Coaching Intervention in Women At-risk of Common Mental Disorders

Not Applicable

• Conditions: Common Mental Disorder

• Registration Number: NCT03751696
• Lead Sponsor: The University of Hong Kong

Brief Summary

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 Timeline

• Study First Submitted: 2018-11-10
• Study Start: 2018-11-15
• Study First Submitted QC: 2018-11-21
• Study First Posted: 2018-11-23
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-18
• Last Update Posted: 2021-04-20
• Primary Completion: 2021-09-30
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Depressive symptoms	immediate post-intervention	Measured by the depression subscale of the Depression, Anxiety and Stress Scale
Anxiety symptoms	immediate post-intervention	Measured by the anxiety subscale of the Depression, Anxiety and Stress Scale

Secondary Outcome Measures

Name	Time	Method
Anxiety symptoms	3-month post intervention	Measured by the anxiety subscale of the Depression, Anxiety and Stress Scale
Depressive symptoms	3-month post intervention	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.

Trial Locations

Locations (1)

University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong