Mental Well-beingNCT05694507
Evaluation of Chatbot for Mental Well-being
A study testing Mental Well-being Chatbot in people with Mental Well-being and Mental Health Literacy, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The present study consists of two two-armed randomized controlled trials between experimental and waitlist control groups. It aims to evaluate the effectiveness of conversational chatbot in improving mental health literacy, uptake of self-care behaviors, and mental well-being, compared to the waitlist control, and the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Well-being, Mental Health Literacy
- What is being tested?
- Mental Well-being Chatbot
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 293 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Feb 2023to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years old or above
- Able to read and understand Chinese and spoken Cantonese
- Have access to the Internet
Who cannot join
- Under 18 years old
- Unable to read and understand Chinese and spoken Cantonese
- Unable to access the internet
- Existing users of the Jockey Club TourHeart+ Project and people who have participated in related research projects will be excluded from this study, as chatbots in this study were extracted from this online platform.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Chatbot for Mental Well-being: A Randomized Controlled Trial
The present study consists of two two-armed randomized controlled trials between experimental and waitlist control groups. It aims to evaluate the effectiveness of conversational chatbot in improving mental health literacy, uptake of self-care behaviors, and mental well-being, compared to the waitlist control, and the effectiveness of daily notification on adherence. This study will provide important findings for the future development and implementation of chatbots in mental health, which may increase public access to immediate mental health support. It is hypothesized that participants in the experimental condition will show (H1) better mental health literacy (H2) better improvement in self-care and self-efficacy in mental well-being, and (H3) better mental well-being, compared with participants in the control condition. Also, it is hypothesized that participants with daily reminders will show (H4) a better adherence rate in using chatbot compared with participants without daily reminders
Read the detailed description
Background
In Hong Kong, insufficient resources in the current public health system cause a long waiting time. Mental health services provided by the public health system mainly rely on traditional one-to-one face-to-face sessions. In the past 12 months, there were 48,520 new bookings in public psychiatry outpatient clinics and the longest waiting time was 94 weeks. Priority is always given to people with more severe mental health issues, which causes long waiting time for people with mild mental health symptoms. Untreated mental health issues can be escalated to more severe symptoms. Thus, in addition to treating mental illness, preventing common mental health issues and fostering mental health self-care in the general population are crucial to promote public mental health and reduce illness burden in the society.
The Hong Kong Mental Morbidity Study found 1 in 7 individuals in Hong Kong has either depression, anxiety, or a mix of the two disorders; however, only a quarter of them sought professional help. Rather than resorting to mental health professionals for face-to-face service to treat common mental health concerns, digital technology provides a highly scalable and accessible means through which individuals can access mental health resources for self-care. Among these tools, conversational agent is one of the viable options. It has been applied in health care industries to cater to different health needs, including providing timely information and supporting mental health disorders. Healthcare conversational agents were found to be effective in reducing depression and anxiety symptoms and had higher engagement rate compared with standard industry metrics. Chatbot is a type of conversational agent. It is a rule-based computer algorithm that conducts an automatic conversation with people based on predefined instructions. Based on a self-guided approach, users can search for topics that they are interested in and engage with pre-designed computer algorithms at the convenience of their own space and time without the constraints of specialized care. Applying chatbots in mental health self-care provides an opportunity for individuals to directly learn about relevant mental health-related knowledge and tips as well as practice self-care exercises at anytime, anywhere.
The Present Study
The present study aims to evaluate the effectiveness of conversational chatbot in improving mental health literacy, uptake of self-care behaviors, and mental well-being, compared to the waitlist control, and the effectiveness of daily notification on adherence. This study will provide important findings for the future development and implementation of chatbots in mental health, which may increase public access to immediate mental health support. It is hypothesized that participants in the experimental condition will show (H1) better mental health literacy (H2) better improvement in self-care and self-efficacy in mental well-being, and (H3) better mental well-being, compared with participants in the control condition. Also, it is hypothesized that participants with daily reminders will show (H4) a better adherence rate in using chatbot compared with participants without daily reminders
Participants
Participants will be recruited through (1) advertising at popular online networking platforms (e.g., Facebook and Instagram), mass mailing at investigator's institutions, and snowball sampling.
