Mental Well-beingNCT05395312
Evaluation of Online Mental Well-being Intervention for Working Adults
A study testing Online blended stepped-care mental well-being platform in people with Mental Well-being and Mental Health Issue, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study aims to evaluate the effectiveness and cost-effectiveness of the online stepped-care mental well-being system together with offline programs in comparison to care as usual. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Well-being, Mental Health Issue, Mental Health Wellness 1
- What is being tested?
- Online blended stepped-care mental well-being platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteHong Kong
- Study dates
- 30 Jul 2022to 31 May 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Working adults aged 18 years old or above
- Able to read and understand Chinese, spoken Cantonese
- Have access to the Internet
Who cannot join
- High suicidal risk
- Who are unwilling to receive the intervention by random assignment
- Existing users of the JCTH project platform
- Non-working adults
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Blended Stepped-care Mental Well-being Intervention for Adults: A Randomized Controlled Trial
This study aims to evaluate the effectiveness and cost-effectiveness of the online stepped-care mental well-being system together with offline programs in comparison to care as usual. This study will provide important findings for future health economic analyses of blended stepped-care mental well-being interventions which may increase public's access to mental well-being services and ease the long waiting time under the current public healthcare system. It is hypothesized that participants in the intervention group show (H1) greater reduction in depressive and anxiety symptoms, (H2) better improvement of well-being, (H3) better improvement of quality of life, and (H4) lower incremental cost-effectiveness ratio (ICER), compared to care as usual.
Read the detailed description
In Hong Kong, mental disorders such as anxiety and depression are common. With the 13.3% of respondents reported to have symptoms of anxiety, depression, or comorbid anxiety and depression, only 26% of them sought for mental health services within the past year. The same morbidity survey also revealed as much as 11.25% of working adults were affected by symptoms of common mood disorders. The COVID-19 pandemic and social movement further increase stress and feelings of uncertainties on the general population. Two telephone surveys of over 1000 working adults each conducted in Dec 2017 and Feb 2020 suggested that 24.3% and 26.3% of working adults experienced anxiety and depressive symptoms in the past two weeks (the Jockey Club TourHeart Project, JCTH). Yet, 46% and 28% of respondents indicated they would not seek help for their psychological distress.
The services provided by the current public health system and private sector in Hong Kong are insufficient, mainly due to a shortage of professionals such as clinical psychologists and psychiatrists. There are also relatively less resources from the government and non-governmental organizations to the working adults comparing with the more 'vulnerable' populations, such as children, adolescents, and older people. A survey conducted in 2019 found more than 90% of the interviewees expressed that their companies did not offer sufficient support on employees' mental well-being. The same study suggested that 55% of the interviewees reported feeling ashamed about their own mental health issues or knowing someone with mental health issues, with these being named barriers to service. The needs of the working adults are unlikely to be fulfilled by companies or employers because of tightened budget, lack of awareness and knowledge, and stigma on mental illness. There exists a significant gap between the tremendous need for taking care of mental well-being and the mental well-being support services among the working adults in Hong Kong.
Online Stepped-Care Mental Well-being Interventions
The mental well-being services provided by the current public healthcare system in Hong Kong mainly rely on the traditional face-to-face and one-to-one therapy sessions. Due to the shortage of professionals, the waiting time for new service users is unbearably long while the follow-ups for returning users is infrequent. Also, priority is usually given to people with more severe mental well-being issues which causes the waiting time for people with mild to moderate mental well-being needs even longer.
The stepped-care model takes the approach of using the least restrictive method to commensurate with mental well-being needs and profiles of the service users with self-correcting process. Based on timely assessment of mental well-being status of the service users, corresponding treatments with matched levels of intensity could be utilized. According to treatment progress of the service users, stepped-care model enables mechanism to step up or down by adjusting the levels of intensity of the interventions. The National Institute of Health and Care Excellence (NICE) has issued evidence-based guidance detailing the stepped-care model for treatment of depression and anxiety in order to enhance treatment of these common mental disorders. A systematic review and meta-analysis suggested that the stepped-care approach was significantly better than care-as-usual in the treatment of anxiety although it could not significantly prevent or reduce future incidence of depression and anxiety. The stepped-care approach is proposed to reduce time, cost, and associated treatment burden on the clinicians and the service users.
Internet-based interventions for anxiety and depression have been found to be effective in reducing anxiety and depressive symptoms. Transdiagnostic treatments are recommended rather than disorder-specific treatments with the consideration of co-occurrence of depression and anxiety. Internet-delivered cognitive behavioural therapy has been recommended by the NICE guidelines as one of the low-intensity interventions for people with depression and anxiety. Applying the stepped-care model with an online mental well-being self-care platform, the service users can access mental well-being services at any time and any place. Online scientific evidence-based psychological interventions provide solutions for the service users on their mental well-being issues without practical burdens resulted from long waiting time, high expenses, and stigmatization.
Cost-Effectiveness
Cost is one of the elements causing economic burdens of mental disorders. Among the working population, absenteeism and productivity losses added extra costs to the companies. These mental well-being issues costs employers HKD 5.5-12.4 billion a year on average. Data about cost-effectiveness of online stepped-care mental well-being approach was relatively scarce. A systematic review suggested that internet-based therapy has more than 50% probability of being cost-effective compared with no treatment or conventional face-to-face therapy. Results from two studies with randomised controlled trial design found that online therapy was more cost-effective than treatment-as-usual. Some studies suggest that the cost-effectiveness of using stepped-care approach remains inconclusive. There is a need to understand the cost-effectiveness of the online stepped-care mental well-being approach. Economic evaluation is a common way to examine the cost-effectiveness of interventions by estimating the treatment effects relative to the associated cost.
The Current Study
The current study aims to evaluate the effectiveness and cost-effectiveness of the online stepped-care mental well-being system together with offline programs in comparison to the care-as-usual group. This study will provide important findings for future health economic analyses of blended stepped-care mental well-being interventions which may increase public's access to mental well-being services and ease the long waiting time under the current public healthcare system. It is hypothesized that participants in blended stepped-care group will show (H1) greater reduction in depressive and anxiety symptoms, (H2) better improvement of well-being, (H3) better improvement of quality of life, and (H4) lower incremental cost-effectiveness ratio (ICER), compared to the care-as-usual group.
Participants will be recruited through (1) mass mailing and emails to staff through higher educational institutes, unions, enterprises, professional, and nongovernmental organizations, (2) distribution of posters and leaflets to enterprises, governmental organisations, local nongovernmental organisations, social service centres, public libraries, health clinics, counselling centres, (3) information posting at popular online networking platforms (e.g., Facebook and Instagram), newspapers, magazines, roadshows, and promotional booths for recruitment purposes.
Upon obtaining consent of the study, participants will complete a screening. Participants with high suicidal risk will be recommended with appropriate referral services in public and private settings as follow-up after seeking approval from clinical psychologist in the team. Eligible participants will be assigned to blended stepped-care group or care-as-usual group by randomization after completion of baseline questionnaire. Participants in the blended stepped-care group can access the online materials at levels based on their psychological distress through login to the platform of the JCTH+ project. They can choose their preferred online courses by using online course taster. Also, they can join offline programs corresponding to their levels of psychological distress. Participants in the waitlist control group will receive their usual treatment and follow their usual practice if any. They will be offered the opportunity to receive the services in the blended stepped-care group after the study has ended. Both groups of participants will be invited to complete the set of questionnaires online at baseline, 3rd and 6th month.
- Being tested
- Online blended stepped-care mental well-being platform
- Keywords
- online, stepped-care, mental well-being, working adults, RCT, psychological distress, depression, anxiety
- Medical subject headings
- Psychological Well-Being, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online blended stepped-care mental well-being platformOther
Participants in experimental group will be stratified according to their level of anxiety and/or depressive symptoms.
Level 2 (normal range)
- Topic-based personal growth articles, exercises, and chatbots
- Webinars and talks on varied mental health related topics
- Virtual support community
Level 3 (mild to moderate)
- Online self-guided mental well-being training programs, such as mindfulness-based intervention, rumination-focused cognitive behavioural therapy, and transdiagnostic cognitive behavioural therapy
- Offline/online skills-based workshops, questions-and-answers sessions, retreats
Level 4 (severe)
- Online coach-guided mental well-being training programs, such as mindfulness-based intervention, rumination-focused cognitive behavioural therapy, and transdiagnostic cognitive behavioural therapy
- Offline/online group therapy, 4-week group cognitive behavioural therapy or 8-week group mindfulness-based cognitive therapy
| Study group | Role | What they receive |
|---|---|---|
| Blended stepped-care group | Experimental | Participants in the blended stepped-care group can access the online materials at levels based on their psychological distress through login to the platform of the JCTH+ project. They can choose their preferred online courses by using online course taster. Also, they can join offline programs corresponding to their levels of psychological distress. Receives: Other: Online blended stepped-care mental well-being platform |
| Waitlist control group | No intervention | Participants in the waitlist control group will receive their usual treatment and follow their usual practice if any. They will be offered the opportunity to receive the services in the blended stepped-care group after the study has ended. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms - Patient Health Questionnaire (PHQ-9)
It includes 9 items to assess the extent of which respondents are bothered by depression related symptoms using a 4-point Likert 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. Total scores range from 0 to 27. Scores of 5, 10, 15, and 20 denote mild, moderate, moderately severe, and severe level of depression respectively.
Measured: at baseline
Depressive symptoms - Patient Health Questionnaire (PHQ-9)
It includes 9 items to assess the extent of which respondents are bothered by depression related symptoms using a 4-point Likert 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. Total scores range from 0 to 27. Scores of 5, 10, 15, and 20 denote mild, moderate, moderately severe, and severe level of depression respectively.
Measured: 3rd month
Depressive symptoms - Patient Health Questionnaire (PHQ-9)
It includes 9 items to assess the extent of which respondents are bothered by depression related symptoms using a 4-point Likert 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. Total scores range from 0 to 27. Scores of 5, 10, 15, and 20 denote mild, moderate, moderately severe, and severe level of depression respectively.
Measured: 6th month
Anxiety symptoms - Generalized Anxiety Disorder Assessment (GAD-7)
It is a 7-item scale to assess the extent of which respondents are bothered by anxiety related symptoms using a 4-point Likert scale from 0 (not at all) to 3 (nearly every day). GAD-7 is a well-established scale with good reliability and procedural validity. Total scores range from 0 to 21. Scores of 5, 10, and 15 denote mild, moderate, and severe level of anxiety respectively.
