Counselling Service for Low-income EM in Hong Kong

NCT04811170 | Unknown DMC

• 1 other identifier: EM RCT
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• The change of the level of depressive symptoms

  Measured by the Depression sub-scale of Depression, Anxiety and Stress Scale 21-item version. The subscale has 7 items, each rated from 0 to 3, the total score will be doubled for interpretation of its severity. The higher score indicates the more severe depressive symptoms.

  From Time 0 (baseline) to Time 1 (at week 8 or 12)

• The change of the level of anxiety symptoms

  Measured by the Anxiety sub-scale of Depression, Anxiety and Stress Scale 21-item version. The subscale has 7 items, each rated from 0 to 3, the total score will be doubled for interpretation of its severity. The higher score indicates the more severe depressive symptoms.

  From Time 0 (baseline) to Time 1 (at week 8 or 12)

• The change of the level of stress symptoms

  Measured by the Stress sub-scale of Depression, Anxiety and Stress Scale 21-item version. The subscale has 7 items, each rated from 0 to 3, the total score will be doubled for interpretation of its severity. The higher score indicates the more severe depressive symptoms.

  From Time 0 (baseline) to Time 1 (at week 8 or 12)

Secondary Outcomes (1)

• The change of subjective quality of life

  From Time 0 (baseline) to Time 1 (at week 8 or 12)

Study Arms (2)

Counselling group

EXPERIMENTAL

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.

Other: Counselling

Waiting group

OTHER

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.

Other: Counselling

Interventions

Counselling 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.

Counselling group; Waiting group

Eligibility Criteria

• Age: 15 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• South Asian ethnic minorities (except domestic helper) in Hong Kong;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead
• The Zubin Foundation: collaborator

Study Sites (1)

University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (1)

• 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.

  PMID: 37597877 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Counseling

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Eric Yu Hai Chen, MD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

YI Nam Suen, PhD

CONTACT

39179579; suenyn@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Professor

Study Record Dates

• First Submitted: March 6, 2021
• First Posted: March 23, 2021
• Study Start: March 22, 2021
• Primary Completion: January 31, 2023
• Study Completion: July 31, 2023
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)