Trial Outcomes & Findings for Clinical Investigation of Wysa (NCT NCT05533190)

NCT ID: NCT05533190

Last Updated: 2025-02-03

Results Overview

Score on the PHQ-9, total scores range from 0 to 27 (higher scores indicated more severe depression)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 76 participants
• Primary outcome timeframe: 3 months post-randomisation
• Results posted on: 2025-02-03

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	53	23
Overall Study COMPLETED	30	16
Overall Study NOT COMPLETED	23	7

Reasons for withdrawal

Measure	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.	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.
Overall Study Lost to Follow-up	19	7
Overall Study Failed to download app	1	0
Overall Study Thought app was a scam	1	0
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

Clinical Investigation of Wysa

Baseline characteristics by cohort

Measure	Wysa AI Chatbot Mental Health App n=30 Participants 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.	Waitlist Control n=16 Participants 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.	Total n=46 Participants Total of all reporting groups
Age, Continuous	36.0 years STANDARD_DEVIATION 14.4 • n=5 Participants	37.1 years STANDARD_DEVIATION 15.8 • n=7 Participants	36.3 years STANDARD_DEVIATION 14.7 • n=5 Participants
Sex/Gender, Customized Female	18 Participants n=5 Participants	11 Participants n=7 Participants	29 Participants n=5 Participants
Sex/Gender, Customized Male	10 Participants n=5 Participants	4 Participants n=7 Participants	14 Participants n=5 Participants
Sex/Gender, Customized Transgender female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex/Gender, Customized Declined to respond	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian or Asian British	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Not known	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Other ethnic groups	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized White	21 Participants n=5 Participants	8 Participants n=7 Participants	29 Participants n=5 Participants
Race/Ethnicity, Customized Black or Black British	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
PHQ-9	11.9 units on a scale STANDARD_DEVIATION 5.07 • n=5 Participants	11.0 units on a scale STANDARD_DEVIATION 4.38 • n=7 Participants	11.6 units on a scale STANDARD_DEVIATION 4.81 • n=5 Participants
GAD-7	11.3 units on a scale STANDARD_DEVIATION 4.92 • n=5 Participants	11.9 units on a scale STANDARD_DEVIATION 4.92 • n=7 Participants	11.5 units on a scale STANDARD_DEVIATION 4.87 • n=5 Participants

PRIMARY outcome

Timeframe: 3 months post-randomisation

Score on the PHQ-9, total scores range from 0 to 27 (higher scores indicated more severe depression)

Outcome measures

Measure	Wysa AI Chatbot Mental Health App n=30 Participants 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.	Waitlist Control n=16 Participants 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.
Depression Severity	9.28 units on a scale Standard Deviation 6.56	8.41 units on a scale Standard Deviation 3.82

SECONDARY outcome

Timeframe: 3 months post-randomisation

Score on the GAD-7, total scores range from 0 to 21 (higher scores indicated more severe anxiety)

Outcome measures

Measure	Wysa AI Chatbot Mental Health App n=30 Participants 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.	Waitlist Control n=16 Participants 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.
Anxiety Severity	8.98 units on a scale Standard Deviation 6.13	8.19 units on a scale Standard Deviation 3.22

SECONDARY outcome

Timeframe: 3 months post-randomisation

Population: 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

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

Outcome measures

Measure	Wysa AI Chatbot Mental Health App n=30 Participants 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.	Waitlist Control n=16 Participants 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.
Crisis Identification Users triggered in-app escalation	4 participants	—
Crisis Identification App identified and flagged suicidal language	1 participants	—
Crisis Identification Self-reports to the service or crisis service reports (iaptus record)	0 participants	0 participants

SECONDARY outcome

Timeframe: 3 months post-randomisation

Population: Participants randomly assigned to intervention group

Uptake rates of participants randomised into intervention group

Outcome measures

Measure	Wysa AI Chatbot Mental Health App n=53 Participants 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.	Waitlist Control n=23 Participants 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.
Uptake Rates	30 Participants	16 Participants

SECONDARY outcome

Timeframe: 3 months post-randomisation

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

Outcome measures

Measure	Wysa AI Chatbot Mental Health App n=53 Participants 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.	Waitlist Control n=23 Participants 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.
Dropout Rates	23 Participants	7 Participants

