Enhancing adherence to antipsychotic treatment for bipolar disorders. Comparison of mobile app-based psychoeducation, group psychoeducation, and the combination of both: protocol of a three-arm single-blinded parallel-group multi-centre randomised trial

doi: 10.7417/CT.2020.2194

  • A. Pozza Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Siena
  • A. Coluccia Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Siena
  • G. Gualtieri Legal Medicine Unit, Santa Maria alle Scotte University Hospital of Siena, Siena, Italy
  • F. Ferretti Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Siena

Abstract

Group Psychoeducation (PE) is an effective strategy to enhance adherence to antipsychotic treatment in Bipolar Disorders (BD). However, it requires attendance to weekly sessions during a period of about 6 months. This may impede its application for those patients living far from mental health centres, resulting inequality in access to evidence-based care. Therefore, there is an increasing need to find new efficient strategies to deliver and extend PE programs to a wider population of BD patients. Mobile apps are a cost-effective way to deliver PE.


In the Italian healthcare context, no evidence about the use of apps is available. The current paper presents the protocol about the development of a smartphone app to deliver PE for BD and the protocol for a trial assessing its effectiveness. In euthymic BD patients, the study will compare the adherence rates to antipsychotics between PE delivered through Bipolar mobile Application (Bip.App), group PE and a combination of both, will investigate demographic, socio-cultural and clinical predictors of lower adherence in the arms, and will investigate whether PE combined with Bip.App is associated with lower risk of recurrence of (hypo)manic and depressive episodes than group PE alone, and assess the feasibility and satisfaction for Bip.App.


Participants will be recruited from mental health centres and included if they are 18-65 year-old, have primary BD in the euthymic phase, they have been prescribed a second-generation oral antipsychotic as a maintenance/prophylactic therapy for at least 1 year, they have not undergone a structured protocol of PE for BD, they have access to a smartphone and sufficient competence in using it. Participants will be excluded if they have neurological disease, mental retardation or learning disability, psychosis, limited fluency in Italian.


Adherence will be assessed through count pills, blood levels, and self-reported adherence. A single-blinded parallel-group superiority multi-centre randomised controlled trial design will be used

Published
2020-03-04
How to Cite
POZZA, A. et al. Enhancing adherence to antipsychotic treatment for bipolar disorders. Comparison of mobile app-based psychoeducation, group psychoeducation, and the combination of both: protocol of a three-arm single-blinded parallel-group multi-centre randomised trial. La Clinica Terapeutica, [S.l.], v. 2, n. 171, p. e7 - e93, mar. 2020. ISSN 1972-6007. Available at: <http://www.clinicaterapeutica.it/ojs/index.php/ClinicaTerapeutica/article/view/592>. Date accessed: 04 apr. 2020.
Section
Clinical Trial