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

Medical University of Graz

Status: Completed

Conditions: Bipolar Affective Disorder

Treatments: Device: Smartphone APP

Study type: Interventional

Funder types: Other

Identifiers

NCT03275714

bipolarAPP

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

People With a Bipolar Affective Disorder

Active Comparator group

Treatment:

Device: Smartphone APP

Control subjects without a psychiatric disorder

Active Comparator group

Treatment:

Device: Smartphone APP