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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Depressive Symptoms; Mental Health Issue
• Intervention / Treatment: Device: Wysa AI chatbot mental health app

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, NW1 3AX
    • Central North West London NHS
  • Devon
    • Plymouth, Devon, United Kingdom, PL4 6DN
      • University of Plymouth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Willing and able to provide informed consent;
• Aged 18 years or older;
• Ability to speak English to a secondary school standard;
• Own a mobile device capable of supporting Wysa;
• A valid email address;
• Referred or self-referred to proceed through the standard IAPT care pathway.

Exclusion Criteria:

• Patients ineligible for the standard IAPT care pathway;
• Patients with previous and current known major mental illness such as Schizophrenia, severe depression, any co-morbid neurological or neuro-psychiatric condition such as epilepsy;
• Patients with current psychosis or a history of psychotic symptoms within the last 6 months;
• Patients with suicidal ideation;
• Patients scoring > 15 points on PHQ 9;
• Patients scoring > 15 points on GAD-7;
• Patients with significant cognitive disorders;
• Patients with noted neurodevelopmental conditions such as autism or ADHD;
• Patients previously diagnosed with a personality disorder;
• Patients who been under the care of CMHT or a specialised mental health services in the last 2 years;
• Patients who failed IAPT previously;
• Patients with referrals for specialist presentations of pre-existing, diagnosed conditions requiring a specialised assessment beyond the standard clinical pathway;
• Incapable of self-consent;
• In a dependent/unequal relationship with the research or care teams or any PPI representatives.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Wysa AI chatbot mental health app; Wysa is a guided self-help and triaging tool delivered to patients via an app or widget. It uses Natural Language Processing to understand individuals' written inputs but not to generate responses. Wysa makes use of a wide range of clinically underpinned modules whilst gamification, clinical outcome measures and AI promotes engagement, improving efficacy and triage and reducing the cost of scale.	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.
No Intervention: Waitlist control; The intervention will be compared against a waitlist group. This comparator was selected to compare Wysa to the current standard of care for patients waiting for standard IAPT assessment and treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression Severity	Score on the PHQ-9, total scores range from 0 to 27 (higher scores indicated more severe depression)	3 months post-randomisation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety Severity	Score on the GAD-7, total scores range from 0 to 21 (higher scores indicated more severe anxiety)	3 months post-randomisation
Crisis Identification	Planned to compare number of users identified by the app for escalation of care compared to the number of patients in the control group who access A&E or out-of-hours services while waiting for treatment; this was not possible, data reported reflect risk events triggered by Wysa or the participant in-app	3 months post-randomisation
Uptake Rates	Uptake rates of participants randomised into intervention group	3 months post-randomisation
Dropout Rates	Dropout rates of participants who are randomised into intervention group and start using the app	3 months post-randomisation
Use of the App	Participant engagement with the app (whether it was used at all based on app usage data)	3-7 months post-randomisation
Engagement	Qualitative feedback from semi-structured interviews about engagement with the app	3-7 months post randomisation
Patient Perceptions of Acceptability	Qualitative feedback from semi-structured interviews about the acceptability of the app	3-7 months post randomisation
General Health State	5-level EQ-5D version (EQ-5D-5L) which measures health-related quality of life via 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and a visual scale - total survey scores were calculated and can range from 5 to 125 (higher scores indicate more severe health problems). A single index was obtained by transforming the ordinal survey responses using the 'eq5d' package in R. Range: The EQ-5D index score typically ranges from -0.594 to 1 (depending on the country-specific value set used). Interpretation: 1.000 represents full health (the best possible outcome). 0.000 represents a health state equivalent to death (neutral point). Negative values (e.g., -0.594) indicate health states perceived as worse than death. Higher index values indicate better health outcomes, while lower values represent poorer health states. https://euroqol.org/wp-content/uploads/2023/11/EQ-5D-5LUserguide-23-07.pdf	Measured at baseline and 3 months post-randomisation
Type of App Usage - Exercises Completed	Frequency and duration of app use	3 months post-randomisation
Type of App Usage - Sessions Completed	Frequency and duration of app use	3 months post-randomisation
Type of App Usage - Messages to Chatbot	Frequency and duration of app use	3 months post-randomisation

Collaborators and Investigators

• Sponsor: University of Plymouth
• Collaborators: Imperial College London; University of Oxford; Institute of Cancer Research, United Kingdom; University of Warwick
• Investigators: Principal Investigator: Rohit Shankar, FRCPsych, University of Plymouth

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2022
• Primary Completion (Actual): July 23, 2023
• Study Completion (Actual): July 25, 2023

Study Registration Dates

• First Submitted: September 1, 2022
• First Submitted That Met QC Criteria: September 5, 2022
• First Posted (Actual): September 8, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 30, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Telemedicine; Mental Health; Artificial Intelligence; Conversational Agent
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: AM1000411

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only the Academic CIs and their research staff will have access to research data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No