Clinical Investigation of Wysa

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05533190
• Other study ID #: AM1000411
• Status: Recruiting
• Phase: N/A
• Start date: December 13, 2022
• Est. completion date: October 31, 2023

Study information

• Verified date: March 2023
• Source: University of Plymouth
• Contact: Edward Meinert, PhD
• Phone: 01752600600
• Email: edward.meinert[@]plymouth.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Depressive Symptoms
• Mental Health Issue

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Central North West London NHS	London
United Kingdom	University of Plymouth	Plymouth	Devon

Sponsors (5)

Lead Sponsor	Collaborator
University of Plymouth	Imperial College London, Institute of Cancer Research, United Kingdom, University of Oxford, University of Warwick

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Anxiety severity	Score on the GAD-7, total scores range from 0 to 21 (higher scores indicated more severe anxiety)	3 months post-randomisation
Secondary	Crisis identification	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	Over 9 month intervention period
Secondary	Uptake rates	Uptake rates of participants randomised into intervention group	Over 9 month intervention period
Secondary	Dropout rates	Dropout rates of participants who are randomised into intervention group and start using the app	Over 9 month intervention period
Secondary	App usage data	Frequency and duration of app use	Over 9 month intervention period
Secondary	Engagement	Qualitative feedback from semi-structured interviews about engagement with the app	Over 9 month intervention period
Secondary	Patient perceptions of acceptability	Qualitative feedback from semi-structured interviews about the acceptability of the app	Over 9 month intervention period
Secondary	Self-reported acceptability through the app	Automated review questions periodically requested during general use of the tool	Over 9 month intervention period
Secondary	General health state	Assessed using the EQ-5D-5L, total scores ranging from 5 to 125 (higher scores indicate more severe health problems)	Measured at baseline and 3 months post-randomisation
Secondary	Impact of health on everyday life	Assessed using the Short Form 12 (SF-12) health survey, total scores ranging from 0 to 100 (higher scores indicate better physical and mental functioning)	Measured at baseline and 3 months post-randomisation
Secondary	Cost-analysis	Assessed using compiled cost data relating to health and social care service use, medication and treatment use, Wysa's implementation, and patients' personal payments or related productivity losses	Over 9 month intervention period