Smartphone-based Ambulatory Assessment of Early Warning Signs

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Device: Smartphone-Based Ambulatory Assessment, Feedback via physician


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Bipolar Disorders (I/II) > 3 affective episodes in 5 years prior to index episode, with one of them being a (hypo)manic episode Age > 18 years Male or female Inpatients or outpatients Smartphone usage Each patient must have a level of understanding sufficient to agree to all tasks required by the protocol. Patients must be considered reliable. Each patient must sign an informed consent document prior to enrollment. Exclusion Criteria: Current substance use disorder (except for tobacco and caffeine), moderate or severe, at enrolment Borderline personality disorder, antisocial personality disorder Dementia, organic brain disorders Unstable/inadequately treated medical illness Clinically significant cardiac, renal, hepatic, neoplastic or cerebrovascular disease Any medical condition posing a significant risk regarding adherence to study protocol

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SBAA+<br>Upon exceeding pre defined SBAA-threshold limits during the randomisation phase the treating physician is alerted (+) to this signal and required to contact the patient so as to assess the current mental status and collaboratively discuss the potential need for medical/psychiatric treatment with the patient. | Device: Smartphone-Based Ambulatory Assessment, Feedback via physician<br>* Participants in the experimental condition SBAA+ will be contacted by their treating physician, once the predefined threshold for Smartphone activity is exceeded.<br>* Other names: Smartphone feedback via server;|
| No Intervention: SBAA<br>Continuous monitoring will occur analogous to SBAA+. Exceeding the pre defined SBAA-threshold will not result in any action taken. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to relapse | Time until new affective episode (hypomanic, manic, mixed, depressed) according to DSM V criteria | Duration of trial after randomisation (total of 18 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total time in episode | Percentage of assessments during intervention phase at which the criteria for an affective episode are met | Duration of trial after randomisation (total of 18 months) | 
| Severity of manic symptomatology | Average severity of manic symptoms at assessments during intervention phase, as judged by YMRS score | Duration of trial after randomisation (total of 18 months) | 
| Severity of depressive symptomatology | Average severity of depressive symptoms at assessments during intervention phase, as judged by IDS score. | Duration of trial after randomisation (total of 18 months) | 
| Total hospitalisation | Percentage of assessments during intervention phase at which the patient was hospitalized for an affective episode | Duration of trial after randomisation (total of 18 months) |