Evaluation of Online Mental Well-being Intervention for Working Adults

• Sponsor: Chinese University of Hong Kong (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05395312
• Collaborator: (none)
• Enrollment: 402
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 17.1
• Patients Per Site Per Month: 23.6

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Mental Well-being; Mental Health Issue; Mental Health Wellness 1	Other: Online blended stepped-care mental well-being platform	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 402 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Masking Description: Researchers do not know the group allocation until the end of study. An individual party is responsible to randomly allocate participants into blended stepped-care group and waitlist control group.
• Primary Purpose: Treatment
• Official Title: Evaluation of Blended Stepped-care Mental Well-being Intervention for Adults: A Randomized Controlled Trial
• Actual Study Start Date: Jul 30, 2022
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Blended stepped-care group 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.	Other: Online blended stepped-care mental well-being platform; 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
No Intervention: Waitlist control group 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.

Outcome Measures

Primary Outcome Measures

1. Depressive symptoms - Patient Health Questionnaire (PHQ-9) [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.

2. Depressive symptoms - Patient Health Questionnaire (PHQ-9) [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.

3. Depressive symptoms - Patient Health Questionnaire (PHQ-9) [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.

4. Anxiety symptoms - Generalized Anxiety Disorder Assessment (GAD-7) [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.

5. Anxiety symptoms - Generalized Anxiety Disorder Assessment (GAD-7) [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.

6. Anxiety symptoms - Generalized Anxiety Disorder Assessment (GAD-7) [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.

Secondary Outcome Measures

1. Productivity - The Institute for Medical Technology Assessment (iMTA) Productivity Costs Questionnaire (iPCQ) [at baseline, 3rd, and 6th month]

   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.

2. Medical consumption - Utilization of Health Services [at baseline, 3rd, and 6th month]

   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.

3. Quality of life - Short-Form Six Dimensions Health Survey (SF-6D) [at baseline, 3rd, and 6th month]

   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.

4. Well-being - PERMA-Profiler (PERMA) [at baseline, 3rd, and 6th month]

   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.

5. Workplace well-being [at baseline, 3rd, and 6th month]

   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.

6. Treatment acceptability [at baseline, 3rd, and 6th month]

   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.

7. Implicit Theories of Intelligence (Self-Theory Scale) [at baseline, 3rd, and 6th month]

   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.

8. Self-Efficacy - General Self-Efficacy Scale (GSE-6) [at baseline, 3rd, and 6th month]

   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.

9. Resilience - Connor-Davidson Resilience Scale (CD-RISC-2) [at baseline, 3rd, and 6th month]

   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.

10. Nonattachment - Nonattachment Scale-Short Form (NAS-SF) [at baseline, 3rd, and 6th month]

    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.

11. Emotion Regulation - Emotion Regulation Questionnaire (ERQ) [at baseline, 3rd, and 6th month]

    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

12. Work and Social Adjustment - Work and Social Adjustment (WSAS) [at baseline, 3rd, and 6th month]

    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.

13. Daily Hassles - LIVES-Daily Hassles Scale (LIVES-DHS) [at baseline, 3rd, and 6th month]

    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.

14. Attitude towards Psychological Online Intervention (APOI) [at baseline, 3rd, and 6th month]

    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.

15. Behavioural Intention - E-therapy Attitude and Process Questionnaire (eTAP) [at baseline, 3rd, and 6th month]

    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).

16. Subjective Norm - E-therapy Attitude and Process Questionnaire (eTAP) [at baseline, 3rd, and 6th month]

    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'.

17. Mental Health Experiences - The Mental Health Experiences Scale [at baseline, 3rd, and 6th month]

    The Mental Health Experiences Scale 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.

18. Self-Stigma - The Self-Stigma of Seeking Psychological Help (SSOSH) [at baseline, 3rd, and 6th month]

    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).

19. Coping strategy - The Proactive Coping Inventory (PCI) [at baseline, 3rd, and 6th month]

    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

20. Tolerance for Ambiguity - Tolerance for Ambiguity Scale (TAS) [at baseline, 3rd, and 6th month]

    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.

21. System Usability - System Usability Scale [at baseline, 3rd, and 6th month]

    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

22. Work Engagement - Utrecht Work Engagement Scale (UWES-3) [at baseline, 3rd, and 6th month]

    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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Working adults aged 18 years old or above

• Able to read and understand Chinese, spoken Cantonese

• Have access to the Internet

Exclusion Criteria:

• High suicidal risk

• Who are unwilling to receive the intervention by random assignment

• Existing users of the JCTH project platform

• Non-working adults

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Diversity and Well-being Lab, CUHK	Sha Tin	N.t.	Hong Kong

Sponsors and Collaborators

• Chinese University of Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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• Responsible Party: Winnie W.S. MAK, Professor, Chinese University of Hong Kong
• ClinicalTrials.gov Identifier: NCT05395312
• Other Study ID Numbers: IRB/REC: 2021.334
• First Posted: May 27, 2022
• Last Update Posted: Aug 17, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Winnie W.S. MAK, Professor, Chinese University of Hong Kong: online; stepped-care; mental well-being; working adults; RCT; psychological distress; depression; anxiety

Study Results

No Results Posted as of Aug 17, 2022