<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/NCT01719289</url>
  </required_header>
  <id_info>
    <org_study_id>CNPq 575320/2008-7</org_study_id>
    <nct_id>NCT01719289</nct_id>
  </id_info>
  <brief_title>Efficacy of a Program for the Management of Depression in Pregnant Women in Primary Care in São Paulo, Brazil</brief_title>
  <acronym>PROGRAVIDA</acronym>
  <official_title>Cluster Randomised Controlled Trial of a Primary-care Based Intervention to Improve Depressive Symptoms of Pregnant Women in Sao Paulo, Brazil</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Conselho Nacional de Desenvolvimento Científico e Tecnológico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Sao Paulo General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: depression during pregnancy is an important problem for public health. It has&#xD;
      direct consequences for the affected woman, her children and family, and is a strong&#xD;
      predictor of post-partum depression. In developing countries depression during pregnancy is&#xD;
      highly common, and usually unrecognized and untreated.&#xD;
&#xD;
      Aim: to evaluate the effectiveness and cost-effectiveness of an intervention delivered by&#xD;
      nurse assistants in the management of pregnant women with depression in primary care clinics&#xD;
      that adopt the Family Health Strategy in Sao Paulo, Brazil.&#xD;
&#xD;
      Method: PROGRAVIDA is a cluster randomized controlled trial with pregnant women with&#xD;
      depression attending pre-natal care in 12 Primary Care Units with Family Health Program,&#xD;
      covering an area of 400,000 inhabitants in Sao Paulo, Brazil. The intervention follows a&#xD;
      stepped-care approach and is delivered by health professionals working at the primary care&#xD;
      unit responsible by the care of the women. All women from the intervention group receive a&#xD;
      program based on psycho-education and problem solving techniques, delivered by a nurse&#xD;
      assistant at the women's homes. The program comprises 8 sessions, 6 during pregnancy and 2&#xD;
      after delivery. Intensity of depressive symptoms is assessed using the PHQ-9, at the&#xD;
      beginning of the sessions. Women with severe depression are referred to the family doctor and&#xD;
      are assessed for the need of antidepressant medication. The control group receives routine&#xD;
      care. The primary outcome is remission of depressive symptoms 4-months after the inclusion in&#xD;
      the study. Secondary outcomes include remission of depressive symptoms at 6 months after&#xD;
      delivery. Women are also assessed for socioeconomic and household characteristics, social&#xD;
      support and obstetric complications. The effectiveness and cost-effectiveness of the&#xD;
      intervention will be assessed with intention-to-treat analysis, using the clinical outcome&#xD;
      and the assessment of quality of life (EQ-5D) four months after inclusion in the trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite the high prevalence of depressive disorders in pregnancy and puerperium and the&#xD;
      possible negative consequences of these frames for women, children and family, there are&#xD;
      still very scarce evidence on the effectiveness of interventions of low cost and viable, that&#xD;
      can be made available on the net of Primary Health Care in Brazil and other middle or low&#xD;
      income countries.&#xD;
&#xD;
      The main objective of this study is to evaluate the effectiveness of a depression management&#xD;
      program, simple and low cost, delivered by nurse assistants, in reducing symptoms of&#xD;
      depression in pregnant women treated in primary care clinics that adopt the Family Health&#xD;
      Strategy (FHS) in São Paulo, compared to routine care. We will also assess the&#xD;
      cost-effectiveness of this intervention.&#xD;
&#xD;
      We are conducting a community cluster randomized trial with pregnant women with symptoms of&#xD;
      depression, attending antenatal care in primary care clinics that adopt the FHS in São Paulo.&#xD;
      Participating clinics (12) were randomly allocated to have their nurse assistants receiving&#xD;
      training and supervision to perform a program for management of depression among pregnant&#xD;
      women (experimental group) or to offer routine care (control group).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2011</start_date>
  <completion_date type="Anticipated">September 2014</completion_date>
  <primary_completion_date type="Anticipated">November 2013</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>Patient Health Questionnaire (PHQ-9)</measure>
    <time_frame>4 months after inclusion in the study</time_frame>
    <description>PHQ-9 score=&lt;4 will be considered success</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PHQ-9</measure>
