ArthritisNCT04620668
Can Mental Health Chatbots Help Chronic Disease Populations?
A study testing Wysa in people with Arthritis and Diabetes, run by Luke MacNeill at 1 site in Canada.
Trial summary
Past research has shown that patients suffering from chronic health conditions tend to experience high levels of negative mental health symptoms (e.g., depression). The purpose of the current study is to evaluate whether an artificial intelligence (A.I.) mental health chatbot can be used to reduce negative mental… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Arthritis, Diabetes, Depression
- What is being tested?
- Wysa
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2021to 31 Oct 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have a diagnosis of diabetes (type 1 or type 2 diabetes) or arthritis (osteoarthritis, rheumatoid arthritis, or another type of arthritis).
- Participants must have a phone with an active Internet connection.
Who cannot join
- Participants must not be receiving ongoing treatment from a mental health professional.
- Participants must not be using a mental health chatbot (i.e., prior to the study).
- Participants must not have started or experienced a dosage change in a psychopharmacological drug within the previous month.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre for Research in Integrated Care, University of New Brunswick
Saint John, New Brunswick, E2L4L5
About this study
Official title: Evaluating the Usefulness of an Artificial Intelligence (A.I.) Mental Health Chatbot in a Healthcare Setting
Past research has shown that patients suffering from chronic health conditions tend to experience high levels of negative mental health symptoms (e.g., depression). The purpose of the current study is to evaluate whether an artificial intelligence (A.I.) mental health chatbot can be used to reduce negative mental health symptoms within this population. A minimum of 60 individuals with a chronic health condition (diabetes or arthritis) will be recruited. Participants will be randomly assigned to either a treatment group or a control group. Those assigned to the treatment group will use the mental health chatbot Wysa (Touchkin eServices, Bangalore) over a period of four weeks. Those assigned to the control group will receive no chatbot. Participants will complete measures of depression, anxiety, stress, and life satisfaction via Qualtrics at the outset of the study, two weeks into the study, and four weeks into the study (i.e., the final assessment point). Results from the treatment and control groups will be compared using ANOVA models. Participants in the treatment group will also be asked to complete some open-ended questions about their experiences with the chatbot program. A subset of participants from the treatment group may be asked to complete optional phone or video interviews to gain a better understanding of their experiences. Results will provide insight into the usefulness of chatbot programs for reducing negative mental health symptoms among patients with a chronic health condition. Results may also be used to inform policy decisions about the use of these programs for healthcare delivery, and to provide practical insight into how these programs can be best integrated into healthcare settings.
Read the detailed description
People dealing with chronic health conditions are susceptible to mental health issues such as depression and anxiety. Providing conventional mental health services to all of these individuals is not practical given the limited resources of the healthcare system. Artificial intelligence (A.I.) mental health chatbots may be an accessible and cost-effective means by which people can receive some degree of mental health support while they cope with their conditions. These automated programs act as a source of virtual support, talking with individuals and providing them with therapeutic exercises to improve their mental wellbeing. Several chatbots have been designed to deliver interventions based on popular psychological therapies (e.g., Wysa, Woebot, and Tess). Research has shown that these programs can reduce symptoms of depression, anxiety, and stress in nonclinical populations. However, the effectiveness of these programs has not been tested in chronic disease populations.
The purpose of the current research is to gain a better understanding of the usefulness of mental health chatbots for chronic disease populations. This research will be guided by two fundamental objectives: (1) to determine whether a mental health chatbot can reduce or prevent negative mental health symptoms in individuals who are dealing with a chronic health condition, and (2) to learn more about how individuals with a chronic health condition view these programs, particularly in terms of their potential benefits or drawbacks when used in healthcare settings. This research will focus on two specific chronic disease populations that are prone to elevated levels of mental health symptoms: people with arthritis and diabetes.
