Randomized Controlled Trial on Precision Mental Health

Study Overview
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Brief Summary
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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.

Detailed Description
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In Hong Kong, insufficient resources in the current public health system lead to a long waiting time. Mental health services provided by the public health system mainly rely on traditional one-to-one face-to-face sessions. In the past 12 months, there were 47,879 new bookings in public psychiatry outpatient clinics and the longest waiting time was 94 weeks. Priority is always given to people with more severe mental health issues, which causes long waiting time for people with mild mental health symptoms. Untreated mental health issues can be escalated to more severe symptoms. Thus, in addition to treating mental illness, preventing common mental health issues and fostering mental health self-care in the general population are crucial to promote public mental health and reduce the illness burden in society. Rather than resorting to mental health professionals for face-to-face service to treat common mental health concerns, digital technology provides a highly scalable and accessible means through which individuals can access mental health resources for self-care. Internet-delivered psychological therapy is one of the viable options for this situation. Internet-delivered cognitive behavioural therapy (ICBT) has been recommended by the NICE guidelines as one of the low-intensity interventions for people with depression and anxiety. 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. Internet-delivered mindfulness-based intervention (MBI) have emerged as a promising approach in reducing depressive and anxiety symptoms and improving mental well-being. A meta-analysis found that online MBIs had beneficial impact on depression, anxiety, well-being and mindfulness. It also found that guided online MBIs had larger effects on stress and mindfulness compared to unguided MBIs. In this study, participants will be recruited through (1) advertising on online networking platforms (e.g., Facebook and Instagram), (2) mass mailing at investigator's institutions, and (3) snowball sampling. Upon completing the screening and pre-evaluation questionnaire, participants will be randomly assigned to one of the groups based on computer-generated random digits. They will complete 5 more sets of questionnaires, including a mid-evaluation 4 weeks after group allocation, a post-evaluation 8 weeks after group allocation, and three follow-up questionnaires at 16 weeks, 6 months, and 12 months after group allocation. In experimental groups, participants will complete guided or self-guided transdiagnostic cognitive behavioural therapy, or self-guided mindfulness-based intervention within 8 weeks. In the waitlist control group, participants are to refrain from participating in psychological intervention until they finish the follow-up questionnaire.

Official Title
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Randomized Controlled Trial on Precision Mental Health

Conditions
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Mental Well-being, Mental Health Issue, Mental Health Wellness 1, Precision Mental Health

