Clinical trial NCT05533190: Clinical Investigation of Wysa
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Issue
Anxiety
Depressive Symptoms
Keywords: Artificial Intelligence
Mental Health
Telemedicine
Conversational Agent
Lead sponsor: University of Plymouth
Sponsor class: OTHER
Collaborators: name: Institute of Cancer Research, United Kingdom
name: Imperial College London
name: University of Warwick
name: University of Oxford
First posted: 2022-09-08
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly allocated to the intervention condition or a standard care waitlist control condition.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Depression Severity
timeFrame: 3 months post-randomisation
Secondary outcomes:
measure: Anxiety Severity
timeFrame: 3 months post-randomisation
measure: Crisis Identification
timeFrame: 3 months post-randomisation
measure: Uptake Rates
timeFrame: 3 months post-randomisation
measure: Dropout Rates
timeFrame: 3 months post-randomisation
measure: Use of the App
timeFrame: 3-7 months post-randomisation
measure: Engagement
timeFrame: 3-7 months post randomisation
measure: Patient Perceptions of Acceptability
timeFrame: 3-7 months post randomisation
measure: General Health State
timeFrame: Measured at baseline and 3 months post-randomisation
measure: Type of App Usage - Exercises Completed
timeFrame: 3 months post-randomisation
measure: Type of App Usage - Sessions Completed
timeFrame: 3 months post-randomisation
measure: Type of App Usage - Messages to Chatbot
timeFrame: 3 months post-randomisation
Other outcomes:
Locations:
city: Plymouth
country: United Kingdom
facility: University of Plymouth
state: Devon
city: London
country: United Kingdom
facility: Central North West London NHS
Study officials:
affiliation: University of Plymouth
name: Rohit Shankar, FRCPsych
role: PRINCIPAL_INVESTIGATOR
References: