Randomized Controlled Trial on Precision Mental Health
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Mental Well-being
- Sponsor
- Chinese University of Hong Kong
- Enrollment
- 320
- Locations
- 1
- Primary Endpoint
- Patient Health Questionnaire
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Detailed Description
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.
Investigators
Winnie W.S. MAK
Professor
Chinese University of Hong Kong
Eligibility Criteria
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
Outcomes
Primary Outcomes
Patient Health Questionnaire
Time Frame: 16th week
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.
The Short Warwick-Edinburgh Mental Wellbeing Scale
Time Frame: 16th week
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.
Generalized Anxiety Disorder Assessment
Time Frame: 16th week
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.
Secondary Outcomes
- Nonattachment Scale-Short Form(16th week)
- Intolerance of Uncertainty Scale (Short version)(16th week)
- The Brief Experiential Avoidance Questionnaire (BEAQ)(16th week)
- Anxiety Sensitivity Index-3(16th week)
- Generalized Anxiety Disorder Assessment(12 months)
- The Five Facet Mindfulness Questionnaire(16th week)
- Behavioral Activation for Depression Scale - Short Form(16th week)
- Emotion Regulation Questionnaire (ERQ)(16th week)
- Need for autonomy(8th week)
- Ruminative response scale-short version(16th week)
- Patient Health Questionnaire(12 months)
- The Short Warwick-Edinburgh Mental Wellbeing Scale(12 months)