<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/NCT04491045</url>
  </required_header>
  <id_info>
    <org_study_id>1R01MH112630-01A1</org_study_id>
    <nct_id>NCT04491045</nct_id>
  </id_info>
  <brief_title>Implementation Strategies for Task-Shifting Depression Care Depression Care in Vietnam</brief_title>
  <official_title>Randomized Control Trial on Implementation Strategies for Task-Shifting Depression Care in Vietnam</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>City University of New York, School of Public Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hanoi University of Public Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>City University of New York, School of Public Health</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>
      The study is a Hybrid Implementation-Effectiveness study that will primarily test the&#xD;
      implementation strategies on provider adoption and implementation quality in three Vietnam&#xD;
      provinces. Secondarily, the effectiveness of the multicomponent collaborative care model for&#xD;
      depression intervention on patient outcomes will be tested. A cluster randomized control&#xD;
      trial design, with a mixed-methods approach, will be used to assess the effectiveness of the&#xD;
      three implementation strategies on both organizational and provider implementation outcomes&#xD;
      and patient effectiveness outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Depression is a prevalent and debilitating mental health condition that is relatively common&#xD;
      in almost all countries around the world, including Vietnam, and is one of the largest&#xD;
      burdens of health. Although effective treatments exist, many with depression do not receive&#xD;
      appropriate care. In Vietnam, numerous barriers exist to implementation of evidence-based&#xD;
      mental health services but recently there has been growing recognition of the need to address&#xD;
      the treatment gap. In order to close the treatment gap for depression, within the health care&#xD;
      system, effective depression care needs to be scaled up to a wider network of community&#xD;
      health stations that are supported by the local psychiatric hospitals. However, it is unclear&#xD;
      what the best implementation model is for supporting depression care in primary care&#xD;
      settings.&#xD;
&#xD;
      The aim of this project is to compare three different models of implementation support for&#xD;
      depression care in two Vietnam provinces: 1) Supported Implementation when implementation&#xD;
      support is provided and 2) Sustainment Phases, when study funded implementation supports are&#xD;
      withdrawn. The providers in select community health stations (CHSs) within these two&#xD;
      provinces) will receive training workshops and varying levels of implementation support based&#xD;
      on the implementation models (described below) to provide depression care to their patients.&#xD;
      The three models are : 1) Usual Implementation (UI) - a basic depression workshop, limited&#xD;
      technical assistance to set up the program, and implementation toolkits 2) Enhanced&#xD;
      Supervision (ES) - UI + ongoing structured supportive supervision; and 3) Community Engaged&#xD;
      Learning Collaborative (CELC) - ES + community collaborative learning.&#xD;
&#xD;
      The three models will be evaluated based on the RE-AIM framework, which will be assessed&#xD;
      using implementation and patient outcomes across supported implementation phase and&#xD;
      sustainment phase. Both implementation and patient outcomes will be assessed during the&#xD;
      sustainment phase after resources are withdrawn to evaluate the sustainability of the&#xD;
      program. Knowledge gained from this project will be used to inform implementation of&#xD;
      depression care services across Vietnam, and help increase access and quality of depression&#xD;
      care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 1, 2021</start_date>
  <completion_date type="Anticipated">December 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</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>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>All participants are offered depression care services at the CHS, therefore participants are not aware of the different implementation supports provided to the supervisors.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Provider Adoption of Project Dep and Depression Care- Count</measure>
    <time_frame>24 months</time_frame>
    <description>Delivery of Project Dep and depression care components (Counts of depression care components delivered - # of screening, assessment, individual therapy, medication).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Provider Adoption of LIFE-DM and Depression Care - Percentage</measure>
    <time_frame>24 months</time_frame>
    <description>Delivery of Project Dep and depression care components (% of depression care components delivered - screening, assessment, individual therapy, medication).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Provider Competence Scores</measure>
    <time_frame>24 months</time_frame>
    <description>Providers will be assessed by their supervisors for their overall competence in delivering the components of depression care every 6 months for 24 months. There are 18 items related to depression care skills (e.g., screening, psychoeducation, behavior activation, problem solving, medication management, etc.), Each item is scored on a 3 point scale from 1 to 3 (1-needs improvement, 2-satisfactory, 3-excellent). A total of 54 points can be obtained, with higher score indicating higher competence. N/A is used when a particular skill is not expected of that provider (i.e., community health workers are not expected to assess or manage medication). These ratings are conducted by supervisors at 0, 6, 12, and 24 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Depression Scores (PHQ) Change from Baseline to 6 month</measure>
    <time_frame>6 months</time_frame>
    <description>Patients will be assessed for depression using self-reported depression measure (PHQ). The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as &quot;0&quot; (not at all) to &quot;3&quot; (nearly every day). Total scores are used and they range from 0 to 27, with PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Provider Participation</measure>
    <time_frame>12 months</time_frame>
    <description>Provider Participation in Training Activities (Count / % of workshop attendance, supervision meetings, and learning collaborative meetings).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Provider Implementation Quality</measure>
    <time_frame>24 months</time_frame>
    <description>Supervisor Rated LIFE-DM session adherence and quality. Supervision of groups involve observation of group facilitation by supervisors, who provide adherence and quality ratings of sessions. Each item is assessed on a 4 point scale - 0 (did not do), 1 (delivered but poor), 2 (average), and 3 (excellent). The items are averaged to provide a session speciﬁc score of adherence and quality. Session adherence /quality scores are used to compute provider level adherence and quality averages. Each supervisor was expected to provide ratings for a minimum of 3 assessments out of the 12 group sessions. These session ratings are used to compute the average adherence and quality score for each provider. Higher scores indicate higher adherence and quality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implementation Barriers and Facilitators</measure>
    <time_frame>24 months</time_frame>
    <description>Qualitative Interviews of Providers and Program Staff to Assess Barriers and Facilitators of Implementation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Patient Functioning</measure>
    <time_frame>6 months</time_frame>
    <description>Patient - SF-12 - Change in functioning from baseline to 6 months. The SF-12 Health Survey is a 12-item subset of the SF-36v2™ that measures the same eight domains of health (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, Mental Health). It is a brief, reliable measure of overall health status. Scores are calibrated so that 50 is the average score or norm. This norm-based score allows comparison among the three surveys and across the more than 19,000 studies published in the past 20 years.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Patient Family Functioning</measure>
    <time_frame>6 months</time_frame>
    <description>Patient - McMaster Family Functioning Scale - Change from baseline to 6 months. This is a 12 item scale (on a 4 point scale). the average score across items is used to determine the degree of problematic family functioning. A score of 2.00 or above indicates problematic family functioning. The higher the score, the more problematic the family member perceives the family's overall functioning.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">918</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Community-Engaged Learning Collaborative (CELC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The CELC arm is an integration of community engagement and learning collaborative approach which involves province-wide collaborative meetings for commune health stations (6 CHSs for each province) randomized into the CELC implementation condition. CELC CHSs will meet monthly initially for 3 months, followed by bi-monthly meetings for 12 months to engage in continuous quality improvement process, track implementation goals, problem solve implementation barriers, and engage in cross-site learning. This is in addition to usual implementation condition (supervision, workshops, technical assistance, and evidence-based toolkit)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced Supervision (ES)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is an evidence-based training approach which involves 6-9 months of ongoing group supervision support from psychiatric hospital mental health specialist (psychiatrist, psychiatric nurse, or psychologist) for each community health station randomized to the ES condition. Supervision approach is structured and involves observation of sessions, feedback on fidelity and quality. Supervision support will be provided biweekly initially and monthly after completion of one practice case. This is in addition to usual implementation condition (workshops, technical assistance, and evidence-based toolkit)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Implementation (UI)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Usual Implementation (UI) Control intervention that will be enhanced usual implementation and includes hybrid training workshops on basic implementation and training supports for Multicomponent Collaborative Care for Depression program, which is an evidence-based stepped collaborative care intervention for integrating depression care into primary care settings. It consists of six components: routine screening, diagnostic assessment, psychoeducation, antidepressant medication, adherence management, behavior activation therapy.&#xD;
This implementation and training supports includes a series of online training modules, weekly webinars, and 3 one-day in-person workshops on collaborative care for depression (MCCD), limited technical assistance, and toolkit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Workshop Training on Multicomponent Collaborative Care for Depression</intervention_name>
    <description>Hybrid Workshop Trainings on Stepped collaborative care model for depression that involves using a team-based approach to integrating depression care components (screening, psychoeducation, Behavior Activation therapy, and antidepressant medications) into primary care settings. This integration involves task-shifting mental health tasks from mental health specialist to community providers at the commune health stations.</description>
