Coaching Intervention in Women At-risk for Common Mental Disorders

Coaching Intervention to Improve Mental Well-being of Community Women Who Are At-risk for Common Mental Disorders in Hong Kong: a Randomised Controlled Trial

This study aims to provide coaching intervention for prevention of developing common mental disorders to 60 at-risk women in Hong Kong.

Study Overview

• Status: Completed
• Conditions: Common Mental Disorders
• Intervention / Treatment: Other: Coaching; Other: Self-help tips plus telephone support

Detailed Description

Participants will be recruited through online screening tool. Eligible subjects with informed consent provided will be randomly assigned to coaching group or self-help tips plus telephone support group.

To test the effectiveness of the coaching intervention, data collection will be conducted on demographics, symptoms and psychosocial aspects at baseline, immediately, 3-month and 12-month post-intervention. A self-reported brief questionnaire will be administered at every intervention as well.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older 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 common mental disorders (CMD) indicated by 10 - 20 of Depression subscale of Depression, Anxiety and Stress Scale (DASS) or 8-14 of Anxiety subscale of DASS

Exclusion Criteria:

• 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: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Coaching; The present intervention is a structured, group-based coaching program that is facilitating an active process of change through the identification of achievable personal goals, the formulation of action plans, the provision of constructive feedback, and progressive monitoring of goal attainment.	Other: Coaching; Participants will receive 4 sessions of group coaching intervention within 6 weeks. Each session is in a group of 3-4 women and lasts for approximately 1.5 hours. The sessions will be conducted by experienced social workers.
Active Comparator: Self-help tips plus telephone support; Self-help tips including stress coping methods. Our project staff will contact the subject to encourage her to make use of the tips we sent her.	Other: Self-help tips plus telephone support; Participants will receive 4 self-help tips sent via SMS and 4 phone call from a social worker in 6-week of time. During the telephone call, the social worker will advise the client to make use of the tips we sent to her.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in depressive symptoms	Score of depression subscale of Depression, Anxiety and Stress Scale (DASS) at 6-month post-intervention will be compared with that at baseline.	6-month post-intervention
Changes in anxiety symptoms	Score of anxiety subscale of Depression, Anxiety and Stress Scale (DASS) at 6-month post-intervention will be compared with that at baseline.	6-month post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in depressive symptoms	Score of depression subscale of Depression, Anxiety and Stress Scale (DASS) immediate and 3-month post-intervention will be compared with that at baseline.	Immediate and 3-month post-intervention
Changes in anxiety symptoms	Score of anxiety subscale of Depression, Anxiety and Stress Scale (DASS) immediate and 3-month post-intervention will be compared with that at baseline.	Immediate and 3-month post-intervention
Changes in quality of life	Score of 12-Item Short Form Health Survey version 2 (SF-12 v2) immediate, 3- and 6-month post-intervention will be compared with that at baseline.	Immediate, 3- and 6-month post-intervention

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): February 1, 2022

Study Registration Dates

• First Submitted: November 16, 2020
• First Submitted That Met QC Criteria: November 16, 2020
• First Posted (Actual): November 20, 2020

Study Record Updates

• Last Update Posted (Actual): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 22, 2022
• Last Verified: May 1, 2022

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: iCMD_Coaching_RCT

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
• product manufactured in and exported from the U.S.: No