Measured: at baseline
Anxiety symptoms - Generalized Anxiety Disorder Assessment (GAD-7)
It is a 7-item scale to assess the extent of which respondents are bothered by anxiety related symptoms using a 4-point Likert scale from 0 (not at all) to 3 (nearly every day). GAD-7 is a well-established scale with good reliability and procedural validity. Total scores range from 0 to 21. Scores of 5, 10, and 15 denote mild, moderate, and severe level of anxiety respectively.
Measured: 3rd month
Anxiety symptoms - Generalized Anxiety Disorder Assessment (GAD-7)
It is a 7-item scale to assess the extent of which respondents are bothered by anxiety related symptoms using a 4-point Likert scale from 0 (not at all) to 3 (nearly every day). GAD-7 is a well-established scale with good reliability and procedural validity. Total scores range from 0 to 21. Scores of 5, 10, and 15 denote mild, moderate, and severe level of anxiety respectively.
Measured: 6th month
Secondary outcomes (22)
Productivity - The Institute for Medical Technology Assessment (iMTA) Productivity Costs Questionnaire (iPCQ)
It is a 12-item scale to assess productivity losses of paid work due to absenteeism and presenteeism, as well as productivity losses related to unpaid work. Calculation of the scale score will be based on iMTA formula.
Measured: at baseline, 3rd, and 6th month
Medical consumption - Utilization of Health Services
It is a questionnaire to assess the medical consumption in the local context of Hong Kong by counting visits and costs of general clinics, specialist clinics, hospitals, Chinese medical doctors, psychologists, and other public and private health units in the past three months. Total expenditure of medical consumption will be calculated.
Measured: at baseline, 3rd, and 6th month
Quality of life - Short-Form Six Dimensions Health Survey (SF-6D)
It is a 6-item survey to assess health-related quality of life valued by the standard gamble technique. The six-dimension composed of six dimensions of health namely physical functioning, role limitation, social functioning, bodily pain, mental health, and vitality. The quality-adjusted life-year (QALY) and the preference-based utility value of the health state can be estimated using a scoring algorithm validated for the Chinese Hong Kong population.
Measured: at baseline, 3rd, and 6th month
Well-being - PERMA-Profiler (PERMA)
It includes 23 items to assess well-being of respondents using a 11-point Likert scale from 0 (never/terrible/not at all) to 10 (always/excellent/completely). Average scores will be calculated, with high scores indicate better well-being. It includes domains in positive emotion, engagement, relationship, meaning, accomplishment, negative emotion, physical health, loneliness, and overall well-being.
Measured: at baseline, 3rd, and 6th month
Workplace well-being
It includes 24 items to examine respondents' well-being in workplace using 6-point Likert scale from 1 (never/strongly disagree) to 7 (always/strongly agree). It includes domains in support from colleagues \& company, emotional and work-life balance, gains from job, mental health resources, and company culture. Average scores will be calculated, with high scores indicate better workplace well-being.
Measured: at baseline, 3rd, and 6th month
Treatment acceptability
It includes 4 items to examine the overall user satisfaction toward the online mental health platform. Average scores will be calculated, with high scores indicate higher levels of treatment acceptability.
Measured: at baseline, 3rd, and 6th month
Implicit Theories of Intelligence (Self-Theory Scale)
It includes 8 items to examine respondents' beliefs on whether they can change their mental well-being by making efforts using 6-point Likert scale from 1 (strongly agree) to 6 (strongly disagree). The Cronbach's alpha was 0.9.
Measured: at baseline, 3rd, and 6th month
Self-Efficacy - General Self-Efficacy Scale (GSE-6)
Short form of the General Self-Efficacy Scale (GSE-6). It was developed based on the full General Self-Efficacy Scale (GSE). It includes 6 items with the highest coefficients of variation in GSE to assess respondents' self-efficacy using 4-point scale from 1 (not at all trye) to 4 (exactly true). The Cronbach's alpha was 0.79 to 0.88.
Measured: at baseline, 3rd, and 6th month
Resilience - Connor-Davidson Resilience Scale (CD-RISC-2)
It includes 2 items to measure respondents' stress coping ability using 5-point Likert scale from 0 (never) to 4 (always). Total scores will be calculated. It ranges from 0 to 8, with high scores indicate higher levels in resilience.
Measured: at baseline, 3rd, and 6th month
Nonattachment - Nonattachment Scale-Short Form (NAS-SF)
It includes 8 items to measure nonattachment using 6-point Likert scale from 1 (strongly disagree) to 6 (strongly agree). Average scores will be calculated, with high scores indicate higher levels of nonattachment.
Measured: at baseline, 3rd, and 6th month
Emotion Regulation - Emotion Regulation Questionnaire (ERQ)
It includes 10 items to measure respondents' approach in regulating their emotion using 7-point Likert scale from 0 (strongly disagree) to 7 (strongly agree). Average scores will be calculated, with high scores indicate higher levels of emotion regulation
Measured: at baseline, 3rd, and 6th month
Work and Social Adjustment - Work and Social Adjustment (WSAS)
It includes 5 items to measure participants perceived functional impairment using a 9-point Likert scale from 0 (not at all impaired) to 8 (very severely impaired). Total scores range from 0 to 40, with high scores indicate higher levels of functional impairment.
Measured: at baseline, 3rd, and 6th month
Daily Hassles - LIVES-Daily Hassles Scale (LIVES-DHS)
It measure the extent to which a series of potential daily hassles concern participants using a 5-point Likert scale from 1 (not at all) to 5 (very much). Average scores will be calculated, with high scores indicate higher levels of concerns in potential daily hassles. The scale consists of 18 items to evaluate five sources of daily hassles, included professional, environmental, relational, physical and financial.
Measured: at baseline, 3rd, and 6th month
Attitude towards Psychological Online Intervention (APOI)
It measures respondents' attitude towards psychological online intervention using a 5-point Likert scale from 1 (strongly agree) to 5 (strongly disagree). The scale consists of 16 items to evaluate participants' attitude towards scepticism and perception of risks, confidence in effectiveness, technologization threat, and anonymity benefits in psychological online intervention.
Measured: at baseline, 3rd, and 6th month
Behavioural Intention - E-therapy Attitude and Process Questionnaire (eTAP)
It includes 3 items to measures participants' intention in using online psychological intervention. It is measured by a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree) . The subscale showed excellence reliability (Cronbach's alpha = 0.94).
Measured: at baseline, 3rd, and 6th month
Subjective Norm - E-therapy Attitude and Process Questionnaire (eTAP)
It includes 4 items to measures the subjective norm towards online psychological intervention using a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree). Three items were adapted in the context of Hong Kong. Two relevant items were constructed and included in the scale. They are 'people in my social network will use online interventions if they have mental health needs' and 'people in my social network world support using online interventions for mental health'.
Measured: at baseline, 3rd, and 6th month
Mental Health Experiences - The Mental Health Experiences Questionnaire
The Mental Health Experiences Questionnaire measures whether respondents access mental health services by 9 items. One question regarding the mode of mental health service or related resources is added. Moreover, options are adapted in the context of Hong Kong. For example, in the question regarding the accessed service and resources, respondents can choose from workshop, group, and one-on-one therapy as they are common resources in Hong Kong.
Measured: at baseline, 3rd, and 6th month
Self-Stigma - The Self-Stigma of Seeking Psychological Help (SSOSH)
It measures the reaction of respondents when they seek help from mental health professionals. This is measured by 10 items using 5-point Likert scale from 1 (strongly disagree) to 7 (strongly agree).
Measured: at baseline, 3rd, and 6th month
Coping strategy - The Proactive Coping Inventory (PCI)
It includes 7 domains and this study only includes 5 domains from the scale, which measure proactive coping, strategic planning, instrumental support seeking, emotional support seeking, and avoidance coping. Coping strategy is measured by thirty-four items using a 4-points scale from 1 (not at all true) to 4 (completely true) in this study
Measured: at baseline, 3rd, and 6th month
Tolerance for Ambiguity - Tolerance for Ambiguity Scale (TAS)
It consists of 12 items to measure respondents' tendency to perceive ambiguous situation as desirable using 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Research found improved internal consistency and factor structure for TAS compared to common measure of tolerance for ambiguity in existing literature.
Measured: at baseline, 3rd, and 6th month
System Usability - System Usability Scale
It consists of 10 items to measure the experience of using the online platform. It is a 5-point Likert scale from 0 (strongly disagree) to 4 (strongly agree). To calculate SUS score, item scores of each respondent are summed up and then multiplied by 2.5. The range of score is 0 to 100. A SUS score above 68 would be considered as above average
Measured: at baseline, 3rd, and 6th month
Work Engagement - Utrecht Work Engagement Scale (UWES-3)
It includes 3 items to measure participants experience of being engaged at work in 7-point Likert scale from 0 (Never) to 6 (always/everyday). It shared 86-92% variance with longer nine-item version and pattern of correlation of both versions was similar
Measured: at baseline, 3rd, and 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start30 Jul 2022
- Primary completion3 Feb 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (66)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 360 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05395312
- Sponsor's protocol ID
- IRB/REC: 2021.334
- Status last verified
- Mar 2024
- First submitted
- 18 May 2022
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Abd-Alrazaq AA, Alajlani M, Alalwan AA, Bewick BM, Gardner P, Househ M. An overview of the features of chatbots in mental health: A scoping review. Int J Med Inform. 2019 Dec;132:103978. doi: 10.1016/j.ijmedinf.2019.103978. Epub 2019 Sep 25.
PubMed 31622850Andrews G, Basu A, Cuijpers P, Craske MG, McEvoy P, English CL, Newby JM. Computer therapy for the anxiety and depression disorders is effective, acceptable and practical health care: An updated meta-analysis. J Anxiety Disord. 2018 Apr;55:70-78. doi: 10.1016/j.janxdis.2018.01.001. Epub 2018 Feb 1.
PubMed 29422409Araya R, Flynn T, Rojas G, Fritsch R, Simon G. Cost-effectiveness of a primary care treatment program for depression in low-income women in Santiago, Chile. Am J Psychiatry. 2006 Aug;163(8):1379-87. doi: 10.1176/ajp.2006.163.8.1379.
