Effects of Smartphone-based Treatment for Bipolar Disorder - the Smart Bipolar
NCT ID: NCT04230421
Last Updated: 2023-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
200 participants
INTERVENTIONAL
2021-03-01
2026-07-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The CAG Bipolar the CAG Bipolar RCT
NCT04229875
Development of a Personalized Real-time Intervention for Bipolar Disorder
NCT01670123
Daily Subjective and Objective Smartphone Measures of Illness Activity to Treat Bipolar Disorder- The MONARCA II Trial
NCT02221336
Improving Early Recognition and Intervention in At-risk Stages of Bipolar Disorders
NCT02456545
Does Bipolar Disease Program (BDP) Intervention Improve Long Term Manic and Depressive Symptoms.
NCT00007761
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This is an application from the entire Mental Health Services, Capital Region of Denmark including all psychiatric centers in the region. The Smart Bipolar randomized controlled trial is a pragmatic trial aiming to investigate the effects of smartphone-based add-on treatment in large-scale clinical practice (N= 200 patients). Findings from the study will have a great impact on future IT monitoring and treatment in bipolar disorder.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Monsenso with feedback
Daily smartphone-based monitoring and treatment using the Monsenso system with a clinical feedback loop feedback.
The Monsenso system with feedback
See description under intervention
Monsenso without feedback
Daily smartphone-based monitoring and treatment using the Monsenso system WITHOUT a clinical feedback loop feedback.
The Monsenso system without feedback
See description under intervention
Control
CAG Bipolar treatment alone and daily mood monitoring using only the mood monitoring part of the Monsenso system.
CAG Bipola and mood monitoring only
See description under intervention
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
The Monsenso system with feedback
See description under intervention
The Monsenso system without feedback
See description under intervention
CAG Bipola and mood monitoring only
See description under intervention
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Maria Faurholt-Jepsen, MD, DMSc
UNKNOWN
The Mental Health Services in the Capital Region of Denmark
UNKNOWN
Mental Health Services in the Capital Region, Denmark
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Lars Vedel Kessing
Prof., Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Psychiatric Center Copenhagen, Rigshospitalet
Copenhagen, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Maria Faurholt-Jepsen
Role: primary
Lars Vedel Kessing
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
Faurholt-Jepsen M, Kyster NB, Dyreholt MS, Christensen EM, Bondo-Kozuch P, Lerche AS, Smidt B, Knorr U, Brondmark K, Cardoso AB, Mathiesen A, Sjaelland R, Norbak-Emig H, Sponsor LL, Mardosas D, Sarauw-Nielsen IP, Bukh JD, Heller TV, Frost M, Iversen N, Bardram JE, Busk J, Vinberg M, Kessing LV. The effect of smartphone-based monitoring and treatment including clinical feedback versus smartphone-based monitoring without clinical feedback in bipolar disorder: the SmartBipolar trial-a study protocol for a randomized controlled parallel-group trial. Trials. 2023 Sep 12;24(1):583. doi: 10.1186/s13063-023-07625-1.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H-19067259
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.