NCT04637971

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

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 16, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2020

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

May 24, 2022

Status Verified

May 1, 2022

Enrollment Period

1.1 years

First QC Date

November 16, 2020

Last Update Submit

May 22, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • Changes in depressive symptoms

    Immediate and 3-month post-intervention

  • Changes in anxiety symptoms

    Immediate and 3-month post-intervention

  • Changes in quality of life

    Immediate, 3- and 6-month post-intervention

Study Arms (2)

Coaching

EXPERIMENTAL

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

Self-help tips plus telephone support

ACTIVE COMPARATOR

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

Interventions

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.

Coaching

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.

Self-help tips plus telephone support

Eligibility Criteria

Age18 Years - 69 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAdult women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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, Hong Kong

Location

Study Officials

  • Yi Nam Suen, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

November 16, 2020

First Posted

November 20, 2020

Study Start

December 1, 2020

Primary Completion

January 1, 2022

Study Completion

February 1, 2022

Last Updated

May 24, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations