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Can Mental Health Chatbots Help Chronic Disease Populations?

Evaluating the Usefulness of an Artificial Intelligence (A.I.) Mental Health Chatbot in a Healthcare Setting

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04620668
Enrollment
79
Registered
2020-11-09
Start date
2021-10-01
Completion date
2022-10-31
Last updated
2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Arthritis, Depression, Diabetes, Stress

Keywords

Arthritis, Diabetes, Depression, Anxiety, Stress, Chatbot, Conversational Agent

Brief 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 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.

Interventions

DEVICEWysa

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.

Sponsors

New Brunswick Innovation Foundation
CollaboratorOTHER
Touchkin eServices Pvt. Ltd.
CollaboratorINDUSTRY
Luke MacNeill
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Changes in Depression as Measured by the Patient Health Questionnaire (PHQ-9)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)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)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.

Secondary

MeasureTime frameDescription
Changes in Life Satisfaction as Measured by the Satisfaction With Life ScaleParticipants are assessed at baseline, two weeks into the study, and four weeks into the study.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.

Countries

Canada

Participant flow

Recruitment details

Recruitment occurred from October 2021 to October 2022.

Pre-assignment details

98 individuals were assessed for eligibility. 19 did not meet inclusion criteria. 79 were assigned to groups.

Participants by arm

ArmCount
Treatment Group (Wysa)
Wysa: 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.
34
Control Group
No treatment control group.
34
Total68

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyIneligible despite claims at outset of the study10
Overall StudyRemoved before analysis: failed multiple quality check questions12
Overall StudyRemoved before analysis: missing data20
Overall StudyRemoved before analysis: statistical outlier12
Overall StudyWithdrawal by Subject20

Baseline characteristics

CharacteristicTreatment Group (Wysa)Control GroupTotal
Age, Continuous43.50 years
STANDARD_DEVIATION 11
42.24 years
STANDARD_DEVIATION 11.66
42.87 years
STANDARD_DEVIATION 11.27
Chronic Diseases
Arthritis
18 Participants18 Participants36 Participants
Chronic Diseases
Diabetes
16 Participants16 Participants32 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Asian / Pacific Islander
5 Participants4 Participants9 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Black / African Canadian
0 Participants1 Participants1 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Hispanic / Latino
1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Indigenous / First Nations
1 Participants2 Participants3 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Middle Eastern
0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Mixed Race or Ethnicity
2 Participants1 Participants3 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Other
0 Participants1 Participants1 Participants
Race/Ethnicity, Customized
Race/Ethnicity
White
25 Participants25 Participants50 Participants
Region of Enrollment
Canada
34 participants34 participants68 participants
Sex/Gender, Customized
Gender
Men
8 Participants12 Participants20 Participants
Sex/Gender, Customized
Gender
Transgender Men
0 Participants1 Participants1 Participants
Sex/Gender, Customized
Gender
Women
26 Participants21 Participants47 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 340 / 34
other
Total, other adverse events
1 / 342 / 34
serious
Total, serious adverse events
1 / 341 / 34

Outcome results

Primary

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.

Time frame: Participants are assessed at baseline, two weeks into the study, and four weeks into the study.

ArmMeasureGroupValue (MEAN)Dispersion
Treatment Group (Wysa)Changes in Anxiety as Measured by the Generalized Anxiety Disorder Scale (GAD-7)Baseline7.44 units on a scaleStandard Deviation 5.37
Treatment Group (Wysa)Changes in Anxiety as Measured by the Generalized Anxiety Disorder Scale (GAD-7)Week 25.85 units on a scaleStandard Deviation 4.02
Treatment Group (Wysa)Changes in Anxiety as Measured by the Generalized Anxiety Disorder Scale (GAD-7)Week 44.74 units on a scaleStandard Deviation 3.3
Control GroupChanges in Anxiety as Measured by the Generalized Anxiety Disorder Scale (GAD-7)Baseline6.09 units on a scaleStandard Deviation 6.27
Control GroupChanges in Anxiety as Measured by the Generalized Anxiety Disorder Scale (GAD-7)Week 26.32 units on a scaleStandard Deviation 6.66
Control GroupChanges in Anxiety as Measured by the Generalized Anxiety Disorder Scale (GAD-7)Week 46.56 units on a scaleStandard Deviation 6.45
p-value: <0.001Mixed ANOVA
p-value: <0.001Repeated Measures ANOVA
p-value: 0.05Dependent t-test (2-sided)
p-value: 0.024Dependent t-test (2-sided)
p-value: 0.674Repeated Measures ANOVA
Primary

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.

