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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02258711
First Posted: October 7, 2014
Last Update Posted: February 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Centro de Investigación Biomédica en Red de Salud Mental
Sodep S.A.
Information provided by (Responsible Party):
Diego Hidalgo-Mazzei, Hospital Clinic of Barcelona
  Purpose

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.


Condition Intervention
Bipolar Disorder Device: SIMPLE 2.0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: SIgns and Symptoms Self-Monitoring and Psychoeducation in bipoLar Patients With a Smart-phonE Application (SIMPLE)

Resource links provided by NLM:


Further study details as provided by Diego Hidalgo-Mazzei, Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Number of relapses during intervention [ Time Frame: During the entire 6 months study period ]
    Number of relapses during intervention (manic, hypomanic and depressive episodes according to DSM-5 criteria).


Secondary Outcome Measures:
  • Biological rhythms [ Time Frame: During the entire 6 months study period of the clinical trial and during 6-month post-intervention follow-up ]
    Difference in biological rhythms using the Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN) during the entire 6 months study period of the clinical trial and during 6-month post-intervention follow-up.

  • Number of Relapses during 6-month post-intervention [ Time Frame: 6-months post-intervention ]
    Number of Relapses during 6-month post-intervention follow-up (Manic, hypomanic and depressive episodes according to DSM-5 criteria).

  • Number of Manic and depressive symptoms [ Time Frame: During the entire 6 months study period ]
    Difference in manic symptoms using the Young Mania Rating Scale (YMRS), depressive symptoms using the Hamilton depression Rating Scale (HDRS) during the entire 6 months study period.

  • Quality of life [ Time Frame: During the entire 6 months study period of the clinical trial and during 6-month post-intervention follow-up ]
    Difference in quality of life measured by World Health Organization quality of life assessment (WHOQOL-BREF) during the entire 6 months study period of the clinical trial and during 6-month post-intervention follow-up.

  • Treatment adherence [ Time Frame: During the entire 6 months study period of the clinical trial and during 6-month post-intervention follow-up ]
    Difference in treatment adherence using the Morisky Green 8-item scale during the entire 6 months study period of the clinical trial and during 6-month post-intervention follow-up.

  • Functional impairment [ Time Frame: During the entire 6 months study period of the clinical trial and during 6-month post-intervention follow-up. ]
    Difference in functional impairment using the Functioning Assessment Short Test (FAST) during the entire 6 months study period of the clinical trial and during 6-month post-intervention follow-up.


Estimated Enrollment: 148
Study Start Date: October 2014
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SIMPLe 2.0 plus Treatment as Usual (TAU)
Psychoeducative and self-monitoring smart-phone application plus treatment as usual which includes pharmacological and psychological treatment.
Device: SIMPLE 2.0
SIMPLE 2.0 psychoeducative and self-monitoring smart-phone application plus treatment as usual.
No Intervention: Treatment as usual (TAU)
Treatment as usual which includes pharmacological and psychological treatment.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02258711


Locations
Spain
Hospital Clínic i Provincial de Barcelona
Barcelona, Catalonia, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Centro de Investigación Biomédica en Red de Salud Mental
Sodep S.A.
Investigators
Study Director: Francesc Colom, PhD Hospital Clínic of Barcelona
Study Chair: Eduard Vieta, MD, PhD Hospital Clínic of Barcelona
Principal Investigator: Diego Hidalgo-Mazzei, MD Hospital Clínic of Barcelona
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Diego Hidalgo-Mazzei, Diego Hidalgo-Mazzei, M.D., Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT02258711     History of Changes
Other Study ID Numbers: HCPPFR02062014
First Submitted: October 3, 2014
First Posted: October 7, 2014
Last Update Posted: February 19, 2016
Last Verified: February 2016

Keywords provided by Diego Hidalgo-Mazzei, Hospital Clinic of Barcelona:
Bipolar disorder
Psychoeducation
Smart-phone monitoring

Additional relevant MeSH terms:
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders