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Coaching Intervention in Women At-risk for Common Mental Disorders

Primary Purpose

Common Mental Disorders

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Coaching
Self-help tips plus telephone support
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Common Mental Disorders

Eligibility Criteria

18 Years - 69 Years (Adult, Older 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 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

Sites / Locations

  • University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Coaching

Self-help tips plus telephone support

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
November 16, 2020
Last Updated
May 22, 2022
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04637971
Brief Title
Coaching Intervention in Women At-risk for Common Mental Disorders
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
February 1, 2022 (Actual)

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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Coaching
Arm Type
Experimental
Arm Description
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.
Arm Title
Self-help tips plus telephone support
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Coaching
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Self-help tips plus telephone support
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in depressive symptoms
Description
Score of depression subscale of Depression, Anxiety and Stress Scale (DASS) at 6-month post-intervention will be compared with that at baseline.
Time Frame
6-month post-intervention
Title
Changes in anxiety symptoms
Description
Score of anxiety subscale of Depression, Anxiety and Stress Scale (DASS) at 6-month post-intervention will be compared with that at baseline.
Time Frame
6-month post-intervention
Secondary Outcome Measure Information:
Title
Changes in depressive symptoms
Description
Score of depression subscale of Depression, Anxiety and Stress Scale (DASS) immediate and 3-month post-intervention will be compared with that at baseline.
Time Frame
Immediate and 3-month post-intervention
Title
Changes in anxiety symptoms
Description
Score of anxiety subscale of Depression, Anxiety and Stress Scale (DASS) immediate and 3-month post-intervention will be compared with that at baseline.
Time Frame
Immediate and 3-month post-intervention
Title
Changes in quality of life
Description
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.
Time Frame
Immediate, 3- and 6-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
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Nam Suen, PhD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Hong Kong
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No

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Coaching Intervention in Women At-risk for Common Mental Disorders

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