Coaching Intervention in Women At-risk for Common Mental Disorders

Sponsor
The University of Hong Kong (Other)
Overall Status
Completed
CT.gov ID
NCT04637971
Collaborator
(none)
60
1
2
14
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Coaching
  • Other: Self-help tips plus telephone support
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Dec 1, 2020
Actual Primary Completion Date :
Jan 1, 2022
Actual Study Completion Date :
Feb 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Changes in depressive symptoms [6-month post-intervention]

    Score of depression subscale of Depression, Anxiety and Stress Scale (DASS) at 6-month post-intervention will be compared with that at baseline.

  2. Changes in anxiety symptoms [6-month post-intervention]

    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

  1. Changes in depressive symptoms [Immediate and 3-month post-intervention]

    Score of depression subscale of Depression, Anxiety and Stress Scale (DASS) immediate and 3-month post-intervention will be compared with that at baseline.

  2. Changes in anxiety symptoms [Immediate and 3-month post-intervention]

    Score of anxiety subscale of Depression, Anxiety and Stress Scale (DASS) immediate and 3-month post-intervention will be compared with that at baseline.

  3. Changes in quality of life [Immediate, 3- and 6-month post-intervention]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 69 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Hong Kong Hong Kong Hong Kong

Sponsors and Collaborators

  • The University of Hong Kong

Investigators

  • Principal Investigator: Yi Nam Suen, PhD, The University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Yi-Nam Suen, Research Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT04637971
Other Study ID Numbers:
  • iCMD_Coaching_RCT
First Posted:
Nov 20, 2020
Last Update Posted:
May 24, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 24, 2022