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Coaching Intervention in Women At-risk of Common Mental Disorders

Primary Purpose

Common Mental Disorder

Status

Unknown status

Phase

Not Applicable

Locations

Hong Kong

Study Type

Interventional

Intervention

Group Coaching

SMS self-help tips

About this trial

This is an interventional treatment trial for Common Mental Disorder

Eligibility Criteria

18 Years - 64 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group coaching

SMS Self-help tips

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Depressive symptoms

Measured by the depression subscale of the Depression, Anxiety and Stress Scale

Anxiety symptoms

Measured by the anxiety subscale of the Depression, Anxiety and Stress Scale

Secondary Outcome Measures

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.

Anxiety symptoms

Measured by the anxiety subscale of the Depression, Anxiety and Stress Scale

Full Information

NCT ID

NCT03751696

First Posted

November 10, 2018

Last Updated

April 18, 2021

Sponsor

The University of Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT03751696

Brief Title

Coaching Intervention in Women At-risk of Common Mental Disorders

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Unknown status

Study Start Date

November 15, 2018 (Actual)

Primary Completion Date

September 30, 2021 (Anticipated)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Common Mental Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group coaching

Arm Type

Experimental

Arm Description

Arm Title

SMS Self-help tips

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Group Coaching

Intervention Description

4 sessions of 1-1.5-hour group coaching intervention within 8 weeks

Intervention Type

Behavioral

Intervention Name(s)

SMS self-help tips

Intervention Description

4 mental well-being tips through sms within 8 weeks

Primary Outcome Measure Information:

Title

Depressive symptoms

Description

Measured by the depression subscale of the Depression, Anxiety and Stress Scale

Time Frame

immediate post-intervention

Title

Anxiety symptoms

Description

Measured by the anxiety subscale of the Depression, Anxiety and Stress Scale

Time Frame

immediate post-intervention

Secondary Outcome Measure Information:

Title

Depressive symptoms

Description

Time Frame

3-month post intervention

Title

Anxiety symptoms

Description

Measured by the anxiety subscale of the Depression, Anxiety and Stress Scale

Time Frame

3-month post intervention

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Adult women

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Suen YN, PhD

Phone

22554486

suenyn@hku.hk

First Name & Middle Initial & Last Name or Official Title & Degree

Chan Yuk Yu

Phone

22554486

vinciyy@connect.hku.hk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eric YH Chen, MD

Organizational Affiliation

The University of Hong Kong

Official's Role

Study Director

Facility Information:

Facility Name

University of Hong Kong

City

Hong Kong

ZIP/Postal Code

0000

Country

Hong Kong

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yi Nam Suen

12. IPD Sharing Statement

Plan to Share IPD

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Coaching Intervention in Women At-risk of Common Mental Disorders

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