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 randomised controlled parallel-group trial
Authors: Faurholt-Jepsen Maria , Kyster Natacha Blauenfeldt , Dyreholt Malene Schwarz , Christensen Ellen Margrethe , Bondo-Kozuch Pernille , Lerche Anna Skovgaard , Smidt Birte , Knorr Ulla Benedichte , Broendmark Kim , Cardoso Anne-Marie Bangsgaard , Mathiesen Anja , Sjaelland Rene , Nørbak-Emig Henrik , Sponsor Lotte Linnemann , Mardosas Darius , Sarauw-Nielsen Ida Palmblad , Bukh Jens Drachmann , Heller Trine Vøgg , Frost Mads , Iversen Nanna , Bardram Jakob Eyvind , Busk Jonas , Vinberg Maj , Kessing Lars Vedel 
Published: August 2023

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 hospitalisation and relapse.
During the last decade, we have developed and tested a smartphone-based system for monitoring bipolar disorder. The present SmartBipolar randomised 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 randomised controlled parallel-group trial. Patients with bipolar disorder are invited to participate as part of their specialised outpatient treatment for patients with bipolar disorder in Mental Health Services in the Capital Region of Denmark. The included patients will be randomised 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 specialised 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 hospitalisations, 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 number: NCT04230421.
Protocol version:Date March 1st, 2021. Version 1.