Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Coaching Intervention in Women At-risk of Depressive Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03751696
Recruitment Status : Not yet recruiting
First Posted : November 22, 2018
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Professor Eric Y.H. Chen, The University of Hong Kong

Brief Summary:
This study aims to provide preventative intervention to more than 500 women who are at risk of depressive disorders in Hong Kong using validated screening tool.

Condition or disease Intervention/treatment Phase
Depressive Disorder Behavioral: Group Coaching Behavioral: 'General wellbeing' class (GMWP) Not Applicable

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 general mental well-being group. To test the effectiveness of the provided intervention programs, symptoms and cognitive assessments and data collection on demographics and psychosocial data will be carried out during baseline, immediately after 8 weeks, 6 months and 12 months post-intervention.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 510 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 Depressive Disorders in Hong Kong: A Randomized Controlled Trials
Estimated Study Start Date : November 15, 2018
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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 2.5 hours. The sessions will be conducted by experienced social workers.
Behavioral: Group Coaching
4 sessions of 2.5-hour group coaching intervention within 8 weeks

Active Comparator: 'General wellbeing' class (GMWP)
The participants in the control group will receive four group sessions in a group of 6. Each session will also last for approximately 2.5 hours. The content of the classes includes workshop related to on self-compassion, body-mind-spirit, social relationship, career, family and peer support groups. The classes will be executed by the non-governmental organizations which the project can identify for collaboration.
Behavioral: 'General wellbeing' class (GMWP)
4 sessions of 2.5-hour 'general wellbeing' class within 8 weeks




Primary Outcome Measures :
  1. Level of well-being [ Time Frame: Change from baseline to immediate post-intervention ]
    Measured by The Chinese version of Warwick Edinburgh Mental Wellbeing Scale (CWEMWS). The CWEMWS consists of 14 questions, the response ranges from 1 (none of the time) to 5 (all of the time). The higher score represents the better mental well-being

  2. Level of well-being [ Time Frame: Change from baseline to 6-month post-intervention ]
    Measured by The Chinese version of Warwick Edinburgh Mental Wellbeing Scale (CWEMWS). The CWEMWS consists of 14 questions, the response ranges from 1 (none of the time) to 5 (all of the time). The higher score represents the better mental well-being

  3. Level of well-being [ Time Frame: Change from baseline to 12-month post-intervention ]
    Measured by The Chinese version of Warwick Edinburgh Mental Wellbeing Scale (CWEMWS). The CWEMWS consists of 14 questions, the response ranges from 1 (none of the time) to 5 (all of the time). The higher score represents the better mental well-being

  4. Conversion rate from incipient depression to depression [ Time Frame: 12-month post-intervention ]
    Proportion of subjects developed depression


Secondary Outcome Measures :
  1. Depressive symptoms [ Time Frame: immediate, 6-month, and 12-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. Level of self-efficacy [ Time Frame: immediate, 6-month, and 12-month post intervention ]
    Measured by General Self-Efficacy Scale (GSE). The GSE consists of 10 questions, each response ranges from 1 (totally incorrect) to 4 (totally correct). The higher score represents better self-efficacy.

  3. Health-related quality of life [ Time Frame: immediate, 6-month, and 12-month post intervention ]
    Measured by 12-Item Short Form Health Survey (SF-12)

  4. Functioning [ Time Frame: immediate, 6-month, and 12-month post intervention ]
    Measured by Social and Occupational Functioning Assessment Scale (SOFAS) and Role Functioning Scale (RFS). The SOFAS is an observer rating scale. Ratings should be based on subject's behavior during the last 1 month. The score ranges from 0-100. A higher score represents a better outcome. The RFS is comprised of four single rating scaled for evaluating the functioning of individuals in specified areas of everyday life. The four role functions assessed are:(1)Working: productivity, (2) Independent living and self care, (3) Immediate social network relationships, and (4) Extended social network relationship. The values on each of the four scales range from 1 (minimal level of role functioning), to 7 (hypothetically optimal level of role functioning). Each of the seven points on the scales is accompanied by a behaviorally defined description. The two scales will be evaluated separately.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Adult women
Accepts Healthy Volunteers:   No
Criteria

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
  • Edinburgh Postnatal Depression Scale (EPDS) scores 10-13

Exclusion Criteria:

  • A positive response in items about suicidal thoughts ("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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03751696


Contacts
Layout table for location contacts
Contact: Suen YN, PhD 22554486 suenyn@hku.hk
Contact: Chan Yuk Yu 22554486 vinciyy@connect.hku.hk

Sponsors and Collaborators
The University of Hong Kong
Investigators
Layout table for investigator information
Study Director: Eric YH Chen, MD The University of Hong Kong

Layout table for additonal information
Responsible Party: Professor Eric Y.H. Chen, Chair Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03751696     History of Changes
Other Study ID Numbers: CoachingRCT
First Posted: November 22, 2018    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Depressive Disorder
Depression
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms