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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03275714

Enrollment

Registered

2017-09-07

Start date

2017-09-01

Completion date

2019-11-20

Last updated

2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Affective Disorder

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

Interventions

DEVICESmartphone 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Patient acceptance	6 months	evaluated by a questionnaire

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026