PubMed 16877650Ayse, E. B. (2018). Adaptation of the PERMA Well-Being Scale into Turkish: Validity and reliability Studies. Educational Research and Reviews, 13(4), 129-35.
Bouwmans, C., Hakkaart-van Roijen, L., Koopmanschap, M., Krol, M., Severens, H., Brouwer, W. (2013). Manual of the iMTA Productivity Cost Questionnaire (iPCQ). Rotterdam: iMTA, Erasmus University Rotterdam.
Bouwmans C, Krol M, Brouwer W, Severens JL, Koopmanschap MA, Hakkaart L. IMTA Productivity Cost Questionnaire (IPCQ). Value Health. 2014 Nov;17(7):A550. doi: 10.1016/j.jval.2014.08.1791. Epub 2014 Oct 26. No abstract available.
PubMed 27201788Bower P, Gilbody S. Stepped care in psychological therapies: access, effectiveness and efficiency. Narrative literature review. Br J Psychiatry. 2005 Jan;186:11-7. doi: 10.1192/bjp.186.1.11.
PubMed 15630118Brazier J, Usherwood T, Harper R, Thomas K. Deriving a preference-based single index from the UK SF-36 Health Survey. J Clin Epidemiol. 1998 Nov;51(11):1115-28. doi: 10.1016/s0895-4356(98)00103-6.
PubMed 9817129Briggs AH, Wonderling DE, Mooney CZ. Pulling cost-effectiveness analysis up by its bootstraps: a non-parametric approach to confidence interval estimation. Health Econ. 1997 Jul-Aug;6(4):327-40. doi: 10.1002/(sici)1099-1050(199707)6:43.0.co;2-w.
PubMed 9285227Butler, J., & Kern, M. L. (2016). The PERMA-Profiler: A brief multidimensional measure of flourishing. International Journal of Wellbeing, 6(3), 1-48.
Buttorff C, Hock RS, Weiss HA, Naik S, Araya R, Kirkwood BR, Chisholm D, Patel V. Economic evaluation of a task-shifting intervention for common mental disorders in India. Bull World Health Organ. 2012 Nov 1;90(11):813-21. doi: 10.2471/BLT.12.104133. Epub 2012 Sep 14.
PubMed 23226893Choi I, Andrews G, Sharpe L, Hunt C. Help-seeking characteristics of Chinese- and English-speaking Australians accessing Internet-delivered cognitive behavioural therapy for depression. Soc Psychiatry Psychiatr Epidemiol. 2015 Jan;50(1):89-97. doi: 10.1007/s00127-014-0956-3. Epub 2014 Sep 6.
PubMed 25193374Choi I, Zou J, Titov N, Dear BF, Li S, Johnston L, Andrews G, Hunt C. Culturally attuned Internet treatment for depression amongst Chinese Australians: a randomised controlled trial. J Affect Disord. 2012 Feb;136(3):459-68. doi: 10.1016/j.jad.2011.11.003. Epub 2011 Dec 16.
PubMed 22177742City Mental Health Alliance Hong Kong. (2018). The cost of mental ill health for employers in Hong Kong. Hong Kong: City Mental Health Alliance Hong Kong.
City Mental Health Alliance Hong Kong. (2019). Mental health in the workplace: Survey of Hong Kong employees in professional services firms. Hong Kong: City Mental Health Alliance Hong Kong.
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Blended Stepped-care Mental Well-being Intervention for Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05395312
- Acronym / sponsor ID
- IRB/REC: 2021.334
- Keywords
- online, stepped-care, mental well-being, working adults, RCT, psychological distress, depression, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 30 Jul 2022 (actual)
- Primary completion
- 3 Feb 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 27 May 2022 (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.
This study aims to evaluate the effectiveness and cost-effectiveness of the online stepped-care mental well-being system together with offline programs in comparison to care as usual. This study will provide important findings for future health economic analyses of blended stepped-care mental well-being interventions which may increase public's access to mental well-being services and ease the long waiting time under the current public healthcare system. It is hypothesized that participants in the intervention group show (H1) greater reduction in depressive and anxiety symptoms, (H2) better improvement of well-being, (H3) better improvement of quality of life, and (H4) lower incremental cost-effectiveness ratio (ICER), compared to care as usual.
Detailed description
In Hong Kong, mental disorders such as anxiety and depression are common. With the 13.3% of respondents reported to have symptoms of anxiety, depression, or comorbid anxiety and depression, only 26% of them sought for mental health services within the past year. The same morbidity survey also revealed as much as 11.25% of working adults were affected by symptoms of common mood disorders. The COVID-19 pandemic and social movement further increase stress and feelings of uncertainties on the general population. Two telephone surveys of over 1000 working adults each conducted in Dec 2017 and Feb 2020 suggested that 24.3% and 26.3% of working adults experienced anxiety and depressive symptoms in the past two weeks (the Jockey Club TourHeart Project, JCTH). Yet, 46% and 28% of respondents indicated they would not seek help for their psychological distress.
