Randomized Controlled Trial on Precision Mental Health

NCT05825040 | Recruiting

• 1 other identifier: WMHICS-HK
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

The current study aims to evaluate the effectiveness of different online psychological interventions, including guided and unguided transdiagnostic cognitive behavioural therapy, and unguided mindfulness-based intervention, on mental well-being in comparison to waitlist control. It is hypothesized that participants with the guided psychological intervention will show (H1) a greater reduction in mental health symptoms, and (H2) better mental well-being compared with participants with unguided psychological intervention and the control condition.

Conditions

Mental Well-being; Mental Health Issue; Mental Health Wellness 1; Precision Mental Health

Keywords

Online Psychological Intervention; Mental health; Mental well-being; Precision Mental Health

Outcome Measures

Primary Outcomes (6)

• Patient Health Questionnaire

  It includes 9 items to assess the extent to which respondents are bothered by depression-related symptoms using a 4-point scale from 0 (not at all) to 3 (nearly every day). PHQ-9 has been validated and used widely in the general population for screening and measuring depression severity. Scores of 5, 10, 15, and 20 denote mild, moderate, moderately severe, and severe levels of depression respectively (range: 0-27). PHQ-9 has sensitivity of 0.88 and specificity of 0.88 in detecting major depressive disorder (MDD) at a cut-off of 10. The internal consistency reliability of the Chinese version of the scale was 0.86.

  8th week

• Patient Health Questionnaire

  It includes 9 items to assess the extent to which respondents are bothered by depression-related symptoms using a 4-point scale from 0 (not at all) to 3 (nearly every day). PHQ-9 has been validated and used widely in the general population for screening and measuring depression severity. Scores of 5, 10, 15, and 20 denote mild, moderate, moderately severe, and severe levels of depression respectively (range: 0-27). PHQ-9 has sensitivity of 0.88 and specificity of 0.88 in detecting major depressive disorder (MDD) at a cut-off of 10. The internal consistency reliability of the Chinese version of the scale was 0.86.

  16th week

• Generalized Anxiety Disorder Assessment

  It is a 7-item scale to assess the extent to which respondents are bothered by anxiety-related symptoms using a 4-point scale from 0 (not at all) to 3 (nearly every day). Scores of 5, 10, and 15 denote the mild, moderate, and severe levels of anxiety respectively (range: 0-21). At a cut-off of 10, GAD-7 has sensitivity of 0.89 and specificity of 0.82 in detecting generalized anxiety disorder (GAD). The internal consistency of the Chinese version was 0.93.

  8th week

• Generalized Anxiety Disorder Assessment

  It is a 7-item scale to assess the extent to which respondents are bothered by anxiety-related symptoms using a 4-point scale from 0 (not at all) to 3 (nearly every day). Scores of 5, 10, and 15 denote the mild, moderate, and severe levels of anxiety respectively (range: 0-21). At a cut-off of 10, GAD-7 has sensitivity of 0.89 and specificity of 0.82 in detecting generalized anxiety disorder (GAD). The internal consistency of the Chinese version was 0.93.

  16th week

• The Short Warwick-Edinburgh Mental Wellbeing Scale

  It contains 7 positively phrased items on a 5-point Likert scale from 1 (none of the time) to 5 (all of the time). Total scores ranged from 7 to 35, where higher scores indicated higher overall mental well-being. SWEMWBS satisfies the strict criteria for measurement demanded by the RASCH model and is preferable to the original 14-item WEMWBS scale. The Chinese version of SWEMWBS is reliable (Cronbach's alpha = 0.89) and has been validated among a sample in Hong Kong.

  8th week

• The Short Warwick-Edinburgh Mental Wellbeing Scale

  It contains 7 positively phrased items on a 5-point Likert scale from 1 (none of the time) to 5 (all of the time). Total scores ranged from 7 to 35, where higher scores indicated higher overall mental well-being. SWEMWBS satisfies the strict criteria for measurement demanded by the RASCH model and is preferable to the original 14-item WEMWBS scale. The Chinese version of SWEMWBS is reliable (Cronbach's alpha = 0.89) and has been validated among a sample in Hong Kong.

