Randomized Controlled Trial on Precision Mental Health

The Chinese University of Hong Kong

Status: Enrolling

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

Treatments: Behavioral: Online self-guided transdiagnostic cognitive behavioural therapy; Behavioral: Online guided transdiagnostic cognitive behavioural therapy; Behavioral: Online self-guided mindfulness-based intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05825040

WMHICS-HK

Details and patient eligibility

About

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.

Full 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.

Enrollment: 320 estimated patients

Sex: All

Ages: 17+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 4 patient groups

Online guided transdiagnostic cognitive behavioral therapy

Experimental group

Description:

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.

Treatment:

Behavioral: Online guided transdiagnostic cognitive behavioural therapy

Online self-guided transdiagnostic cognitive behavioral therapy

Experimental group

Description:

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.

Treatment:

Behavioral: Online self-guided transdiagnostic cognitive behavioural therapy

Waitlist control group

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: Online self-guided mindfulness-based intervention