The services provided by the current public health system and private sector in Hong Kong are insufficient, mainly due to a shortage of professionals such as clinical psychologists and psychiatrists. There are also relatively less resources from the government and non-governmental organizations to the working adults comparing with the more 'vulnerable' populations, such as children, adolescents, and older people. A survey conducted in 2019 found more than 90% of the interviewees expressed that their companies did not offer sufficient support on employees' mental well-being. The same study suggested that 55% of the interviewees reported feeling ashamed about their own mental health issues or knowing someone with mental health issues, with these being named barriers to service. The needs of the working adults are unlikely to be fulfilled by companies or employers because of tightened budget, lack of awareness and knowledge, and stigma on mental illness. There exists a significant gap between the tremendous need for taking care of mental well-being and the mental well-being support services among the working adults in Hong Kong.
Online Stepped-Care Mental Well-being Interventions
The mental well-being services provided by the current public healthcare system in Hong Kong mainly rely on the traditional face-to-face and one-to-one therapy sessions. Due to the shortage of professionals, the waiting time for new service users is unbearably long while the follow-ups for returning users is infrequent. Also, priority is usually given to people with more severe mental well-being issues which causes the waiting time for people with mild to moderate mental well-being needs even longer.
The stepped-care model takes the approach of using the least restrictive method to commensurate with mental well-being needs and profiles of the service users with self-correcting process. Based on timely assessment of mental well-being status of the service users, corresponding treatments with matched levels of intensity could be utilized. According to treatment progress of the service users, stepped-care model enables mechanism to step up or down by adjusting the levels of intensity of the interventions. The National Institute of Health and Care Excellence (NICE) has issued evidence-based guidance detailing the stepped-care model for treatment of depression and anxiety in order to enhance treatment of these common mental disorders. A systematic review and meta-analysis suggested that the stepped-care approach was significantly better than care-as-usual in the treatment of anxiety although it could not significantly prevent or reduce future incidence of depression and anxiety. The stepped-care approach is proposed to reduce time, cost, and associated treatment burden on the clinicians and the service users.
Internet-based interventions for anxiety and depression have been found to be effective in reducing anxiety and depressive symptoms. Transdiagnostic treatments are recommended rather than disorder-specific treatments with the consideration of co-occurrence of depression and anxiety. Internet-delivered cognitive behavioural therapy has been recommended by the NICE guidelines as one of the low-intensity interventions for people with depression and anxiety. Applying the stepped-care model with an online mental well-being self-care platform, the service users can access mental well-being services at any time and any place. Online scientific evidence-based psychological interventions provide solutions for the service users on their mental well-being issues without practical burdens resulted from long waiting time, high expenses, and stigmatization.
Cost-Effectiveness
Cost is one of the elements causing economic burdens of mental disorders. Among the working population, absenteeism and productivity losses added extra costs to the companies. These mental well-being issues costs employers HKD 5.5-12.4 billion a year on average. Data about cost-effectiveness of online stepped-care mental well-being approach was relatively scarce. A systematic review suggested that internet-based therapy has more than 50% probability of being cost-effective compared with no treatment or conventional face-to-face therapy. Results from two studies with randomised controlled trial design found that online therapy was more cost-effective than treatment-as-usual. Some studies suggest that the cost-effectiveness of using stepped-care approach remains inconclusive. There is a need to understand the cost-effectiveness of the online stepped-care mental well-being approach. Economic evaluation is a common way to examine the cost-effectiveness of interventions by estimating the treatment effects relative to the associated cost.
The Current Study
The current study aims to evaluate the effectiveness and cost-effectiveness of the online stepped-care mental well-being system together with offline programs in comparison to the care-as-usual group. This study will provide important findings for future health economic analyses of blended stepped-care mental well-being interventions which may increase public's access to mental well-being services and ease the long waiting time under the current public healthcare system. It is hypothesized that participants in blended stepped-care group will show (H1) greater reduction in depressive and anxiety symptoms, (H2) better improvement of well-being, (H3) better improvement of quality of life, and (H4) lower incremental cost-effectiveness ratio (ICER), compared to the care-as-usual group.
Participants will be recruited through (1) mass mailing and emails to staff through higher educational institutes, unions, enterprises, professional, and nongovernmental organizations, (2) distribution of posters and leaflets to enterprises, governmental organisations, local nongovernmental organisations, social service centres, public libraries, health clinics, counselling centres, (3) information posting at popular online networking platforms (e.g., Facebook and Instagram), newspapers, magazines, roadshows, and promotional booths for recruitment purposes.
