Can Mental Health Chatbots Help Chronic Disease Populations?
NCT ID: NCT04620668
Last Updated: 2024-08-26
Study Results
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View full resultsBasic Information
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COMPLETED
NA
79 participants
INTERVENTIONAL
2021-10-01
2022-10-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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.
Control Group
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Participants must have a phone with an active Internet connection.
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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New Brunswick Innovation Foundation
OTHER
Touchkin eServices Pvt. Ltd.
INDUSTRY
Luke MacNeill
OTHER
Responsible Party
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Luke MacNeill
Postdoctoral Fellow
Principal Investigators
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Luke MacNeill, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre for Research in Integrated Care, University of New Brunswick
Locations
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Centre for Research in Integrated Care, University of New Brunswick
Saint John, New Brunswick, Canada
Countries
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References
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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.
Fulmer 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.
Inkster 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.
Ly 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.
Clarke 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.
MacNeill 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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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REB 036-2020
Identifier Type: -
Identifier Source: org_study_id
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