<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03751696</url>
  </required_header>
  <id_info>
    <org_study_id>CoachingRCT</org_study_id>
    <nct_id>NCT03751696</nct_id>
  </id_info>
  <brief_title>Coaching Intervention in Women At-risk of Common Mental Disorders</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Hong Kong</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to provide preventative intervention to 60 women who are at risk of common&#xD;
      mental disorders in Hong Kong.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be recruited through the following routes: 1) by our partner&#xD;
      non-governmental organizations, 2) by our research team through community outreach or&#xD;
      training activities, 3) online screening tool, and 4) referral from organizations that&#xD;
      provide service to women (e.g., Maternal and Child Health Clinics of Department of Health).&#xD;
      Eligible subjects with informed consent provided will be randomly assigned to coaching group&#xD;
      or SMS self-help tips. To test the effectiveness of the provided intervention programs,&#xD;
      symptoms assessments and data collection on demographics and psychosocial data will be&#xD;
      carried out during baseline, immediately, and 3 months post-intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 15, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Depressive symptoms</measure>
    <time_frame>immediate post-intervention</time_frame>
    <description>Measured by the depression subscale of the Depression, Anxiety and Stress Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety symptoms</measure>
    <time_frame>immediate post-intervention</time_frame>
    <description>Measured by the anxiety subscale of the Depression, Anxiety and Stress Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Depressive symptoms</measure>
    <time_frame>3-month post intervention</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety symptoms</measure>
    <time_frame>3-month post intervention</time_frame>
    <description>Measured by the anxiety subscale of the Depression, Anxiety and Stress Scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Common Mental Disorder</condition>
  <arm_group>
    <arm_group_label>Group coaching</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SMS Self-help tips</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group Coaching</intervention_name>
    <description>4 sessions of 1-1.5-hour group coaching intervention within 8 weeks</description>
    <arm_group_label>Group coaching</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SMS self-help tips</intervention_name>
    <description>4 mental well-being tips through sms within 8 weeks</description>
    <arm_group_label>SMS Self-help tips</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willing to provide written informed consent&#xD;
&#xD;
          -  Able to understand Cantonese and read/write Chinese&#xD;
&#xD;
          -  With subsyndromal or minor depressive symptoms indicated by&#xD;
&#xD;
          -  Depression subscale of Depression, Anxiety and Stress Scale (DASS) score 10-20 or&#xD;
&#xD;
          -  Edinburgh Postnatal Depression Scale (EPDS) scores 10-13&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A positive response in items about suicidal thoughts if applicable (&quot;Yes, quite often&quot;&#xD;
             and &quot;sometimes&quot; in EPDS) (These participants will be referred to suicidal management)&#xD;
&#xD;
          -  Those mental conditions that require other treatment priorities (e.g., suicidal risk,&#xD;
             substance abuse, current or past episodes of psychotic disorder, personality&#xD;
             disorders)&#xD;
&#xD;
          -  Those medical conditions that severely limit participation, comprehension, or&#xD;
             adherence to treatment (e.g., epilepsy, dementia, terminal medical illness)&#xD;
&#xD;
          -  Those who are receiving structured psychotherapy or counseling&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Adult women</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric YH Chen, MD</last_name>
    <role>Study Director</role>
    <affiliation>The University of Hong Kong</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Suen YN, PhD</last_name>
    <phone>22554486</phone>
    <email>suenyn@hku.hk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Chan Yuk Yu</last_name>
    <phone>22554486</phone>
    <email>vinciyy@connect.hku.hk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <zip>0000</zip>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yi Nam Suen</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>November 10, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>April 18, 2021</last_update_submitted>
  <last_update_submitted_qc>April 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Professor Eric Y.H. Chen</investigator_full_name>
    <investigator_title>Chair Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Psychotic Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03751696
org study id: CoachingRCT
nct id: NCT03751696
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to provide preventative intervention to 60 women who are at risk of common
      mental disorders in Hong Kong.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Depressive symptoms
time frame: immediate post-intervention
description: Measured by the depression subscale of the Depression, Anxiety and Stress Scale
measure: Anxiety symptoms
time frame: immediate post-intervention
description: Measured by the anxiety subscale of the Depression, Anxiety and Stress Scale
measure: Depressive symptoms
time frame: 3-month post intervention
description: 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.
measure: Anxiety symptoms
time frame: 3-month post intervention
description: Measured by the anxiety subscale of the Depression, Anxiety and Stress Scale
arm group label: Group coaching
arm group type: Experimental
description: 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.
arm group label: SMS Self-help tips
arm group type: Active Comparator
description: 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.
intervention type: Behavioral
intervention name: Group Coaching
description: 4 sessions of 1-1.5-hour group coaching intervention within 8 weeks
arm group label: Group coaching
intervention type: Behavioral
intervention name: SMS self-help tips
description: 4 mental well-being tips through sms within 8 weeks
arm group label: SMS Self-help tips
criteria: 
gender: Female
gender based: Yes
gender description: Adult women
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: No
last name: Eric YH Chen, MD
role: Study Director
affiliation: The University of Hong Kong
last name: Suen YN, PhD
phone: 22554486
email: suenyn@hku.hk
last name: Chan Yuk Yu
phone: 22554486
email: vinciyy@connect.hku.hk
facility: 
status: Recruiting
contact: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: The University of Hong Kong
investigator full name: Professor Eric Y.H. Chen
investigator title: Chair Professor
mesh term: Mental Disorders
mesh term: Psychotic Disorders
sharing ipd: No