Procedure Upon completing the screening and pre-evaluation questionnaire, participants will be randomly assigned to the experimental group or waitlist control group, with and without notifications based on computer-generated random digits. They will complete 2 more sets of questionnaires, including a post-evaluation 11 days after group allocation, and a follow-up questionnaire 21 days after group allocation. In the experimental group, participants will go through one assigned chatbot each day for 10 days, with the sequence of the assigned chatbot randomized. The chatbot contents are developed by clinical psychologists and well-being promotion officers. Content includes relationships, stress, value, emotion, and positive psychology. Each chatbot can only be assessed on the day of distribution. The access link will expire upon completion and the day after distribution to prevent repeat and delay in completion. Experimental group participants can freely access all chatbots after the completion of post-evaluation and before the follow-up questionnaire is sent to them. In the waitlist control group, participants are to refrain from using the chatbot until they finished the follow-up questionnaire. All participants will be able to access the chatbot materials in an online platform after they have completed the research.
- Conditions
- Mental Well-being, Mental Health Literacy
- Being tested
- Mental Well-being Chatbot
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental Well-being ChatbotOther
The chatbot contents are developed by Clinical psychologists and well-being promotion officers. Content includes relationships, stress, value, emotion, and positive psychology.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | In the experimental group, participants will go through one assigned chatbot each day for 10 days, with the sequence of the assigned chatbot randomized. One group of participants will receive chatbot notifications for 10 days, another group of participants will not receive chatbot notifications. They can freely access all chatbots after the completion of post-evaluation. After completing the pre-evaluation questionnaire, they will complete 2 more sets of questionnaires, including a post-evaluation 11 days after group allocation, and a follow-up questionnaire 21 days after group allocation. All participants will be able to access the chatbot materials in an online platform after they have completed the research. Receives: Other: Mental Well-being Chatbot |
| Waitlist control group | No intervention | In the waitlist control group, participants are to refrain from using the chatbot until they finished the follow-up questionnaire. One group of participants will receive study notifications for 10 days, another group of participants will not receive study notifications. After completing the pre-evaluation questionnaire, they will complete 2 more sets of questionnaires, including a post-evaluation 11 days after group allocation, and a follow-up questionnaire 21 days after group allocation. All participants will be able to access the chatbot materials in an online platform after they have completed the research. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Care Self-efficacy - Strategies Used by People to Promote Health (SUPPH)
The scale is reliable, with a Cronbach's alpha of internal consistency of 0.93 . It includes 29 items to measure self-care self-efficacy using a 6-point scale from 1 (very little confidence) to 5 (quite a lot of confidence). High scores reflect better self-care self-efficacy. The SUPPH includes three subscales, stress reduction, decision-making, and positive attitudes. This study only includes items on stress reduction and positive attitudes. Cronbach's alpha of stress reduction and positive attitudes were 0.92 and 0.92 respectively.
Measured: Day 10
Self-Care Self-efficacy - Strategies Used by People to Promote Health (SUPPH)
The scale is reliable, with a Cronbach's alpha of internal consistency of 0.93 . It includes 29 items to measure self-care self-efficacy using a 6-point scale from 1 (very little confidence) to 5 (quite a lot of confidence). High scores reflect better self-care self-efficacy. The SUPPH includes three subscales, stress reduction, decision-making, and positive attitudes. This study only includes items on stress reduction and positive attitudes. Cronbach's alpha of stress reduction and positive attitudes were 0.92 and 0.92 respectively.
Measured: Day 20
Self-Care - Self-Care Behavior Inventory
It includes 19 items to measure self-care behavior using a 5-point scale from 1 (very little) to 5 (quite a lot). Internal consistency if the scale was 0.83. One item regarding medication is removed, while two items related to time spent on things that respondents enjoy and feel interested in and time spent alone were added.
Measured: Day 10
Self-Care - Self-Care Behavior Inventory
It includes 19 items to measure self-care behavior using a 5-point scale from 1 (very little) to 5 (quite a lot). Internal consistency if the scale was 0.83. One item regarding medication is removed, while two items related to time spent on things that respondents enjoy and feel interested in and time spent alone were added.
Measured: Day 20
Mental Health Literacy
Sixteen items were developed to measure the knowledge of various aspects to do with mental health. Items are rated on a 7-points scale from 1 (strongly disagree) to 7 (strongly agree). Items are designed according to the content of chatbots and a well-developed Mental Health Literacy Scale.