SECONDARY outcome

Timeframe: 3-7 months post-randomisation

Population: Participants assigned to Wysa group

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

Outcome measures

Measure	Wysa AI Chatbot Mental Health App n=30 Participants 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.	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.
Use of the App Engaged with Wysa	18 Participants	—
Use of the App Did not engage with Wysa	12 Participants	—

SECONDARY outcome

Timeframe: 3-7 months post randomisation

Population: 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

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

Outcome measures

Measure	Wysa AI Chatbot Mental Health App n=4 Participants 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.	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.
Engagement Minimal transfer of skills beyond app	4 participants	—
Engagement Reminders helped prompt use but app was easy to ignore	4 participants	—
Engagement Varying patterns of use for individuals	4 participants	—
Engagement Decrease in use over time	2 participants	—

SECONDARY outcome

Timeframe: 3-7 months post randomisation

Population: 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

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

Outcome measures

Measure	Wysa AI Chatbot Mental Health App n=4 Participants 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.	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.
Patient Perceptions of Acceptability App did not meet all needs; not long-term solution or replacement for therapy	4 participants	—
Patient Perceptions of Acceptability Easy to use but a bit overwhelming	4 participants	—
Patient Perceptions of Acceptability Limited chatbot frustrated users	4 participants	—
Patient Perceptions of Acceptability Range of resources were useful for users	4 participants	—
Patient Perceptions of Acceptability Suggestions for improvement	3 participants	—
Patient Perceptions of Acceptability Tone affected user connection with app	3 participants	—
Patient Perceptions of Acceptability Tool was exciting and a relief because of accessible support and expected benefit	4 participants	—
Patient Perceptions of Acceptability Trustworthiness shaped by source credibility and personal experience	4 participants	—

SECONDARY outcome

Timeframe: Measured at baseline and 3 months post-randomisation

Population: Not all participants completed the follow-up assessment

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

Outcome measures

Measure	Wysa AI Chatbot Mental Health App n=30 Participants 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.	Waitlist Control n=16 Participants 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.
General Health State Baseline	0.681 units on a scale Standard Deviation 0.163	0.607 units on a scale Standard Deviation 0.235
General Health State 12 weeks	0.688 units on a scale Standard Deviation 0.174	0.644 units on a scale Standard Deviation 0.192

SECONDARY outcome

Timeframe: 3 months post-randomisation

Population: Participants assigned to Wysa intervention group; data from some participants was missing if they did not use that feature.

Frequency and duration of app use

Outcome measures

Measure	Wysa AI Chatbot Mental Health App n=30 Participants 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.	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.
Type of App Usage - Exercises Completed	7.11 Exercises completed Standard Deviation 7.79	—

SECONDARY outcome

Timeframe: 3 months post-randomisation

Population: Participants assigned to Wysa intervention group; data from some participants was missing if they did not use that feature.

Frequency and duration of app use

Outcome measures

Measure	Wysa AI Chatbot Mental Health App n=18 Participants 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.	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.
Type of App Usage - Sessions Completed	24.3 Sessions completed Standard Deviation 29.8	—

SECONDARY outcome

Timeframe: 3 months post-randomisation

Population: Participants assigned to Wysa intervention group; data from some participants was missing if they did not use that feature.

Frequency and duration of app use

Outcome measures

Measure	Wysa AI Chatbot Mental Health App n=18 Participants 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.	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.
Type of App Usage - Messages to Chatbot	227 Messages to chatbot Standard Deviation 319	—

Adverse Events

Wysa AI Chatbot Mental Health App

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Waitlist Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Wysa AI Chatbot Mental Health App n=30 participants at risk 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.	Waitlist Control n=16 participants at risk 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.
General disorders Suicidal language	3.3% 1/30 • 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.	0.00% 0/16 • 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.
General disorders User-triggered escalation in app	13.3% 4/30 • 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.	0.00% 0/16 • 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.

Additional Information

Prof Ceire Costelloe

The Institute of Cancer Research

Phone: 20 3437 6777

Email: ceire.costelloe@icr.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place