Counselling Service for Low-income EM in Hong Kong

Sponsor
The University of Hong Kong (Other)
Overall Status
Recruiting
CT.gov ID
NCT04811170
Collaborator
The Zubin Foundation (Other)
120
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2
28.3
4.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Counselling
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effectiveness of Counselling on Mood Symptoms of Low-income Ethnic Minorities in Hong Kong: a Wait-list Randomised Controlled Trial
Actual Study Start Date :
Mar 22, 2021
Anticipated Primary Completion Date :
Jan 31, 2023
Anticipated Study Completion Date :
Jul 31, 2023

Arms and Interventions

Arm Intervention/Treatment
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
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.

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
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.

Outcome Measures

Primary Outcome Measures

  1. The change of the level of depressive symptoms [From Time 0 (baseline) to Time 1 (at week 8 or 12)]

    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.

  2. The change of the level of anxiety symptoms [From Time 0 (baseline) to Time 1 (at week 8 or 12)]

    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.

  3. The change of the level of stress symptoms [From Time 0 (baseline) to Time 1 (at week 8 or 12)]

    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.

Secondary Outcome Measures

  1. The change of subjective quality of life [From Time 0 (baseline) to Time 1 (at week 8 or 12)]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 64 Years
Sexes Eligible for Study:
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:
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Hong Kong Hong Kong Hong Kong

Sponsors and Collaborators

  • The University of Hong Kong
  • The Zubin Foundation

Investigators

  • Principal Investigator: Eric Yu Hai Chen, MD, The University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Professor Eric Y.H. Chen, Chair Professor, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT04811170
Other Study ID Numbers:
  • EM RCT
First Posted:
Mar 23, 2021
Last Update Posted:
May 26, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 26, 2022