Evaluation of an App for Smartphones for People With a Bipolar Affective Disorder

Study Overview
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Brief Summary
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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

Official Title
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Evaluation of an App for Smartphones for People With a Bipolar Affective Disorder

Conditions
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Bipolar Affective Disorder

Intervention / Treatment
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* Device: Smartphone APP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written consent of the participant after clarification Patients with a bipolar affective disorder (group of patients) Or control persons without a mental illness (control group) Age between 18 and 70 years Knowledge about using a smartphone Exclusion Criteria: Rejection of participation Lack of knowledge about how to deal with a smartphone Congenital / early-childhood intelligence reduction Moderate / severe dementia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: People With a Bipolar Affective Disorder<br> | Device: Smartphone APP<br>* 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.<br>|
| Active Comparator: Control subjects without a psychiatric disorder<br> | Device: Smartphone APP<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient acceptance | evaluated by a questionnaire | 6 months |