Counselling Service for Low-income EM in Hong Kong

NCT ID: NCT04811170

Last Updated: 2022-05-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-22
• Study Completion Date: 2023-07-31

Brief Summary

This study will recruit 120 ethnic minorities in Hong Kong from the Zubin Foundation (TZF) at the Ethnic Minority Well-being Centre (EMWBC), which is a service provider of EM mental health support in Hong Kong. This service provides counselling service and referrals to HA via the Integrated Community Centre for Mental Wellness (ICCMW) to psychiatrists. The service covers the South Asians population of approximately eighty-four thousands people in Hong Kong. Participants will be recruited by the Zubin Foundation through outreach activities screening and counselling will be conducted in partnering schools and NGOs (e.g., Yan Oi Tong in Tuen Mun and Yew Chung College of Early Childhood Education in Aberdeen).

The study aims to evaluate the effectiveness of counselling service for improving mood symptoms in EM, also to assess the effectiveness of counselling service in improving psychological functioning (i.e. resilience and rumination, self-compassion, self-efficacy and life satisfaction), social functioning and quality of life and to assess whether the counselling service is cost-effective and offers good value for money.

The study is a wait-list RCT. Participants will be randomly assigned into either the intervention group (n = 60) or the wait-list control group (n = 60) in a 1:1 ratio. Each participant in the intervention group will be paired up with a participant from the control group, the number of sessions and duration of waiting period varies depending on the severity of mood symptoms. Participants with mild to moderate mood symptoms will receive a maximum of 6 counselling sessions and will be assessed at baseline (T0, W1), at post

-treatment for counselling group (T1, W8), and after 2 booster sessions. Participants in the waiting list control group will receive the same counselling service after the counselling group completed the intervention. Participants with severe mood symptoms will receive a maximum of 10 counselling sessions and will be assessed at baseline (T0, W1), at post-treatment for counselling group (T1, W12), and after 2 booster sessions. Participants in the waiting list control group will receive the same counselling service after the counselling group completed the intervention.

This evaluation study will provide data to inform the government in mental health policy review and development.

Conditions

Depression, Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Counselling group

Counselling sessions will be conducted at the designated centers operated by the Zubin foundation. According to the level of the DASS score, 6 to 10 sessions (based on the algorithm) of counselling service will be provided to the participants by three registered counsellors. A lead counsellor will oversee all cases and services. The counselling program consists of 6-10 60-minute sessions, and the sessions can be flexibly delivered over 1 to 2 weeks, ranging from one 60-minute session biweekly or weekly.

Group Type: EXPERIMENTAL

Counselling

Intervention Type: OTHER

Participants with mild to moderate mood symptoms will receive a maximum of 6 counselling sessions and will be assessed at baseline (T0, W1), at post-treatment for counselling group (T1, W8), and after 2 booster sessions. Participants in the waiting list control group will receive the same counselling service after the counselling group completed the intervention. Participants with severe mood symptoms will receive a maximum of 10 counselling sessions and will be assessed at baseline (T0, W1), at post-treatment for counselling group (T1, W12), and after 2 booster sessions. Participants in the waiting list control group will receive the same counselling service after the counselling group completed the intervention.

Waiting group

For participants in the waiting list control group, they will receive monitoring service over phone calls during the 8-12 weeks wait period. Counselling service will be offered after the post-treatment assessment.

Group Type: OTHER

Counselling

Intervention Type: OTHER

Participants with mild to moderate mood symptoms will receive a maximum of 6 counselling sessions and will be assessed at baseline (T0, W1), at post-treatment for counselling group (T1, W8), and after 2 booster sessions. Participants in the waiting list control group will receive the same counselling service after the counselling group completed the intervention. Participants with severe mood symptoms will receive a maximum of 10 counselling sessions and will be assessed at baseline (T0, W1), at post-treatment for counselling group (T1, W12), and after 2 booster sessions. Participants in the waiting list control group will receive the same counselling service after the counselling group completed the intervention.

Interventions

Counselling

Participants with mild to moderate mood symptoms will receive a maximum of 6 counselling sessions and will be assessed at baseline (T0, W1), at post-treatment for counselling group (T1, W8), and after 2 booster sessions. Participants in the waiting list control group will receive the same counselling service after the counselling group completed the intervention. Participants with severe mood symptoms will receive a maximum of 10 counselling sessions and will be assessed at baseline (T0, W1), at post-treatment for counselling group (T1, W12), and after 2 booster sessions. Participants in the waiting list control group will receive the same counselling service after the counselling group completed the intervention.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• South Asian ethnic minorities (except domestic helper) in Hong Kong;
• 15 - 64 years
• reach at least the mild level of the Depression Anxiety Stress Scales - 21 Items in at least one of the following scores: the Depression Score (DASS-D), Anxiety Score (DASS-A) or Stress Score (DASS-S), or low Quality of Life score
• have sufficient proficiency in English, Hindi or Urdu to understand verbal instructions and give informed consent.

Exclusion Criteria

• from high-income family (cut off ranges from HK$15K for single person family to HK$45K of 6 or more people family)
• mental conditions that require other treatment priorities (e.g., suicidal risk, substance abuse, current or past episodes of psychotic disorder, personality disorders)
• medical conditions that severely limit participation, comprehension, or adherence to treatment (e.g., epilepsy, dementia, terminal medical illness) and,
• current usage of antidepressant or mood stabilizers.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Zubin Foundation

UNKNOWN

Sponsor Role: collaborator

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Professor Eric Y.H. Chen

Chair Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric Yu Hai Chen, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

University of Hong Kong

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

YI Nam Suen, PhD

Role: CONTACT

suenyn@hku.hk

39179579

Facility Contacts

Yi Nam Suen

Role: primary

References

Suen YN, Chen EYH, Wong YC, Ng W, Patwardhan S, Cheung C, Hui CLM, Wong SMY, Wong MTH, Mahtani S. Effects of a culturally adapted counselling service for low-income ethnic minorities experiencing mental distress: a pragmatic randomised clinical trial. BMJ Ment Health. 2023 Aug;26(1):e300788. doi: 10.1136/bmjment-2023-300788.

Reference Type: DERIVED

PMID: 37597877 (View on PubMed)

Other Identifiers

EM RCT

Identifier Type: -

Identifier Source: org_study_id