Depression, AnxietyNCT04811170
Counselling Service for Low-income EM in Hong Kong
A study testing Counselling in people with Depression, Anxiety, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 64 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Counselling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteHong Kong
- Study dates
- 22 Mar 2021to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
University of Hong Kong
Hong Kong
Yi Nam Suen
About this study
Official title: The Effectiveness of Counselling on Mood Symptoms of Low-income Ethnic Minorities in Hong Kong: a Wait-list Randomised Controlled Trial
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.
Read more
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
- Being tested
- Counselling
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CounsellingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Time 0 (baseline) to Time 1 (at week 8 or 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start22 Mar 2021
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The Zubin Foundation
- Responsible party
- Principal investigator, Professor Eric Y.H. Chen, The University of Hong Kong
- Investigators
- Eric Yu Hai Chen, MD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04811170
- Sponsor's protocol ID
- EM RCT
- Status last verified
- May 2022
- First submitted
- 6 Mar 2021
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37597877
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Counselling on Mood Symptoms of Low-income Ethnic Minorities in Hong Kong: a Wait-list Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04811170
- Acronym / sponsor ID
- EM RCT
- Conditions
- Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- The Zubin Foundation
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 23 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Counselling group | Experimental | Other: CounsellingCounselling 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. |
| Waiting group | Other | Other: CounsellingFor 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. |
Who may qualify
- Ages
- 15 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CounsellingParticipants 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 | Counselling group, Waiting group |
Primary outcome
The change of the level of depressive symptoms
Time frame: 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.
The change of the level of anxiety symptoms
Time frame: 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.
The change of the level of stress symptoms
Time frame: 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.
1 secondary outcome
The change of subjective quality of life
Time frame: From Time 0 (baseline) to Time 1 (at week 8 or 12)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Derived from this study: PubMed 37597877Suen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Yu Hai Chen, MD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counselling in people with Depression, Anxiety, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YI Nam Suen, PhD (39179579, suenyn@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of the level of depressive symptoms (time frame: From Time 0 (baseline) to Time 1 (at week 8 or 12)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04811170, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.