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

Hidalgo-Mazzei D, Mateu A, Reinares M, Undurraga J, Bonnín Cdel M, Sánchez-Moreno J, Vieta E, Colom F - BMC Psychiatry (2015)

Bottom Line: 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.This 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.

View Article: PubMed Central - PubMed

Affiliation: Bipolar Disorders Unit, Neurosciences Institute, Hospital Clínic de Barcelona, IDIBAPS, CIBERSAM, Universitat de Barcelona, Villarroel 170, 08036, Barcelona, Catalonia, Spain. dahidalg@clinic.ub.es.

ABSTRACT

Background: New 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/design: The 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.

Discussion: This 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 registration: Clinical Trials.gov: NCT02258711 (October 2014).

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Related in: MedlinePlus

The figure shows a flowchart of the SIMPLe project phases (left) and their expected duration (right). *Current status of the study. TAU = Treatment as usual.
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Fig1: The figure shows a flowchart of the SIMPLe project phases (left) and their expected duration (right). *Current status of the study. TAU = Treatment as usual.

Mentions: Given the incipient nature of the field, we adopted an eclectic approach considering and combining multiple guidelines and recommendations about developing internet and mobile interventions for mental health [34-36]. In order to consider technical aspects and an adequate clinical validation while including patients preferences and safety along the process, it was determined that the project will be carried out in three complementary phases, which will include two clinical studies. The studies will follow the Consolidated Standards of Reporting Trials (CONSORT) guidelines to describe, report and publish the results [37] (Figure 1).Figure 1


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

Hidalgo-Mazzei D, Mateu A, Reinares M, Undurraga J, Bonnín Cdel M, Sánchez-Moreno J, Vieta E, Colom F - BMC Psychiatry (2015)

The figure shows a flowchart of the SIMPLe project phases (left) and their expected duration (right). *Current status of the study. TAU = Treatment as usual.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4379950&req=5

Fig1: The figure shows a flowchart of the SIMPLe project phases (left) and their expected duration (right). *Current status of the study. TAU = Treatment as usual.
Mentions: Given the incipient nature of the field, we adopted an eclectic approach considering and combining multiple guidelines and recommendations about developing internet and mobile interventions for mental health [34-36]. In order to consider technical aspects and an adequate clinical validation while including patients preferences and safety along the process, it was determined that the project will be carried out in three complementary phases, which will include two clinical studies. The studies will follow the Consolidated Standards of Reporting Trials (CONSORT) guidelines to describe, report and publish the results [37] (Figure 1).Figure 1

Bottom Line: 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.This 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.

View Article: PubMed Central - PubMed

Affiliation: Bipolar Disorders Unit, Neurosciences Institute, Hospital Clínic de Barcelona, IDIBAPS, CIBERSAM, Universitat de Barcelona, Villarroel 170, 08036, Barcelona, Catalonia, Spain. dahidalg@clinic.ub.es.

ABSTRACT

Background: New 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/design: The 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.

Discussion: This 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 registration: Clinical Trials.gov: NCT02258711 (October 2014).

Show MeSH
Related in: MedlinePlus