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Daily Subjective and Objective Smartphone Measures of Illness Activity to Treat Bipolar Disorder- The MONARCA II Trial (MONARCAII)

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ClinicalTrials.gov Identifier: NCT02221336
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : April 6, 2018
Sponsor:
Collaborators:
University of Copenhagen
IT University of Copenhagen
Information provided by (Responsible Party):
Maria Faurholt-Jepsen, Psychiatric Centre Rigshospitalet

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Bipolar Disorder Device: The MONARCA II system Device: Non-MONARCA II system Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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)
Study Start Date : September 2014
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
Placebo Comparator: Non-MONARCA II system
Use of smartphone for normal communicative purposes only. No self-monitoring and no feedback loop.
Device: Non-MONARCA II system
Daily use of smartphone for normal communicative purposes. No self-monitoring in the MONARCA II system.

Experimental: The MONARCA II system
Daily electronic monitoring of subjective and objective smartphone measures including a feedback loop
Device: The MONARCA II system
Daily electronic monitoring of subjective and objective smartphone measures including a feedback loop
Other Name: Non-MONARCA II system (control group condition)




Primary Outcome Measures :
  1. Differences between the groups in depressive and manic symptoms and the number of affective episodes [ Time Frame: Baseline and up to 9 months ]
    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


Secondary Outcome Measures :
  1. Differences between the groups in smartphone measures [ Time Frame: Baseline and up to 9 months ]

    Differences between the groups in:

    -Automatically generated objective smartphone measures


  2. Differences between the groups in number of hospitalizations [ Time Frame: Baseline up to 9 months follow up ]
    Differences between the groups in number of hospitalization

  3. Differences between the groups in number of contacts to clinicians and emergency rooms [ Time Frame: Baseline up to 9 months follow up ]
    Differences between the groups in number of contacts to clinicians and emergency rooms

  4. Differences between the groups in functioning [ Time Frame: Baseline up to 9 months follow up ]
    Differences between the groups in functioning measured using the FAST questionnaire

  5. Differences between the groups in perceived stress [ Time Frame: Baseline up to 9 months ]
    Differences between the groups in perceived stress using the perceived stress questionnaire

  6. Differences between the groups in quality of life [ Time Frame: Baseline up to 9 months follow up ]
    Differences between the groups in quality of life measured using the WHOQoL questionnaire

  7. Differences between the groups in self-rated depressive symptoms [ Time Frame: Baseline up to 9 months ]
    Differences between the groups in self-rated depresisve symptoms using the BDI questionnaire

  8. Differences in self-rated manic symptoms [ Time Frame: Baseline up to 9 months follow up ]
    Differences between the groups in self-rated manic symptoms using the ASRM questionnaire

  9. Differences between the groups in adherence to medication [ Time Frame: Baseline up to 9 months follow up ]
    Differences between the groups in adherence to medication measured using the questionnaire MARS

  10. Differences between the groups in recovery [ Time Frame: Baseline up to 9 months follow up ]
    Differences between the groups in recovery using the questionnaire Recovery Assessment Scale (RAS)

  11. Differences between the groups in empowerment [ Time Frame: baseline up ot 9 months ]
    Differences between the groups in empowerment using the questionnaire Rogers Empowerment scale.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Bipolar Disorder according to SCAN interview
  • ≥18 years of age
  • Patients who previously have received a course of treatment at the Clinic for Affective Disorders, Psychiatric Centre Copenhagen, Denmark

Exclusion Criteria:

  • Pregnancy
  • Lack of Danish language skills
  • Patients who previously have received and used the MONARCA I system for self-monitoring

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02221336


Locations
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Denmark
Psychiatric Centre Copenhagen, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Psychiatric Centre Rigshospitalet
University of Copenhagen
IT University of Copenhagen
Investigators
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Principal Investigator: Maria Faurholt-Jepsen, MD Psychiatric Centre Copenhagen, Rigshospitalet, Denmark

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maria Faurholt-Jepsen, Principal Investigator, MD and PhD student, Psychiatric Centre Rigshospitalet
ClinicalTrials.gov Identifier: NCT02221336     History of Changes
Other Study ID Numbers: H-2-2014-059
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018
Keywords provided by Maria Faurholt-Jepsen, Psychiatric Centre Rigshospitalet:
Bipolar disorder
Daily electronic monitoring
Smartphones
Subjective and objective smartphone data
Feedback loop
Additional relevant MeSH terms:
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Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders