<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/NCT02221336</url>
  </required_header>
  <id_info>
    <org_study_id>H-2-2014-059</org_study_id>
    <nct_id>NCT02221336</nct_id>
  </id_info>
  <brief_title>Daily Subjective and Objective Smartphone Measures of Illness Activity to Treat Bipolar Disorder- The MONARCA II Trial</brief_title>
  <acronym>MONARCAII</acronym>
  <official_title>Daily Electronic Monitoring of Subjective and Objective Measures of Illness Activity in Bipolar Disorder - The MONARCA II Trial (MONitoring, treAtment and pRediCtion of bipolAr Disorder Episodes II)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Psychiatric Centre Rigshospitalet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Copenhagen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>IT University of Copenhagen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Psychiatric Centre Rigshospitalet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Bipolar disorder is associated with a high risk of relapse and hospitalisation and many&#xD;
      patients do not recover to their previous psychosocial function. Major reasons for poor&#xD;
      outcomes are delayed intervention for prodromal depressive and manic symptoms as well as&#xD;
      decreased adherence with treatment.&#xD;
&#xD;
      Recently, in the MONARCA I trial (NCT01446406), the investigators developed and deployed a&#xD;
      smartphone based self-monitoring system (the MONARCA I system) in a randomized controlled&#xD;
      trial, to test the effect of daily reporting of subjective self-monitoring of depressive and&#xD;
      manic symptoms as well as a bi-directional feedback loop on depressive and manic symptoms.&#xD;
&#xD;
      In the MONARCA II trial the investigators will develop and deploy a new version of the&#xD;
      smartphone based monitoring system. The investigators will in a randomized controlled single&#xD;
      blind trial investigate whether daily electronic monitoring of subjective and objective&#xD;
      measures of illness activity using a smartphone based self-monitoring system including&#xD;
      feedback on subjective as well as automatically generated objective data (e.g.social&#xD;
      activity, physical activity etc.) (the MONARCA II system) reduces the severity of depressive&#xD;
      and manic symptoms and improves functioning more than a control group receiving a smartphone.&#xD;
      All patients will be followed for 9 months with outcome assessments at baseline, after 4&#xD;
      weeks, after 3 months, after 6 months and after 9 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">January 2018</completion_date>
  <primary_completion_date type="Actual">January 2018</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>Differences between the groups in depressive and manic symptoms and the number of affective episodes</measure>
    <time_frame>Baseline and up to 9 months</time_frame>
    <description>Differences between the groups in depressive and manic symptoms measured using Hamilton Depression Rating Scale (HDRS) and Young Mania Rating Scale (YMRS) and episodes defined ad HDRS&lt;= 14 and/or YMRS&lt;= 14</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Differences between the groups in smartphone measures</measure>
    <time_frame>Baseline and up to 9 months</time_frame>
    <description>Differences between the groups in:&#xD;
-Automatically generated objective smartphone measures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences between the groups in number of hospitalizations</measure>
    <time_frame>Baseline up to 9 months follow up</time_frame>
    <description>Differences between the groups in number of hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences between the groups in number of contacts to clinicians and emergency rooms</measure>
    <time_frame>Baseline up to 9 months follow up</time_frame>
    <description>Differences between the groups in number of contacts to clinicians and emergency rooms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences between the groups in functioning</measure>
    <time_frame>Baseline up to 9 months follow up</time_frame>
    <description>Differences between the groups in functioning measured using the FAST questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences between the groups in perceived stress</measure>
    <time_frame>Baseline up to 9 months</time_frame>
    <description>Differences between the groups in perceived stress using the perceived stress questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences between the groups in quality of life</measure>
    <time_frame>Baseline up to 9 months follow up</time_frame>
    <description>Differences between the groups in quality of life measured using the WHOQoL questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences between the groups in self-rated depressive symptoms</measure>
    <time_frame>Baseline up to 9 months</time_frame>
    <description>Differences between the groups in self-rated depresisve symptoms using the BDI questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences in self-rated manic symptoms</measure>
    <time_frame>Baseline up to 9 months follow up</time_frame>
    <description>Differences between the groups in self-rated manic symptoms using the ASRM questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences between the groups in adherence to medication</measure>
    <time_frame>Baseline up to 9 months follow up</time_frame>
