Clinical trial NCT05825040: Randomized Controlled Trial on Precision Mental Health
Official title: Randomized Controlled Trial on Precision Mental Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 320
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Patient Health Questionnaire
timeFrame: 8th week
measure: Patient Health Questionnaire
timeFrame: 16th week
measure: Generalized Anxiety Disorder Assessment
timeFrame: 8th week
measure: Generalized Anxiety Disorder Assessment
timeFrame: 16th week
measure: The Short Warwick-Edinburgh Mental Wellbeing Scale
timeFrame: 8th week
measure: The Short Warwick-Edinburgh Mental Wellbeing Scale
timeFrame: 16th week
Secondary outcomes:
measure: The Brief Experiential Avoidance Questionnaire (BEAQ)
timeFrame: 8th week
measure: The Brief Experiential Avoidance Questionnaire (BEAQ)
timeFrame: 16th week
measure: Behavioral Activation for Depression Scale - Short Form
timeFrame: 8th week
measure: Behavioral Activation for Depression Scale - Short Form
timeFrame: 16th week
measure: Intolerance of Uncertainty Scale (Short version)
timeFrame: 8th week
measure: Intolerance of Uncertainty Scale (Short version)
timeFrame: 16th week
measure: Emotion Regulation Questionnaire (ERQ)
timeFrame: 8th week
measure: Emotion Regulation Questionnaire (ERQ)
timeFrame: 16th week
measure: Anxiety Sensitivity Index-3
timeFrame: 8th week
measure: Anxiety Sensitivity Index-3
timeFrame: 16th week
measure: Ruminative response scale-short version
timeFrame: 8th week
measure: Ruminative response scale-short version
timeFrame: 16th week
measure: Nonattachment Scale-Short Form
timeFrame: 8th week
measure: Nonattachment Scale-Short Form
timeFrame: 16th week
measure: Need for autonomy
timeFrame: 8th week
measure: Patient Health Questionnaire
timeFrame: 6 months
measure: Patient Health Questionnaire
timeFrame: 12 months
measure: Generalized Anxiety Disorder Assessment
timeFrame: 6 months
measure: Generalized Anxiety Disorder Assessment
timeFrame: 12 months
measure: The Short Warwick-Edinburgh Mental Wellbeing Scale
timeFrame: 6 months
measure: The Short Warwick-Edinburgh Mental Wellbeing Scale
timeFrame: 12 months
measure: The Five Facet Mindfulness Questionnaire
timeFrame: 8th week
measure: The Five Facet Mindfulness Questionnaire
timeFrame: 16th week
Other outcomes:
Locations:
city: Sha Tin
country: Hong Kong
facility: Diversity and Well-being Lab, Dept of Psychology, CUHK
state: N.t.
Study officials:
affiliation: Professor
name: Winnie WS Mak
role: PRINCIPAL_INVESTIGATOR
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