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OpenTrials
Completed

NCT Number: NCT05533190

Clinical Investigation of Wysa

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.

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Key information

Conditions

Mental Health Issue Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Depressive Symptoms Mental Disorders Personal Satisfaction Psychological Well-Being

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Plymouth, Plymouth, Devon, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. Crisis Identification

    Time frame: 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

  3. Uptake Rates

    Time frame: 3 months post-randomisation

    Uptake rates of participants randomised into intervention group

  4. Dropout Rates

    Time frame: 3 months post-randomisation

    Dropout rates of participants who are randomised into intervention group and start using the app

  5. Use of the App

    Time frame: 3-7 months post-randomisation

    Participant engagement with the app (whether it was used at all based on app usage data)

  6. Engagement

    Time frame: 3-7 months post randomisation

    Qualitative feedback from semi-structured interviews about engagement with the app

  7. Patient Perceptions of Acceptability

    Time frame: 3-7 months post randomisation

    Qualitative feedback from semi-structured interviews about the acceptability of the app

  8. General Health State

    Time frame: 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

  9. Type of App Usage - Exercises Completed

    Time frame: 3 months post-randomisation

    Frequency and duration of app use

  10. Type of App Usage - Sessions Completed

    Time frame: 3 months post-randomisation

    Frequency and duration of app use

  11. Type of App Usage - Messages to Chatbot

    Time frame: 3 months post-randomisation

    Frequency and duration of app use

Sponsors and collaborators

Lead sponsor

University of Plymouth

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 8, 2022
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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