Measured: Day 10
Mental Health Literacy
Sixteen items were developed to measure the knowledge of various aspects to do with mental health. Items are rated on a 7-points scale from 1 (strongly disagree) to 7 (strongly agree). Items are designed according to the content of chatbots and a well-developed Mental Health Literacy Scale.
Measured: Day 20
Secondary outcomes (9)
Depressive symptoms - Patient Health Questionnaire (PHQ-9)
Patient Health Questionnaire. It includes 9 items to assess the extent to which respondents are bothered by depression-related symptoms using a 4-point scale from 0 (not at all) to 3 (nearly every day). PHQ-9 has been validated and used widely in the general population for screening and measuring depression severity. Scores of 5, 10, 15, and 20 denote mild, moderate, moderately severe, and severe levels of depression respectively (range: 0-27). PHQ-9 has a sensitivity of 0.88 and a specificity of 0.88 in detecting major depressive disorder (MDD) at a cut-off of 10. The internal consistency reliability of the Chinese version of the scale was 0.86.
Measured: Day 10 and 20
Anxiety symptoms - Generalized Anxiety Disorder Assessment (GAD-7)
It is a 7-item scale to assess the extent to which respondents are bothered by anxiety-related symptoms using a 4-point scale from 0 (not at all) to 3 (nearly every day). Scores of 5, 10, and 15 denote the mild, moderate, and severe levels of anxiety respectively (range: 0-21). At a cut-off of 10, GAD-7 has sensitivity of 0.89 and specificity of 0.82 in detecting generalized anxiety disorder (GAD). The internal consistency of the Chinese version was 0.93.
Measured: Day 10 and 20
Mindfulness - Mindful Awareness Attention Scale (MASS)
It is a 15-item scale to measure individual differences in mindful states during the previous week using a 6-point scale from 1 (almost always) to 6 (almost never). Higher scores reflect higher levels of dispositional mindfulness. The internal consistency among general adults was 0.87.
Measured: Day 10 and 20
Well-being - PERMA-Profiler (PERMA)
It includes 23 items to assess respondents' well-being using an 11-point scale from 0 (never/terrible/not at all) to 10 (always/excellent/completely). It includes domains in positive emotion, engagement, relationship, meaning, accomplishment, negative emotion, physical health, loneliness, and overall well-being. PERMA is reliable (Cronbach's alpha = 0.94) and has been validated in different populations such as Australian, Italian, Malaysian, and Turkish.
Measured: Day 10 and 20
Behavioral Intention - a subscale in the E-therapy Attitude and Process Questionnaire (eTAP)
It includes 3 items to measure participants' intention in using online psychological intervention on a 7-point scale from 1 (strongly disagree) to 7 (strongly agree). The subscale showed excellent reliability (Cronbach's alpha = 0.94).
Measured: Day 10 and 20
Attitude towards chatbot
Nine items were developed to measure attitudes toward the ability of chatbots in improving mental well-being. It is measured by a 7-points scale from 1 (strongly disagree) to 7 (strongly agree).
Measured: Day 10 and 20
Credibility and Expectancy. The Credibility and Expectancy Questionnaire (CEQ)
It measures treatment expectancy and rationale credibility for use in clinical outcomes. Six items are rated from 0% to 100%. The first section of the questionnaire is about thoughts toward online self-care intervention and the second part is about feelings toward online self-care intervention. The internal consistency of the scale was 0.81.
Measured: Day 10 and 20
Usability
Twenty-four items were developed to measure the usability of the chatbot, including satisfaction, engagement, functions, favorite elements, and useful topics of chatbots.
Measured: Day 10 and 20
Usage
Chatbot usage, including time spent on chatbots, number of conversations engaged with the chatbot, completion of exercises, behavioral change, attitudinal shifts, condition improvements, and the level of knowledge transfer, will be extracted from the back-end system.
Measured: Day 10 and 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start1 Feb 2023
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Mental Well-beingStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental and waitlist control groups
- Masking
- None (open label)
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Winnie W.S. MAK, Chinese University of Hong Kong
- Investigators
- Winnie WS MAK, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05694507
- Sponsor's protocol ID
- SBRE-22-0383
- Status last verified
- Aug 2023
- First submitted
- 5 Jan 2023
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ayse, E. B. (2018). Adaptation of the PERMA Well-Being Scale into Turkish: Validity and reliability Studies. Educational Research and Reviews, 13(4), 129-35.
Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.
PubMed 12703651Butler, J., & Kern, M. L. (2016). The PERMA-Profiler: A brief multidimensional measure of flourishing. International Journal of Wellbeing, 6(3), 1-48.
Clough BA, Eigeland JA, Madden IR, Rowland D, Casey LM. Development of the eTAP: A brief measure of attitudes and process in e-interventions for mental health. Internet Interv. 2019 Jun 18;18:100256. doi: 10.1016/j.invent.2019.100256. eCollection 2019 Dec.
PubMed 31890610Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.
PubMed 11132119Fitzpatrick 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 28588005Giangrasso, B. (2018). Psychometric properties of the PERMA-Profiler as hedonic and eudaimonic well-being measure in an Italian context. Current Psychology, 40, 1-10.
Hospital Authority. (n.d.). Waiting time for new case booking at Psychiatry specialist out-patient clinics. Retrieved December 20, 2022, from https://www.ha.org.hk/visitor/sopc_waiting_time.asp?id=7&lang=ENG
Iasiello, M., Bartholomaeus, J., Jarden, A., & Kelly, G. (2017). Measuring PERMA+ in South Australia, the State of Wellbeing: A comparison with national and international norms. Journal of Positive Psychology and Wellbeing, 1(2), 53-72.
Khaw, D., & Kern, M. (2014). A cross-cultural comparison of the PERMA model of well-being. Undergraduate Journal of Psychology at Berkeley, University of California, 8, 10-23.
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Lev EL, Owen SV. A measure of self-care self-efficacy. Res Nurs Health. 1996 Oct;19(5):421-9. doi: 10.1002/(SICI)1098-240X(199610)19:53.0.CO;2-S.
PubMed 8848626Martinengo L, Jabir AI, Goh WWT, Lo NYW, Ho MR, Kowatsch T, Atun R, Michie S, Tudor Car L. Conversational Agents in Health Care: Scoping Review of Their Behavior Change Techniques and Underpinning Theory. J Med Internet Res. 2022 Oct 3;24(10):e39243. doi: 10.2196/39243.
PubMed 36190749Meheli S, Sinha C, Kadaba M. Understanding People With Chronic Pain Who Use a Cognitive Behavioral Therapy-Based Artificial Intelligence Mental Health App (Wysa): Mixed Methods Retrospective Observational Study. JMIR Hum Factors. 2022 Apr 27;9(2):e35671. doi: 10.2196/35671.
PubMed 35314422O'Connor M, Casey L. The Mental Health Literacy Scale (MHLS): A new scale-based measure of mental health literacy. Psychiatry Res. 2015 Sep 30;229(1-2):511-6. doi: 10.1016/j.psychres.2015.05.064. Epub 2015 Jul 16.
PubMed 26228163
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Chatbot for Mental Well-being: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05694507
- Acronym / sponsor ID
- SBRE-22-0383
- Conditions
- Mental Well-being, Mental Health Literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 23 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study consists of two two-armed randomized controlled trials between experimental and waitlist control groups. It aims to evaluate the effectiveness of conversational chatbot in improving mental health literacy, uptake of self-care behaviors, and mental well-being, compared to the waitlist control, and the effectiveness of daily notification on adherence. This study will provide important findings for the future development and implementation of chatbots in mental health, which may increase public access to immediate mental health support. It is hypothesized that participants in the experimental condition will show (H1) better mental health literacy (H2) better improvement in self-care and self-efficacy in mental well-being, and (H3) better mental well-being, compared with participants in the control condition. Also, it is hypothesized that participants with daily reminders will show (H4) a better adherence rate in using chatbot compared with participants without daily reminders
Detailed description
Background
In Hong Kong, insufficient resources in the current public health system cause a long waiting time. Mental health services provided by the public health system mainly rely on traditional one-to-one face-to-face sessions. In the past 12 months, there were 48,520 new bookings in public psychiatry outpatient clinics and the longest waiting time was 94 weeks. Priority is always given to people with more severe mental health issues, which causes long waiting time for people with mild mental health symptoms. Untreated mental health issues can be escalated to more severe symptoms. Thus, in addition to treating mental illness, preventing common mental health issues and fostering mental health self-care in the general population are crucial to promote public mental health and reduce illness burden in the society.
