Self-monitoring and psychoeducation in bipolar patients with a smart-phone application (SIMPLe) project: design, development and studies protocols

Abstract

BackgroundNew technologies have recently been used for monitoring signs and symptoms of mental health illnesses and particularly have been tested to improve the outcomes in bipolar disorders. Web-based psychoeducational programs for bipolar disorders have also been implemented, yet to our knowledge, none of them have integrated both approaches in one single intervention. The aim of this project is to develop and validate a smartphone application to monitor symptoms and signs and empower the self-management of bipolar disorder, offering customized embedded psychoeducation contents, in order to identify early symptoms and prevent relapses and hospitalizations.Methods/designThe project will be carried out in three complementary phases, which will include a feasibility study (first phase), a qualitative study (second phase) and a randomized controlled trial (third phase) comparing the smartphone application (SIMPLe) on top of treatment as usual with treatment as usual alone. During the first phase, feasibility and satisfaction will be assessed with the application usage log data and with an electronic survey. Focus groups will be conducted and technical improvements will be incorporated at the second phase. Finally, at the third phase, survival analysis with multivariate data analysis will be performed and relationships between socio-demographic, clinical variables and assessments scores with relapses in each group will be explored.DiscussionThis project could result in a highly available, user-friendly and not costly monitoring and psychoeducational intervention that could improve the outcome of people suffering from bipolar disorders in a practical and secure way.Trial registrationClinical Trials.gov: NCT02258711 (October 2014).

Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) 2018 guidelines for the management of patients with bipolar disorder

“…While many patients will agree with the value of completing a mood diary, and this strategy has been shown to improve treatment, regular completion can be a burden 65. Online solutions such as mobile apps may improve adherence,66 such as the Self‐Monitoring and Psychoeducation In Bipolar Patients smartphone app (SIMPLE) which provides weekly and daily mood tests, with reminders to take medication or see their doctor 67, 68, 69…”

Self-Monitoring and Psychoeducation in Bipolar Patients with a Smart-phone application (SIMPLe) project: Preliminary results from a feasibility study

“…Feasibility study, and finally, after further improvements, 3. a Randomized Clinical Trial (RCT) assessing relapses prevention. A secondary long-term objective of the SIMPLe project is to integrate clinical correlates, biomarkers and genetics with the mobile behavior information collected in order to determine predictive relapses patterns [11]. We present in this paper preliminary results of the feasibility study.…”

“…If the patient agreed to participate an informed consent was handed out and signed, if not, the psychiatrist recollected the age, sex, socioeconomic status and reasons given for not participating. For details about the methodology employed for the others phases of the project please refer to the published protocols [11].…”

Is a SIMPLe smartphone application capable of improving biological rhythms in bipolar disorder?

“…Detailed baseline characteristics of the sample, the app design process and the results of the feasibility study are described in detail elsewhere (Hidalgo-Mazzei et al, 2016, 2015b.…”

“…The psychoeducational contents cover all the modules of evidence-based psychoeducational programs. Furthermore, content related to sleep/wake cycles was especially emphasized both in the app monitoring and psychoeducational messages (Hidalgo-Mazzei et al 2015b). The central purpose of the SIMPLe app, as an adjunctive to treatment as usual, is to promote BD patients' self-management and empowerment in order to modify behaviours and prevent relapses alongside quality of life improvement.…”