Clinical trial NCT05395312: Evaluation of Online Mental Well-being Intervention for Working Adults
Official title: Evaluation of Blended Stepped-care Mental Well-being Intervention for Adults: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Well-being
Mental Health Issue
Mental Health Wellness 1
Keywords: online
stepped-care
mental well-being
working adults
RCT
psychological distress
depression
anxiety
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-05-27
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Depressive symptoms - Patient Health Questionnaire (PHQ-9)
timeFrame: at baseline
measure: Depressive symptoms - Patient Health Questionnaire (PHQ-9)
timeFrame: 3rd month
measure: Depressive symptoms - Patient Health Questionnaire (PHQ-9)
timeFrame: 6th month
measure: Anxiety symptoms - Generalized Anxiety Disorder Assessment (GAD-7)
timeFrame: at baseline
measure: Anxiety symptoms - Generalized Anxiety Disorder Assessment (GAD-7)
timeFrame: 3rd month
measure: Anxiety symptoms - Generalized Anxiety Disorder Assessment (GAD-7)
timeFrame: 6th month
Secondary outcomes:
measure: Productivity - The Institute for Medical Technology Assessment (iMTA) Productivity Costs Questionnaire (iPCQ)
timeFrame: at baseline, 3rd, and 6th month
measure: Medical consumption - Utilization of Health Services
timeFrame: at baseline, 3rd, and 6th month
measure: Quality of life - Short-Form Six Dimensions Health Survey (SF-6D)
timeFrame: at baseline, 3rd, and 6th month
measure: Well-being - PERMA-Profiler (PERMA)
timeFrame: at baseline, 3rd, and 6th month
measure: Workplace well-being
timeFrame: at baseline, 3rd, and 6th month
measure: Treatment acceptability
timeFrame: at baseline, 3rd, and 6th month
measure: Implicit Theories of Intelligence (Self-Theory Scale)
timeFrame: at baseline, 3rd, and 6th month
measure: Self-Efficacy - General Self-Efficacy Scale (GSE-6)
timeFrame: at baseline, 3rd, and 6th month
measure: Resilience - Connor-Davidson Resilience Scale (CD-RISC-2)
timeFrame: at baseline, 3rd, and 6th month
measure: Nonattachment - Nonattachment Scale-Short Form (NAS-SF)
timeFrame: at baseline, 3rd, and 6th month
measure: Emotion Regulation - Emotion Regulation Questionnaire (ERQ)
timeFrame: at baseline, 3rd, and 6th month
measure: Work and Social Adjustment - Work and Social Adjustment (WSAS)
timeFrame: at baseline, 3rd, and 6th month
measure: Daily Hassles - LIVES-Daily Hassles Scale (LIVES-DHS)
timeFrame: at baseline, 3rd, and 6th month
measure: Attitude towards Psychological Online Intervention (APOI)
timeFrame: at baseline, 3rd, and 6th month
measure: Behavioural Intention - E-therapy Attitude and Process Questionnaire (eTAP)
timeFrame: at baseline, 3rd, and 6th month
measure: Subjective Norm - E-therapy Attitude and Process Questionnaire (eTAP)
timeFrame: at baseline, 3rd, and 6th month
measure: Mental Health Experiences - The Mental Health Experiences Questionnaire
timeFrame: at baseline, 3rd, and 6th month
measure: Self-Stigma - The Self-Stigma of Seeking Psychological Help (SSOSH)
timeFrame: at baseline, 3rd, and 6th month
measure: Coping strategy - The Proactive Coping Inventory (PCI)
timeFrame: at baseline, 3rd, and 6th month
measure: Tolerance for Ambiguity - Tolerance for Ambiguity Scale (TAS)
timeFrame: at baseline, 3rd, and 6th month
measure: System Usability - System Usability Scale
timeFrame: at baseline, 3rd, and 6th month
measure: Work Engagement - Utrecht Work Engagement Scale (UWES-3)
timeFrame: at baseline, 3rd, and 6th month
Other outcomes:
Locations:
city: Sha Tin
country: Hong Kong
facility: Diversity and Well-being Lab, CUHK
state: N.t.
Study officials:
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