Upon obtaining consent of the study, participants will complete a screening. Participants with high suicidal risk will be recommended with appropriate referral services in public and private settings as follow-up after seeking approval from clinical psychologist in the team. Eligible participants will be assigned to blended stepped-care group or care-as-usual group by randomization after completion of baseline questionnaire. Participants in the blended stepped-care group can access the online materials at levels based on their psychological distress through login to the platform of the JCTH+ project. They can choose their preferred online courses by using online course taster. Also, they can join offline programs corresponding to their levels of psychological distress. Participants in the waitlist control group will receive their usual treatment and follow their usual practice if any. They will be offered the opportunity to receive the services in the blended stepped-care group after the study has ended. Both groups of participants will be invited to complete the set of questionnaires online at baseline, 3rd and 6th month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blended stepped-care group | Experimental | Other: Online blended stepped-care mental well-being platformParticipants in the blended stepped-care group can access the online materials at levels based on their psychological distress through login to the platform of the JCTH+ project. They can choose their preferred online courses by using online course taster. Also, they can join offline programs corresponding to their levels of psychological distress. |
| Waitlist control group | No intervention | –Participants in the waitlist control group will receive their usual treatment and follow their usual practice if any. They will be offered the opportunity to receive the services in the blended stepped-care group after the study has ended. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Working adults aged 18 years old or above
- Able to read and understand Chinese, spoken Cantonese
- Have access to the Internet
Key exclusion criteria (4 listed)
- High suicidal risk
- Who are unwilling to receive the intervention by random assignment
- Existing users of the JCTH project platform
- Non-working adults
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 |
|---|---|---|
| Online blended stepped-care mental well-being platformParticipants in experimental group will be stratified according to their level of anxiety and/or depressive symptoms. Level 2 (normal range) * Topic-based personal growth articles, exercises, and chatbots * Webinars and talks on varied mental health related topics * Virtual support community Level 3 (mild to moderate) * Online self-guided mental well-being training programs, such as mindfulness-based intervention, rumination-focused cognitive behavioural therapy, and transdiagnostic cognitive behavioural therapy * Offline/online skills-based workshops, questions-and-answers sessions, retreats Level 4 (severe) * Online coach-guided mental well-being training programs, such as mindfulness-based intervention, rumination-focused cognitive behavioural therapy, and transdiagnostic cognitive behavioural therapy * Offline/online group therapy, 4-week group cognitive behavioural therapy or 8-week group mindfulness-based cognitive therapy | Other | Blended stepped-care group |
Primary outcome
Depressive symptoms - Patient Health Questionnaire (PHQ-9)
Time frame: at baseline
It includes 9 items to assess the extent of which respondents are bothered by depression related symptoms using a 4-point Likert 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. Total scores range from 0 to 27. Scores of 5, 10, 15, and 20 denote mild, moderate, moderately severe, and severe level of depression respectively.
Depressive symptoms - Patient Health Questionnaire (PHQ-9)
Time frame: 3rd month
It includes 9 items to assess the extent of which respondents are bothered by depression related symptoms using a 4-point Likert 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. Total scores range from 0 to 27. Scores of 5, 10, 15, and 20 denote mild, moderate, moderately severe, and severe level of depression respectively.
Depressive symptoms - Patient Health Questionnaire (PHQ-9)
Time frame: 6th month
It includes 9 items to assess the extent of which respondents are bothered by depression related symptoms using a 4-point Likert 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. Total scores range from 0 to 27. Scores of 5, 10, 15, and 20 denote mild, moderate, moderately severe, and severe level of depression respectively.
Anxiety symptoms - Generalized Anxiety Disorder Assessment (GAD-7)
Time frame: at baseline
It is a 7-item scale to assess the extent of which respondents are bothered by anxiety related symptoms using a 4-point Likert scale from 0 (not at all) to 3 (nearly every day). GAD-7 is a well-established scale with good reliability and procedural validity. Total scores range from 0 to 21. Scores of 5, 10, and 15 denote mild, moderate, and severe level of anxiety respectively.
Anxiety symptoms - Generalized Anxiety Disorder Assessment (GAD-7)
Time frame: 3rd month
It is a 7-item scale to assess the extent of which respondents are bothered by anxiety related symptoms using a 4-point Likert scale from 0 (not at all) to 3 (nearly every day). GAD-7 is a well-established scale with good reliability and procedural validity. Total scores range from 0 to 21. Scores of 5, 10, and 15 denote mild, moderate, and severe level of anxiety respectively.
Anxiety symptoms - Generalized Anxiety Disorder Assessment (GAD-7)
Time frame: 6th month
It is a 7-item scale to assess the extent of which respondents are bothered by anxiety related symptoms using a 4-point Likert scale from 0 (not at all) to 3 (nearly every day). GAD-7 is a well-established scale with good reliability and procedural validity. Total scores range from 0 to 21. Scores of 5, 10, and 15 denote mild, moderate, and severe level of anxiety respectively.
