NCT03751696

Brief Summary

This study aims to provide preventative intervention to 60 women who are at risk of common mental disorders in Hong Kong.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

November 15, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 23, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 20, 2021

Status Verified

April 1, 2021

Enrollment Period

2.9 years

First QC Date

November 10, 2018

Last Update Submit

April 18, 2021

Conditions

Common Mental Disorder

Outcome Measures

Primary Outcomes (2)

  • Depressive symptoms

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

    immediate post-intervention

  • Anxiety symptoms

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

    immediate post-intervention

Secondary Outcomes (2)

  • Depressive symptoms

    3-month post intervention

  • Anxiety symptoms

    3-month post intervention

Study Arms (2)

Group coaching

EXPERIMENTAL

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

SMS Self-help tips

ACTIVE COMPARATOR

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

Interventions

Group CoachingBEHAVIORAL

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

Group coaching
SMS self-help tipsBEHAVIORAL

4 mental well-being tips through sms within 8 weeks

SMS Self-help tips

Eligibility Criteria

Age18 Years - 64 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAdult women
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hong Kong

Hong Kong, 0000, Hong Kong

RECRUITING

Study Officials

  • Eric YH Chen, MD

    The University of Hong Kong

    STUDY DIRECTOR

Central Study Contacts

Suen YN, PhD

CONTACT

22554486suenyn@hku.hk

Chan Yuk Yu

CONTACT

22554486vinciyy@connect.hku.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair Professor

Study Record Dates

First Submitted

November 10, 2018

First Posted

November 23, 2018

Study Start

November 15, 2018

Primary Completion

September 30, 2021

Study Completion

December 31, 2021

Last Updated

April 20, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)