<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/NCT02232854</url>
  </required_header>
  <id_info>
    <org_study_id>1130230</org_study_id>
    <nct_id>NCT02232854</nct_id>
  </id_info>
  <brief_title>Training and Supervision Program for Depression Management</brief_title>
  <official_title>Comprehensive Technology-Assisted Training and Supervision Program to Enhance Depression Management in Primary Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chile</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Chile</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      According to the literature the management of depressive disorders at primary care level is&#xD;
      not always consistent with guidelines. The main objective of this study is to test whether a&#xD;
      Comprehensive Technology-Assisted Training and Supervision Program will improve depression&#xD;
      management in Primary Health Care clinics in Santiago, Chile.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A cluster randomized controlled clinical trial will be conducted in four Primary Health Care&#xD;
      (PHC) clinics in Santiago, Chile.&#xD;
&#xD;
      The sample selection of the PHC clinics will be performed in two steps. Firstly, two urban&#xD;
      municipalities of Santiago Metropolitan Region, Chile, will be randomly selected if they work&#xD;
      with the Faculty of Medicine of the U.Chile and have at least two PHC.Municipalities with a&#xD;
      high Human Development Index, high percentage of immigrants and older population, and&#xD;
      Psychiatry residents working in PHC , will be excluded.Secondly in each selected&#xD;
      municipalities,two PHC will be randomly selected for the active and control arm.&#xD;
&#xD;
      To detect a difference of 20%, in a one-sided model, with an alpha of 5% and power of 80%,&#xD;
      152 depressed persons, 76 to each group, will be required for the study. A design effect of&#xD;
      2.42 was estimated. After applying the design effect the sample needed increased to 368&#xD;
      depressed persons. Considering a retention rate of approximately 85%, 434 depressed cases&#xD;
      will be needed required for the study, hence 109 cases in each of the 4 primary health care&#xD;
      clinics.&#xD;
&#xD;
      Analysis and presentation of the results will be in accordance with CONSORT guidelines for&#xD;
      randomized clinical trials, with the primary comparative analysis being conducted on an&#xD;
      intention to treat basis and due emphasis placed on confidence intervals for the between-arm&#xD;
      comparisons.&#xD;
&#xD;
      Initially descriptive analysis to assess the balance between two groups will be conducted.&#xD;
      The primary analysis will employ multilevel multivariable lineal regression to investigate&#xD;
      differences in the PHQ-9 scores between groups at 3 and 6 months after randomization,&#xD;
      adjusting for baseline outcome variable scores. Sensitivity analysis making different&#xD;
      assumptions will be conducted to investigate the potential effects of missing data. Similar&#xD;
      analysis will be done for the secondary outcomes measures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline Depressive Symptomatology at 3 months</measure>
    <time_frame>Baseline , 3 months</time_frame>
    <description>Depressive symptomatology measured with the Patient Health Questionnaire - Nine Item (PHQ-9) at 3 months after patient recruitment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline Depressive Symptomatology at 6 months</measure>
    <time_frame>Baseline, 6 months.</time_frame>
    <description>Depressive symptomatology measured with the Patient Health Questionnaire - Nine Item (PHQ-9) at 6 months after patient recruitment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adherence to depression treatment at patient's level</measure>
    <time_frame>3 and 6 months after baseline.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Quality of life at 3 and 6 months</measure>
    <time_frame>Baseline , 3 months, 6 months.</time_frame>
    <description>Quality of life at patient's level measured with the Health Survey, Short form (SF-36), at 3 months and 6 months after patient recruitment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Clinical Outcomes at 3 and 6 months</measure>
    <time_frame>Baseline , 3 months, 6 months.</time_frame>
    <description>Clinical outcomes at patient's level measured with the Outcome Questionnaire-45.2 (OQ-45.2), at 3 months and 6 months after patient recruitment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of Health Care services at patient's level</measure>
    <time_frame>3 and 6 months after baseline</time_frame>
    <description>Use of Health Care services at patient's level measured with and ad-hoc built questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of treated depressed cases at Primary Care team level</measure>
    <time_frame>12 months before randomization and 12 months after.</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">256</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Depression training/supervision program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A complex intervention, which will include:&#xD;
Primary Health Care team training in depression&#xD;
A focus group, after training&#xD;
Telephone monitoring of patients&#xD;
Web-based supervision of clinicians</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in the control group will receive all the interventions that are guaranteed for persons with depression in Chile: treatment in Primary Health Care clinics with the Primary Health Care team and referral to the regional specialized psychiatric service.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Depression training/supervision program</intervention_name>
    <description>The intervention will be composed of:&#xD;
Training of Primary Health Care teams to ensure compliance to the &quot;Clinical Guidelines of the Ministry of Health for the Treatment of Depression&quot;. Primary Health Care teams will undergo an Objective Structured Clinical Examination (OSCE) for evaluation.&#xD;
After the training, a focus group between Primary Health Care teams and study researchers will be held in order to address barriers to clinical guidelines implementation.&#xD;
Primary Health Care clinics' trained administrative staff will contact patients from a call-center to support treatment adherence.&#xD;
Psychiatrists, using a web-based platform, will supervise the course of the program, the allocated treatments, the patients' progress, and their response to treatment.</description>
    <arm_group_label>Depression training/supervision program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  signing written informed consent&#xD;
&#xD;
          -  age between 18-65 years&#xD;
&#xD;
          -  current depressive episode, according to the Mini-International Neuropsychiatric&#xD;
             Interview (MINI)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  current depression treatment&#xD;
&#xD;
          -  no access to telephone&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CESFAM Garín</name>
      <address>
        <city>Quinta Normal</city>
        <state>Santiago</state>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CESFAM Lo Franco</name>
      <address>
        <city>Quinta Normal</city>
        <state>Santiago</state>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CESFAM Barros Luco</name>
      <address>
        <city>San Miguel</city>
        <state>Santiago</state>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CESFAM Recreo</name>
      <address>
        <city>San Miguel</city>
        <state>Santiago</state>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Chile</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2014</study_first_posted>
  <last_update_submitted>October 24, 2017</last_update_submitted>
  <last_update_submitted_qc>October 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Chile</investigator_affiliation>
    <investigator_full_name>Graciela Rojas Castillo</investigator_full_name>
    <investigator_title>Dr.med. Psychyatrist</investigator_title>
  </responsible_party>
  <keyword>Depression</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>
  <!-- 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/NCT02232854
org study id: 1130230
nct id: NCT02232854
lead sponsor: 
has dmc: No
According to the literature the management of depressive disorders at primary care level is
      not always consistent with guidelines. The main objective of this study is to test whether a
      Comprehensive Technology-Assisted Training and Supervision Program will improve depression
      management in Primary Health Care clinics in Santiago, Chile.
A cluster randomized controlled clinical trial will be conducted in four Primary Health Care
      (PHC) clinics in Santiago, Chile.

