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

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Recruiting

CT.gov ID

NCT05758285

Collaborator

(none)

7,000

Enrollment

Location

23.1

Anticipated Duration (Months)

303.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Mental Health Care Mental Disorders	Other: AI-Based Prediction of Treatment Engagement and Outcomes

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

7000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2025

Anticipated Study Completion Date :

Feb 1, 2025

Outcome Measures

Primary Outcome Measures

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

Other Outcome Measures

Number of messages sent by client [week 1 until week 8]
Patients' engagement with the digital psychotherapy intervention by assessing the number of patient messages
Number of messages received by client [week 1 until week 8]
Patients' engagement with the digital psychotherapy intervention by assessing the number of therapist messages
Number of phone calls to physician notes [week 1 until week 8]
Patients' engagement with the digital psychotherapy intervention by assessing the number of phone calls
Number of times client logged in [week 1 until week 8]
Patients' engagement with the digital psychotherapy intervention by assessing the number of lessons accessed

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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 2021.
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.