns may be achieved by implementing AI-based approaches, such as Machine Learning prediction models. Personalised prediction models may lead to a better understanding of who profits most from what kind of DTx in a real-world setting. Taken together, personalisation of DTx treatment outcomes and engagement may i) improve decision making processes in patient-clinician dyads, ii) improve efficiency of digital psychotherapy, iii) reduce suffering of patients, and iv) reduce direct and indirect cost related to mental health care. There is a need to account for potential discrimination due to mental health in AI-based predictions models. Unbiased and non- discriminating AI is often referred to as responsible AI. Accounting for bias in AI-based prediction models based on a specific dataset is especially important in mental health care to prevent acceleration of health discrimination.

This study is to develop AI-based models for the personalised prediction of treatment engagement and treatment outcomes in patients engaging in digital psychotherapy. A large, real-world dataset of patients in a digital psychotherapy program will be used to train AI algorithms. Responsible AI algorithms will be developed by describing, accounting for, and mitigating bias due to severity of mental disturbances in AI-based models, in addition to considering bias due to other sensitive attributes, such as gender, ethnicity, and socio-demographic status. The aim of the proposed project is to estimate AI-based prediction models of treatment engagement and outcomes based on data from the Online Therapy Unit by Prof. Heather Hadjistavropoulos from the University of Regina, Canada. The Online Therapy Unit dataset contains a large amount of data on DTx from people with mental disorders (collected as part of research trials in the Online Therapy Unit from 2013 to 2021) and is derived from the publicly funded, internet-delivered, cognitive behaviour therapy (iCBT) program in Saskatchewan, Canada. In sum, the Online Therapy Unit dataset is highly suitable as a training and test dataset for AI-based prediction models, as it comprises a large number of participants, longitudinal data retrieved from the real world opposed to a clinical trial, and a rich set of predictive features.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants that were screened as eligible to take part in a Wellbeing Course trial offered at the Online Therapy Unit between Nov 4 2013 and Dec 21
  • Participants that consented to the use of their data to evaluate and improve iCBT services.
  • Accessed Lesson 1 of the course content and completed baseline questionnaires.

排除标准

  • Data will only be excluded in case of errors in data collection

结局指标

主要结局

Change in Patient Health Questionnaire 9-item (PHQ9) (percent change)

时间窗: week 1 until week 8

Change in PHQ9 (percent change) to evaluate symptom improvement vs. no symptom improvement pre- to post-digital psychotherapy intervention. Patient Health Questionnaire (PHQ-9): Total = /27 ; Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.

Change in General Anxiety Disorder-7 Questionnaire (GAD7) (percent change)

时间窗: week 1 until week 8

Change in General Anxiety Disorder-7 Questionnaire (GAD7) to evaluate symptom improvement vs. no symptom improvement pre- to post-digital psychotherapy intervention. Score 0-4: Minimal Anxiety · Score 5-9: Mild Anxiety · Score 10-14: Moderate Anxiety · Score greater than 15: Severe Anxiety.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验