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

Not Applicable

Completed

• Conditions: Bipolar Disorder
• Interventions: Device: Non-MONARCA II system; Device: The MONARCA II system

• Registration Number: NCT02221336
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-12
• Study First Submitted QC: 2014-08-18
• Study First Posted: 2014-08-20
• Study Start: 2014-09
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-05
• Last Update Posted: 2018-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-MONARCA II system	Non-MONARCA II system	Use of smartphone for normal communicative purposes only. No self-monitoring and no feedback loop.
The MONARCA II system	The MONARCA II system	Daily electronic monitoring of subjective and objective smartphone measures including a feedback loop

Primary Outcome Measures

Name	Time	Method
Differences between the groups in depressive and manic symptoms and the number of affective episodes	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

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

Trial Locations

Locations (1)

Psychiatric Centre Copenhagen, Rigshospitalet; 🇩🇰 Copenhagen, Denmark