Clinical Investigation of Wysa

NCT05533190 | Completed Results

• 1 other identifier: AM1000411
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

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

Keywords

Artificial Intelligence; Mental Health; Telemedicine; Conversational Agent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Anxiety Severity

  3 months post-randomisation

• Crisis Identification

  3 months post-randomisation

• Uptake Rates

  3 months post-randomisation

• Dropout Rates

  3 months post-randomisation

• Use of the App

  3-7 months post-randomisation

Study Arms (2)

Wysa AI chatbot mental health app

EXPERIMENTAL

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

Waitlist control

NO INTERVENTION

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.

Interventions

Wysa AI chatbot mental health app 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.

Wysa AI chatbot mental health app

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Plymouth: lead
• Institute of Cancer Research, United Kingdom: collaborator
• Imperial College London: collaborator
• University of Warwick: collaborator
• University of Oxford: collaborator

Study Sites (2)

University of Plymouth

Plymouth, Devon, PL4 6DN, United Kingdom

Location

Central North West London NHS

London, NW1 3AX, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 40503087 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression; Psychological Well-Being

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Personal Satisfaction

Results Point of Contact

• Title: Prof Ceire Costelloe
• Organization: The Institute of Cancer Research

ceire.costelloe@icr.ac.uk

20 3437 6777

Study Officials

• Rohit Shankar, FRCPsych

  University of Plymouth

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of eHealth

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

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 8, 2022
• Study Start: December 13, 2022
• Primary Completion: July 23, 2023
• Study Completion: July 25, 2023
• Last Updated: February 3, 2025
• Results First Posted: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)