    <description>Differences between the groups in adherence to medication measured using the questionnaire MARS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences between the groups in recovery</measure>
    <time_frame>Baseline up to 9 months follow up</time_frame>
    <description>Differences between the groups in recovery using the questionnaire Recovery Assessment Scale (RAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences between the groups in empowerment</measure>
    <time_frame>baseline up ot 9 months</time_frame>
    <description>Differences between the groups in empowerment using the questionnaire Rogers Empowerment scale.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">146</enrollment>
  <condition>Bipolar Disorder</condition>
  <arm_group>
    <arm_group_label>Non-MONARCA II system</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Use of smartphone for normal communicative purposes only. No self-monitoring and no feedback loop.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>The MONARCA II system</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Daily electronic monitoring of subjective and objective smartphone measures including a feedback loop</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>The MONARCA II system</intervention_name>
    <description>Daily electronic monitoring of subjective and objective smartphone measures including a feedback loop</description>
    <arm_group_label>The MONARCA II system</arm_group_label>
    <other_name>Non-MONARCA II system (control group condition)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Non-MONARCA II system</intervention_name>
    <description>Daily use of smartphone for normal communicative purposes. No self-monitoring in the MONARCA II system.</description>
    <arm_group_label>Non-MONARCA II system</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Bipolar Disorder according to SCAN interview&#xD;
&#xD;
          -  ≥18 years of age&#xD;
&#xD;
          -  Patients who previously have received a course of treatment at the Clinic for&#xD;
             Affective Disorders, Psychiatric Centre Copenhagen, Denmark&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Lack of Danish language skills&#xD;
&#xD;
          -  Patients who previously have received and used the MONARCA I system for&#xD;
             self-monitoring&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria Faurholt-Jepsen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Psychiatric Centre Copenhagen, Rigshospitalet, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Psychiatric Centre Copenhagen, Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <reference>
    <citation>Faurholt-Jepsen M, Frost M, Vinberg M, Christensen EM, Bardram JE, Kessing LV. Smartphone data as objective measures of bipolar disorder symptoms. Psychiatry Res. 2014 Jun 30;217(1-2):124-7. doi: 10.1016/j.psychres.2014.03.009. Epub 2014 Mar 13.</citation>
    <PMID>24679993</PMID>
  </reference>
  <reference>
    <citation>Faurholt-Jepsen M, Vinberg M, Christensen EM, Frost M, Bardram J, Kessing LV. Daily electronic self-monitoring of subjective and objective symptoms in bipolar disorder--the MONARCA trial protocol (MONitoring, treAtment and pRediCtion of bipolAr disorder episodes): a randomised controlled single-blind trial. BMJ Open. 2013 Jul 24;3(7):e003353. doi: 10.1136/bmjopen-2013-003353. Print 2013.</citation>
    <PMID>23883891</PMID>
  </reference>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>April 5, 2018</last_update_submitted>
  <last_update_submitted_qc>April 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Psychiatric Centre Rigshospitalet</investigator_affiliation>
    <investigator_full_name>Maria Faurholt-Jepsen</investigator_full_name>
    <investigator_title>Principal Investigator, MD and PhD student</investigator_title>
  </responsible_party>
  <keyword>Bipolar disorder</keyword>
  <keyword>Daily electronic monitoring</keyword>
  <keyword>Smartphones</keyword>
  <keyword>Subjective and objective smartphone data</keyword>
  <keyword>Feedback loop</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bipolar 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/NCT02221336
org study id: H-2-2014-059
nct id: NCT02221336
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Bipolar disorder is associated with a high risk of relapse and hospitalisation and many
      patients do not recover to their previous psychosocial function. Major reasons for poor
      outcomes are delayed intervention for prodromal depressive and manic symptoms as well as
      decreased adherence with treatment.

      Recently, in the MONARCA I trial (NCT01446406), the investigators developed and deployed a
      smartphone based self-monitoring system (the MONARCA I system) in a randomized controlled
      trial, to test the effect of daily reporting of subjective self-monitoring of depressive and
      manic symptoms as well as a bi-directional feedback loop on depressive and manic symptoms.

      In the MONARCA II trial the investigators will develop and deploy a new version of the
      smartphone based monitoring system. The investigators will in a randomized controlled single
      blind trial investigate whether daily electronic monitoring of subjective and objective
      measures of illness activity using a smartphone based self-monitoring system including
      feedback on subjective as well as automatically generated objective data (e.g.social
      activity, physical activity etc.) (the MONARCA II system) reduces the severity of depressive
      and manic symptoms and improves functioning more than a control group receiving a smartphone.
