<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/NCT03026426</url>
  </required_header>
  <id_info>
    <org_study_id>1U19MH098780-02PERU</org_study_id>
    <secondary_id>1U19MH098780</secondary_id>
    <nct_id>NCT03026426</nct_id>
  </id_info>
  <brief_title>Effectiveness of a mHealth Intervention for the Treatment of Depression in People With Diabetes or Hypertension in Peru</brief_title>
  <acronym>LATIN-MHPeru</acronym>
  <official_title>A Randomized Controlled Trial to Evaluate the Effectiveness of a Mobile Technology Intervention in the Treatment of Depressive Symptoms in People With Diabetes or Hypertension in Peru</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Peruana Cayetano Heredia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Sao Paulo General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidad Peruana Cayetano Heredia</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>
      Background: Depression is a common comorbidity of physical chronic diseases such as diabetes&#xD;
      and/or hypertension and constitutes an important public health problem. It correlates&#xD;
      negatively with the patients' quality of life and self-care, as well as compliance with&#xD;
      medical treatment. In low- and middle-income countries depression often goes unrecognized and&#xD;
      untreated, and there are limited human resources to treat depression and other mental&#xD;
      problems.&#xD;
&#xD;
      Aim: The present study aims to test a 6-week low-intensity psychological intervention (CONEMO&#xD;
      - CONtrol EMOcional) delivered by a smartphone application to people with depressive symptoms&#xD;
      and co-morbid diabetes and/or hypertension recruited in primary health care centers and&#xD;
      public hospitals in Lima, Peru.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Epidemiologic research has clearly established the significant public health importance of&#xD;
      mental disorders in low- and middle-income countries (LMIC). Among mental disorders,&#xD;
      depression has become a major problem as a single condition and, more often, as part of&#xD;
      complex clinical settings in which multiple conditions and risk factors are combined.&#xD;
&#xD;
      There is substantial co-morbidity between depression and chronic physical conditions, and the&#xD;
      outcome of both conditions is impaired when there is this co-morbidity. Most of the disease&#xD;
      burden in Latin America is attributable to chronic diseases such as cardio-vascular diseases&#xD;
      as hypertension and diabetes, as well as to mental disorders such as depression. Despite the&#xD;
      public health impact of depression, it often goes unrecognized and untreated. One important&#xD;
      factor for this treatment gap are the limited financial and human resources. The mental&#xD;
      health resources available in LMIC are often not optimally distributed either. Funds and&#xD;
      trained personnel are typically allocated to tertiary health care services, such as&#xD;
      psychiatric hospitals.&#xD;
&#xD;
      Therefore, any short- and medium-term efforts to develop, evaluate, and disseminate effective&#xD;
      mental health interventions in LMIC must adapt to these severe workforce shortages, resource&#xD;
      limitations, and budgetary inequities. The mental health field needs to consider developing&#xD;
      self-help automated interventions that can reach people where there is insufficient access to&#xD;
      specialized health care providers. This can be partially addressed applying two strategies:&#xD;
      1) increasing effective self-management; and 2) task-shifting roles to less specialized but&#xD;
      appropriately trained health workers.&#xD;
&#xD;
      The investigators are conducting a randomized controlled trial with individuals with chronic&#xD;
      diseases, i.e. hypertension and/or diabetes, and symptoms of depression in primary health&#xD;
      centers and hospitals in Lima, Peru. Participants will be randomly assigned to the control&#xD;
      arm or the intervention arm. The later will receive the CONEMO intervention, monitored by&#xD;
      nurses.&#xD;
&#xD;
      The focus of this project is on using a self-help intervention that provides advice, support,&#xD;
      and motivation. However, studies suggest that depressed patients left alone with the devices&#xD;
      fail to make good use of self-help interventions. Therefore, nurses will monitor participants&#xD;
      by a web-based dashboard connected to the smartphone application (CONEMO), motivate to&#xD;
      continue using CONEMO if participants are non-adherent and give technical support. Nurses&#xD;
      will take part in supervision meetings at least once a week.&#xD;
&#xD;
      Method:&#xD;
&#xD;
      CONEMO is a randomized controlled trial conducted with 432 chronic patients who present&#xD;
      diabetes and/or hypertension and depressive symptoms recruited in primary health care centers&#xD;
      and public hospitals in Lima, Peru. Half of these participants will be randomized to receive&#xD;
      the CONEMO intervention and the other half will receive enhanced usual care. The&#xD;
      randomization will be made based on 2 strata: the health center/hospital the participant&#xD;
      comes from and his/her PHQ9 score at screening (≤14; ≥15).&#xD;
