MedTrace Logo

Smartphone-based Ambulatory Assessment of Early Warning Signs

NCT02782910 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2018-05-29

No results posted yet for this study

Summary

Bipolar disorders are severe chronic disorders, marked by recurrent episodes of depression and (hypo)mania. The disorder usually emerges in early adulthood and tends to have a highly unpredictable course. Prevention of these episodes is essential, as they are associated with marked impairment in social and occupational functioning. The investigators propose to conduct a randomized, multi-center, observer-blind, parallel group controlled trial with an 78 week (18 month) intervention phase to test the hypothesis that continuous ambulatory real-time monitoring of early warning signs for new depressive or (hypo)manic episodes by smartphone based, innovative technology (e.g. GPS, acceleration sensor), including individual threshold- based early intervention for these early warning signs, will prolong time to a new mood episode and reduce hospitalizations (intervention group). In the control group ambulatory monitoring of early warning signs for emerging depressive or (hypo)manic episodes will occur in an identical manner, but the results will not be transmitted to the treating psychiatrist. All patients in this trial, irrespective of their group assignment, will receive guideline-based, state-of-the-art maintenance treatment.

Conditions

Interventions

DEVICE

Smartphone-Based Ambulatory Assessment, Feedback via physician

Participants in the experimental condition SBAA+ will be contacted by their treating physician, once the predefined threshold for Smartphone activity is exceeded.

Sponsors & Collaborators

  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV

  • KIT (Karlsruher Institut für Technologie)

    collaborator UNKNOWN

  • Technische Universität Dresden

    lead OTHER

Principal Investigators

  • Michael Bauer, MD · Technische Universität Dresden

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2020-07-31
Completion
2020-07-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT02782910 on ClinicalTrials.gov