    <arm_group_label>Community-Engaged Learning Collaborative (CELC)</arm_group_label>
    <arm_group_label>Enhanced Supervision (ES)</arm_group_label>
    <arm_group_label>Usual Implementation (UI)</arm_group_label>
    <other_name>Workshop Training on Stepped collaborative care program for depression</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Supervision</intervention_name>
    <description>Ongoing supervision and coaching is provided to community health providers by local mental health specialist from the provincial psychiatric hospital for 6-9 months</description>
    <arm_group_label>Community-Engaged Learning Collaborative (CELC)</arm_group_label>
    <arm_group_label>Enhanced Supervision (ES)</arm_group_label>
    <other_name>Coaching</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Community-Engaged Learning Collaborative</intervention_name>
    <description>The CELC group will receive support for continuous quality improvement using a province-wide learning collaborative that will meet monthly for 3 months, followed by bi-monthly meetings for 12 months.</description>
    <arm_group_label>Community-Engaged Learning Collaborative (CELC)</arm_group_label>
    <other_name>Continuous Quality Improvement</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patient Participants:&#xD;
&#xD;
          -  18-65 years of age&#xD;
&#xD;
          -  PHQ-9 score of 10 or above&#xD;
&#xD;
          -  Planning to receive care at an eligible community health station&#xD;
&#xD;
          -  Able to provide written informed consent&#xD;
&#xD;
        Provider Participants:&#xD;
&#xD;
        • General practitioners, nurses, social workers, and other qualified health care providers&#xD;
        at a selected community health station selected by CHS Directors for depression care&#xD;
        project.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patient Participants:&#xD;
&#xD;
          -  Psychosis&#xD;
&#xD;
          -  Mania&#xD;
&#xD;
          -  Substance Abuse&#xD;
&#xD;
          -  High suicide risk&#xD;
&#xD;
        Provider Participants: Cannot commit to full participation for the two year project period.&#xD;
        Examples of reasons for potential barriers to commitment include leaving due to pursuit of&#xD;
        advanced formal training at universities, anticipation of promotion or change in job&#xD;
        status, anticipation of relocation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Victoria Ngo, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CUNY Graduate School of Public Health and Health Policy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Minh V Hoang, MD</last_name>
    <role>Study Director</role>
    <affiliation>Hanoi University of Public Health</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Thinh Vu, MSc</last_name>
    <phone>646-309-7981</phone>
    <email>Thinh.Vu@sph.cuny.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Quan Vu, MA</last_name>
    <phone>(+84) 969758692</phone>
    <email>Quan.Vu@sph.cuny.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Commune Health Stations</name>
      <address>
        <city>Bắc Giang</city>
        <country>Vietnam</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ngoc Nguyen, MPH</last_name>
      <phone>(+84)972-962-358</phone>
      <email>nbn@huph.edu.vn</email>
    </contact>
    <investigator>
      <last_name>Minh V Hoang, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Commune Health Stations</name>
      <address>
        <city>Phú Thọ</city>
        <country>Vietnam</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ngoc Nguyen, MPH</last_name>
      <phone>(+84)972-962-358</phone>
      <email>nbn@huph.edu.vn</email>
    </contact>
    <investigator>
      <last_name>Minh V Hoang, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Vietnam</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>May 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>March 22, 2023</last_update_submitted>
  <last_update_submitted_qc>March 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>City University of New York, School of Public Health</investigator_affiliation>
    <investigator_full_name>Victoria Ngo</investigator_full_name>
    <investigator_title>Director of the Center for Innovation in Mental Health</investigator_title>
  </responsible_party>
  <keyword>Behavior Activation</keyword>
  <keyword>Problem solving therapy</keyword>
  <keyword>Depression Treatment</keyword>
  <keyword>Depression care integration</keyword>
  <keyword>Implementation research</keyword>
  <keyword>Task shifting</keyword>
  <keyword>Collaborative care</keyword>
  <keyword>Depression</keyword>
  <keyword>Depressive Disorder</keyword>
  <keyword>Behavioral Symptoms</keyword>
  <keyword>Mood Disorders</keyword>
  <keyword>Mental Disorders</keyword>
  <keyword>Antidepressive Agents</keyword>
  <keyword>Psychotropic Drugs</keyword>
  <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>
  <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/NCT04491045
org study id: 1R01MH112630-01A1
nct id: NCT04491045
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study is a Hybrid Implementation-Effectiveness study that will primarily test the
      implementation strategies on provider adoption and implementation quality in three Vietnam
      provinces. Secondarily, the effectiveness of the multicomponent collaborative care model for
      depression intervention on patient outcomes will be tested. A cluster randomized control
      trial design, with a mixed-methods approach, will be used to assess the effectiveness of the
      three implementation strategies on both organizational and provider implementation outcomes
      and patient effectiveness outcomes.
