Mental Health Issue Clinical Trial
Official title:
Randomized Controlled Trial on Precision Mental Health
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.
Status | Not yet recruiting |
Enrollment | 320 |
Est. completion date | December 31, 2025 |
Est. primary completion date | May 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 17 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Diversity and Well-being Lab, Dept of Psychology, CUHK | Sha Tin | N.t. |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
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* Note: There are 26 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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