Coaching Intervention in Women At-risk of Common Mental Disorders

Common Mental Disorder Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03751696
• Other study ID #: CoachingRCT
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2021
• Source: The University of Hong Kong
• Contact: Suen YN, PhD
• Phone: 22554486
• Email: suenyn[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Common Mental Disorder
• Mental Disorders
• Psychotic Disorders

Intervention

Behavioral:
• Group Coaching
4 sessions of 1-1.5-hour group coaching intervention within 8 weeks
• SMS self-help tips
4 mental well-being tips through sms within 8 weeks

Locations

Country	Name	City	State
Hong Kong	University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive symptoms	Measured by the depression subscale of the Depression, Anxiety and Stress Scale	immediate post-intervention
Primary	Anxiety symptoms	Measured by the anxiety subscale of the Depression, Anxiety and Stress Scale	immediate post-intervention
Secondary	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
Secondary	Anxiety symptoms	Measured by the anxiety subscale of the Depression, Anxiety and Stress Scale	3-month post intervention