&#xD;
      The intervention, based on behavior activation, is delivered by a smartphone and monitored by&#xD;
      nurses who mediate this intervention, motivating and supporting the participant and&#xD;
      monitoring his/her performance. The CONEMO intervention is delivered 3 times a week for a&#xD;
      period of 6 weeks, summing up to a total of 18 sessions. Intensity of depressive symptoms is&#xD;
      assessed by research assistants using the PHQ-9 at baseline, 3- and 6-month follow-up&#xD;
      assessments.&#xD;
&#xD;
      Outcomes:&#xD;
&#xD;
      The primary outcome in this study is the proportion of participants with a reduction of 50%&#xD;
      or more in the PHQ-9 score at the 3-month assessment. The secondary outcomes are the&#xD;
      proportion of participants with a reduction of 50% or more in the PHQ-9 score at the 6-month&#xD;
      assessment, and the improvement in quality of life, adherence to diabetes, level of activity&#xD;
      and hypertension medication and social functioning. There will also be a cost-effectiveness&#xD;
      evaluation using a intention to treat analysis, and a process evaluation. For the process&#xD;
      evaluation, data will be collected from questionnaires about the CONEMO system, filled out by&#xD;
      with participants at 3 months after inclusion, and interviews with the nurses at the end of&#xD;
      the intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 24, 2017</start_date>
  <completion_date type="Actual">December 19, 2018</completion_date>
  <primary_completion_date type="Actual">March 31, 2018</primary_completion_date>
  <phase>Phase 3</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 (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of participants with a reduction of 50% or more in the Patient Health Questionnaire (PHQ-9) score at the 3-month assessment</measure>
    <time_frame>3 months after inclusion</time_frame>
    <description>Presence and severity of depressive symptoms is measured with the PHQ-9. A reduction of 50% or more in the PHQ-9 score at the 3-month assessment as compared to the PHQ-9 score at baseline will be considered as treatment success.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants with a reduction of 50% or more in the PHQ-9 score at the 6-month assessment</measure>
    <time_frame>6 months after inclusion</time_frame>
    <description>Presence and severity of depressive symptoms is measured with the PHQ-9. A reduction of 50% or more in the PHQ-9 score at the 6-month assessment as compared to the PHQ-9 score at baseline will be considered as treatment success.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in scores for Quality of Life measured by the EQD5 at the 3- and 6-month assessment</measure>
    <time_frame>3 and 6 months after inclusion</time_frame>
    <description>Quality of life will be measured at the 3- and 6-month assessments and compared to baseline using the EQ-5D, a standardized instrument that investigates 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants who improve adherence to diabetes or hypertension medications, evaluated by the Morisky questionnaire at the 3- and 6-month assessments</measure>
    <time_frame>3 and 6 months after inclusion</time_frame>
    <description>Medication adherence to diabetes or hypertension will be measured using the Morisky Medication Adherence Scale (MMAS-4) at the 3- and 6-month assessments after inclusion and compared to baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants who improve on social functioning at the 3- and 6-month assessments compared to the baseline.</measure>
    <time_frame>3 and 6 months after inclusion</time_frame>
    <description>Social functioning will be assessed with the WHO-DAS 2.0 12-item Interviewer-administered version in Spanish at the 3- and 6-month assessments after inclusion and compared to baseline. Its structure is unidimensional and has high internal consistency.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness: Number of medical consultations, hospitalizations, and visits to the health care team</measure>
    <time_frame>3 and 6 months after inclusion</time_frame>
    <description>Data on the use of health services will be collected at baseline, 3-month and 6-month assessments. Information about medical consultations, hospitalizations, and visits to the health care team will be obtained with a standardized questionnaire and cost-effectiveness analysis will be conducted.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants who improve level of activity at the 3- and 6-month assessments</measure>
    <time_frame>3 and 6 months after inclusion</time_frame>
    <description>Level of activity will be evaluated by the short form of the Behavioral Activation for Depression Scale (BADS) and assessed at baseline, 3-month, and 6-month follow-ups. It is a 9-item scale used to measure the frequency of activation and avoidance behaviors hypothetically underlying depression mechanisms.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">432</enrollment>
  <condition>Depression</condition>
  <condition>Diabetes</condition>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>CONEMO</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the intervention arm will receive a smartphone with CONEMO, an application with 18 sessions that are delivered 3 times a week for 6 weeks.&#xD;
