Clinical Investigation of Wysa

• ClinicalTrials.gov Identifier: NCT05533190
• Recruitment Status: Recruiting
• First Posted: September 8, 2022
• Last Update Posted: March 24, 2023
• Sponsor: University of Plymouth
• Collaborators: Institute of Cancer Research, United Kingdom; Imperial College London; University of Warwick; University of Oxford
• Information provided by (Responsible Party): Edward Meinert, PhD, University of Plymouth

Tracking Information

• First Submitted Date: September 1, 2022
• First Posted Date: September 8, 2022
• Last Update Posted Date: March 24, 2023
• Actual Study Start Date: December 13, 2022
• Estimated Primary Completion Date: October 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 5, 2022)

Depression severity [ Time Frame: 3 months post-randomisation ]

Score on the PHQ-9, total scores range from 0 to 27 (higher scores indicated more severe depression)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 5, 2022)

• Anxiety severity [ Time Frame: 3 months post-randomisation ]
  Score on the GAD-7, total scores range from 0 to 21 (higher scores indicated more severe anxiety)
• Crisis identification [ Time Frame: Over 9 month intervention period ]
  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
• Uptake rates [ Time Frame: Over 9 month intervention period ]
  Uptake rates of participants randomised into intervention group
• Dropout rates [ Time Frame: Over 9 month intervention period ]
  Dropout rates of participants who are randomised into intervention group and start using the app
• App usage data [ Time Frame: Over 9 month intervention period ]
  Frequency and duration of app use
• Engagement [ Time Frame: Over 9 month intervention period ]
  Qualitative feedback from semi-structured interviews about engagement with the app
• Patient perceptions of acceptability [ Time Frame: Over 9 month intervention period ]
  Qualitative feedback from semi-structured interviews about the acceptability of the app
• Self-reported acceptability through the app [ Time Frame: Over 9 month intervention period ]
  Automated review questions periodically requested during general use of the tool
• General health state [ Time Frame: Measured at baseline and 3 months post-randomisation ]
  Assessed using the EQ-5D-5L, total scores ranging from 5 to 125 (higher scores indicate more severe health problems)
• Impact of health on everyday life [ Time Frame: Measured at baseline and 3 months post-randomisation ]
  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)
• Cost-analysis [ Time Frame: Over 9 month intervention period ]
  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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Clinical Investigation of Wysa
• 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

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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Participants will be randomly allocated to the intervention condition or a standard care waitlist control condition.

Masking: None (Open Label)
Masking Description:

Due to the nature of the intervention, no blinding of participants will be possible in the study, as all participants will know whether or not they are using the app. Clinical treatment teams will also not be blinded as they will know through the electronic patient record if a participant has received the intervention. The evaluation team will be blinded to treatment using the randomisation algorithm.

Primary Purpose: Treatment

Condition

• Mental Health Issue
• Anxiety
• Depressive Symptoms

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.

Study Arms

• 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.
  Intervention: Device: Wysa AI chatbot mental health app
• 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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 5, 2022): 480
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 31, 2023
• Estimated Primary Completion Date: October 31, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Edward Meinert, PhD; 01752600600; edward.meinert@plymouth.ac.uk

Contact: Madison Milne-Ives, MSc; 01752600600; madison.milne-ives@plymouth.ac.uk

• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT05533190
• Other Study ID Numbers: AM1000411
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: Only the Academic CIs and their research staff will have access to research data.

• Current Responsible Party: Edward Meinert, PhD, University of Plymouth
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Plymouth
• Original Study Sponsor: Same as current

Collaborators

• Institute of Cancer Research, United Kingdom
• Imperial College London
• University of Warwick
• University of Oxford

Investigators

• Principal Investigator: Rohit Shankar, FRCPsych; University of Plymouth

• PRS Account: University of Plymouth
• Verification Date: March 2023