<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/NCT03001063</url>
  </required_header>
  <id_info>
    <org_study_id>0762-05</org_study_id>
    <nct_id>NCT03001063</nct_id>
  </id_info>
  <brief_title>Mental Health in Adults and Children- Frugal Innovations (MAC-FI): Adult Depression Component</brief_title>
  <acronym>MAC-FI</acronym>
  <official_title>Mental Health in Adults and Children: Frugal Innovations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Simon Fraser University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Grand Challenges Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ministry of Labour - Invalids and Social Affairs</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Simon Fraser University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This stepped wedge, randomized controlled trial will test the effectiveness of a Supported&#xD;
      Self-Management intervention for depression among adults in Vietnam. The intervention will be&#xD;
      delivered at the community level in 8 Vietnamese provinces by primary care providers and&#xD;
      social workers. The intervention group will receive the Supported Self-Management&#xD;
      intervention, while the control group will receive enhanced treatment as usual. The primary&#xD;
      outcome measure for depression is the Self-Reporting Questionnaire-20 (SRQ-20). The World&#xD;
      Health Organization's Disability Assessment Scale (WHODAS 2.00 and the CAGE&#xD;
      (Concern/Cut-down, Anger, Guilt, and Eye-opener) measures are also used to assess functional&#xD;
      ability and alcohol misuse.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2016</start_date>
  <completion_date type="Actual">March 2019</completion_date>
  <primary_completion_date type="Actual">January 2019</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>Self-Reporting Questionnaire 20 (SRQ-20)</measure>
    <time_frame>Two months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>World Health Organization's Disability Assessment Scale (WHODAS 2.0)</measure>
    <time_frame>Two months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">376</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm will receive the Supported Self- Management intervention, which consists of bibliotherapy that is provided with the regular support of health or social workers for a duration of two months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This arm will receive enhanced treatment as usual, which consists of a leaflet with information about depression and regular care as provided by primary care centres. The control arm will receive the intervention after the intervention arm has completed the intervention period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Supported Self-Management</intervention_name>
    <description>This Supported Self-Management intervention consists of bibliotherapy (the Antidepressant Skills Workshop) that is provided to a patient by a health or social worker. The patient is supported in the use of the skills found in the workbook over the course of two months. The skills in the workbook are based on the principles of Cognitive Behavioural Therapy.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Enhanced treatment as usual</intervention_name>
    <description>Participants in the control arm will received enhanced treatment as usual in the form of usual care at primary care centres and a leaflet providing information about depression.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Score of &gt;7 on SRQ-20 indicating depression caseness&#xD;
&#xD;
          -  Consent to participate and complete all measures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cognitive disturbance&#xD;
&#xD;
          -  Psychotic symptoms&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John O'Neil, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Simon Fraser University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Vu Cong Nguyen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Population, Health and Development</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute of Population, Health and Development</name>
      <address>
        <city>Hanoi</city>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Vietnam</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>May 26, 2022</last_update_submitted>
  <last_update_submitted_qc>May 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Simon Fraser University</investigator_affiliation>
    <investigator_full_name>John O'Neil</investigator_full_name>
    <investigator_title>Dean, Faculty of Health Sciences</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <!-- 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/NCT03001063
org study id: 0762-05
nct id: NCT03001063
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
This stepped wedge, randomized controlled trial will test the effectiveness of a Supported
      Self-Management intervention for depression among adults in Vietnam. The intervention will be
      delivered at the community level in 8 Vietnamese provinces by primary care providers and
      social workers. The intervention group will receive the Supported Self-Management
      intervention, while the control group will receive enhanced treatment as usual. The primary
      outcome measure for depression is the Self-Reporting Questionnaire-20 (SRQ-20). The World
      Health Organization's Disability Assessment Scale (WHODAS 2.00 and the CAGE
      (Concern/Cut-down, Anger, Guilt, and Eye-opener) measures are also used to assess functional
      ability and alcohol misuse.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Self-Reporting Questionnaire 20 (SRQ-20)
time frame: Two months
measure: World Health Organization's Disability Assessment Scale (WHODAS 2.0)
time frame: Two months
arm group label: Intervention
arm group type: Experimental
description: This arm will receive the Supported Self- Management intervention, which consists of bibliotherapy that is provided with the regular support of health or social workers for a duration of two months.
arm group label: Control
arm group type: Other
description: This arm will receive enhanced treatment as usual, which consists of a leaflet with information about depression and regular care as provided by primary care centres. The control arm will receive the intervention after the intervention arm has completed the intervention period.
intervention type: Other
intervention name: Supported Self-Management
description: This Supported Self-Management intervention consists of bibliotherapy (the Antidepressant Skills Workshop) that is provided to a patient by a health or social worker. The patient is supported in the use of the skills found in the workbook over the course of two months. The skills in the workbook are based on the principles of Cognitive Behavioural Therapy.
arm group label: Intervention
intervention type: Other
intervention name: Enhanced treatment as usual
description: Participants in the control arm will received enhanced treatment as usual in the form of usual care at primary care centres and a leaflet providing information about depression.
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John O'Neil, PhD
role: Principal Investigator
affiliation: Simon Fraser University
last name: Vu Cong Nguyen, MD
role: Principal Investigator
affiliation: Institute of Population, Health and Development
facility: 
country: Vietnam
responsible party type: Principal Investigator
investigator affiliation: Simon Fraser University
investigator full name: John O'Neil
investigator title: Dean, Faculty of Health Sciences
mesh term: Depression
mesh term: Depressive Disorder