Skip to main content
OpenTrials
Completed

NCT Number: NCT03275714

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bipolar Affective Disorder Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinik für Psychiatrie und Psychotherapeutische Medizin

Graz, 8010, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Sleep duration

    Time frame: 6 months

    in minutes

  2. Movement behaviour

    Time frame: 6 months

    evaluated through motion sensors and localization services

  3. Mood

    Time frame: 6 months

    evaluated by mood surveys

  4. Communication behaviour

    Time frame: 6 months

    Frequency of usage of communication services

Secondary outcomes

  1. Patient acceptance

    Time frame: 6 months

    evaluated by a questionnaire

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 7, 2017
Registry last updated
Dec 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.