Smartphone-based Ambulatory Assessment of Early Warning Signs

NCT ID: NCT02782910

Last Updated: 2018-05-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2020-07-31

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.

Conditions

Bipolar Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

SBAA+

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.

Group Type: EXPERIMENTAL

Smartphone-Based Ambulatory Assessment, Feedback via physician

Intervention Type: DEVICE

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

SBAA

Continuous monitoring will occur analogous to SBAA+. Exceeding the pre defined SBAA-threshold will not result in any action taken.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Smartphone feedback via server

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role: collaborator

KIT (Karlsruher Institut für Technologie)

UNKNOWN

Sponsor Role: collaborator

Technische Universität Dresden

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Bauer, MD

Role: STUDY_DIRECTOR

Technische Universität Dresden

Locations

Department of Psychiatry and Psychotherapy

Dresden, Saxony, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Emanuel Severus, MD

Role: CONTACT

emanuel.severus@uniklinikum-dresden.de

+49 351 458 15489

Philipp Ritter, MD

Role: CONTACT

philipp.ritter@uniklinikum-dresden.de

+49 351 458 18763

Facility Contacts

Emanuel Severus, M.D.

Role: primary

References

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.

Reference Type: DERIVED

PMID: 30367608 (View on PubMed)

Related Links

http://www.bipolife.org

Central study website

Other Identifiers

BipoLife_A3

Identifier Type: -

Identifier Source: org_study_id