Depression is a prevalent and debilitating mental health condition that is relatively common
      in almost all countries around the world, including Vietnam, and is one of the largest
      burdens of health. Although effective treatments exist, many with depression do not receive
      appropriate care. In Vietnam, numerous barriers exist to implementation of evidence-based
      mental health services but recently there has been growing recognition of the need to address
      the treatment gap. In order to close the treatment gap for depression, within the health care
      system, effective depression care needs to be scaled up to a wider network of community
      health stations that are supported by the local psychiatric hospitals. However, it is unclear
      what the best implementation model is for supporting depression care in primary care
      settings.

      The aim of this project is to compare three different models of implementation support for
      depression care in two Vietnam provinces: 1) Supported Implementation when implementation
      support is provided and 2) Sustainment Phases, when study funded implementation supports are
      withdrawn. The providers in select community health stations (CHSs) within these two
      provinces) will receive training workshops and varying levels of implementation support based
      on the implementation models (described below) to provide depression care to their patients.
      The three models are : 1) Usual Implementation (UI) - a basic depression workshop, limited
      technical assistance to set up the program, and implementation toolkits 2) Enhanced
      Supervision (ES) - UI + ongoing structured supportive supervision; and 3) Community Engaged
      Learning Collaborative (CELC) - ES + community collaborative learning.

      The three models will be evaluated based on the RE-AIM framework, which will be assessed
      using implementation and patient outcomes across supported implementation phase and
      sustainment phase. Both implementation and patient outcomes will be assessed during the
      sustainment phase after resources are withdrawn to evaluate the sustainability of the
      program. Knowledge gained from this project will be used to inform implementation of
      depression care services across Vietnam, and help increase access and quality of depression
      care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Participant)
masking description: All participants are offered depression care services at the CHS, therefore participants are not aware of the different implementation supports provided to the supervisors.
measure: Provider Adoption of Project Dep and Depression Care- Count
time frame: 24 months
description: Delivery of Project Dep and depression care components (Counts of depression care components delivered - # of screening, assessment, individual therapy, medication).
measure: Provider Adoption of LIFE-DM and Depression Care - Percentage
time frame: 24 months
description: Delivery of Project Dep and depression care components (% of depression care components delivered - screening, assessment, individual therapy, medication).
measure: Change in Provider Competence Scores
time frame: 24 months
description: Providers will be assessed by their supervisors for their overall competence in delivering the components of depression care every 6 months for 24 months. There are 18 items related to depression care skills (e.g., screening, psychoeducation, behavior activation, problem solving, medication management, etc.), Each item is scored on a 3 point scale from 1 to 3 (1-needs improvement, 2-satisfactory, 3-excellent). A total of 54 points can be obtained, with higher score indicating higher competence. N/A is used when a particular skill is not expected of that provider (i.e., community health workers are not expected to assess or manage medication). These ratings are conducted by supervisors at 0, 6, 12, and 24 months.
measure: Patient Depression Scores (PHQ) Change from Baseline to 6 month
time frame: 6 months
description: Patients will be assessed for depression using self-reported depression measure (PHQ). The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Total scores are used and they range from 0 to 27, with PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively.
measure: Provider Participation
time frame: 12 months
description: Provider Participation in Training Activities (Count / % of workshop attendance, supervision meetings, and learning collaborative meetings).
measure: Provider Implementation Quality
time frame: 24 months
description: Supervisor Rated LIFE-DM session adherence and quality. Supervision of groups involve observation of group facilitation by supervisors, who provide adherence and quality ratings of sessions. Each item is assessed on a 4 point scale - 0 (did not do), 1 (delivered but poor), 2 (average), and 3 (excellent). The items are averaged to provide a session speciﬁc score of adherence and quality. Session adherence /quality scores are used to compute provider level adherence and quality averages. Each supervisor was expected to provide ratings for a minimum of 3 assessments out of the 12 group sessions. These session ratings are used to compute the average adherence and quality score for each provider. Higher scores indicate higher adherence and quality.
