Common Mental DisorderNCT03751696
Coaching Intervention in Women At-risk of Common Mental Disorders
A study testing Group Coaching and SMS self-help tips in people with Common Mental Disorder, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study aims to provide preventative intervention to 60 women who are at risk of common mental disorders in Hong Kong. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Common Mental Disorder
- What is being tested?
- Group Coaching and SMS self-help tips
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Nov 2018to 31 Dec 2021
- 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 18 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Willing to provide written informed consent
- Able to understand Cantonese and read/write Chinese
- With subsyndromal or minor depressive symptoms indicated by
- Depression subscale of Depression, Anxiety and Stress Scale (DASS) score 10-20 or
- Edinburgh Postnatal Depression Scale (EPDS) scores 10-13
Who cannot join
- A positive response in items about suicidal thoughts if applicable ("Yes, quite often" and "sometimes" in EPDS) (These participants will be referred to suicidal management)
- Those mental conditions that require other treatment priorities (e.g., suicidal risk, substance abuse, current or past episodes of psychotic disorder, personality disorders)
- Those medical conditions that severely limit participation, comprehension, or adherence to treatment (e.g., epilepsy, dementia, terminal medical illness)
- Those who are receiving structured psychotherapy or counseling
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
University of Hong Kong
Hong Kong, 0000
Yi Nam Suen
About this study
Official title: Coaching Intervention to Improve Mental Well-being of Community Women Who Are At-risk of Common Mental Disorders in Hong Kong: A Pilot Randomized Controlled Trials
This study aims to provide preventative intervention to 60 women who are at risk of common mental disorders in Hong Kong.
Read the detailed description
Participants will be recruited through the following routes: 1) by our partner non-governmental organizations, 2) by our research team through community outreach or training activities, 3) online screening tool, and 4) referral from organizations that provide service to women (e.g., Maternal and Child Health Clinics of Department of Health). Eligible subjects with informed consent provided will be randomly assigned to coaching group or SMS self-help tips. To test the effectiveness of the provided intervention programs, symptoms assessments and data collection on demographics and psychosocial data will be carried out during baseline, immediately, and 3 months post-intervention.
- Conditions
- Common Mental Disorder
- Being tested
- Group Coaching, SMS self-help tips
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group CoachingBehavioural
4 sessions of 1-1.5-hour group coaching intervention within 8 weeks
SMS self-help tipsBehavioural
4 mental well-being tips through sms within 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group coaching | Experimental | There will be a total of 4 sessions of group coaching intervention within 8 weeks. Each session is in a group of 5-6 women and lasts for approximately 1-1.5 hours. The sessions will be conducted by experienced social workers online. Receives: Behavioral: Group Coaching |
| SMS Self-help tips | Active comparator | The participants in the control group will receive four self-help tips on mental well-being on the same schedule as the group coaching group. Receives: Behavioral: SMS self-help tips |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms
Measured by the depression subscale of the Depression, Anxiety and Stress Scale
Measured: immediate post-intervention
Anxiety symptoms
Measured by the anxiety subscale of the Depression, Anxiety and Stress Scale
Measured: immediate post-intervention
Secondary outcomes (2)
Depressive symptoms
Measured by the depression subscale of the Depression, Anxiety and Stress Scale (DASS). The subscale consists of 7 questions, each responses range from 0 (not applicable) to 3 (the most applicable). The higher score represents more severe depressive symptoms.
Measured: 3-month post intervention
Anxiety symptoms
Measured by the anxiety subscale of the Depression, Anxiety and Stress Scale
Measured: 3-month post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start15 Nov 2018
- Primary completion30 Sep 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common Mental DisorderStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Eric Y.H. Chen, The University of Hong Kong
- Investigators
- Eric YH Chen, MD, Study director, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751696
- Sponsor's protocol ID
- CoachingRCT
- Status last verified
- Apr 2021
- First submitted
- 10 Nov 2018
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coaching Intervention to Improve Mental Well-being of Community Women Who Are At-risk of Common Mental Disorders in Hong Kong: A Pilot Randomized Controlled Trials
- ClinicalTrials.gov ID
- NCT03751696
- Acronym / sponsor ID
- CoachingRCT
- Conditions
- Common Mental Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 23 Nov 2018 (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 aims to provide preventative intervention to 60 women who are at risk of common mental disorders in Hong Kong.
Detailed description
Participants will be recruited through the following routes: 1) by our partner non-governmental organizations, 2) by our research team through community outreach or training activities, 3) online screening tool, and 4) referral from organizations that provide service to women (e.g., Maternal and Child Health Clinics of Department of Health). Eligible subjects with informed consent provided will be randomly assigned to coaching group or SMS self-help tips. To test the effectiveness of the provided intervention programs, symptoms assessments and data collection on demographics and psychosocial data will be carried out during baseline, immediately, and 3 months post-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group coaching | Experimental | Behavioral: Group CoachingThere will be a total of 4 sessions of group coaching intervention within 8 weeks. Each session is in a group of 5-6 women and lasts for approximately 1-1.5 hours. The sessions will be conducted by experienced social workers online. |
| SMS Self-help tips | Active comparator | Behavioral: SMS self-help tipsThe participants in the control group will receive four self-help tips on mental well-being on the same schedule as the group coaching group. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Willing to provide written informed consent
- Able to understand Cantonese and read/write Chinese
- With subsyndromal or minor depressive symptoms indicated by
- Depression subscale of Depression, Anxiety and Stress Scale (DASS) score 10-20 or
- Edinburgh Postnatal Depression Scale (EPDS) scores 10-13
Key exclusion criteria (4 listed)
- A positive response in items about suicidal thoughts if applicable ("Yes, quite often" and "sometimes" in EPDS) (These participants will be referred to suicidal management)
- Those mental conditions that require other treatment priorities (e.g., suicidal risk, substance abuse, current or past episodes of psychotic disorder, personality disorders)
- Those medical conditions that severely limit participation, comprehension, or adherence to treatment (e.g., epilepsy, dementia, terminal medical illness)
- Those who are receiving structured psychotherapy or counseling
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 |
|---|---|---|
| Group Coaching4 sessions of 1-1.5-hour group coaching intervention within 8 weeks | Behavioural | Group coaching |
| SMS self-help tips4 mental well-being tips through sms within 8 weeks | Behavioural | SMS Self-help tips |
Primary outcome
Depressive symptoms
Time frame: immediate post-intervention
Measured by the depression subscale of the Depression, Anxiety and Stress Scale
Anxiety symptoms
Time frame: immediate post-intervention
Measured by the anxiety subscale of the Depression, Anxiety and Stress Scale
2 secondary outcomes
Depressive symptoms
Time frame: 3-month post intervention
Anxiety symptoms
Time frame: 3-month post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- 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 YH Chen, MD study director
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 Group Coaching and SMS self-help tips in people with Common Mental Disorder, 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 5 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 20 Apr 2021. 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 Suen YN, PhD (22554486, suenyn@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptoms (time frame: immediate post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2021.