CClinicalTrials.gg
Status unknownNCT04811170Updated May 26, 2022

Counselling Service for Low-income EM in Hong Kong

An interventional study of Counselling in Depression, Anxiety, sponsored by The University of Hong Kong. Status unknown at 1 site in Hong Kong. Open to participants aged 15 Years to 64 Years. Per ClinicalTrials.gov, last updated 2022-05-26.

Sponsored by The University of Hong Kong · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
15 Years to 64 Years
Sex
All
01

Study 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.

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Conditions studied

  • Depression, Anxiety

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03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's planned enrollment of 120 is above the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    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.

    Other: Counselling

  • Other
    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.

    Other: Counselling

Interventions

  • OtherCounselling

    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.

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

  3. 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.

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

Secondary outcomes

  1. The change of subjective quality of life

    Measured by the Mental Component Summary (MCS) of Short Form 12 version 2. Min: 0, max:100. The higher score indicates better mental health related subjective quality of life.

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

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Study locations

1 of 1 sites recruiting
  • University of Hong Kong
    Hong Kong, Hong Kong
    • Yi Nam Suen · Contact
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04811170
Lead sponsor
The University of Hong Kong
Collaborators
The Zubin Foundation
Responsible party
Professor Eric Y.H. Chen (Chair Professor, The University of Hong Kong) — Principal investigator
First posted
Mar 23, 2021
Start date
Mar 22, 2021
Primary completion
Jan 31, 2023 (estimated)
Completion
Jul 31, 2023 (estimated)
Last update
May 26, 2022

Study contacts

YI Nam Suen, PhD
Contact
suenyn@hku.hk
39179579
Eric Yu Hai Chen, MD
principal investigator · The University of Hong Kong

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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