Can Mental Health Chatbots Help Chronic Disease Populations?

July 31, 2024 updated by: Luke MacNeill

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
79

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L4L5
        • Centre for Research in Integrated Care, University of New Brunswick

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control Group
Experimental: Treatment Group (Wysa)
Device: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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)
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.
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)
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.
Participants are assessed at baseline, two weeks into the study, and four weeks into the study.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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.
Participants are assessed at baseline, two weeks into the study, and four weeks into the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Luke MacNeill

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
New Brunswick Innovation Foundation
Touchkin eServices Private Limited

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Luke MacNeill, PhD, Centre for Research in Integrated Care, University of New Brunswick

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REB 036-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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