Participants will be recruited through social media channels (including online groups), newspaper advertisements, and emails and newsletters from relevant organizations (e.g., the Arthritis Society, Diabetes Canada). After volunteering to participate, participants will set up a phone or video conferencing call with the primary investigator to orient them into the study. Participants will be randomly assigned to either a treatment group or control group. Those assigned to the treatment group will download the mental health chatbot Wysa (Touchkin eServices, Bangalore) on their smartphones. They will interact with the chatbot a minimum of two times per week over a period of four weeks, with each interaction lasting a minimum of five minutes. Participants assigned to the control group will receive no chatbot (i.e., they will be in a no-treatment control group).
Regardless of their group assignment, participants will complete online materials via Qualtrics at the outset of the study, two weeks into the study, and four weeks into the study (i.e., the final assessment point). At the outset of the study, participants will fill out an informed consent form, a demographic questionnaire, and four psychological assessments tools: measures of depression, anxiety, stress, and life satisfaction. Two weeks into the study, participants will complete the four psychological assessment tools a second time. Four weeks into the study, participants will complete the four assessment tools a final time, and those in the treatment group will be presented with a post-study questionnaire that contains qualitative questions regarding their experiences with the chatbot. Participants in both groups will be presented with a debriefing form providing more information about the study. Those in the control group will be given the opportunity to download and use the chatbot at this point.
After the data from the four-week study are analyzed, a subset of participants from the treatment group may be asked to complete optional phone or video interviews to gain more insight into their experiences with and opinions on the chatbot program. Approximately 15 to 20 participants will be sought for the interviews. The questions for these interviews will be developed based on the collective results from the quantitative and qualitative analysis described above.
- Conditions
- Arthritis, Diabetes, Depression, Anxiety, Stress
- Being tested
- Wysa
- Keywords
- Arthritis, Diabetes, Depression, Anxiety, Stress, Chatbot, Conversational Agent
- Medical subject headings
- Arthritis, Diabetes Mellitus, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WysaDevice
Wysa is an AI-based mental health chatbot. It uses evidence-based techniques to help users build mental resilience skills and improve their mental health.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group (Wysa) | Experimental | Not described Receives: Device: Wysa |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Depression as Measured by the Patient Health Questionnaire (PHQ-9)
The Patient Health Questionnaire (PHQ-9) contains nine items, each of which is rated on a scale of 0 to 3. Ratings are summed for a composite score; the minimum score is 0 and the maximum score is 27. Higher scores indicate higher levels of depression.
Measured: Participants are assessed at baseline, two weeks into the study, and four weeks into the study.
Changes in Anxiety as Measured by the Generalized Anxiety Disorder Scale (GAD-7)
The Generalized Anxiety Disorder Scale (GAD-7) contains seven items, each of which is rated on a scale of 0 to 3. Ratings are summed for a composite score; the minimum score is 0 and the maximum score is 21. Higher scores indicate higher levels of anxiety.
Measured: Participants are assessed at baseline, two weeks into the study, and four weeks into the study.
Changes in Stress as Measured by the Perceived Stress Scale (PSS-10)
The Perceived Stress Scale (PSS-10) contains ten items, each of which is rated on a scale of 0 to 4. Ratings are summed for a composite score; the minimum score is 0 and the maximum score is 40. Higher scores indicate higher levels of stress.
Measured: Participants are assessed at baseline, two weeks into the study, and four weeks into the study.
Secondary outcomes (1)
Changes in Life Satisfaction as Measured by the Satisfaction With Life Scale
The Satisfaction with Life Scale contains five items, each of which is rated on a scale of 1 to 7. Scores are summed for a composite score; the minimum score is 5 and the maximum score is 35. Higher scores indicate higher levels of life satisfaction.
Measured: Participants are assessed at baseline, two weeks into the study, and four weeks into the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start1 Oct 2021
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
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 (6)Papers the sponsor has linked to this study.
- Other trials for ArthritisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to one of two groups. The treatment group will use a mental health chatbot (Wysa) over a period of four weeks. The control group will receive no intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luke MacNeill
- Sponsor type
- University, hospital or other
- Collaborators
- New Brunswick Innovation Foundation, Touchkin eServices Pvt. Ltd.
