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

Psychiatric Centre Rigshospitalet

Status: Completed

Conditions: Bipolar Disorder

Treatments: Device: Non-MONARCA II system; Device: The MONARCA II system

Study type: Interventional

Funder types: Other

Identifiers

NCT02221336

H-2-2014-059

Details and patient eligibility

About

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.

Enrollment: 146 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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146 participants in 2 patient groups, including a placebo group

Non-MONARCA II system

Placebo Comparator group

Description:

Use of smartphone for normal communicative purposes only. No self-monitoring and no feedback loop.

Treatment:

Device: Non-MONARCA II system

The MONARCA II system

Experimental group

Description:

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

Treatment:

Device: The MONARCA II system