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

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

Study Description

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

Study Design

• 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

Arms and Interventions

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)

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

Denmark

Psychiatric Centre Copenhagen, Rigshospitalet

Copenhagen, Denmark, 2100

Sponsors and Collaborators

Psychiatric Centre Rigshospitalet

University of Copenhagen

IT University of Copenhagen

Investigators

• Principal Investigator: Maria Faurholt-Jepsen, MD; Psychiatric Centre Copenhagen, Rigshospitalet, Denmark

More Information

Publications:

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.

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). pii: e003353. doi: 10.1136/bmjopen-2013-003353. Print 2013.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Melbye SA, Stanislaus S, Vinberg M, Frost M, Bardram JE, Sletved K, Coello K, Kjærstad HL, Christensen EM, Faurholt-Jepsen M, Kessing LV. Mood, activity, and sleep measured via daily smartphone-based self-monitoring in young patients with newly diagnosed bipolar disorder, their unaffected relatives and healthy control individuals. Eur Child Adolesc Psychiatry. 2020 Aug 2. doi: 10.1007/s00787-020-01611-7. [Epub ahead of print]

Faurholt-Jepsen M, Frost M, Christensen EM, Bardram JE, Vinberg M, Kessing LV. Validity and characteristics of patient-evaluated adherence to medication via smartphones in patients with bipolar disorder: exploratory reanalyses on pooled data from the MONARCA I and II trials. Evid Based Ment Health. 2020 Feb;23(1):2-7. doi: 10.1136/ebmental-2019-300106.

Faurholt-Jepsen M, Frost M, Busk J, Christensen EM, Bardram JE, Vinberg M, Kessing LV. Differences in mood instability in patients with bipolar disorder type I and II: a smartphone-based study. Int J Bipolar Disord. 2019 Feb 1;7(1):5. doi: 10.1186/s40345-019-0141-4.

Faurholt-Jepsen M, Vinberg M, Frost M, Christensen EM, Bardram J, Kessing LV. Daily electronic monitoring of subjective and objective measures of illness activity in bipolar disorder using smartphones--the MONARCA II trial protocol: a randomized controlled single-blind parallel-group trial. BMC Psychiatry. 2014 Nov 25;14:309. doi: 10.1186/s12888-014-0309-5.

• Responsible Party: Maria Faurholt-Jepsen, Principal Investigator, MD and PhD student, Psychiatric Centre Rigshospitalet
• ClinicalTrials.gov Identifier: NCT02221336
• Other Study ID Numbers: H-2-2014-059
• First Posted: August 20, 2014
• 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:

Disease; Bipolar Disorder; Pathologic Processes; Bipolar and Related Disorders; Mental Disorders