Evaluation of Online Mental Well-being Intervention for Working Adults

NCT05395312 | Completed

• 1 other identifier: IRB/REC: 2021.334
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  6th month

Secondary Outcomes (22)

• Productivity - The Institute for Medical Technology Assessment (iMTA) Productivity Costs Questionnaire (iPCQ)

  at baseline, 3rd, and 6th month

• Medical consumption - Utilization of Health Services

  at baseline, 3rd, and 6th month

• Quality of life - Short-Form Six Dimensions Health Survey (SF-6D)

  at baseline, 3rd, and 6th month

• Well-being - PERMA-Profiler (PERMA)

  at baseline, 3rd, and 6th month

• Workplace well-being

  at baseline, 3rd, and 6th month

Study Arms (2)

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.

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.

Interventions

Online blended stepped-care mental well-being platform OTHER

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

Blended stepped-care group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Working adults aged 18 years old or above
• Able to read and understand Chinese, spoken Cantonese
• Have access to the Internet

You may not qualify if:

• High suicidal risk
• Who are unwilling to receive the intervention by random assignment
• Existing users of the JCTH project platform
• Non-working adults

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Diversity and Well-being Lab, CUHK

Shatin, N.T., Hong Kong

Location

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MeSH Terms

Conditions

Psychological Well-Being; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Behavioral Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 27, 2022
• Study Start: July 30, 2022
• Primary Completion: February 3, 2023
• Study Completion: May 31, 2023
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

HK (1)