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

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  • Natacha Blauenfeldt Kyster
  • Malene Schwarz Dyreholt
  • Ellen Margrethe Christensen
  • Pernille Bondo-Kozuch
  • Anna Skovgaard Lerche
  • Birte Smidt
  • Kim Brøndmark
  • Anne-Marie Bangsgaard Cardoso
  • Anja Mathiesen
  • Rene Sjælland
  • Henrik Nørbak-Emig
  • Lotte Linnemann Sponsor
  • Darius Mardosas
  • Ida Palmblad Sarauw-Nielsen
  • Trine Vøgg Heller
  • Mads Frost
  • Nanna Iversen
  • Jakob Eyvind Bardram
  • Jonas Busk

Introduction: A substantial proportion of patients with bipolar disorder experience daily subsyndromal mood swings, and the term “mood instability” reflecting the variability in mood seems associated with poor prognostic factors, including impaired functioning, and increased risk of hospitalization and relapse. During the last decade, we have developed and tested a smartphone-based system for monitoring bipolar disorder. The present SmartBipolar randomized controlled trial (RCT) aims to investigate whether (1) daily smartphone-based outpatient monitoring and treatment including clinical feedback versus (2) daily smartphone-based monitoring without clinical feedback or (3) daily smartphone-based mood monitoring only improves mood instability and other clinically relevant patient-related outcomes in patients with bipolar disorder. Methods and analysis: The SmartBipolar trial is a pragmatic randomized controlled parallel-group trial. Patients with bipolar disorder are invited to participate as part of their specialized outpatient treatment for patients with bipolar disorder in Mental Health Services in the Capital Region of Denmark. The included patients will be randomized to (1) daily smartphone-based monitoring and treatment including a clinical feedback loop (intervention group) or (2) daily smartphone-based monitoring without a clinical feedback loop (control group) or (3) daily smartphone-based mood monitoring only (control group). All patients receive specialized outpatient treatment for bipolar disorder in the Mental Health Services in the Capital Region of Denmark. The trial started in March 2021 and has currently included 150 patients. The outcomes are (1) mood instability (primary), (2) quality of life, self-rated depressive symptoms, self-rated manic symptoms, perceived stress, satisfaction with care, cumulated number and duration of psychiatric hospitalizations, and medication (secondary), and (3) smartphone-based measures per month of stress, anxiety, irritability, activity, and sleep as well as the percentage of days with presence of mixed mood, days with adherence to medication and adherence to smartphone-based self-monitoring. A total of 201 patients with bipolar disorder will be included in the SmartBipolar trial. Ethics and dissemination: The SmartBipolar trial is funded by the Capital Region of Denmark and the Independent Research Fund Denmark. Ethical approval has been obtained from the Regional Ethical Committee in The Capital Region of Denmark (H-19067248) as well as data permission (journal number: P-2019–809). The results will be published in peer-reviewed academic journals, presented at scientific meetings, and disseminated to patients’ organizations and media outlets. Trial registration: Trial registration number: NCT04230421. Date March 1, 2021. Version 1.

OriginalsprogEngelsk
Artikelnummer583
TidsskriftTrials
Vol/bind24
Antal sider15
ISSN1745-6215
DOI
StatusUdgivet - 2023

Bibliografisk note

Funding Information:
The SmartBipolar RCT is funded by the Mental Health Services, Capital Region of Denmark (A6508) and the Independent Research Fund Denmark (0134-00027B). The funders have no role in the design, analyses, and reporting of the findings form the SmartBipolar trial. The Mental Health Services, Capital Region of Denmark, is the sponsor (Prof. Lars Vedel Kessing: lars.vedel.kessing@regionh.dk). LVK and MFJ will collect the data, analyze the data, and write the scientific reports. Professional writers will not be used. We will adhere to Vancouver eligibility guidelines for authorship.

Publisher Copyright:
© 2023, BioMed Central Ltd., part of Springer Nature.

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