Additionally, all study participants, including those in the intervention arm, who present a high risk of suicide and/or have a PHQ-9 score ≥20 are referred to the system for follow up. Participants with lower levels of depressive symptoms receive the recommendation of going to a mental health professional.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the control group will receive enhanced usual care. Participants who present a high risk of suicide and/or have a PHQ-9 score ≥20 are referred to the system for follow up. Participants with lower levels of depressive symptoms receive the recommendation of going to a mental health professional.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CONEMO</intervention_name>
    <description>Participants will be offered a behavioral activation-based intervention delivered by an application for smartphones (CONEMO) oriented to encourage them to be more active and to incorporate more activities in participants' everyday life.&#xD;
Nurses will train participants to use CONEMO, make phone calls when participants are non-adherent, and provide technical support when necessary. Nurses will be supervised by clinical psychologists.</description>
    <arm_group_label>CONEMO</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 21 or older&#xD;
&#xD;
          -  Presenting depressive symptoms (PHQ9≥10)&#xD;
&#xD;
          -  Clinical diagnosis of diabetes and/or hypertension&#xD;
&#xD;
          -  Able to read&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  If pregnant, the diagnosis of hypertension or diabetes is not related to the current&#xD;
             pregnancy&#xD;
&#xD;
          -  Moderate or severe suicide risk (Level B2 or C measured by S-RAP)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paulo R Menezes, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Sao Paulo General Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ricardo B Araya, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>London School of Hygiene and Tropical Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jaime Miranda, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad Peruana Cayetano Heredia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lisa Colpe, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institute of Mental Health (NIMH)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Francisco Diez-Canseco, MSc, MPH</last_name>
    <role>Study Chair</role>
    <affiliation>Universidad Peruana Cayetano Heredia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lena R Brandt, MSc</last_name>
    <role>Study Chair</role>
    <affiliation>Universidad Peruana Cayetano Heredia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Policlínico Bellavista</name>
      <address>
        <city>Callao</city>
        <zip>07011</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlínico Hermana María Donrose Sutmöller</name>
      <address>
        <city>Callao</city>
        <zip>07051</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Nacional Dos de Mayo</name>
      <address>
        <city>Lima</city>
        <zip>15003</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlínico Juan José Rodríguez Lazo</name>
      <address>
        <city>Lima</city>
        <zip>15054</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Nacional Arzobispo Loayza</name>
      <address>
        <city>Lima</city>
        <zip>15082</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Nacional Cayetano Heredia</name>
      <address>
        <city>Lima</city>
        <zip>15102</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAP III Carabayllo</name>
      <address>
        <city>Lima</city>
        <zip>15316</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universidad Peruana Cayetano Heredia</name>
      <address>
        <city>Lima</city>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Peru</country>
  </location_countries>
  <reference>
    <citation>Menezess PR, Araya R, Miranda J, Mohr DC, Price le SN. The Latin American treatment and innovation network in mental health h (LATINMH): rationale and scope. Rev Fac Cien Med Univ Nac Cordoba. 2015;72(4):321-30.</citation>
    <PMID>27107284</PMID>
  </reference>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>May 6, 2021</last_update_submitted>
  <last_update_submitted_qc>May 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Peruana Cayetano Heredia</investigator_affiliation>
    <investigator_full_name>Jaime Miranda</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>Depression</keyword>
  <keyword>Chronic diseases</keyword>
  <keyword>Mobile technology</keyword>
  <keyword>Clinical trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03026426
org study id: 1U19MH098780-02PERU
secondary id: 1U19MH098780
nct id: NCT03026426
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Background: Depression is a common comorbidity of physical chronic diseases such as diabetes
      and/or hypertension and constitutes an important public health problem. It correlates
      negatively with the patients' quality of life and self-care, as well as compliance with
      medical treatment. In low- and middle-income countries depression often goes unrecognized and
      untreated, and there are limited human resources to treat depression and other mental
      problems.