The Hong Kong Mental Morbidity Study found 1 in 7 individuals in Hong Kong has either depression, anxiety, or a mix of the two disorders; however, only a quarter of them sought professional help. Rather than resorting to mental health professionals for face-to-face service to treat common mental health concerns, digital technology provides a highly scalable and accessible means through which individuals can access mental health resources for self-care. Among these tools, conversational agent is one of the viable options. It has been applied in health care industries to cater to different health needs, including providing timely information and supporting mental health disorders. Healthcare conversational agents were found to be effective in reducing depression and anxiety symptoms and had higher engagement rate compared with standard industry metrics. Chatbot is a type of conversational agent. It is a rule-based computer algorithm that conducts an automatic conversation with people based on predefined instructions. Based on a self-guided approach, users can search for topics that they are interested in and engage with pre-designed computer algorithms at the convenience of their own space and time without the constraints of specialized care. Applying chatbots in mental health self-care provides an opportunity for individuals to directly learn about relevant mental health-related knowledge and tips as well as practice self-care exercises at anytime, anywhere.
The Present Study
The present study aims to evaluate the effectiveness of conversational chatbot in improving mental health literacy, uptake of self-care behaviors, and mental well-being, compared to the waitlist control, and the effectiveness of daily notification on adherence. This study will provide important findings for the future development and implementation of chatbots in mental health, which may increase public access to immediate mental health support. It is hypothesized that participants in the experimental condition will show (H1) better mental health literacy (H2) better improvement in self-care and self-efficacy in mental well-being, and (H3) better mental well-being, compared with participants in the control condition. Also, it is hypothesized that participants with daily reminders will show (H4) a better adherence rate in using chatbot compared with participants without daily reminders
Participants
Participants will be recruited through (1) advertising at popular online networking platforms (e.g., Facebook and Instagram), mass mailing at investigator's institutions, and snowball sampling.
Procedure Upon completing the screening and pre-evaluation questionnaire, participants will be randomly assigned to the experimental group or waitlist control group, with and without notifications based on computer-generated random digits. They will complete 2 more sets of questionnaires, including a post-evaluation 11 days after group allocation, and a follow-up questionnaire 21 days after group allocation. In the experimental group, participants will go through one assigned chatbot each day for 10 days, with the sequence of the assigned chatbot randomized. The chatbot contents are developed by clinical psychologists and well-being promotion officers. Content includes relationships, stress, value, emotion, and positive psychology. Each chatbot can only be assessed on the day of distribution. The access link will expire upon completion and the day after distribution to prevent repeat and delay in completion. Experimental group participants can freely access all chatbots after the completion of post-evaluation and before the follow-up questionnaire is sent to them. In the waitlist control group, participants are to refrain from using the chatbot until they finished the follow-up questionnaire. All participants will be able to access the chatbot materials in an online platform after they have completed the research.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental and waitlist control groups
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Mental Well-being ChatbotIn the experimental group, participants will go through one assigned chatbot each day for 10 days, with the sequence of the assigned chatbot randomized. One group of participants will receive chatbot notifications for 10 days, another group of participants will not receive chatbot notifications. They can freely access all chatbots after the completion of post-evaluation. After completing the pre-evaluation questionnaire, they will complete 2 more sets of questionnaires, including a post-evaluation 11 days after group allocation, and a follow-up questionnaire 21 days after group allocation. All participants will be able to access the chatbot materials in an online platform after they have completed the research. |
| Waitlist control group | No intervention | –In the waitlist control group, participants are to refrain from using the chatbot until they finished the follow-up questionnaire. One group of participants will receive study notifications for 10 days, another group of participants will not receive study notifications. After completing the pre-evaluation questionnaire, they will complete 2 more sets of questionnaires, including a post-evaluation 11 days after group allocation, and a follow-up questionnaire 21 days after group allocation. All participants will be able to access the chatbot materials in an online platform after they have completed the research. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 years old or above
- Able to read and understand Chinese and spoken Cantonese
- Have access to the Internet
Key exclusion criteria (4 listed)
- Under 18 years old
- Unable to read and understand Chinese and spoken Cantonese
- Unable to access the internet
- Existing users of the Jockey Club TourHeart+ Project and people who have participated in related research projects will be excluded from this study, as chatbots in this study were extracted from this online platform.