Intervention / Treatment
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* Behavioral: Online guided transdiagnostic cognitive behavioural therapy
* Behavioral: Online self-guided transdiagnostic cognitive behavioural therapy
* Behavioral: Online self-guided mindfulness-based intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 17 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Online guided transdiagnostic cognitive behavioral therapy<br>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<br>* 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<br>|
| Experimental: Online self-guided transdiagnostic cognitive behavioral therapy<br>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<br>* 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.<br>|
| No Intervention: Waitlist control group<br>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. | |
| Experimental: Online self-guided mindfulness-based intervention<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Brief Experiential Avoidance Questionnaire (BEAQ) | The Brief Experiential Avoidance Questionnaire includes 15 items to measure experiential avoidance in 2 subscales: cognitive avoidance and behavioral avoidance. Items are rated on a 6-point Likert scale from 1 (strongly disagree) to 6 (strongly agree). Item 6 is reverse-coded. The BEAQ shows good reliability (Cronbach's alpha = 0.80-0.89) for various samples. | 8th week | 
| The Brief Experiential Avoidance Questionnaire (BEAQ) | The Brief Experiential Avoidance Questionnaire includes 15 items to measure experiential avoidance in 2 subscales: cognitive avoidance and behavioral avoidance. Items are rated on a 6-point Likert scale from 1 (strongly disagree) to 6 (strongly agree). Item 6 is reverse-coded. The BEAQ shows good reliability (Cronbach's alpha = 0.80-0.89) for various samples. | 16th week | 
| Behavioral Activation for Depression Scale - Short Form | The 9-item short version of Behavioral Activation for Depression Scale measures changes in activation and avoidance in the previous week. Items are rated on a 7-point Likert scale from 0 (not at all) to 6 (completely). Items 1, 6, 7, and 8 are reverse-coded. Higher scores on the total score represent increased activation. The BADS-SF has demonstrated good internal consistency (Cronbach's alpha = 0.82), construct validity, and predictive validity. | 8th week | 
| Behavioral Activation for Depression Scale - Short Form | The 9-item short version of Behavioral Activation for Depression Scale measures changes in activation and avoidance in the previous week. Items are rated on a 7-point Likert scale from 0 (not at all) to 6 (completely). Items 1, 6, 7, and 8 are reverse-coded. Higher scores on the total score represent increased activation. The BADS-SF has demonstrated good internal consistency (Cronbach's alpha = 0.82), construct validity, and predictive validity. | 16th week | 
| Intolerance of Uncertainty Scale (Short version) | The Intolerance of Uncertainty Scale - Short Version contains 12 items on a 5-point Likert scale from 1 (not at all characteristic of me) to 5 (entirely characteristic of me). It includes 2 subscales, prospective anxiety and inhibitory anxiety, which measure the approach-oriented and avoidance-oriented responses to uncertainty respectively. IUS-12 shows good reliability (Cronbach's alpha = 0.91) and convergent validity | 8th week | 
| Intolerance of Uncertainty Scale (Short version) | The Intolerance of Uncertainty Scale - Short Version contains 12 items on a 5-point Likert scale from 1 (not at all characteristic of me) to 5 (entirely characteristic of me). It includes 2 subscales, prospective anxiety and inhibitory anxiety, which measure the approach-oriented and avoidance-oriented responses to uncertainty respectively. IUS-12 shows good reliability (Cronbach's alpha = 0.91) and convergent validity | 16th week | 
| Emotion Regulation Questionnaire (ERQ) | It is a 10-item survey to assess two emotion-regulation strategies: cognitive reappraisal and expressive suppression. Items are rated on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). It demonstrated acceptable levels of reliability. | 8th week | 
| Emotion Regulation Questionnaire (ERQ) | It is a 10-item survey to assess two emotion-regulation strategies: cognitive reappraisal and expressive suppression. Items are rated on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). It demonstrated acceptable levels of reliability. | 16th week | 
| Anxiety Sensitivity Index-3 | It includes 18 items to measure the degree of physical, cognitive and social concerns about anxiety using a 5-point Likert scale from 0 (very little) to 4 (very much). ASI-3 is reliable (Cronbach's alpha = 0.79-0.91) with good convergent, discriminant and criterion-related validity and is preferable to the original ASI scale. | 8th week | 
| Anxiety Sensitivity Index-3 | It includes 18 items to measure the degree of physical, cognitive and social concerns about anxiety using a 5-point Likert scale from 0 (very little) to 4 (very much). ASI-3 is reliable (Cronbach's alpha = 0.79-0.91) with good convergent, discriminant and criterion-related validity and is preferable to the original ASI scale. | 16th week | 
| Ruminative response scale-short version | 5 items from the brooding subscale are adopted to assess the passive thoughts to compare the current state with unrealistic standards using a 4-point Likert scale from 1 (almost never) to 4 (almost always). The brooding subscale demonstrated reliability (Cronbach's alpha = 0.77) and significant predictivity in depressive symptoms. The Chinese version of the scale was reliable and valid in examining rumination | 8th week | 
| Ruminative response scale-short version | 5 items from the brooding subscale are adopted to assess the passive thoughts to compare the current state with unrealistic standards using a 4-point Likert scale from 1 (almost never) to 4 (almost always). The brooding subscale demonstrated reliability (Cronbach's alpha = 0.77) and significant predictivity in depressive symptoms. The Chinese version of the scale was reliable and valid in examining rumination | 16th week | 
| Nonattachment Scale-Short Form | Nonattachment Scale-Short Form (NAS-SF) includes 8 items to measure nonattachment using 6-point Likert scale from 1 (strongly disagree) to 6 (strongly agree). It yielded satisfactory internal consistency and validity. | 8th week | 
| Nonattachment Scale-Short Form | Nonattachment Scale-Short Form (NAS-SF) includes 8 items to measure nonattachment using 6-point Likert scale from 1 (strongly disagree) to 6 (strongly agree). It yielded satisfactory internal consistency and validity. | 16th week | 
| Need for autonomy | Two items adopted previous studies measure the need for autonomy. Items are rated on a 5-point Likert scale from 1 (completely disagree) to 5 (completely agree) | 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. | 6 months | 
| 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. | 12 months | 
| 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. | 6 months | 
| 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. | 12 months | 
| 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. | 6 months | 
| 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. | 12 months | 
| The Five Facet Mindfulness Questionnaire | It includes 20 items to measure mindfulness in 5 subscales: observing, describing, acting with awareness, nonjudging, and nonreacting. Items are rated on a 5-point scale from 1 (never or very rarely true) to 5 (very often true or always true). The FFMQ-C shows good test-retest reliability (0.88) and high internal consistency (Cronbach's alpha = 0.80-0,83) for various samples. | 8th week | 
| The Five Facet Mindfulness Questionnaire | It includes 20 items to measure mindfulness in 5 subscales: observing, describing, acting with awareness, nonjudging, and nonreacting. Items are rated on a 5-point scale from 1 (never or very rarely true) to 5 (very often true or always true). The FFMQ-C shows good test-retest reliability (0.88) and high internal consistency (Cronbach's alpha = 0.80-0,83) for various samples. | 16th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Online Psychological Intervention, Mental health, Mental well-being, Precision Mental Health