- Responsible party
- Sponsor-investigator, Luke MacNeill, University of New Brunswick
- Investigators
- Luke MacNeill, PhD, Principal investigator, Centre for Research in Integrated Care, University of New Brunswick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04620668
- Sponsor's protocol ID
- REB 036-2020
- Status last verified
- Jul 2024
- First submitted
- 2 Nov 2020
- Last updated
- 26 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fitzpatrick KK, Darcy A, Vierhile M. Delivering Cognitive Behavior Therapy to Young Adults With Symptoms of Depression and Anxiety Using a Fully Automated Conversational Agent (Woebot): A Randomized Controlled Trial. JMIR Ment Health. 2017 Jun 6;4(2):e19. doi: 10.2196/mental.7785.
PubMed 28588005Fulmer R, Joerin A, Gentile B, Lakerink L, Rauws M. Using Psychological Artificial Intelligence (Tess) to Relieve Symptoms of Depression and Anxiety: Randomized Controlled Trial. JMIR Ment Health. 2018 Dec 13;5(4):e64. doi: 10.2196/mental.9782.
PubMed 30545815Inkster B, Sarda S, Subramanian V. An Empathy-Driven, Conversational Artificial Intelligence Agent (Wysa) for Digital Mental Well-Being: Real-World Data Evaluation Mixed-Methods Study. JMIR Mhealth Uhealth. 2018 Nov 23;6(11):e12106. doi: 10.2196/12106.
PubMed 30470676Ly KH, Ly AM, Andersson G. A fully automated conversational agent for promoting mental well-being: A pilot RCT using mixed methods. Internet Interv. 2017 Oct 10;10:39-46. doi: 10.1016/j.invent.2017.10.002. eCollection 2017 Dec.
PubMed 30135751Clarke DM, Currie KC. Depression, anxiety and their relationship with chronic diseases: a review of the epidemiology, risk and treatment evidence. Med J Aust. 2009 Apr 6;190(S7):S54-60. doi: 10.5694/j.1326-5377.2009.tb02471.x.
PubMed 19351294MacNeill AL, Doucet S, Luke A. Effectiveness of a Mental Health Chatbot for People With Chronic Diseases: Randomized Controlled Trial. JMIR Form Res. 2024 May 30;8:e50025. doi: 10.2196/50025.
PubMed 38814681
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Usefulness of an Artificial Intelligence (A.I.) Mental Health Chatbot in a Healthcare Setting
- ClinicalTrials.gov ID
- NCT04620668
- Acronym / sponsor ID
- REB 036-2020
- Conditions
- Arthritis, Diabetes, Depression, Anxiety, Stress
- Keywords
- Arthritis, Diabetes, Depression, Anxiety, Stress, Chatbot, Conversational Agent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Luke MacNeillUniversity, hospital or other
- Collaborators
- New Brunswick Innovation Foundation, Touchkin eServices Pvt. Ltd.
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 9 Nov 2020 (actual)
- Results
- Posted 26 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Past research has shown that patients suffering from chronic health conditions tend to experience high levels of negative mental health symptoms (e.g., depression). The purpose of the current study is to evaluate whether an artificial intelligence (A.I.) mental health chatbot can be used to reduce negative mental health symptoms within this population. A minimum of 60 individuals with a chronic health condition (diabetes or arthritis) will be recruited. Participants will be randomly assigned to either a treatment group or a control group. Those assigned to the treatment group will use the mental health chatbot Wysa (Touchkin eServices, Bangalore) over a period of four weeks. Those assigned to the control group will receive no chatbot. Participants will complete measures of depression, anxiety, stress, and life satisfaction via Qualtrics at the outset of the study, two weeks into the study, and four weeks into the study (i.e., the final assessment point). Results from the treatment and control groups will be compared using ANOVA models. Participants in the treatment group will also be asked to complete some open-ended questions about their experiences with the chatbot program. A subset of participants from the treatment group may be asked to complete optional phone or video interviews to gain a better understanding of their experiences. Results will provide insight into the usefulness of chatbot programs for reducing negative mental health symptoms among patients with a chronic health condition. Results may also be used to inform policy decisions about the use of these programs for healthcare delivery, and to provide practical insight into how these programs can be best integrated into healthcare settings.
