<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/NCT02200367</url>
  </required_header>
  <id_info>
    <org_study_id>1100205</org_study_id>
    <nct_id>NCT02200367</nct_id>
  </id_info>
  <brief_title>E-mental Health Support for Rural Areas</brief_title>
  <official_title>AN e- MENTAL HEALTH COLLABORATIVE PROGRAMME TO DEPRESSION MANAGEMENT IN RURAL PRIMARY CARE IN CHILE:A PILOT CLINICAL STUDY.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chile</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fondo Nacional de Desarrollo Científico y Tecnológico, Chile</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Chile</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the treatment of depression, primary care team play an important role, but they are most&#xD;
      effective when inserted into a collaborative model of disease management.&#xD;
&#xD;
      Hypotheses:Depressed patients treated in rural primary care clinics participating in a&#xD;
      e-mental heath collaborative programme to manage depression achieve at least 20% better&#xD;
      recovery rates in comparison with the control group three months after the baseline&#xD;
      assessment.&#xD;
&#xD;
      Goal: to compare the effectiveness of a e-mental health collaborative programme with usual&#xD;
      care in rural primary-care clinics.&#xD;
&#xD;
      Methodology: a clinical trial with two arms will be conducted in 13 community rural hospitals&#xD;
      in Chile. The active group will participate in a collaborative programme between primary care&#xD;
      teams and specialized teams, with support from an electronic platform and a call center.The&#xD;
      control group will receive usual care, according to the Ministry of Health's Guidelines to&#xD;
      Depression.To evaluate inclusion criteria -depressive patients aged between 18 and 70 years-&#xD;
      and exclusion criteria -current in treatment for depression- an interview will be used that&#xD;
      will include the Mini-International Neuropsychiatric Interview (MINI) to evaluate depression&#xD;
      .The principal outcome will be depressive symptoms measured with the Beck Depression&#xD;
      Inventory (BDI-I), and secondary outcome quality of life measured with the Health Survey&#xD;
      (SF-36) at three and six months after baseline assessment.To detect a difference of 20%, in a&#xD;
      one-sided model, with an alpha of 5% and power of 80%, would require 152 depressed persons&#xD;
      (76 to intervention and 76 to control group).A design effect of 1.35 based on an Intraclass&#xD;
      Coefficient Correlation (ICC) of 0,03839 and 13 clinics were considered. After applying the&#xD;
      design effect the sample needed increased to 206 depressed persons. Considering a retention&#xD;
      rate of approximately 85% 237 depressed cases will be needed.&#xD;
&#xD;
      A program of this kind may be useful to assist primary care teams in remote areas of the&#xD;
      country, in order to improve treatment outcomes for depression that is currently addressed at&#xD;
      the primary care level.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Depressive Symptoms change after baseline</measure>
    <time_frame>three and six months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life change after baseline</measure>
    <time_frame>three and six months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">254</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>e-mental health collaborative programme</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>It is a complex intervention to support primary care providers of rural primary care service to manage depressed patients. Primary care providers at the intervention sites were supported by psychiatrist using an electronic platform.Patients were monitored through a call center.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients in this arm received all the interventions that are guaranteed for the persons with depression in Chile: treatment in the primary clinics with the primary care team and referral to the regional specialized psychiatric service</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>e-mental health collaborative programme</intervention_name>
    <arm_group_label>e-mental health collaborative programme</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects aged 18 or more with a current major depressive episode according to&#xD;
             Diagnostic and Statistical Manual of Mental Disorders IV criteria (DSM-IV)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Depressive treatment currently in process.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>July 23, 2014</last_update_submitted>
  <last_update_submitted_qc>July 23, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 25, 2014</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>Primary health care</keyword>
  <keyword>Computer communication network</keyword>
  <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/NCT02200367
org study id: 1100205
nct id: NCT02200367
lead sponsor: 
collaborator: 
has dmc: No
In the treatment of depression, primary care team play an important role, but they are most
      effective when inserted into a collaborative model of disease management.

      Hypotheses:Depressed patients treated in rural primary care clinics participating in a
      e-mental heath collaborative programme to manage depression achieve at least 20% better
      recovery rates in comparison with the control group three months after the baseline
      assessment.

      Goal: to compare the effectiveness of a e-mental health collaborative programme with usual
      care in rural primary-care clinics.

      Methodology: a clinical trial with two arms will be conducted in 13 community rural hospitals
      in Chile. The active group will participate in a collaborative programme between primary care
      teams and specialized teams, with support from an electronic platform and a call center.The
      control group will receive usual care, according to the Ministry of Health's Guidelines to
      Depression.To evaluate inclusion criteria -depressive patients aged between 18 and 70 years-
      and exclusion criteria -current in treatment for depression- an interview will be used that
      will include the Mini-International Neuropsychiatric Interview (MINI) to evaluate depression
      .The principal outcome will be depressive symptoms measured with the Beck Depression
      Inventory (BDI-I), and secondary outcome quality of life measured with the Health Survey
      (SF-36) at three and six months after baseline assessment.To detect a difference of 20%, in a
      one-sided model, with an alpha of 5% and power of 80%, would require 152 depressed persons
      (76 to intervention and 76 to control group).A design effect of 1.35 based on an Intraclass
      Coefficient Correlation (ICC) of 0,03839 and 13 clinics were considered. After applying the
      design effect the sample needed increased to 206 depressed persons. Considering a retention
      rate of approximately 85% 237 depressed cases will be needed.

      A program of this kind may be useful to assist primary care teams in remote areas of the
      country, in order to improve treatment outcomes for depression that is currently addressed at
      the primary care level.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Depressive Symptoms change after baseline
time frame: three and six months
measure: Quality of Life change after baseline
time frame: three and six months
arm group label: e-mental health collaborative programme
arm group type: Experimental
description: It is a complex intervention to support primary care providers of rural primary care service to manage depressed patients. Primary care providers at the intervention sites were supported by psychiatrist using an electronic platform.Patients were monitored through a call center.
arm group label: Usual Care
arm group type: Other
description: Patients in this arm received all the interventions that are guaranteed for the persons with depression in Chile: treatment in the primary clinics with the primary care team and referral to the regional specialized psychiatric service
intervention type: Behavioral
intervention name: e-mental health collaborative programme
arm group label: e-mental health collaborative programme
intervention type: Other
intervention name: Usual Care
arm group label: Usual Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
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