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

Bipolar Disorder Clinical Trial

— MONARCAII  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02221336
• Other study ID #: H-2-2014-059
• Status: Completed
• Phase: N/A
• First received: August 12, 2014
• Last updated: April 5, 2018
• Start date: September 2014
• Est. completion date: January 2018

Study information

• Verified date: April 2018
• Source: Psychiatric Centre Rigshospitalet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease

Intervention

Device:
• The MONARCA II system
Daily electronic monitoring of subjective and objective smartphone measures including a feedback loop
• Non-MONARCA II system
Daily use of smartphone for normal communicative purposes. No self-monitoring in the MONARCA II system.

Locations

Country	Name	City	State
Denmark	Psychiatric Centre Copenhagen, Rigshospitalet	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
Psychiatric Centre Rigshospitalet	IT University of Copenhagen, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Differences between the groups in smartphone measures	Differences between the groups in: -Automatically generated objective smartphone measures	Baseline and up to 9 months
Secondary	Differences between the groups in number of hospitalizations	Differences between the groups in number of hospitalization	Baseline up to 9 months follow up
Secondary	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
Secondary	Differences between the groups in functioning	Differences between the groups in functioning measured using the FAST questionnaire	Baseline up to 9 months follow up
Secondary	Differences between the groups in perceived stress	Differences between the groups in perceived stress using the perceived stress questionnaire	Baseline up to 9 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Differences between the groups in empowerment	Differences between the groups in empowerment using the questionnaire Rogers Empowerment scale.	baseline up ot 9 months