Detailed description
People dealing with chronic health conditions are susceptible to mental health issues such as depression and anxiety. Providing conventional mental health services to all of these individuals is not practical given the limited resources of the healthcare system. Artificial intelligence (A.I.) mental health chatbots may be an accessible and cost-effective means by which people can receive some degree of mental health support while they cope with their conditions. These automated programs act as a source of virtual support, talking with individuals and providing them with therapeutic exercises to improve their mental wellbeing. Several chatbots have been designed to deliver interventions based on popular psychological therapies (e.g., Wysa, Woebot, and Tess). Research has shown that these programs can reduce symptoms of depression, anxiety, and stress in nonclinical populations. However, the effectiveness of these programs has not been tested in chronic disease populations.
The purpose of the current research is to gain a better understanding of the usefulness of mental health chatbots for chronic disease populations. This research will be guided by two fundamental objectives: (1) to determine whether a mental health chatbot can reduce or prevent negative mental health symptoms in individuals who are dealing with a chronic health condition, and (2) to learn more about how individuals with a chronic health condition view these programs, particularly in terms of their potential benefits or drawbacks when used in healthcare settings. This research will focus on two specific chronic disease populations that are prone to elevated levels of mental health symptoms: people with arthritis and diabetes.
Participants will be recruited through social media channels (including online groups), newspaper advertisements, and emails and newsletters from relevant organizations (e.g., the Arthritis Society, Diabetes Canada). After volunteering to participate, participants will set up a phone or video conferencing call with the primary investigator to orient them into the study. Participants will be randomly assigned to either a treatment group or control group. Those assigned to the treatment group will download the mental health chatbot Wysa (Touchkin eServices, Bangalore) on their smartphones. They will interact with the chatbot a minimum of two times per week over a period of four weeks, with each interaction lasting a minimum of five minutes. Participants assigned to the control group will receive no chatbot (i.e., they will be in a no-treatment control group).
Regardless of their group assignment, participants will complete online materials via Qualtrics at the outset of the study, two weeks into the study, and four weeks into the study (i.e., the final assessment point). At the outset of the study, participants will fill out an informed consent form, a demographic questionnaire, and four psychological assessments tools: measures of depression, anxiety, stress, and life satisfaction. Two weeks into the study, participants will complete the four psychological assessment tools a second time. Four weeks into the study, participants will complete the four assessment tools a final time, and those in the treatment group will be presented with a post-study questionnaire that contains qualitative questions regarding their experiences with the chatbot. Participants in both groups will be presented with a debriefing form providing more information about the study. Those in the control group will be given the opportunity to download and use the chatbot at this point.
After the data from the four-week study are analyzed, a subset of participants from the treatment group may be asked to complete optional phone or video interviews to gain more insight into their experiences with and opinions on the chatbot program. Approximately 15 to 20 participants will be sought for the interviews. The questions for these interviews will be developed based on the collective results from the quantitative and qualitative analysis described above.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be assigned to one of two groups. The treatment group will use a mental health chatbot (Wysa) over a period of four weeks. The control group will receive no intervention.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group (Wysa) | Experimental | Device: Wysa |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants must have a diagnosis of diabetes (type 1 or type 2 diabetes) or arthritis (osteoarthritis, rheumatoid arthritis, or another type of arthritis).
- Participants must have a phone with an active Internet connection.
Key exclusion criteria (3 listed)
- Participants must not be receiving ongoing treatment from a mental health professional.
- Participants must not be using a mental health chatbot (i.e., prior to the study).
- Participants must not have started or experienced a dosage change in a psychopharmacological drug within the previous month.
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 |
|---|---|---|
| WysaWysa is an AI-based mental health chatbot. It uses evidence-based techniques to help users build mental resilience skills and improve their mental health. | Device | Treatment Group (Wysa) |
Primary outcome
Changes in Depression as Measured by the Patient Health Questionnaire (PHQ-9)
Time frame: Participants are assessed at baseline, two weeks into the study, and four weeks into the study.