      Aim: The present study aims to test a 6-week low-intensity psychological intervention (CONEMO
      - CONtrol EMOcional) delivered by a smartphone application to people with depressive symptoms
      and co-morbid diabetes and/or hypertension recruited in primary health care centers and
      public hospitals in Lima, Peru.
Epidemiologic research has clearly established the significant public health importance of
      mental disorders in low- and middle-income countries (LMIC). Among mental disorders,
      depression has become a major problem as a single condition and, more often, as part of
      complex clinical settings in which multiple conditions and risk factors are combined.

      There is substantial co-morbidity between depression and chronic physical conditions, and the
      outcome of both conditions is impaired when there is this co-morbidity. Most of the disease
      burden in Latin America is attributable to chronic diseases such as cardio-vascular diseases
      as hypertension and diabetes, as well as to mental disorders such as depression. Despite the
      public health impact of depression, it often goes unrecognized and untreated. One important
      factor for this treatment gap are the limited financial and human resources. The mental
      health resources available in LMIC are often not optimally distributed either. Funds and
      trained personnel are typically allocated to tertiary health care services, such as
      psychiatric hospitals.

      Therefore, any short- and medium-term efforts to develop, evaluate, and disseminate effective
      mental health interventions in LMIC must adapt to these severe workforce shortages, resource
      limitations, and budgetary inequities. The mental health field needs to consider developing
      self-help automated interventions that can reach people where there is insufficient access to
      specialized health care providers. This can be partially addressed applying two strategies:
      1) increasing effective self-management; and 2) task-shifting roles to less specialized but
      appropriately trained health workers.

      The investigators are conducting a randomized controlled trial with individuals with chronic
      diseases, i.e. hypertension and/or diabetes, and symptoms of depression in primary health
      centers and hospitals in Lima, Peru. Participants will be randomly assigned to the control
      arm or the intervention arm. The later will receive the CONEMO intervention, monitored by
      nurses.

      The focus of this project is on using a self-help intervention that provides advice, support,
      and motivation. However, studies suggest that depressed patients left alone with the devices
      fail to make good use of self-help interventions. Therefore, nurses will monitor participants
      by a web-based dashboard connected to the smartphone application (CONEMO), motivate to
      continue using CONEMO if participants are non-adherent and give technical support. Nurses
      will take part in supervision meetings at least once a week.

      Method:

      CONEMO is a randomized controlled trial conducted with 432 chronic patients who present
      diabetes and/or hypertension and depressive symptoms recruited in primary health care centers
      and public hospitals in Lima, Peru. Half of these participants will be randomized to receive
      the CONEMO intervention and the other half will receive enhanced usual care. The
      randomization will be made based on 2 strata: the health center/hospital the participant
      comes from and his/her PHQ9 score at screening (≤14; ≥15).

      The intervention, based on behavior activation, is delivered by a smartphone and monitored by
      nurses who mediate this intervention, motivating and supporting the participant and
      monitoring his/her performance. The CONEMO intervention is delivered 3 times a week for a
      period of 6 weeks, summing up to a total of 18 sessions. Intensity of depressive symptoms is
      assessed by research assistants using the PHQ-9 at baseline, 3- and 6-month follow-up
      assessments.

      Outcomes:

