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

Not Applicable

Completed

• Conditions: Bipolar Affective Disorder
• Interventions: Device: Smartphone APP

• Registration Number: NCT03275714
• Lead Sponsor: Medical University of Graz

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-31
• Study Start: 2017-09-01
• Study First Submitted QC: 2017-09-06
• Study First Posted: 2017-09-07
• Primary Completion: 2019-11-20
• Study Completion: 2019-11-20
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-13
• Last Update Posted: 2019-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
People With a Bipolar Affective Disorder	Smartphone APP	-
Control subjects without a psychiatric disorder	Smartphone APP	-

Primary Outcome Measures

Name	Time	Method
Mood	6 months	evaluated by mood surveys
Sleep duration	6 months	in minutes
Movement behaviour	6 months	evaluated through motion sensors and localization services
Communication behaviour	6 months	Frequency of usage of communication services

Secondary Outcome Measures

Name	Time	Method
Patient acceptance	6 months	evaluated by a questionnaire

Trial Locations

Locations (1)

Universitätsklinik für Psychiatrie und Psychotherapeutische Medizin; 🇦🇹 Graz, Austria