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| Name | Class |
|---|---|
| Institute of Cancer Research, United Kingdom | OTHER |
| Imperial College London | OTHER |
| University of Warwick | OTHER |
| University of Oxford |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Depression Severity | Score on the PHQ-9, total scores range from 0 to 27 (higher scores indicated more severe depression) | 3 months post-randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety Severity | Score on the GAD-7, total scores range from 0 to 21 (higher scores indicated more severe anxiety) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rohit Shankar, FRCPsych | University of Plymouth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Plymouth | Plymouth | Devon | PL4 6DN | United Kingdom | ||
| Central North West London NHS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40503087 | Derived | 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. |
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Only the Academic CIs and their research staff will have access to research data.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Depression Severity | Score on the PHQ-9, total scores range from 0 to 27 (higher scores indicated more severe depression) | Posted | Mean | Standard Deviation | units on a scale | 3 months post-randomisation |
|
3 months post-randomisation
We have included risk events for the purpose of clarity; appropriate signposting was provided for all of the users with risk events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal language | General disorders | Non-systematic Assessment | Suicidal language used by participants in their discussions with the chatbot was detected by the app and flagged |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Ceire Costelloe | The Institute of Cancer Research | 20 3437 6777 | ceire.costelloe@icr.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 1, 2023 | May 14, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 8, 2023 | May 14, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D010549 | Personal Satisfaction |
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| OTHER |
Participants will be randomly allocated to the intervention condition or a standard care waitlist control condition.
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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.
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| 3 months post-randomisation |
| Uptake Rates | Uptake rates of participants randomised into intervention group | 3 months post-randomisation |
| Dropout Rates | Dropout rates of participants who are randomised into intervention group and start using the app | 3 months post-randomisation |
| Use of the App | Participant engagement with the app (whether it was used at all based on app usage data) | 3-7 months post-randomisation |
| Engagement | Qualitative feedback from semi-structured interviews about engagement with the app | 3-7 months post randomisation |
| Patient Perceptions of Acceptability | Qualitative feedback from semi-structured interviews about the acceptability of the app | 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 at baseline and 3 months post-randomisation |
| Type of App Usage - Exercises Completed | Frequency and duration of app use | 3 months post-randomisation |
| Type of App Usage - Sessions Completed | Frequency and duration of app use | 3 months post-randomisation |
| Type of App Usage - Messages to Chatbot | Frequency and duration of app use | 3 months post-randomisation |
| London |
| NW1 3AX |
| United Kingdom |
| Thought app was a scam |
|
| Withdrawal by Subject |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| PHQ-9 | Score on the PHQ-9, total scores range from 0 to 27 (higher scores indicated more severe depression) | Mean | Standard Deviation | units on a scale |
|
| GAD-7 | Score on the GAD-7, total scores range from 0 to 21 (higher scores indicated more severe anxiety) | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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. |
|
|
| Secondary | Anxiety Severity | Score on the GAD-7, total scores range from 0 to 21 (higher scores indicated more severe anxiety) | Posted | Mean | Standard Deviation | units on a scale | 3 months post-randomisation |
|
|
|
| Secondary | 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 | Waitlist control group was not analysed for "Users triggered in-app escalation" or "App identified and flagged suicidal language" because these participants did not have access to the app | Posted | Number | participants | 3 months post-randomisation |
|
|
|
| Secondary | Uptake Rates | Uptake rates of participants randomised into intervention group | Participants randomly assigned to intervention group | Posted | Count of Participants | Participants | 3 months post-randomisation |
|
|
|
| Secondary | Dropout Rates | Dropout rates of participants who are randomised into intervention group and start using the app | Posted | Count of Participants | Participants | 3 months post-randomisation |
|
|
|
| Secondary | Use of the App | Participant engagement with the app (whether it was used at all based on app usage data) | Participants assigned to Wysa group | Posted | Count of Participants | Participants | 3-7 months post-randomisation |
|
|
|
| Secondary | Engagement | Qualitative feedback from semi-structured interviews about engagement with the app | Participants in the Wysa group who completed semi-structured interviews - the numbers reported are counts of the number of participants who expressed a particular theme generated from the thematic analysis | Posted | Number | participants | 3-7 months post randomisation |
|
|
|
| Secondary | Patient Perceptions of Acceptability | Qualitative feedback from semi-structured interviews about the acceptability of the app | Participants in the Wysa group who completed semi-structured interviews - the numbers reported are counts of the number of participants who expressed a particular theme generated from the thematic analysis | Posted | Number | participants | 3-7 months post randomisation |
|
|
|
| Secondary | 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 | Not all participants completed the follow-up assessment | Posted | Mean | Standard Deviation | units on a scale | Measured at baseline and 3 months post-randomisation |
|
|
|
| Secondary | Type of App Usage - Exercises Completed | Frequency and duration of app use | Participants assigned to Wysa intervention group; data from some participants was missing if they did not use that feature. | Posted | Mean | Standard Deviation | Exercises completed | 3 months post-randomisation |
|
|
|
| Secondary | Type of App Usage - Sessions Completed | Frequency and duration of app use | Participants assigned to Wysa intervention group; data from some participants was missing if they did not use that feature. | Posted | Mean | Standard Deviation | Sessions completed | 3 months post-randomisation |
|
|
|
| Secondary | Type of App Usage - Messages to Chatbot | Frequency and duration of app use | Participants assigned to Wysa intervention group; data from some participants was missing if they did not use that feature. | Posted | Mean | Standard Deviation | Messages to chatbot | 3 months post-randomisation |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 5 |
| 30 |
| EG001 | 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. | 0 | 16 | 0 | 16 | 0 | 16 |
|
| User-triggered escalation in app | General disorders | Non-systematic Assessment | User escalation within the app was captured as a risk event |
|
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| App identified and flagged suicidal language |
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|
| Self-reports to the service or crisis service reports (iaptus record) |
|
|
| Title | Measurements |
|---|---|
|
| Decrease in use over time |
|
| Title | Measurements |
|---|---|
|
| Range of resources were useful for users |
|
| Suggestions for improvement |
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| Tone affected user connection with app |
|
| Tool was exciting and a relief because of accessible support and expected benefit |
|
| Trustworthiness shaped by source credibility and personal experience |
|
| 12 weeks |
|
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