      The sample selection of the PHC clinics will be performed in two steps. Firstly, two urban
      municipalities of Santiago Metropolitan Region, Chile, will be randomly selected if they work
      with the Faculty of Medicine of the U.Chile and have at least two PHC.Municipalities with a
      high Human Development Index, high percentage of immigrants and older population, and
      Psychiatry residents working in PHC , will be excluded.Secondly in each selected
      municipalities,two PHC will be randomly selected for the active and control arm.

      To detect a difference of 20%, in a one-sided model, with an alpha of 5% and power of 80%,
      152 depressed persons, 76 to each group, will be required for the study. A design effect of
      2.42 was estimated. After applying the design effect the sample needed increased to 368
      depressed persons. Considering a retention rate of approximately 85%, 434 depressed cases
      will be needed required for the study, hence 109 cases in each of the 4 primary health care
      clinics.

      Analysis and presentation of the results will be in accordance with CONSORT guidelines for
      randomized clinical trials, with the primary comparative analysis being conducted on an
      intention to treat basis and due emphasis placed on confidence intervals for the between-arm
      comparisons.

      Initially descriptive analysis to assess the balance between two groups will be conducted.
      The primary analysis will employ multilevel multivariable lineal regression to investigate
      differences in the PHQ-9 scores between groups at 3 and 6 months after randomization,
      adjusting for baseline outcome variable scores. Sensitivity analysis making different
      assumptions will be conducted to investigate the potential effects of missing data. Similar
      analysis will be done for the secondary outcomes measures.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: Change from Baseline Depressive Symptomatology at 3 months
time frame: Baseline , 3 months
description: Depressive symptomatology measured with the Patient Health Questionnaire - Nine Item (PHQ-9) at 3 months after patient recruitment.
measure: Change from Baseline Depressive Symptomatology at 6 months
time frame: Baseline, 6 months.
description: Depressive symptomatology measured with the Patient Health Questionnaire - Nine Item (PHQ-9) at 6 months after patient recruitment.
measure: Adherence to depression treatment at patient's level
time frame: 3 and 6 months after baseline.
measure: Change from Baseline Quality of life at 3 and 6 months
time frame: Baseline , 3 months, 6 months.
description: Quality of life at patient's level measured with the Health Survey, Short form (SF-36), at 3 months and 6 months after patient recruitment.
measure: Change from Baseline Clinical Outcomes at 3 and 6 months
time frame: Baseline , 3 months, 6 months.
description: Clinical outcomes at patient's level measured with the Outcome Questionnaire-45.2 (OQ-45.2), at 3 months and 6 months after patient recruitment.
measure: Use of Health Care services at patient's level
time frame: 3 and 6 months after baseline
description: Use of Health Care services at patient's level measured with and ad-hoc built questionnaire.
measure: Rate of treated depressed cases at Primary Care team level
time frame: 12 months before randomization and 12 months after.
arm group label: Depression training/supervision program
arm group type: Experimental
description: A complex intervention, which will include:
Primary Health Care team training in depression
A focus group, after training
Telephone monitoring of patients
Web-based supervision of clinicians
arm group label: Usual Care
arm group type: No Intervention
description: Patients in the control group will receive all the interventions that are guaranteed for persons with depression in Chile: treatment in Primary Health Care clinics with the Primary Health Care team and referral to the regional specialized psychiatric service.
intervention type: Behavioral
intervention name: Depression training/supervision program
description: The intervention will be composed of:
Training of Primary Health Care teams to ensure compliance to the "Clinical Guidelines of the Ministry of Health for the Treatment of Depression". Primary Health Care teams will undergo an Objective Structured Clinical Examination (OSCE) for evaluation.
After the training, a focus group between Primary Health Care teams and study researchers will be held in order to address barriers to clinical guidelines implementation.
Primary Health Care clinics' trained administrative staff will contact patients from a call-center to support treatment adherence.
Psychiatrists, using a web-based platform, will supervise the course of the program, the allocated treatments, the patients' progress, and their response to treatment.
arm group label: Depression training/supervision program
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: Chile
responsible party type: Principal Investigator
investigator affiliation: University of Chile
investigator full name: Graciela Rojas Castillo
investigator title: Dr.med. Psychyatrist
mesh term: Depression
mesh term: Depressive Disorder