Time frame: Participants are assessed at baseline, two weeks into the study, and four weeks into the study.

ArmMeasureGroupValue (MEAN)Dispersion
Treatment Group (Wysa)Changes in Depression as Measured by the Patient Health Questionnaire (PHQ-9)Baseline8.65 units on a scaleStandard Deviation 6.03
Treatment Group (Wysa)Changes in Depression as Measured by the Patient Health Questionnaire (PHQ-9)Week 27.18 units on a scaleStandard Deviation 4.9
Treatment Group (Wysa)Changes in Depression as Measured by the Patient Health Questionnaire (PHQ-9)Week 45.26 units on a scaleStandard Deviation 4.11
Control GroupChanges in Depression as Measured by the Patient Health Questionnaire (PHQ-9)Baseline7.82 units on a scaleStandard Deviation 6.29
Control GroupChanges in Depression as Measured by the Patient Health Questionnaire (PHQ-9)Week 27.41 units on a scaleStandard Deviation 5.88
Control GroupChanges in Depression as Measured by the Patient Health Questionnaire (PHQ-9)Week 47.56 units on a scaleStandard Deviation 6.33
p-value: <0.001Mixed ANOVA
p-value: <0.001Repeated Measures ANOVA
p-value: 0.044Dependent t-test (2-sided)
p-value: 0.001Dependent t-test (2-sided)
p-value: 0.731Repeated Measures ANOVA
Primary

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.

Time frame: Participants are assessed at baseline, two weeks into the study, and four weeks into the study.

ArmMeasureGroupValue (MEAN)Dispersion
Treatment Group (Wysa)Changes in Stress as Measured by the Perceived Stress Scale (PSS-10)Baseline19.00 units on a scaleStandard Deviation 6.79
Treatment Group (Wysa)Changes in Stress as Measured by the Perceived Stress Scale (PSS-10)Week 218.56 units on a scaleStandard Deviation 6.57
Treatment Group (Wysa)Changes in Stress as Measured by the Perceived Stress Scale (PSS-10)Week 417.06 units on a scaleStandard Deviation 6.21
Control GroupChanges in Stress as Measured by the Perceived Stress Scale (PSS-10)Baseline17.53 units on a scaleStandard Deviation 8.83
Control GroupChanges in Stress as Measured by the Perceived Stress Scale (PSS-10)Week 217.47 units on a scaleStandard Deviation 7.82
Control GroupChanges in Stress as Measured by the Perceived Stress Scale (PSS-10)Week 417.35 units on a scaleStandard Deviation 7.93
p-value: 0.159Mixed ANOVA
Secondary

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.

Time frame: Participants are assessed at baseline, two weeks into the study, and four weeks into the study.

ArmMeasureGroupValue (MEAN)Dispersion
Treatment Group (Wysa)Changes in Life Satisfaction as Measured by the Satisfaction With Life ScaleBaseline18.91 units on a scaleStandard Deviation 6.85
Treatment Group (Wysa)Changes in Life Satisfaction as Measured by the Satisfaction With Life ScaleWeek 218.29 units on a scaleStandard Deviation 6.87
Treatment Group (Wysa)Changes in Life Satisfaction as Measured by the Satisfaction With Life ScaleWeek 420.29 units on a scaleStandard Deviation 7.4
Control GroupChanges in Life Satisfaction as Measured by the Satisfaction With Life ScaleBaseline19.59 units on a scaleStandard Deviation 7.06
Control GroupChanges in Life Satisfaction as Measured by the Satisfaction With Life ScaleWeek 219.50 units on a scaleStandard Deviation 7.39
Control GroupChanges in Life Satisfaction as Measured by the Satisfaction With Life ScaleWeek 420.15 units on a scaleStandard Deviation 6.94
p-value: 0.326Mixed ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026