Coaching Intervention in Women At-risk of Common Mental Disorders

Study Overview
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Brief Summary
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This study aims to provide preventative intervention to 60 women who are at risk of common mental disorders in Hong Kong.

Detailed Description
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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.

Official Title
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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

Conditions
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Common Mental Disorder

Intervention / Treatment
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* Behavioral: Group Coaching
* Behavioral: SMS self-help tips


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group coaching<br>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. | Behavioral: Group Coaching<br>* 4 sessions of 1-1.5-hour group coaching intervention within 8 weeks<br>|
| Active Comparator: SMS Self-help tips<br>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. | Behavioral: SMS self-help tips<br>* 4 mental well-being tips through sms within 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive symptoms | Measured by the depression subscale of the Depression, Anxiety and Stress Scale | immediate post-intervention | 
| Anxiety symptoms | Measured by the anxiety subscale of the Depression, Anxiety and Stress Scale | immediate post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3-month post intervention | 
| Anxiety symptoms | Measured by the anxiety subscale of the Depression, Anxiety and Stress Scale | 3-month post intervention |