The Patient Health Questionnaire (PHQ-9) contains nine items, each of which is rated on a scale of 0 to 3. Ratings are summed for a composite score; the minimum score is 0 and the maximum score is 27. Higher scores indicate higher levels of depression.
Changes in Anxiety as Measured by the Generalized Anxiety Disorder Scale (GAD-7)
Time frame: Participants are assessed at baseline, two weeks into the study, and four weeks into the study.
The Generalized Anxiety Disorder Scale (GAD-7) contains seven items, each of which is rated on a scale of 0 to 3. Ratings are summed for a composite score; the minimum score is 0 and the maximum score is 21. Higher scores indicate higher levels of anxiety.
Changes in Stress as Measured by the Perceived Stress Scale (PSS-10)
Time frame: Participants are assessed at baseline, two weeks into the study, and four weeks into the study.
The Perceived Stress Scale (PSS-10) contains ten items, each of which is rated on a scale of 0 to 4. Ratings are summed for a composite score; the minimum score is 0 and the maximum score is 40. Higher scores indicate higher levels of stress.
1 secondary outcome
Changes in Life Satisfaction as Measured by the Satisfaction With Life Scale
Time frame: Participants are assessed at baseline, two weeks into the study, and four weeks into the study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28588005Fitzpatrick KK, Darcy A, Vierhile M. Delivering Cognitive Behavior Therapy to Young Adults With Symptoms of Depression and Anxiety Using a Fully Automated Conversational Agent (Woebot): A Randomized Controlled Trial. JMIR Ment Health. 2017 Jun 6;4(2):e19. doi: 10.2196/mental.7785.
- Background: PubMed 30545815Fulmer R, Joerin A, Gentile B, Lakerink L, Rauws M. Using Psychological Artificial Intelligence (Tess) to Relieve Symptoms of Depression and Anxiety: Randomized Controlled Trial. JMIR Ment Health. 2018 Dec 13;5(4):e64. doi: 10.2196/mental.9782.
- Background: PubMed 30470676Inkster B, Sarda S, Subramanian V. An Empathy-Driven, Conversational Artificial Intelligence Agent (Wysa) for Digital Mental Well-Being: Real-World Data Evaluation Mixed-Methods Study. JMIR Mhealth Uhealth. 2018 Nov 23;6(11):e12106. doi: 10.2196/12106.
- Background: PubMed 30135751Ly KH, Ly AM, Andersson G. A fully automated conversational agent for promoting mental well-being: A pilot RCT using mixed methods. Internet Interv. 2017 Oct 10;10:39-46. doi: 10.1016/j.invent.2017.10.002. eCollection 2017 Dec.
- Background: PubMed 19351294Clarke DM, Currie KC. Depression, anxiety and their relationship with chronic diseases: a review of the epidemiology, risk and treatment evidence. Med J Aust. 2009 Apr 6;190(S7):S54-60. doi: 10.5694/j.1326-5377.2009.tb02471.x.
- Derived from this study: PubMed 38814681MacNeill AL, Doucet S, Luke A. Effectiveness of a Mental Health Chatbot for People With Chronic Diseases: Randomized Controlled Trial. JMIR Form Res. 2024 May 30;8:e50025. doi: 10.2196/50025.
- Individual participant dataSharing planned: No
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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.
Luke MacNeill, PhD principal investigator
Centre for Research in Integrated Care, University of New Brunswick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wysa in people with Arthritis and Diabetes, run by Luke MacNeill at 1 site in Canada.
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 2 inclusion and 3 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 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 26 Aug 2024). 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?
Changes in Depression as Measured by the Patient Health Questionnaire (PHQ-9) (time frame: Participants are assessed at baseline, two weeks into the study, and four weeks into the study.). The study lists 3 primary outcomes in all. 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 NCT04620668, which also lists 6 linked publications.
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 26 Aug 2024.