Coaching Intervention in Women At-risk of Common Mental Disorders

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.

Study Overview

• Status: Recruiting
• Conditions: Common Mental Disorder
• Intervention / Treatment: Behavioral: Group Coaching; Behavioral: SMS self-help tips

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Suen YN, PhD; Phone Number: 22554486; Email: suenyn@hku.hk
• Study Contact Backup: Name: Chan Yuk Yu; Phone Number: 22554486; Email: vinciyy@connect.hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 0000
    • Recruiting
    • University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group coaching; 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; 4 sessions of 1-1.5-hour group coaching intervention within 8 weeks
ACTIVE_COMPARATOR: SMS Self-help tips; 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; 4 mental well-being tips through sms within 8 weeks

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Study Director: Eric YH Chen, MD, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 15, 2018
• Primary Completion (ANTICIPATED): September 30, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: November 10, 2018
• First Submitted That Met QC Criteria: November 21, 2018
• First Posted (ACTUAL): November 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 20, 2021
• Last Update Submitted That Met QC Criteria: April 18, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: CoachingRCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No