Signs and Symptoms Self-monitoring and Psychoeducation in Bipolar Patients with a Smart-phone Application (SIMPLe) Project

Introduction Bipolar disorder is a frequent condition in the general population with a high morbimortality, which consists in dysfunctional temporal fluctuations between different mood phases during which frequently there is a lack of insight. Besides the pharmacological treatment, psychoeducational programs have proved to be a cost-effective approach to help patients recognize early signs and symptoms in order to prevent full-blown episodes, although its broad implementation is still difficult and costly [1]. Objectives and Aims The main aim of this study is to develop and clinically validate a smartphone application to monitor symptoms and signs in stable bipolar patients along with customized embedded psycho-education contents and empower the self-management of their disorder to avoid relapses and hospitalizations. Methods The study will be carried out in three different but complementary phases in order to fully include patients and therapist's preferences: 1. Feasibility study using SIMPLe 1.0 app (subjective information only). 2. Feedback-based improvement process which will incorporate the objective information. 3. Randomized controlled trial with two arms of 74 patients each (SIMPLe 2.0+TAU vs. TAU). Results After the collaborative development of clinical algorithms to ensure adequate sensibility and specificity to detect relapses and personalize psychoeducational messages, a technical pilot test of SIMPLE 1.0 app is underway and the first patients are being recruited to start the 1st phase of the study in Mid-October of 2014. Conclusions The possibility to deliver personalized psychoeducation contents based on monitoring signs and symptoms through a smartphone seems a promising cost-effective method, although a clinical validation is necessary.