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Completed

NCT Number: NCT02221336

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

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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Psychiatric Centre Copenhagen, Rigshospitalet

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The MONARCA II system

Device

Daily electronic monitoring of subjective and objective smartphone measures including a feedback loop

Other names: Non-MONARCA II system (control group condition)

Non-MONARCA II system

Device

Daily use of smartphone for normal communicative purposes. No self-monitoring in the MONARCA II system.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Psychiatric Centre Rigshospitalet

Other

Collaborators

  • IT University of Copenhagen
  • University of Copenhagen

Registry information

Official study 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)

Acronym: MONARCAII

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Aug 20, 2014
Registry last updated
Apr 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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