Coaching Intervention in Women At-risk of Common Mental Disorders

Sponsor
The University of Hong Kong (Other)
Overall Status
Recruiting
CT.gov ID
NCT03751696
Collaborator
(none)
60
1
2
37.5
1.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Group Coaching
  • Behavioral: SMS self-help tips
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Nov 15, 2018
Anticipated Primary Completion Date :
Sep 30, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group coaching

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.

Behavioral: Group Coaching
4 sessions of 1-1.5-hour group coaching intervention within 8 weeks

Active Comparator: SMS Self-help tips

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.

Behavioral: SMS self-help tips
4 mental well-being tips through sms within 8 weeks

Outcome Measures

Primary Outcome Measures

  1. Depressive symptoms [immediate post-intervention]

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

  2. Anxiety symptoms [immediate post-intervention]

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

Secondary Outcome Measures

  1. Depressive symptoms [3-month post intervention]

    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.

  2. Anxiety symptoms [3-month post intervention]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 64 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 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Hong Kong Hong Kong Hong Kong 0000

Sponsors and Collaborators

  • The University of Hong Kong

Investigators

  • Study Director: Eric YH Chen, MD, The University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Professor Eric Y.H. Chen, Chair Professor, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT03751696
Other Study ID Numbers:
  • CoachingRCT
First Posted:
Nov 23, 2018
Last Update Posted:
Apr 20, 2021
Last Verified:
Apr 1, 2021
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 Apr 20, 2021