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The primary objective of the clinical trial is to evaluate the data of an app for smartphones (BiP-App) with regard to sleep, movement, mood and communication behavior.
The data will be compared between two groups: people with a bipolar affective disorder and individuals without a psychiatric disorder.
Secondary objective of the trial is to investigate if it is possible to detect early warning symptoms of depressive / (hypo) manic episodes via the measured behavior patterns.
Furthermore it will be evaluated whether the BiP-app can find applicability in the examined patient group.
Study design: Clinical evaluation of a medical device without CE mark; Parallel study design
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| People With a Bipolar Affective Disorder | Active Comparator |
| |
| Control subjects without a psychiatric disorder | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smartphone APP | Device | Participants use the BiP-App for 6 months. The app continuously records data on light and motion sensors, as well as Global Positioning System (GPS) and mood surveys. |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep duration | in minutes | 6 months |
| Movement behaviour | evaluated through motion sensors and localization services | 6 months |
| Mood | evaluated by mood surveys | 6 months |
| Communication behaviour | Frequency of usage of communication services | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient acceptance | evaluated by a questionnaire | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinik für Psychiatrie und Psychotherapeutische Medizin | Graz | 8010 | Austria |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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