<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/NCT03243799</url>
  </required_header>
  <id_info>
    <org_study_id>PI16/01272</org_study_id>
    <nct_id>NCT03243799</nct_id>
  </id_info>
  <brief_title>Effectiveness of a Psychoeducational Group Intervention in Patients With Depression and Physical Comorbidity</brief_title>
  <acronym>PsiCoDep</acronym>
  <official_title>Effectiveness of a Psychoeducational Group Intervention Conducted by Primary Health Care Nurses in Patients With Depression and Physical Comorbidity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Carlos III Health Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary aim is to evaluate the effectiveness of an intervention based on a&#xD;
      psychoeducational program carried out by primary care nurses, to improve the rate of&#xD;
      remission and response of depression in patients with physical chronic illness (diabetes,&#xD;
      COPD, asthma and / or ischemic heart disease). Secondarily, to assess the cost-effectiveness&#xD;
      of the intervention, the effectiveness to improve the control of physical pathology, the&#xD;
      impact on quality of life and the feasibility of the intervention.&#xD;
&#xD;
      Methods: a multicentre, randomized clinical trial, with two groups and 1 year follow-up&#xD;
      evaluation. Economic evaluation study. We will study 504 patients (252 in each group), over&#xD;
      50 years assigned to 25 primary care teams (PC) from Catalonia (urban, semi-urban and rural)&#xD;
      with major depression and with at least one of the diseases: diabetes mellitus type 2,&#xD;
      chronic obstructive pulmonary disease, asthma, and / or ischemic heart disease. They will be&#xD;
      distributed randomly into two groups. The intervention group will participate in&#xD;
      psychoeducational groups: 12 weekly 90-minute sessions led by two nurses from PC, consisting&#xD;
      of health education on chronic physical illness and depressive symptoms.&#xD;
&#xD;
      Main measurements: clinical remission of depression and / or response to intervention (Beck&#xD;
      depression inventory: BDI-II). Secondary measures: improvement in control of chronic disease&#xD;
      (blood test and physical parameters), drug compliance (test Morinsky-Green and number of&#xD;
      packaging), quality of life (EQ-5D), medical service utilization (appointments and hospital&#xD;
      admissions due to complications) and feasibility of the intervention (satisfaction and&#xD;
      compliance). Evaluations will be masked and conducted at 0, 3 and 12 months. At 6 months,&#xD;
      patients will receive a call from nurses.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">November 6, 2017</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">June 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>Changes in rate of remission of depression</measure>
    <time_frame>At 12 months of follow-up</time_frame>
    <description>Changes in the score of the BDI-II scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in rate of remission of depression</measure>
    <time_frame>At 3 months of follow-up</time_frame>
    <description>Changes in the score of the BDI-II scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the control of DM2</measure>
    <time_frame>At 12 months of follow-up</time_frame>
    <description>Changes in HbA1c</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the control of COPD</measure>
    <time_frame>At 12 months of follow-up</time_frame>
    <description>Changes in FEV1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the control of asthma</measure>
    <time_frame>At 12 months of follow-up</time_frame>
    <description>Changes in FEV1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the control of Ischemic heart disease</measure>
    <time_frame>At 12 months of follow-up</time_frame>
    <description>Changes in LDL cholesterol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Referrals to mental health</measure>
    <time_frame>At 12 months of follow-up</time_frame>
    <description>Number of visits to mental health centers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Record of therapeutic compliance</measure>
    <time_frame>At 12 months of follow-up</time_frame>
    <description>Morisky-Green test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the quality of life</measure>
    <time_frame>At 12 months of follow-up</time_frame>
    <description>Measured by the EuroQol scale (EQ-5D)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantification of the use of services</measure>
    <time_frame>At 12 months of follow-up</time_frame>
    <description>Number of hospital admissions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with the intervention</measure>
    <time_frame>At 3 months of follow-up</time_frame>
    <description>Survey at the end of the intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to the intervention</measure>
    <time_frame>At 3 months of follow-up</time_frame>
    <description>Number of assisted sessions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Qualitative changes of the state of mind at the end of the intervention</measure>
    <time_frame>At 3 and 12 months of follow-up</time_frame>
    <description>better, equal or worse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Qualitative changes of the state of health at the end of the intervention</measure>
    <time_frame>At 3 and 12 months of follow-up</time_frame>
    <description>better, equal or worse</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">504</enrollment>
  <condition>Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group will participate in psychoeducational groups: 12 weekly 90-minute sessions led by two nurses from Primary Care, consisting of health education on chronic physical illness and depressive symptoms.&#xD;
Group psychoeducation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual clinical care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group psychoeducation</intervention_name>
    <description>Educational group sessions for patients with depression and physical comorbidities in order to improve the degree of control of their illnesses</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presence of at least one of the following diseases: type 2 diabetes mellitus, chronic&#xD;