    <time_frame>6 months after delivery</time_frame>
    <description>PHQ-9 score=&lt;4 will be considered success</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General Quality of life (EQ-5D)</measure>
    <time_frame>4 months after inclusion and 6 months after delivery</time_frame>
    <description>The instrument contains 2 parts: a descriptive part that evaluates five domains (mobility, self care, usual activity, discomfort / pain and anxiety / depression). In this section a person assesses the current health on a scale 1-3 (none, moderate and severe). The respondent also makes self-evaluation through visual scale grading their health from 0 (worst possible) to 100 (best possible).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>PROGRAVIDA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All women in this arm receive a stepped-care program for depression based on psycho-education and problem solving techniques.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Primary health care professionals in charge of prenatal care are notified by the research team about all women with depression receiving pre-natal care and included in the trial. Primary health care professionals decide how to treat these women without any interference from the research team.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PROGRAVIDA</intervention_name>
    <description>Women in the intervention group receive a program based on psycho-education and problem solving techniques, delivered by a nurse assistant at the women's homes. The program comprises 8 sessions, 6 during pregnancy and 2 after delivery. Intensity of depressive symptoms is assessed using the PHQ-9, at the beginning of the sessions. Women with severe depression are referred to the family doctor and are assessed for the need of antidepressant medication.</description>
    <arm_group_label>PROGRAVIDA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Pregnant women attending antenatal care in selected primary care clinics with Family Health&#xD;
        Programs, who score a PHQ-9&gt;=5 just after the first antenatal consultation or around the&#xD;
        20th week of pregnancy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Moderate to high suicidal risk (assessed with a standardised protocol),&#xD;
&#xD;
          -  Ongoing psychiatric treatment,&#xD;
&#xD;
          -  Not able to understand Portuguese.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paulo R Menezes, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Sao Paulo</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marcia Scazufca, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Sao Paulo</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Paulo R Menezes, PhD</last_name>
    <phone>+55 11 30617093</phone>
    <email>progravida@usp.br</email>
  </overall_contact>
  <location>
    <facility>
      <name>Faculdade de Medicina da Universidade de Sao Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <zip>01246-903</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Paulo R Menezes, PhD</last_name>
      <phone>551130617093</phone>
      <email>pmenezes@usp.br</email>
    </contact>
    <investigator>
      <last_name>Paulo R Menezes, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marcia Scazufca, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Faculdade de Medicina da Universidade de Sao Paulo</name>
      <address>
        <city>São Paulo</city>
        <zip>01246-903</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Paulo R Menezes, PhD</last_name>
      <phone>551130617093</phone>
      <email>pmenezes@usp.br</email>
    </contact>
    <investigator>
      <last_name>Paulo R Menezes, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marcia Scazufca, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>October 31, 2012</last_update_submitted>
  <last_update_submitted_qc>October 31, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 1, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>depression</keyword>
  <keyword>problem solving</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/NCT01719289
org study id: CNPq 575320/2008-7
nct id: NCT01719289
lead sponsor: 
collaborator: 
has dmc: No
Background: depression during pregnancy is an important problem for public health. It has
      direct consequences for the affected woman, her children and family, and is a strong
      predictor of post-partum depression. In developing countries depression during pregnancy is
      highly common, and usually unrecognized and untreated.

      Aim: to evaluate the effectiveness and cost-effectiveness of an intervention delivered by
      nurse assistants in the management of pregnant women with depression in primary care clinics
      that adopt the Family Health Strategy in Sao Paulo, Brazil.

