Mental Health IssueNCT05533190
Clinical Investigation of Wysa
A study testing Wysa AI chatbot mental health app in people with Mental Health Issue and Anxiety, run by University of Plymouth at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health Issue, Anxiety, Depressive Symptoms
- What is being tested?
- Wysa AI chatbot mental health app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 13 Dec 2022to 25 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 14Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Central North West London NHS
London, NW1 3AX
University of Plymouth
Plymouth, Devon, PL4 6DN
About this study
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
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.
Read more
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
- Being tested
- Wysa AI chatbot mental health app
- Keywords
- Artificial Intelligence, Mental Health, Telemedicine, Conversational Agent
- Medical subject headings
- Anxiety Disorders, Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wysa AI chatbot mental health appDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Severity
Score on the PHQ-9, total scores range from 0 to 27 (higher scores indicated more severe depression)
Measured: 3 months post-randomisation
Secondary outcomes (11)
Anxiety Severity
Score on the GAD-7, total scores range from 0 to 21 (higher scores indicated more severe anxiety)
Measured: 3 months post-randomisation
Crisis Identification
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
Measured: 3 months post-randomisation
Uptake Rates
Uptake rates of participants randomised into intervention group
Measured: 3 months post-randomisation
Dropout Rates
Dropout rates of participants who are randomised into intervention group and start using the app
Measured: 3 months post-randomisation
Use of the App
Participant engagement with the app (whether it was used at all based on app usage data)
Measured: 3-7 months post-randomisation
Engagement
Qualitative feedback from semi-structured interviews about engagement with the app
Measured: 3-7 months post randomisation
Patient Perceptions of Acceptability
Qualitative feedback from semi-structured interviews about the acceptability of the app
Measured: 3-7 months post randomisation
General Health State
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
Measured: Measured at baseline and 3 months post-randomisation
Type of App Usage - Exercises Completed
Frequency and duration of app use
Measured: 3 months post-randomisation
Type of App Usage - Sessions Completed
Frequency and duration of app use
Measured: 3 months post-randomisation
Type of App Usage - Messages to Chatbot
Frequency and duration of app use
Measured: 3 months post-randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start13 Dec 2022
- Primary completion23 Jul 2023
- Study completion25 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly allocated to the intervention condition or a standard care waitlist control condition.
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Plymouth
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Cancer Research, United Kingdom, Imperial College London, University of Warwick, University of Oxford
- Responsible party
- Principal investigator, Edward Meinert, PhD, University of Plymouth
- Investigators
- Rohit Shankar, FRCPsych, Principal investigator, University of Plymouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05533190
- Sponsor's protocol ID
- AM1000411
- Status last verified
- Jan 2025
- First submitted
- 1 Sep 2022
- Last updated
- 3 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only the Academic CIs and their research staff will have access to research data.
Publications
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.
PubMed 40503087
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05533190
- Acronym / sponsor ID
- AM1000411
- Conditions
- Mental Health Issue, Anxiety, Depressive Symptoms
- Keywords
- Artificial Intelligence, Mental Health, Telemedicine, Conversational Agent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of PlymouthUniversity, hospital or other
- Collaborators
- Institute of Cancer Research, United Kingdom, Imperial College London, University of Warwick, University of Oxford
- Study start
- 13 Dec 2022 (actual)
- Primary completion
- 23 Jul 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 8 Sep 2022 (actual)
- Results
- Posted 3 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated to the intervention condition or a standard care waitlist control condition.
| Arm | Type | Receives |
|---|---|---|
| Wysa AI chatbot mental health app | Experimental | Device: Wysa AI chatbot mental health appWysa 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wysa AI chatbot mental health appWysa 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. | Device | Wysa AI chatbot mental health app |
Primary outcome
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)
11 secondary outcomes
Anxiety Severity
Time frame: 3 months post-randomisation
Crisis Identification
Time frame: 3 months post-randomisation
Uptake Rates
Time frame: 3 months post-randomisation
Dropout Rates
Time frame: 3 months post-randomisation
Use of the App
Time frame: 3-7 months post-randomisation
Engagement
Time frame: 3-7 months post randomisation
Patient Perceptions of Acceptability
Time frame: 3-7 months post randomisation
General Health State
Time frame: Measured at baseline and 3 months post-randomisation
Type of App Usage - Exercises Completed
Time frame: 3 months post-randomisation
Type of App Usage - Sessions Completed
Time frame: 3 months post-randomisation
Type of App Usage - Messages to Chatbot
Time frame: 3 months post-randomisation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40503087Milne-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.
- Individual participant dataSharing planned: No. Only the Academic CIs and their research staff will have access to research data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rohit Shankar, FRCPsych principal investigator
University of Plymouth
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wysa AI chatbot mental health app in people with Mental Health Issue and Anxiety, run by University of Plymouth at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression Severity (time frame: 3 months post-randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05533190, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.