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 |
|---|---|---|
| Mental Well-being ChatbotThe chatbot contents are developed by Clinical psychologists and well-being promotion officers. Content includes relationships, stress, value, emotion, and positive psychology. | Other | Experimental group |
Primary outcome
Self-Care Self-efficacy - Strategies Used by People to Promote Health (SUPPH)
Time frame: Day 10
The scale is reliable, with a Cronbach's alpha of internal consistency of 0.93 . It includes 29 items to measure self-care self-efficacy using a 6-point scale from 1 (very little confidence) to 5 (quite a lot of confidence). High scores reflect better self-care self-efficacy. The SUPPH includes three subscales, stress reduction, decision-making, and positive attitudes. This study only includes items on stress reduction and positive attitudes. Cronbach's alpha of stress reduction and positive attitudes were 0.92 and 0.92 respectively.
Self-Care Self-efficacy - Strategies Used by People to Promote Health (SUPPH)
Time frame: Day 20
The scale is reliable, with a Cronbach's alpha of internal consistency of 0.93 . It includes 29 items to measure self-care self-efficacy using a 6-point scale from 1 (very little confidence) to 5 (quite a lot of confidence). High scores reflect better self-care self-efficacy. The SUPPH includes three subscales, stress reduction, decision-making, and positive attitudes. This study only includes items on stress reduction and positive attitudes. Cronbach's alpha of stress reduction and positive attitudes were 0.92 and 0.92 respectively.
Self-Care - Self-Care Behavior Inventory
Time frame: Day 10
It includes 19 items to measure self-care behavior using a 5-point scale from 1 (very little) to 5 (quite a lot). Internal consistency if the scale was 0.83. One item regarding medication is removed, while two items related to time spent on things that respondents enjoy and feel interested in and time spent alone were added.
Self-Care - Self-Care Behavior Inventory
Time frame: Day 20
It includes 19 items to measure self-care behavior using a 5-point scale from 1 (very little) to 5 (quite a lot). Internal consistency if the scale was 0.83. One item regarding medication is removed, while two items related to time spent on things that respondents enjoy and feel interested in and time spent alone were added.
Mental Health Literacy
Time frame: Day 10
Sixteen items were developed to measure the knowledge of various aspects to do with mental health. Items are rated on a 7-points scale from 1 (strongly disagree) to 7 (strongly agree). Items are designed according to the content of chatbots and a well-developed Mental Health Literacy Scale.
Mental Health Literacy
Time frame: Day 20
Sixteen items were developed to measure the knowledge of various aspects to do with mental health. Items are rated on a 7-points scale from 1 (strongly disagree) to 7 (strongly agree). Items are designed according to the content of chatbots and a well-developed Mental Health Literacy Scale.
9 secondary outcomes
Depressive symptoms - Patient Health Questionnaire (PHQ-9)
Time frame: Day 10 and 20
Anxiety symptoms - Generalized Anxiety Disorder Assessment (GAD-7)
Time frame: Day 10 and 20
Mindfulness - Mindful Awareness Attention Scale (MASS)
Time frame: Day 10 and 20
Well-being - PERMA-Profiler (PERMA)
Time frame: Day 10 and 20
Behavioral Intention - a subscale in the E-therapy Attitude and Process Questionnaire (eTAP)
Time frame: Day 10 and 20
Attitude towards chatbot
Time frame: Day 10 and 20
Credibility and Expectancy. The Credibility and Expectancy Questionnaire (CEQ)
Time frame: Day 10 and 20
Usability
Time frame: Day 10 and 20
Usage
Time frame: Day 10 and 20
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- BackgroundAyse, E. B. (2018). Adaptation of the PERMA Well-Being Scale into Turkish: Validity and reliability Studies. Educational Research and Reviews, 13(4), 129-35.
- Background: PubMed 12703651Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.
- BackgroundButler, J., & Kern, M. L. (2016). The PERMA-Profiler: A brief multidimensional measure of flourishing. International Journal of Wellbeing, 6(3), 1-48.
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- 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.
Winnie WS MAK principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental Well-being Chatbot in people with Mental Well-being and Mental Health Literacy, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 3 inclusion and 4 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 1 Sep 2023. 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 Hong Kong. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Self-Care Self-efficacy - Strategies Used by People to Promote Health (SUPPH) (time frame: Day 10). The study lists 6 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 NCT05694507, which also lists 23 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 1 Sep 2023.