measure: Implementation Barriers and Facilitators
time frame: 24 months
description: Qualitative Interviews of Providers and Program Staff to Assess Barriers and Facilitators of Implementation
measure: Change in Patient Functioning
time frame: 6 months
description: Patient - SF-12 - Change in functioning from baseline to 6 months. The SF-12 Health Survey is a 12-item subset of the SF-36v2™ that measures the same eight domains of health (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, Mental Health). It is a brief, reliable measure of overall health status. Scores are calibrated so that 50 is the average score or norm. This norm-based score allows comparison among the three surveys and across the more than 19,000 studies published in the past 20 years.
measure: Change in Patient Family Functioning
time frame: 6 months
description: Patient - McMaster Family Functioning Scale - Change from baseline to 6 months. This is a 12 item scale (on a 4 point scale). the average score across items is used to determine the degree of problematic family functioning. A score of 2.00 or above indicates problematic family functioning. The higher the score, the more problematic the family member perceives the family's overall functioning.
arm group label: Community-Engaged Learning Collaborative (CELC)
arm group type: Experimental
description: The CELC arm is an integration of community engagement and learning collaborative approach which involves province-wide collaborative meetings for commune health stations (6 CHSs for each province) randomized into the CELC implementation condition. CELC CHSs will meet monthly initially for 3 months, followed by bi-monthly meetings for 12 months to engage in continuous quality improvement process, track implementation goals, problem solve implementation barriers, and engage in cross-site learning. This is in addition to usual implementation condition (supervision, workshops, technical assistance, and evidence-based toolkit)
arm group label: Enhanced Supervision (ES)
arm group type: Experimental
description: This is an evidence-based training approach which involves 6-9 months of ongoing group supervision support from psychiatric hospital mental health specialist (psychiatrist, psychiatric nurse, or psychologist) for each community health station randomized to the ES condition. Supervision approach is structured and involves observation of sessions, feedback on fidelity and quality. Supervision support will be provided biweekly initially and monthly after completion of one practice case. This is in addition to usual implementation condition (workshops, technical assistance, and evidence-based toolkit)
arm group label: Usual Implementation (UI)
arm group type: Active Comparator
description: Usual Implementation (UI) Control intervention that will be enhanced usual implementation and includes hybrid training workshops on basic implementation and training supports for Multicomponent Collaborative Care for Depression program, which is an evidence-based stepped collaborative care intervention for integrating depression care into primary care settings. It consists of six components: routine screening, diagnostic assessment, psychoeducation, antidepressant medication, adherence management, behavior activation therapy.
This implementation and training supports includes a series of online training modules, weekly webinars, and 3 one-day in-person workshops on collaborative care for depression (MCCD), limited technical assistance, and toolkit.
intervention type: Other
intervention name: Workshop Training on Multicomponent Collaborative Care for Depression
description: Hybrid Workshop Trainings on Stepped collaborative care model for depression that involves using a team-based approach to integrating depression care components (screening, psychoeducation, Behavior Activation therapy, and antidepressant medications) into primary care settings. This integration involves task-shifting mental health tasks from mental health specialist to community providers at the commune health stations.
arm group label: Community-Engaged Learning Collaborative (CELC)
arm group label: Enhanced Supervision (ES)
arm group label: Usual Implementation (UI)
other name: Workshop Training on Stepped collaborative care program for depression
intervention type: Other
intervention name: Supervision
description: Ongoing supervision and coaching is provided to community health providers by local mental health specialist from the provincial psychiatric hospital for 6-9 months
arm group label: Community-Engaged Learning Collaborative (CELC)
arm group label: Enhanced Supervision (ES)
other name: Coaching
intervention type: Other
intervention name: Community-Engaged Learning Collaborative
description: The CELC group will receive support for continuous quality improvement using a province-wide learning collaborative that will meet monthly for 3 months, followed by bi-monthly meetings for 12 months.
arm group label: Community-Engaged Learning Collaborative (CELC)
other name: Continuous Quality Improvement
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Victoria Ngo, PhD
role: Principal Investigator
affiliation: CUNY Graduate School of Public Health and Health Policy
last name: Minh V Hoang, MD
role: Study Director
affiliation: Hanoi University of Public Health
last name: Thinh Vu, MSc
phone: 646-309-7981
email: Thinh.Vu@sph.cuny.edu
last name: Quan Vu, MA
phone: (+84) 969758692
email: Quan.Vu@sph.cuny.edu
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
country: Vietnam
responsible party type: Principal Investigator
investigator affiliation: City University of New York, School of Public Health
investigator full name: Victoria Ngo
investigator title: Director of the Center for Innovation in Mental Health
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: No