NCT05533190

Clinical Investigation of Wysa

Real World Testing of an Artificial Intelligence-enabled App as an Early Intervention and Support Tool in the Mental Health Referral Care Pathway

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: University of Plymouth · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Mental health concerns are a large burden for individuals, healthcare systems, and the economy. Over a million people are referred to UK mental health services each year, but more than half only receive one session of workbook-based support. Many others have to wait over 12 weeks for assessment and treatment. Wysa is a digital health app with over 3 million users that uses an artificial intelligence (AI) chatbot and a series of self-care exercises to provide mental health support and to help people develop strategies to manage their mental health and improve their resilience. This project aims to examine the impact of using Wysa on patients' symptoms of anxiety and depression during the referral process for standard UK mental health services. Patients will be given access to Wysa at the point of referral to the Improving Access to Psychological Therapies (IAPT) programme and can begin to explore the self-support tools, while they are on the waitlist for assessment and treatment. The investigators will gather a group of patients and members of the public to contribute to the recruitment of patients for the study, the methods we use to evaluate Wysa, and to provide insights on how best to share the results of our study with the general public. The investigators will use the standard IAPT measures of anxiety and depression to look at the effect of using Wysa patients' mental well-being. These questionnaires will be provided through the app and the results will be compared with a waitlist control group. The investigators will examine whether Wysa can identify people who are experiencing severe mental health difficulties so that they can be provided with additional support. Users' levels of engagement with Wysa will be assessed and some participants will be randomly selected to do an interview so the investigators can get a better understanding of what people liked and disliked about using the app and why. Finally, the investigators will be evaluating the cost-effectiveness of Wysa compared with usual care. The investigators expect that the study will show that Wysa helps reduce symptoms of anxiety and depression in people who are on the waiting list for IAPT. If the study shows this positive impact, this will provide evidence to support the use of Wysa to improve the accessibility of mental health support in clinical pathways. The investigators will be publishing the results of our study in academic journals as well as in more generally accessible platforms.

Conditions

• Mental Health Issue
• Anxiety
• Depressive Symptoms

Interventions

Type	Name	Description
DEVICE	Wysa AI chatbot mental health app	Wysa is a guided self-help and triaging tool delivered to patients via an app. It includes a chatbot and makes use of a wide range of clinically underpinned modules to provide mental health support.

Timeline

• Start date: 2022-12-13
• Primary completion: 2023-07-23
• Completion: 2023-07-25
• First posted: 2022-09-08
• Last updated: 2025-02-03
• Results posted: 2025-02-03

Locations

2 sites across 1 country: United Kingdom