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

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)

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.

Study Overview

• Status: Completed
• Conditions: Bipolar Disorder
• Intervention / Treatment: Device: Non-MONARCA II system; Device: The MONARCA II system

• Study Type: Interventional
• Enrollment (Actual): 146
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Psychiatric Centre Copenhagen, Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Non-MONARCA II system (control group condition)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences between the groups in depressive and manic symptoms and the number of affective episodes	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	Baseline and up to 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences between the groups in smartphone measures	Differences between the groups in: -Automatically generated objective smartphone measures	Baseline and up to 9 months
Differences between the groups in number of hospitalizations	Differences between the groups in number of hospitalization	Baseline up to 9 months follow up
Differences between the groups in number of contacts to clinicians and emergency rooms	Differences between the groups in number of contacts to clinicians and emergency rooms	Baseline up to 9 months follow up
Differences between the groups in functioning	Differences between the groups in functioning measured using the FAST questionnaire	Baseline up to 9 months follow up
Differences between the groups in perceived stress	Differences between the groups in perceived stress using the perceived stress questionnaire	Baseline up to 9 months
Differences between the groups in quality of life	Differences between the groups in quality of life measured using the WHOQoL questionnaire	Baseline up to 9 months follow up
Differences between the groups in self-rated depressive symptoms	Differences between the groups in self-rated depresisve symptoms using the BDI questionnaire	Baseline up to 9 months
Differences in self-rated manic symptoms	Differences between the groups in self-rated manic symptoms using the ASRM questionnaire	Baseline up to 9 months follow up
Differences between the groups in adherence to medication	Differences between the groups in adherence to medication measured using the questionnaire MARS	Baseline up to 9 months follow up
Differences between the groups in recovery	Differences between the groups in recovery using the questionnaire Recovery Assessment Scale (RAS)	Baseline up to 9 months follow up
Differences between the groups in empowerment	Differences between the groups in empowerment using the questionnaire Rogers Empowerment scale.	baseline up ot 9 months

Collaborators and Investigators

• Sponsor: Psychiatric Centre Rigshospitalet
• Collaborators: University of Copenhagen; IT University of Copenhagen
• Investigators: Principal Investigator: Maria Faurholt-Jepsen, MD, Psychiatric Centre Copenhagen, Rigshospitalet, Denmark

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: August 12, 2014
• First Submitted That Met QC Criteria: August 18, 2014
• First Posted (Estimate): August 20, 2014

Study Record Updates

• Last Update Posted (Actual): April 6, 2018
• Last Update Submitted That Met QC Criteria: April 5, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Feedback loop; Bipolar disorder; Smartphones; Daily electronic monitoring; Subjective and objective smartphone data
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Bipolar and Related Disorders; Disease; Bipolar Disorder
• Other Study ID Numbers: H-2-2014-059