Bipolar DisorderBipoLife_A3NCT02782910
Smartphone-based Ambulatory Assessment of Early Warning Signs
A study testing Smartphone-Based Ambulatory Assessment, Feedback via physician in people with Bipolar Disorder, run by Technische Universität Dresden at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Smartphone-Based Ambulatory Assessment, Feedback via physician
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2017to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychiatry and Psychotherapy
Dresden, Saxony, 01307
About this study
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.
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.
Read the 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
- Being tested
- Smartphone-Based Ambulatory Assessment, Feedback via physician
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone-Based Ambulatory Assessment, Feedback via physicianDevice
Also called Smartphone feedback via server
Participants in the experimental condition SBAA+ will be contacted by their treating physician, once the predefined threshold for Smartphone activity is exceeded.
| Study group | Role | What they receive |
|---|---|---|
| SBAA+ | Experimental | 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. Receives: Device: Smartphone-Based Ambulatory Assessment, Feedback via physician |
| SBAA | No intervention | Continuous monitoring will occur analogous to SBAA+. Exceeding the pre defined SBAA-threshold will not result in any action taken. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to relapse
Time until new affective episode (hypomanic, manic, mixed, depressed) according to DSM V criteria
Measured: Duration of trial after randomisation (total of 18 months)
Secondary outcomes (4)
Total time in episode
Percentage of assessments during intervention phase at which the criteria for an affective episode are met
Measured: 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
Measured: 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.
Measured: 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
Measured: Duration of trial after randomisation (total of 18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2016 (estimated)
- Study start1 Jan 2017
- Primary completion7 Jul 2022
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Karlsruhe Institute of Technology, German Federal Ministry of Education and Research
- Responsible party
- Sponsor
- Investigators
- Michael Bauer, MD, Study director, Technische Universität Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02782910
- Sponsor's protocol ID
- BipoLife_A3
- Acronym
- BipoLife_A3
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2015
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30367608
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02782910
- Acronym / sponsor ID
- BipoLife_A3 / BipoLife_A3
- Conditions
- Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Karlsruhe Institute of Technology, German Federal Ministry of Education and Research
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 7 Jul 2022 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 25 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBAA+ | Experimental | Device: Smartphone-Based Ambulatory Assessment, Feedback via physicianUpon 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. |
| SBAA | No intervention | –Continuous monitoring will occur analogous to SBAA+. Exceeding the pre defined SBAA-threshold will not result in any action taken. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Bipolar Disorders (I/II)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone-Based Ambulatory Assessment, Feedback via physicianAlso: Smartphone feedback via serverParticipants in the experimental condition SBAA+ will be contacted by their treating physician, once the predefined threshold for Smartphone activity is exceeded. | Device | SBAA+ |
Primary outcome
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
4 secondary outcomes
Total time in episode
Time frame: Duration of trial after randomisation (total of 18 months)
Severity of manic symptomatology
Time frame: Duration of trial after randomisation (total of 18 months)
Severity of depressive symptomatology
Time frame: Duration of trial after randomisation (total of 18 months)
Total hospitalisation
Time frame: Duration of trial after randomisation (total of 18 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Derived from this study: PubMed 30367608Muhlbauer 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.
- Central study websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Bauer, MD study director
Technische Universität Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone-Based Ambulatory Assessment, Feedback via physician in people with Bipolar Disorder, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to relapse (time frame: Duration of trial after randomisation (total of 18 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02782910, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.