      All patients will be followed for 9 months with outcome assessments at baseline, after 4
      weeks, after 3 months, after 6 months and after 9 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Differences between the groups in depressive and manic symptoms and the number of affective episodes
time frame: Baseline and up to 9 months
description: Differences between the groups in depressive and manic symptoms measured using Hamilton Depression Rating Scale (HDRS) and Young Mania Rating Scale (YMRS) and episodes defined ad HDRS<= 14 and/or YMRS<= 14
measure: Differences between the groups in smartphone measures
time frame: Baseline and up to 9 months
description: Differences between the groups in:
-Automatically generated objective smartphone measures
measure: Differences between the groups in number of hospitalizations
time frame: Baseline up to 9 months follow up
description: Differences between the groups in number of hospitalization
measure: Differences between the groups in number of contacts to clinicians and emergency rooms
time frame: Baseline up to 9 months follow up
description: Differences between the groups in number of contacts to clinicians and emergency rooms
measure: Differences between the groups in functioning
time frame: Baseline up to 9 months follow up
description: Differences between the groups in functioning measured using the FAST questionnaire
measure: Differences between the groups in perceived stress
time frame: Baseline up to 9 months
description: Differences between the groups in perceived stress using the perceived stress questionnaire
measure: Differences between the groups in quality of life
time frame: Baseline up to 9 months follow up
description: Differences between the groups in quality of life measured using the WHOQoL questionnaire
measure: Differences between the groups in self-rated depressive symptoms
time frame: Baseline up to 9 months
description: Differences between the groups in self-rated depresisve symptoms using the BDI questionnaire
measure: Differences in self-rated manic symptoms
time frame: Baseline up to 9 months follow up
description: Differences between the groups in self-rated manic symptoms using the ASRM questionnaire
measure: Differences between the groups in adherence to medication
time frame: Baseline up to 9 months follow up
description: Differences between the groups in adherence to medication measured using the questionnaire MARS
measure: Differences between the groups in recovery
time frame: Baseline up to 9 months follow up
description: Differences between the groups in recovery using the questionnaire Recovery Assessment Scale (RAS)
measure: Differences between the groups in empowerment
time frame: baseline up ot 9 months
description: Differences between the groups in empowerment using the questionnaire Rogers Empowerment scale.
arm group label: Non-MONARCA II system
arm group type: Placebo Comparator
description: Use of smartphone for normal communicative purposes only. No self-monitoring and no feedback loop.
arm group label: The MONARCA II system
arm group type: Experimental
description: Daily electronic monitoring of subjective and objective smartphone measures including a feedback loop
intervention type: Device
intervention name: The MONARCA II system
description: Daily electronic monitoring of subjective and objective smartphone measures including a feedback loop
arm group label: The MONARCA II system
other name: Non-MONARCA II system (control group condition)
intervention type: Device
intervention name: Non-MONARCA II system
description: Daily use of smartphone for normal communicative purposes. No self-monitoring in the MONARCA II system.
arm group label: Non-MONARCA II system
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Maria Faurholt-Jepsen, MD
role: Principal Investigator
affiliation: Psychiatric Centre Copenhagen, Rigshospitalet, Denmark
facility: 
country: Denmark
citation: Faurholt-Jepsen M, Frost M, Vinberg M, Christensen EM, Bardram JE, Kessing LV. Smartphone data as objective measures of bipolar disorder symptoms. Psychiatry Res. 2014 Jun 30;217(1-2):124-7. doi: 10.1016/j.psychres.2014.03.009. Epub 2014 Mar 13.
PMID: 24679993
citation: Faurholt-Jepsen M, Vinberg M, Christensen EM, Frost M, Bardram J, Kessing LV. Daily electronic self-monitoring of subjective and objective symptoms in bipolar disorder--the MONARCA trial protocol (MONitoring, treAtment and pRediCtion of bipolAr disorder episodes): a randomised controlled single-blind trial. BMJ Open. 2013 Jul 24;3(7):e003353. doi: 10.1136/bmjopen-2013-003353. Print 2013.
PMID: 23883891
responsible party type: Principal Investigator
investigator affiliation: Psychiatric Centre Rigshospitalet
investigator full name: Maria Faurholt-Jepsen
investigator title: Principal Investigator, MD and PhD student
mesh term: Bipolar Disorder