      Method: PROGRAVIDA is a cluster randomized controlled trial with pregnant women with
      depression attending pre-natal care in 12 Primary Care Units with Family Health Program,
      covering an area of 400,000 inhabitants in Sao Paulo, Brazil. The intervention follows a
      stepped-care approach and is delivered by health professionals working at the primary care
      unit responsible by the care of the women. All women from the intervention group receive a
      program based on psycho-education and problem solving techniques, delivered by a nurse
      assistant at the women's homes. The program comprises 8 sessions, 6 during pregnancy and 2
      after delivery. Intensity of depressive symptoms is assessed using the PHQ-9, at the
      beginning of the sessions. Women with severe depression are referred to the family doctor and
      are assessed for the need of antidepressant medication. The control group receives routine
      care. The primary outcome is remission of depressive symptoms 4-months after the inclusion in
      the study. Secondary outcomes include remission of depressive symptoms at 6 months after
      delivery. Women are also assessed for socioeconomic and household characteristics, social
      support and obstetric complications. The effectiveness and cost-effectiveness of the
      intervention will be assessed with intention-to-treat analysis, using the clinical outcome
      and the assessment of quality of life (EQ-5D) four months after inclusion in the trial.
Despite the high prevalence of depressive disorders in pregnancy and puerperium and the
      possible negative consequences of these frames for women, children and family, there are
      still very scarce evidence on the effectiveness of interventions of low cost and viable, that
      can be made available on the net of Primary Health Care in Brazil and other middle or low
      income countries.

      The main objective of this study is to evaluate the effectiveness of a depression management
      program, simple and low cost, delivered by nurse assistants, in reducing symptoms of
      depression in pregnant women treated in primary care clinics that adopt the Family Health
      Strategy (FHS) in São Paulo, compared to routine care. We will also assess the
      cost-effectiveness of this intervention.

      We are conducting a community cluster randomized trial with pregnant women with symptoms of
      depression, attending antenatal care in primary care clinics that adopt the FHS in São Paulo.
      Participating clinics (12) were randomly allocated to have their nurse assistants receiving
      training and supervision to perform a program for management of depression among pregnant
      women (experimental group) or to offer routine care (control group).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Patient Health Questionnaire (PHQ-9)
time frame: 4 months after inclusion in the study
description: PHQ-9 score=<4 will be considered success
measure: PHQ-9
time frame: 6 months after delivery
description: PHQ-9 score=<4 will be considered success
measure: General Quality of life (EQ-5D)
time frame: 4 months after inclusion and 6 months after delivery
description: The instrument contains 2 parts: a descriptive part that evaluates five domains (mobility, self care, usual activity, discomfort / pain and anxiety / depression). In this section a person assesses the current health on a scale 1-3 (none, moderate and severe). The respondent also makes self-evaluation through visual scale grading their health from 0 (worst possible) to 100 (best possible).
arm group label: PROGRAVIDA
arm group type: Experimental
description: All women in this arm receive a stepped-care program for depression based on psycho-education and problem solving techniques.
arm group label: Treatment as usual
arm group type: No Intervention
description: Primary health care professionals in charge of prenatal care are notified by the research team about all women with depression receiving pre-natal care and included in the trial. Primary health care professionals decide how to treat these women without any interference from the research team.
intervention type: Behavioral
intervention name: PROGRAVIDA
description: Women in the intervention group receive a program based on psycho-education and problem solving techniques, delivered by a nurse assistant at the women's homes. The program comprises 8 sessions, 6 during pregnancy and 2 after delivery. Intensity of depressive symptoms is assessed using the PHQ-9, at the beginning of the sessions. Women with severe depression are referred to the family doctor and are assessed for the need of antidepressant medication.
arm group label: PROGRAVIDA
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paulo R Menezes, PhD
role: Principal Investigator
affiliation: University of Sao Paulo
last name: Marcia Scazufca, PhD
role: Study Director
affiliation: University of Sao Paulo
last name: Paulo R Menezes, PhD
phone: +55 11 30617093
email: progravida@usp.br
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Brazil
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder