Bipolar Disorder
Conditions
Keywords
Bipolar disorder, Daily electronic monitoring, Smartphones, Subjective and objective smartphone data, Feedback loop
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.
Interventions
DEVICEThe MONARCA II system
Daily electronic monitoring of subjective and objective smartphone measures including a feedback loop
DEVICENon-MONARCA II system
Daily use of smartphone for normal communicative purposes. No self-monitoring in the MONARCA II system.
Sponsors
University of Copenhagen
IT University of Copenhagen
Psychiatric Centre Rigshospitalet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 smartphone measures | Baseline and up to 9 months | Differences between the groups in: -Automatically generated objective smartphone measures |
| 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. |
| 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 |
Countries
Denmark
Outcome results
None listed