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COMPLETED
NCT02782910
NA

Smartphone-based Ambulatory Assessment of Early Warning Signs

Sponsor: Technische Universität Dresden

View on ClinicalTrials.gov

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.

Official title: Smartphone-based Ambulatory Assessment of Early Warning Signs, Including Personalized Real-time Data-driven Therapeutic Interventions, in the Long-term Treatment of Bipolar Disorders.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

148

Start Date

2017-01-01

Completion Date

2023-05-31

Last Updated

2026-09-02

Healthy Volunteers

No

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.

Locations (1)

Department of Psychiatry and Psychotherapy

Dresden, Saxony, Germany