search
Back to results

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

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
The MONARCA II system
Non-MONARCA II system
Sponsored by
Psychiatric Centre Rigshospitalet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar disorder, Daily electronic monitoring, Smartphones, Subjective and objective smartphone data, Feedback loop

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Psychiatric Centre Copenhagen, Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Non-MONARCA II system

The MONARCA II system

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Differences between the groups in smartphone measures
Differences between the groups in: -Automatically generated objective smartphone measures
Differences between the groups in number of hospitalizations
Differences between the groups in number of hospitalization
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
Differences between the groups in functioning
Differences between the groups in functioning measured using the FAST questionnaire
Differences between the groups in perceived stress
Differences between the groups in perceived stress using the perceived stress questionnaire
Differences between the groups in quality of life
Differences between the groups in quality of life measured using the WHOQoL questionnaire
Differences between the groups in self-rated depressive symptoms
Differences between the groups in self-rated depresisve symptoms using the BDI questionnaire
Differences in self-rated manic symptoms
Differences between the groups in self-rated manic symptoms using the ASRM questionnaire
Differences between the groups in adherence to medication
Differences between the groups in adherence to medication measured using the questionnaire MARS
Differences between the groups in recovery
Differences between the groups in recovery using the questionnaire Recovery Assessment Scale (RAS)
Differences between the groups in empowerment
Differences between the groups in empowerment using the questionnaire Rogers Empowerment scale.

Full Information

First Posted
August 12, 2014
Last Updated
April 5, 2018
Sponsor
Psychiatric Centre Rigshospitalet
Collaborators
University of Copenhagen, IT University of Copenhagen
search

1. Study Identification

Unique Protocol Identification Number
NCT02221336
Brief Title
Daily Subjective and Objective Smartphone Measures of Illness Activity to Treat Bipolar Disorder- The MONARCA II Trial
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Psychiatric Centre Rigshospitalet
Collaborators
University of Copenhagen, IT University of Copenhagen

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Bipolar disorder, Daily electronic monitoring, Smartphones, Subjective and objective smartphone data, Feedback loop

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-MONARCA II system
Arm Type
Placebo Comparator
Arm Description
Use of smartphone for normal communicative purposes only. No self-monitoring and no feedback loop.
Arm Title
The MONARCA II system
Arm Type
Experimental
Arm Description
Daily electronic monitoring of subjective and objective smartphone measures including a feedback loop
Intervention Type
Device
Intervention Name(s)
The MONARCA II system
Other Intervention Name(s)
Non-MONARCA II system (control group condition)
Intervention Description
Daily electronic monitoring of subjective and objective smartphone measures including a feedback loop
Intervention Type
Device
Intervention Name(s)
Non-MONARCA II system
Intervention Description
Daily use of smartphone for normal communicative purposes. No self-monitoring in the MONARCA II system.
Primary Outcome Measure Information:
Title
Differences between the groups in depressive and manic symptoms and the number of affective episodes
Description
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
Time Frame
Baseline and up to 9 months
Secondary Outcome Measure Information:
Title
Differences between the groups in smartphone measures
Description
Differences between the groups in: -Automatically generated objective smartphone measures
Time Frame
Baseline and up to 9 months
Title
Differences between the groups in number of hospitalizations
Description
Differences between the groups in number of hospitalization
Time Frame
Baseline up to 9 months follow up
Title
Differences between the groups in number of contacts to clinicians and emergency rooms
Description
Differences between the groups in number of contacts to clinicians and emergency rooms
Time Frame
Baseline up to 9 months follow up
Title
Differences between the groups in functioning
Description
Differences between the groups in functioning measured using the FAST questionnaire
Time Frame
Baseline up to 9 months follow up
Title
Differences between the groups in perceived stress
Description
Differences between the groups in perceived stress using the perceived stress questionnaire
Time Frame
Baseline up to 9 months
Title
Differences between the groups in quality of life
Description
Differences between the groups in quality of life measured using the WHOQoL questionnaire
Time Frame
Baseline up to 9 months follow up
Title
Differences between the groups in self-rated depressive symptoms
Description
Differences between the groups in self-rated depresisve symptoms using the BDI questionnaire
Time Frame
Baseline up to 9 months
Title
Differences in self-rated manic symptoms
Description
Differences between the groups in self-rated manic symptoms using the ASRM questionnaire
Time Frame
Baseline up to 9 months follow up
Title
Differences between the groups in adherence to medication
Description
Differences between the groups in adherence to medication measured using the questionnaire MARS
Time Frame
Baseline up to 9 months follow up
Title
Differences between the groups in recovery
Description
Differences between the groups in recovery using the questionnaire Recovery Assessment Scale (RAS)
Time Frame
Baseline up to 9 months follow up
Title
Differences between the groups in empowerment
Description
Differences between the groups in empowerment using the questionnaire Rogers Empowerment scale.
Time Frame
baseline up ot 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Faurholt-Jepsen, MD
Organizational Affiliation
Psychiatric Centre Copenhagen, Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychiatric Centre Copenhagen, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
24679993
Citation
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.
Results Reference
background
PubMed Identifier
23883891
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):e003353. doi: 10.1136/bmjopen-2013-003353. Print 2013.
Results Reference
background
PubMed Identifier
32046986
Citation
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.
Results Reference
derived
PubMed Identifier
30706154
Citation
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.
Results Reference
derived
PubMed Identifier
25420431
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs