Clinical Investigation of Wysa

NCT ID: NCT05533190

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-13
• Study Completion Date: 2023-07-25

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.

Conditions

Mental Health Issue; Anxiety; Depressive Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Wysa AI chatbot mental health app

Intervention Type: DEVICE

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Cancer Research, United Kingdom

OTHER

Sponsor Role: collaborator

Imperial College London

OTHER

Sponsor Role: collaborator

University of Warwick

OTHER

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: collaborator

University of Plymouth

OTHER

Sponsor Role: lead

Responsible Party

Edward Meinert, PhD

Associate Professor of eHealth

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rohit Shankar, FRCPsych

Role: PRINCIPAL_INVESTIGATOR

University of Plymouth

Locations

University of Plymouth

Plymouth, Devon, United Kingdom

Central North West London NHS

London, , United Kingdom

Countries

United Kingdom

References

Milne-Ives M, Homer SR, Andrade J, Meinert E. Mapping the Process of Engagement With Digital Health Interventions: A Cross-Case Synthesis. Mayo Clin Proc Innov Qual Outcomes. 2025 May 27;9(3):100625. doi: 10.1016/j.mayocpiqo.2025.100625. eCollection 2025 Jun.

Reference Type: DERIVED

PMID: 40503087 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

AM1000411

Identifier Type: -

Identifier Source: org_study_id