Clinical trial NCT02782910: Smartphone-based Ambulatory Assessment of Early Warning Signs
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bipolar Disorder
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
name: KIT (Karlsruher Institut für Technologie)
First posted: 2016-05-25
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to relapse
timeFrame: Duration of trial after randomisation (total of 18 months)
Secondary outcomes:
measure: Total time in episode
timeFrame: Duration of trial after randomisation (total of 18 months)
measure: Severity of manic symptomatology
timeFrame: Duration of trial after randomisation (total of 18 months)
measure: Severity of depressive symptomatology
timeFrame: Duration of trial after randomisation (total of 18 months)
measure: Total hospitalisation
timeFrame: Duration of trial after randomisation (total of 18 months)
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Department of Psychiatry and Psychotherapy
state: Saxony
Study officials:
affiliation: Technische Universität Dresden
name: Michael Bauer, MD
role: STUDY_DIRECTOR
References:
citation: Muhlbauer E, Bauer M, Ebner-Priemer U, Ritter P, Hill H, Beier F, Kleindienst N, Severus E. Effectiveness of smartphone-based ambulatory assessment (SBAA-BD) including a predicting system for upcoming episodes in the long-term treatment of patients with bipolar disorders: study protocol for a randomized controlled single-blind trial. BMC Psychiatry. 2018 Oct 26;18(1):349. doi: 10.1186/s12888-018-1929-y.