      The primary outcome in this study is the proportion of participants with a reduction of 50%
      or more in the PHQ-9 score at the 3-month assessment. The secondary outcomes are the
      proportion of participants with a reduction of 50% or more in the PHQ-9 score at the 6-month
      assessment, and the improvement in quality of life, adherence to diabetes, level of activity
      and hypertension medication and social functioning. There will also be a cost-effectiveness
      evaluation using a intention to treat analysis, and a process evaluation. For the process
      evaluation, data will be collected from questionnaires about the CONEMO system, filled out by
      with participants at 3 months after inclusion, and interviews with the nurses at the end of
      the intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Proportion of participants with a reduction of 50% or more in the Patient Health Questionnaire (PHQ-9) score at the 3-month assessment
time frame: 3 months after inclusion
description: Presence and severity of depressive symptoms is measured with the PHQ-9. A reduction of 50% or more in the PHQ-9 score at the 3-month assessment as compared to the PHQ-9 score at baseline will be considered as treatment success.
measure: Proportion of participants with a reduction of 50% or more in the PHQ-9 score at the 6-month assessment
time frame: 6 months after inclusion
description: Presence and severity of depressive symptoms is measured with the PHQ-9. A reduction of 50% or more in the PHQ-9 score at the 6-month assessment as compared to the PHQ-9 score at baseline will be considered as treatment success.
measure: Improvement in scores for Quality of Life measured by the EQD5 at the 3- and 6-month assessment
time frame: 3 and 6 months after inclusion
description: Quality of life will be measured at the 3- and 6-month assessments and compared to baseline using the EQ-5D, a standardized instrument that investigates 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
measure: Proportion of participants who improve adherence to diabetes or hypertension medications, evaluated by the Morisky questionnaire at the 3- and 6-month assessments
time frame: 3 and 6 months after inclusion
description: Medication adherence to diabetes or hypertension will be measured using the Morisky Medication Adherence Scale (MMAS-4) at the 3- and 6-month assessments after inclusion and compared to baseline.
measure: Proportion of participants who improve on social functioning at the 3- and 6-month assessments compared to the baseline.
time frame: 3 and 6 months after inclusion
description: Social functioning will be assessed with the WHO-DAS 2.0 12-item Interviewer-administered version in Spanish at the 3- and 6-month assessments after inclusion and compared to baseline. Its structure is unidimensional and has high internal consistency.
measure: Cost-effectiveness: Number of medical consultations, hospitalizations, and visits to the health care team
time frame: 3 and 6 months after inclusion
description: Data on the use of health services will be collected at baseline, 3-month and 6-month assessments. Information about medical consultations, hospitalizations, and visits to the health care team will be obtained with a standardized questionnaire and cost-effectiveness analysis will be conducted.
measure: Proportion of participants who improve level of activity at the 3- and 6-month assessments
time frame: 3 and 6 months after inclusion
description: Level of activity will be evaluated by the short form of the Behavioral Activation for Depression Scale (BADS) and assessed at baseline, 3-month, and 6-month follow-ups. It is a 9-item scale used to measure the frequency of activation and avoidance behaviors hypothetically underlying depression mechanisms.
arm group label: CONEMO
arm group type: Experimental
description: Participants in the intervention arm will receive a smartphone with CONEMO, an application with 18 sessions that are delivered 3 times a week for 6 weeks.
Additionally, all study participants, including those in the intervention arm, who present a high risk of suicide and/or have a PHQ-9 score ≥20 are referred to the system for follow up. Participants with lower levels of depressive symptoms receive the recommendation of going to a mental health professional.
arm group label: Control Group
arm group type: No Intervention
description: Participants in the control group will receive enhanced usual care. Participants who present a high risk of suicide and/or have a PHQ-9 score ≥20 are referred to the system for follow up. Participants with lower levels of depressive symptoms receive the recommendation of going to a mental health professional.
intervention type: Behavioral
intervention name: CONEMO
description: Participants will be offered a behavioral activation-based intervention delivered by an application for smartphones (CONEMO) oriented to encourage them to be more active and to incorporate more activities in participants' everyday life.
Nurses will train participants to use CONEMO, make phone calls when participants are non-adherent, and provide technical support when necessary. Nurses will be supervised by clinical psychologists.
arm group label: CONEMO
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Paulo R Menezes, MD, PhD
role: Principal Investigator
affiliation: University of Sao Paulo General Hospital
last name: Ricardo B Araya, MD, PhD
role: Principal Investigator
affiliation: London School of Hygiene and Tropical Medicine
last name: Jaime Miranda, MD, PhD
role: Principal Investigator
affiliation: Universidad Peruana Cayetano Heredia
last name: Lisa Colpe, PhD
role: Principal Investigator
affiliation: National Institute of Mental Health (NIMH)
last name: Francisco Diez-Canseco, MSc, MPH
role: Study Chair
affiliation: Universidad Peruana Cayetano Heredia
last name: Lena R Brandt, MSc
role: Study Chair
affiliation: Universidad Peruana Cayetano Heredia
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country: Peru
citation: Menezess PR, Araya R, Miranda J, Mohr DC, Price le SN. The Latin American treatment and innovation network in mental health h (LATINMH): rationale and scope. Rev Fac Cien Med Univ Nac Cordoba. 2015;72(4):321-30.
PMID: 27107284
responsible party type: Principal Investigator
investigator affiliation: Universidad Peruana Cayetano Heredia
investigator full name: Jaime Miranda
investigator title: Dr.
mesh term: Hypertension
mesh term: Diabetes Mellitus
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: Yes