             obstructive pulmonary disease, asthma, and / or ischemic heart disease.&#xD;
&#xD;
          -  Meet major depression criteria at the time of the study: Score above 13 on the BDI-II&#xD;
             scale.&#xD;
&#xD;
          -  Possibility of follow-up of one year by the same primary care team.&#xD;
&#xD;
          -  At least read and write Spanish or Catalan.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of dementia or moderate or high cognitive impairment (5 or more errors&#xD;
             according to the pfeiffer scale).&#xD;
&#xD;
          -  Major depression with psychotic symptoms or with other serious psychiatric&#xD;
             comorbidities.&#xD;
&#xD;
          -  Moderate or high risk of suicide (6 or more points on the MINI suicide scale).&#xD;
&#xD;
          -  Dependency disorders due to alcohol or other drug abuse.&#xD;
&#xD;
          -  Advanced stage physical disease.&#xD;
&#xD;
          -  Inability to travel to the center.&#xD;
&#xD;
          -  Be receiving some psychological therapy by the Center of mental health (CSM) of&#xD;
             reference&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centre d'Atenció Primària (CAP) Santa Margarida de Montbui</name>
      <address>
        <city>Santa Margarida de Montbui</city>
        <state>Barcelona</state>
        <zip>08710</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>May 29, 2019</last_update_submitted>
  <last_update_submitted_qc>May 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03243799
org study id: PI16/01272
nct id: NCT03243799
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The primary aim is to evaluate the effectiveness of an intervention based on a
      psychoeducational program carried out by primary care nurses, to improve the rate of
      remission and response of depression in patients with physical chronic illness (diabetes,
      COPD, asthma and / or ischemic heart disease). Secondarily, to assess the cost-effectiveness
      of the intervention, the effectiveness to improve the control of physical pathology, the
      impact on quality of life and the feasibility of the intervention.

      Methods: a multicentre, randomized clinical trial, with two groups and 1 year follow-up
      evaluation. Economic evaluation study. We will study 504 patients (252 in each group), over
      50 years assigned to 25 primary care teams (PC) from Catalonia (urban, semi-urban and rural)
      with major depression and with at least one of the diseases: diabetes mellitus type 2,
      chronic obstructive pulmonary disease, asthma, and / or ischemic heart disease. They will be
      distributed randomly into two groups. The intervention group will participate in
      psychoeducational groups: 12 weekly 90-minute sessions led by two nurses from PC, consisting
      of health education on chronic physical illness and depressive symptoms.

      Main measurements: clinical remission of depression and / or response to intervention (Beck
      depression inventory: BDI-II). Secondary measures: improvement in control of chronic disease
      (blood test and physical parameters), drug compliance (test Morinsky-Green and number of
      packaging), quality of life (EQ-5D), medical service utilization (appointments and hospital
      admissions due to complications) and feasibility of the intervention (satisfaction and
      compliance). Evaluations will be masked and conducted at 0, 3 and 12 months. At 6 months,
      patients will receive a call from nurses.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Changes in rate of remission of depression
time frame: At 12 months of follow-up
description: Changes in the score of the BDI-II scale
measure: Changes in rate of remission of depression
time frame: At 3 months of follow-up
description: Changes in the score of the BDI-II scale
measure: Changes in the control of DM2
time frame: At 12 months of follow-up
description: Changes in HbA1c
measure: Changes in the control of COPD
time frame: At 12 months of follow-up
description: Changes in FEV1
measure: Changes in the control of asthma
time frame: At 12 months of follow-up
description: Changes in FEV1
measure: Changes in the control of Ischemic heart disease
time frame: At 12 months of follow-up
description: Changes in LDL cholesterol
measure: Referrals to mental health
time frame: At 12 months of follow-up
description: Number of visits to mental health centers
measure: Record of therapeutic compliance
time frame: At 12 months of follow-up
description: Morisky-Green test
measure: Changes in the quality of life
time frame: At 12 months of follow-up
description: Measured by the EuroQol scale (EQ-5D)
measure: Quantification of the use of services
time frame: At 12 months of follow-up
description: Number of hospital admissions
measure: Satisfaction with the intervention
time frame: At 3 months of follow-up
description: Survey at the end of the intervention
measure: Adherence to the intervention
time frame: At 3 months of follow-up
description: Number of assisted sessions
measure: Qualitative changes of the state of mind at the end of the intervention
time frame: At 3 and 12 months of follow-up
description: better, equal or worse
measure: Qualitative changes of the state of health at the end of the intervention
time frame: At 3 and 12 months of follow-up
description: better, equal or worse
arm group label: Intervention Group
arm group type: Experimental
description: The intervention group will participate in psychoeducational groups: 12 weekly 90-minute sessions led by two nurses from Primary Care, consisting of health education on chronic physical illness and depressive symptoms.
Group psychoeducation.
arm group label: Control Group
arm group type: No Intervention
description: Usual clinical care
intervention type: Behavioral
intervention name: Group psychoeducation
description: Educational group sessions for patients with depression and physical comorbidities in order to improve the degree of control of their illnesses
arm group label: Intervention Group
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Depressive Disorder