22 secondary outcomes
Productivity - The Institute for Medical Technology Assessment (iMTA) Productivity Costs Questionnaire (iPCQ)
Time frame: at baseline, 3rd, and 6th month
Medical consumption - Utilization of Health Services
Time frame: at baseline, 3rd, and 6th month
Quality of life - Short-Form Six Dimensions Health Survey (SF-6D)
Time frame: at baseline, 3rd, and 6th month
Well-being - PERMA-Profiler (PERMA)
Time frame: at baseline, 3rd, and 6th month
Workplace well-being
Time frame: at baseline, 3rd, and 6th month
Treatment acceptability
Time frame: at baseline, 3rd, and 6th month
Implicit Theories of Intelligence (Self-Theory Scale)
Time frame: at baseline, 3rd, and 6th month
Self-Efficacy - General Self-Efficacy Scale (GSE-6)
Time frame: at baseline, 3rd, and 6th month
Resilience - Connor-Davidson Resilience Scale (CD-RISC-2)
Time frame: at baseline, 3rd, and 6th month
Nonattachment - Nonattachment Scale-Short Form (NAS-SF)
Time frame: at baseline, 3rd, and 6th month
Emotion Regulation - Emotion Regulation Questionnaire (ERQ)
Time frame: at baseline, 3rd, and 6th month
Work and Social Adjustment - Work and Social Adjustment (WSAS)
Time frame: at baseline, 3rd, and 6th month
Daily Hassles - LIVES-Daily Hassles Scale (LIVES-DHS)
Time frame: at baseline, 3rd, and 6th month
Attitude towards Psychological Online Intervention (APOI)
Time frame: at baseline, 3rd, and 6th month
Behavioural Intention - E-therapy Attitude and Process Questionnaire (eTAP)
Time frame: at baseline, 3rd, and 6th month
Subjective Norm - E-therapy Attitude and Process Questionnaire (eTAP)
Time frame: at baseline, 3rd, and 6th month
Mental Health Experiences - The Mental Health Experiences Questionnaire
Time frame: at baseline, 3rd, and 6th month
Self-Stigma - The Self-Stigma of Seeking Psychological Help (SSOSH)
Time frame: at baseline, 3rd, and 6th month
Coping strategy - The Proactive Coping Inventory (PCI)
Time frame: at baseline, 3rd, and 6th month
Tolerance for Ambiguity - Tolerance for Ambiguity Scale (TAS)
Time frame: at baseline, 3rd, and 6th month
System Usability - System Usability Scale
Time frame: at baseline, 3rd, and 6th month
Work Engagement - Utrecht Work Engagement Scale (UWES-3)
Time frame: at baseline, 3rd, and 6th month
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 15 Mar 2024.
- Background: PubMed 31622850Abd-Alrazaq AA, Alajlani M, Alalwan AA, Bewick BM, Gardner P, Househ M. An overview of the features of chatbots in mental health: A scoping review. Int J Med Inform. 2019 Dec;132:103978. doi: 10.1016/j.ijmedinf.2019.103978. Epub 2019 Sep 25.
- Background: PubMed 29422409Andrews G, Basu A, Cuijpers P, Craske MG, McEvoy P, English CL, Newby JM. Computer therapy for the anxiety and depression disorders is effective, acceptable and practical health care: An updated meta-analysis. J Anxiety Disord. 2018 Apr;55:70-78. doi: 10.1016/j.janxdis.2018.01.001. Epub 2018 Feb 1.
- Background: PubMed 16877650Araya R, Flynn T, Rojas G, Fritsch R, Simon G. Cost-effectiveness of a primary care treatment program for depression in low-income women in Santiago, Chile. Am J Psychiatry. 2006 Aug;163(8):1379-87. doi: 10.1176/ajp.2006.163.8.1379.
- 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.
- BackgroundBouwmans, C., Hakkaart-van Roijen, L., Koopmanschap, M., Krol, M., Severens, H., Brouwer, W. (2013). Manual of the iMTA Productivity Cost Questionnaire (iPCQ). Rotterdam: iMTA, Erasmus University Rotterdam.
- Background: PubMed 27201788Bouwmans C, Krol M, Brouwer W, Severens JL, Koopmanschap MA, Hakkaart L. IMTA Productivity Cost Questionnaire (IPCQ). Value Health. 2014 Nov;17(7):A550. doi: 10.1016/j.jval.2014.08.1791. Epub 2014 Oct 26. No abstract available.
- Background: PubMed 15630118Bower P, Gilbody S. Stepped care in psychological therapies: access, effectiveness and efficiency. Narrative literature review. Br J Psychiatry. 2005 Jan;186:11-7. doi: 10.1192/bjp.186.1.11.
- Background: PubMed 9817129Brazier J, Usherwood T, Harper R, Thomas K. Deriving a preference-based single index from the UK SF-36 Health Survey. J Clin Epidemiol. 1998 Nov;51(11):1115-28. doi: 10.1016/s0895-4356(98)00103-6.
- Background: PubMed 9285227Briggs AH, Wonderling DE, Mooney CZ. Pulling cost-effectiveness analysis up by its bootstraps: a non-parametric approach to confidence interval estimation. Health Econ. 1997 Jul-Aug;6(4):327-40. doi: 10.1002/(sici)1099-1050(199707)6:43.0.co;2-w.
- BackgroundButler, J., & Kern, M. L. (2016). The PERMA-Profiler: A brief multidimensional measure of flourishing. International Journal of Wellbeing, 6(3), 1-48.
- Background: PubMed 23226893Buttorff C, Hock RS, Weiss HA, Naik S, Araya R, Kirkwood BR, Chisholm D, Patel V. Economic evaluation of a task-shifting intervention for common mental disorders in India. Bull World Health Organ. 2012 Nov 1;90(11):813-21. doi: 10.2471/BLT.12.104133. Epub 2012 Sep 14.
- Background: PubMed 25193374Choi I, Andrews G, Sharpe L, Hunt C. Help-seeking characteristics of Chinese- and English-speaking Australians accessing Internet-delivered cognitive behavioural therapy for depression. Soc Psychiatry Psychiatr Epidemiol. 2015 Jan;50(1):89-97. doi: 10.1007/s00127-014-0956-3. Epub 2014 Sep 6.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online blended stepped-care mental well-being platform in people with Mental Well-being and Mental Health Issue, 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 15 Mar 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 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?
Depressive symptoms - Patient Health Questionnaire (PHQ-9) (time frame: at baseline). 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 NCT05395312, which also lists 66 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 15 Mar 2024.