Clinical Investigation of Wysa

Not Applicable

Completed

Conditions: Anxiety
Mental Health Issue
Depressive Symptoms

Interventions: Device: Wysa AI chatbot mental health app

Registration Number: NCT05533190

Lead Sponsor: University of Plymouth

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 76

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wysa AI chatbot mental health app	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Anxiety Severity	3 months post-randomisation	Score on the GAD-7, total scores range from 0 to 21 (higher scores indicated more severe anxiety)
Crisis Identification	3 months post-randomisation	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
Uptake Rates	3 months post-randomisation	Uptake rates of participants randomised into intervention group
Dropout Rates	3 months post-randomisation	Dropout rates of participants who are randomised into intervention group and start using the app
Use of the App	3-7 months post-randomisation	Participant engagement with the app (whether it was used at all based on app usage data)
Engagement	3-7 months post randomisation	Qualitative feedback from semi-structured interviews about engagement with the app
Patient Perceptions of Acceptability	3-7 months post randomisation	Qualitative feedback from semi-structured interviews about the acceptability of the app
General Health State	Measured at baseline and 3 months post-randomisation	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
Type of App Usage - Exercises Completed	3 months post-randomisation	Frequency and duration of app use
Type of App Usage - Sessions Completed	3 months post-randomisation	Frequency and duration of app use
Type of App Usage - Messages to Chatbot	3 months post-randomisation	Frequency and duration of app use