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Completed

NCT Number: NCT02782910

Smartphone-based Ambulatory Assessment of Early Warning Signs

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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry and Psychotherapy

Dresden, Saxony, 01307, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smartphone-Based Ambulatory Assessment, Feedback via physician

Device

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

Other names: Smartphone feedback via server

Primary outcomes

  1. Time to relapse

    Time frame: Duration of trial after randomisation (total of 18 months)

    Time until new affective episode (hypomanic, manic, mixed, depressed) according to DSM V criteria

Secondary outcomes

  1. Total time in episode

    Time frame: Duration of trial after randomisation (total of 18 months)

    Percentage of assessments during intervention phase at which the criteria for an affective episode are met

  2. Severity of manic symptomatology

    Time frame: Duration of trial after randomisation (total of 18 months)

    Average severity of manic symptoms at assessments during intervention phase, as judged by YMRS score

  3. Severity of depressive symptomatology

    Time frame: Duration of trial after randomisation (total of 18 months)

    Average severity of depressive symptoms at assessments during intervention phase, as judged by IDS score.

  4. Total hospitalisation

    Time frame: Duration of trial after randomisation (total of 18 months)

    Percentage of assessments during intervention phase at which the patient was hospitalized for an affective episode

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Collaborators

  • German Federal Ministry of Education and Research
  • Karlsruhe Institute of Technology

Registry information

Official study 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.

Acronym: BipoLife_A3

Important dates

Study start
2017
Primary completion
2022
Study completion
2023
First posted
May 25, 2016
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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