Status:
SUSPENDED
Self-Monitoring and Psychoeducation in Bipolar Patients With a Smart-phone Application
Lead Sponsor:
Hospital Clinic of Barcelona
Collaborating Sponsors:
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Institut Hospital del Mar d'Investigacions Mèdiques (IMIM)
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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 depressi...
Detailed Description
The main aim of this study is to develop and clinically validate a smart-phone application to monitor symptoms and signs in stable bipolar patients, offering also customized embedded psycho-education ...
Eligibility Criteria
Inclusion
- Patients with the current diagnosis of Bipolar disorder type I or type II according to current DSM-5 criteria and confirmed with a semi structured interview (SCID).
- Hamilton Depression Scale score under or equal to 8 during the last month.
- Young Mania Rating Scale score under or equal to 6 during the last month.
- No history of relapses during the last 3 previous months but at least 1 relapse during the last year.
- Availability of a telephone account with an unlimited data plan during the 12 following months.
Exclusion
- Lack of skills to use the offered smart-phone or unwillingness to learn them.
- FAST score above or equal to 20.
- Past or current participation in psychoeducation groups.
- Obsessive-compulsive disorder according to DSM-5 criteria.
- Concomitant severe medical condition.
- Pregnancy.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2020
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT02258711
Start Date
October 1 2014
End Date
November 1 2020
Last Update
December 4 2018
Active Locations (1)
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1
Instituto Hospital del Mar de Investigaciones Médicas
Barcelona, Catalonia, Spain, 08003