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

NCT03275714 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2019-12-16

No results posted yet for this study

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

Conditions

  • Bipolar Affective Disorder

Interventions

DEVICE

Smartphone APP

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.

Sponsors & Collaborators

  • Medical University of Graz

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2019-11-20
Completion
2019-11-20

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03275714 on ClinicalTrials.gov