  16th week

Secondary Outcomes (23)

• The Brief Experiential Avoidance Questionnaire (BEAQ)

  8th week

• The Brief Experiential Avoidance Questionnaire (BEAQ)

  16th week

• Behavioral Activation for Depression Scale - Short Form

  8th week

• Behavioral Activation for Depression Scale - Short Form

  16th week

• Intolerance of Uncertainty Scale (Short version)

  8th week

Study Arms (4)

Online guided transdiagnostic cognitive behavioral therapy

EXPERIMENTAL

In the online guided transdiagnostic cognitive behavioral therapy group, participants will go through 8 modules with coach support in 8 weeks. They will complete 6 sets of questionnaires at the beginning of the study, at the 4th, 8th, and 16th weeks, and at 6 and 12 months after group allocation. All participants will be able to access all psychological interventions after they have completed the research.

Behavioral: Online guided transdiagnostic cognitive behavioural therapy

Online self-guided transdiagnostic cognitive behavioral therapy

EXPERIMENTAL

In the online self-guided transdiagnostic cognitive behavioral therapy group, participants will go through 8 modules without coach support in 8 weeks. They will complete 6 sets of questionnaires at the beginning of the study, at the 4th, 8th, and 16th weeks, and at 6 and 12 months after group allocation. All participants will be able to access all psychological interventions after they have completed the research.

Behavioral: Online self-guided transdiagnostic cognitive behavioural therapy

Waitlist control group

NO INTERVENTION

In the waitlist control group, participants are to refrain from using online psychological interventions until they finished the final questionnaire. They will complete 4 sets of questionnaires at the beginning of the study, at the 4th, 8th, and 16th weeks and at 6 and 12 months after group allocation. All participants will be able to access all psychological interventions after they have completed the research.

Online self-guided mindfulness-based intervention

EXPERIMENTAL

In the online self-guided mindfulness-based intervention group, participants will go through 6 modules in 8 weeks without coach support. They will complete 6 sets of questionnaires at the beginning of the study, at the 4th, 8th, and 16th weeks, and at 6 and 12 months after group allocation. All participants will be able to access all psychological interventions after they have completed the research.

Behavioral: Online self-guided mindfulness-based intervention

Interventions

Online guided transdiagnostic cognitive behavioural therapy BEHAVIORAL

The contents of guided transdiagnostic cognitive behavioural therapy are developed by clinical psychologists and psychological well-being officers. The intervention consists of 8 modules. Contents include emotional awareness, physical sensation, emotion-driven behavior, behavioral activation, worry, cognitive restructuring, behavioral experiment, and relapse prevention. Customized guidance will be provided by coaches once a week based on participants' performance

Online guided transdiagnostic cognitive behavioral therapy

Online self-guided transdiagnostic cognitive behavioural therapy BEHAVIORAL

The contents of self-guided transdiagnostic cognitive behavioural therapy are developed by clinical psychologists and psychological well-being officers. The intervention consists of 8 modules. Contents include emotional awareness, physical sensation, emotion-driven behavior, behavioral activation, worry, cognitive restructuring, behavioral experiment, and relapse prevention. No customized guidance will be provided to participants in the self-guided group.

Online self-guided transdiagnostic cognitive behavioral therapy

Online self-guided mindfulness-based intervention BEHAVIORAL

The contents of online self-guided mindfulness-based intervention are developed by clinical psychologists and psychological well-being officers. The intervention consists of 6 modules. Contents include mindfulness and auto-pilot, react and respond, aversion, craving, equanimity, and 'suffering', thoughts and letting go, starting with loving kindness, and mindfulness in life.

Online self-guided mindfulness-based intervention

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or above
• Able to read Chinese or English
• With internet connection and able to access the internet
• Does not register to Jockey Club TourHeart+ Project or participate in related research projects
• With moderate-severe GAD-7 a/o moderate-severe PHQ-9

You may not qualify if:

• People who are under 17 years old
• Cannot access the internet
• Existing users of Jockey Club TourHeart+ Project or participate in related research
• Without moderate-severe depressive or anxiety symptoms
• With suicidal risk

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Diversity and Well-being Lab, Dept of Psychology, CUHK

Shatin, N.T., Hong Kong

RECRUITING

Related Publications (26)

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MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Winnie WS Mak

  Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Winnie WS Mak

CONTACT

+852 39436577; wwsmak@cuhk.edu.hk

Wing Tung Chung

CONTACT

+852 39433463; wingchung@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: April 24, 2023
• Study Start: May 1, 2024
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)