Coaching Intervention in Women At-risk for Common Mental Disorders

Common Mental Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04637971
• Other study ID #: iCMD_Coaching_RCT
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: February 1, 2022

Study information

• Verified date: May 2022
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Common Mental Disorders
• Mental Disorders
• Psychotic Disorders

Intervention

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.
• 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.

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	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
Primary	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	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
Secondary	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
Secondary	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