Self-Monitoring and Psychoeducation in Bipolar Patients With a Smart-phone Application

Summary

Bipolar disorder is a frequent condition in the general population with a high morbimortality, which consists in dysfunctional temporal fluctuations between different mood phases ranging from depression to manic episodes with frequent subsyndromal symptoms between them. Usually during these phases, the subjects have a lack of insight about the diagnosis and symptoms. Besides the pharmacological treatment, additional psychological interventions have shown to improve the long-term outcome of the disorder, yet taking into account the limited resources currently available, its general implementation is still difficult and costly. Among these interventions, group psychoeducational programs have proved to be cost-effective in helping patients recognize early signs and symptoms in order to prevent full blown episodes which very usually are associated with a high morbidity and hospital admissions.

On the other hand, numerous projects have tested the potential benefits of new technologies such internet in the treatment of bipolar and psychotic disorders patients using either online signs and symptoms monitoring or web-based psychoeducational programs, yet to the investigators knowledge, none of them have integrated both approaches in one single intervention.

The hypothesis that, combining both interventions (signs and symptoms monitoring along with psychoeducational contents) in a single smart-phone application will prove to be at least equal or superior in terms of efficacy comparing to the standard treatment, seems promising, given the fact that both approaches have independently demonstrated their efficacy in the same population. This could extend the range of the patients in whom this kind of additional interventions could be implemented; preventing relapses, suicide attempts, consultations and hospitalizations at a much lower cost.

Conditions

• Bipolar Disorder

Interventions

DEVICE

SIMPLE 2.0

SIMPLE 2.0 psychoeducative and self-monitoring smart-phone application plus treatment as usual.

Sponsors & Collaborators

• Institut d'Investigacions Biomèdiques August Pi i Sunyer

  collaborator OTHER

• Institut Hospital del Mar d'Investigacions Mèdiques (IMIM)

  collaborator UNKNOWN

• Centro de Investigación Biomédica en Red de Salud Mental

  collaborator NETWORK

• Sodep S.A.

  collaborator UNKNOWN

• Hospital Clinic of Barcelona

  lead OTHER

Principal Investigators

• Francesc Colom, PhD · Institut Hospital del Mar d'Investigacions Mèdiques (IMIM)

• Eduard Vieta, MD, PhD · Hospital Clínic of Barcelona

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-10-31

Primary Completion

2020-03-31

Completion

2020-11-30

Countries

• Spain

Study Locations