NCT02782910

Smartphone-based Ambulatory Assessment of Early Warning Signs

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Technische Universität Dresden · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Symptomatic outpatients with bipolar disorders I/II , will be consecutively assessed for eligibility. After having signed informed consent patients will receive open, guideline-based, state-of-the-art treatment for their current symptomatology ((hypo)manic and/or depressed) for up to 16 weeks. As soon as patients meet stabilisation criteria (YMRS total score \< 12 and IDS total score \< 12) they will be equipped with a study smartphone, for exclusive use during the study period, to assess the parameters of interest (activity, communication pattern, sleep pattern) and define the individual symptoms' threshold during 4 consecutive weeks of stabilisation . If patients fulfil randomization criteria (4 consecutive weeks with YMRS total score \< 12 and IDStotal score \< 12), they will enter the observer (rater) - blind, intervention phase, which will continue for 18 months (78 weeks). At randomization patients will be assigned to either the Smartphone-Based Ambulatory Assessment group, including real-time data capture and data-driven, individual symptoms' threshold-defined therapeutic interventions (SBAA+), in addition to state-of-the-art maintenance treatment or the Smartphone-Based Ambulatory Assessment group, only including real-time data capture (SBAA), in addition to state-of-the-art maintenance treatment.

Conditions

• Bipolar Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-01-01
• Primary completion: 2020-07-01
• Completion: 2020-07-01
• First posted: 2016-05-25
• Last updated: 2018-05-29

Locations

1 site across 1 country: Germany