Self-monitoring and Psychoeducation in Bipolar Patients With a Smart-phone Application (SIMPLe) Project: Design, Development and Studies Protocols

Diego Hidalgo-Mazzei; Ainoa Mateu; María Reinares; Juan Undurraga; Caterina del Mar Bonnín; José Sánchez-Moreno; Eduard Vieta; Francesc Colom

Disclosures

BMC Psychiatry. 2015;15(52) 

In This Article

Background

Bipolar disorder is a frequent condition in the general population with a high morbimortality.[1] It is characterized by dysfunctional episodic fluctuations between different mood phases ranging from depression to manic episodes with patients presenting frequent interepisodic subsyndromal symptoms. Frequently, people with this condition have a lack of insight about their diagnosis and symptoms, especially regarding manic phases, which leads to poor prognosis.[2,3]

Besides the pharmacological treatment, adjunctive psychological interventions have shown to improve the long-term outcome of the disorder,[4] although, taking into account the limited resources currently available, their extended implementation is still difficult and costly.[5]

Among psychotherapeutic interventions, psychoeducational programs have proven to be cost-effective in helping patients recognize early signs or symptoms and adopt behavioral measures to prevent full-blown episodes which are frequently associated with a high morbidity and more hospital admissions.[6,7] Accordingly, there is an increased need to make this intervention more widely available, without compromising its quality.[4]

On the other hand, the wide use and availability of new technologies such as the Internet have been successfully adopted in mental health contexts. Using these technologies in patient's assessments and interventions have proved their efficacy and reliability as well as their good acceptability from the patient's perspective.[8,9] The potential improvement in accessibility to healthcare in patients with disabilities or patients living in rural or other remote areas (i.e. telemental health), as well as the lower costs when compared to conventional interventions, makes them an attractive complement to standard treatment.[10–13]

Furthermore, the progressively reduced costs and consequent widespread accessibility to mobile phones with internet connection (smartphones) opens an unlimited number of opportunities to the mental health field. In industrialized countries, these devices have become a very popular way of interacting with each other and with the environment. As an example, in Spain, a recent study of the National Institute of Statistics revealed that almost 70% of the population have internet access and in the majority, through a mobile device.[14] This is a growing phenomenon and includes developing countries as well. According to eMarketer Inc., a company which studies technology market trends, by 2017 one-third of all the population around the globe will be using a smartphone.[15]

In addition, the constant improvement of portability and benefits of mobile devices allows the quick and continuous collection of relevant users' information at a low-cost. Data on subject's activity and interests, through embedded sensors and mobile usage patterns respectively, are collected and complemented with information from other digital services such as social networks, e-mails and internet search patterns. All this information that has been denominated "big data" are integrated, analyzed by data mining and results are used to determine individual user behavior and interests patterns by predictive analytics, which now are commonly used for commercial purposes.[16] Accordingly, there is an increasing interest in medicine and especially in mental health to explore the possibilities and potential applications of this underutilized data.[17–20]

The potential of the great amount of data collected by the patient's smartphones, its analysis and potential applications in treatment interventions are leading the way to the (so-called) "Personalized Medicine" era. Given the diverse types of presentations, course and response to treatments in mental disorders, including new technologies has long been promoted as the obligatory next step in different medical disciplines, and especially in psychiatry.[21–24] However, one major concern about this approach is the potential threats to patient's privacy and consequent utilization of this data with others intends, if it is transmitted, processed or stored insecurely.[25,26]

Several projects have tested the benefits of these new technologies for the treatment of bipolar and psychotic disorders using either online monitoring of signs and symptoms[27,28] or web-based psychoeducational programs,[29–32] yet to our knowledge, none of them have integrated both approaches in one single intervention.

The current technology available makes technically easier to integrate into patient's life a comfortable, simple, time-unconstrained, user-friendly, economical and non-invasive method of registering and monitoring relevant signs and symptoms and provide continuous self-management psychoeducational contents tailored to the specific needs of each individual on the basis of these data registered on their own smartphones.[33] Additionally, this approach could contribute to better understand the pathoetiology as well as prodromal behavior patterns prior to a relapse in bipolar disorders, integrating objective and subjective data with other clinical correlates.[17]

We hypothesized that, combining a signs and symptoms monitoring system with continuous feeds of tailored psychoeducational in a single smartphone application as an adjunctive intervention to usual treatment, would add efficacy in preventing relapses, suicide attempts and health resources consumption in bipolar patients improving their overall prognosis.

The aim of this study is to develop and clinically validate a smartphone application to monitor symptoms and signs in bipolar patients, offering customized embedded psychoeducation contents and empower the self-management of their disorder in order to prevent relapses and hospitalizations. Secondary objectives are to explore other clinical benefits among the smartphone application users such as improvements in biological rhythms, manic/hypomanic and depressive symptoms, quality of life, suicide attempts and pharmacological treatment adherence.

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