Coaching Intervention in Women At-risk of Common Mental Disorders

NCT ID: NCT03751696

Last Updated: 2021-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-15

Study Completion Date

2021-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Common Mental Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Group Coaching

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

SMS self-help tips

Intervention Type BEHAVIORAL

4 mental well-being tips through sms within 8 weeks

Interventions

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Group Coaching

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

Intervention Type BEHAVIORAL

SMS self-help tips

4 mental well-being tips through sms within 8 weeks

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Professor Eric Y.H. Chen

Chair Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric YH Chen, MD

Role: STUDY_DIRECTOR

The University of Hong Kong

Locations

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University of Hong Kong

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Suen YN, PhD

Role: CONTACT

Chan Yuk Yu

Role: CONTACT

Facility Contacts

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Yi Nam Suen

Role: primary

Other Identifiers

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CoachingRCT

Identifier Type: -

Identifier Source: org_study_id

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