NCT02258711

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 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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2014

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

December 4, 2018

Status Verified

December 1, 2018

Enrollment Period

5.4 years

First QC Date

October 3, 2014

Last Update Submit

December 1, 2018

Conditions

Bipolar Disorder

Keywords

Bipolar disorderPsychoeducationSmart-phone monitoring

Outcome Measures

Primary Outcomes (1)

  • Number of relapses during intervention

    Number of relapses during intervention (manic, hypomanic and depressive episodes according to DSM-5 criteria).

    During the entire 6 months study period

Secondary Outcomes (6)

  • Biological rhythms

    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

    6-months post-intervention

  • Number of Manic and depressive symptoms

    During the entire 6 months study period

  • Quality of life

    During the entire 6 months study period of the clinical trial and during 6-month post-intervention follow-up

  • Treatment adherence

    During the entire 6 months study period of the clinical trial and during 6-month post-intervention follow-up

  • +1 more secondary outcomes

Study Arms (2)

SIMPLe 2.0 plus Treatment as Usual (TAU)

EXPERIMENTAL

Psychoeducative and self-monitoring smart-phone application plus treatment as usual which includes pharmacological and psychological treatment.

Device: SIMPLE 2.0

Treatment as usual (TAU)

NO INTERVENTION

Treatment as usual which includes pharmacological and psychological treatment.

Interventions

SIMPLE 2.0DEVICE

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

SIMPLe 2.0 plus Treatment as Usual (TAU)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Hospital del Mar de Investigaciones Médicas

Barcelona, Catalonia, 08003, Spain

Location

Related Publications (3)

  • Hidalgo-Mazzei D, Reinares M, Mateu A, Juruena MF, Young AH, Perez-Sola V, Vieta E, Colom F. Is a SIMPLe smartphone application capable of improving biological rhythms in bipolar disorder? J Affect Disord. 2017 Dec 1;223:10-16. doi: 10.1016/j.jad.2017.07.028. Epub 2017 Jul 10.

    PMID: 28711743DERIVED

  • Hidalgo-Mazzei D, Mateu A, Reinares M, Murru A, Del Mar Bonnin C, Varo C, Valenti M, Undurraga J, Strejilevich S, Sanchez-Moreno J, Vieta E, Colom F. Psychoeducation in bipolar disorder with a SIMPLe smartphone application: Feasibility, acceptability and satisfaction. J Affect Disord. 2016 Aug;200:58-66. doi: 10.1016/j.jad.2016.04.042. Epub 2016 Apr 20.

    PMID: 27128358DERIVED

  • Hidalgo-Mazzei D, Mateu A, Reinares M, Undurraga J, Bonnin Cdel M, Sanchez-Moreno J, Vieta E, Colom F. Self-monitoring and psychoeducation in bipolar patients with a smart-phone application (SIMPLe) project: design, development and studies protocols. BMC Psychiatry. 2015 Mar 20;15:52. doi: 10.1186/s12888-015-0437-6.

    PMID: 25884824DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Francesc Colom, PhD

    Institut Hospital del Mar d'Investigacions Mèdiques (IMIM)

    STUDY DIRECTOR

  • Eduard Vieta, MD, PhD

    Hospital Clínic of Barcelona

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Diego Hidalgo-Mazzei, M.D.

Study Record Dates

First Submitted

October 3, 2014

First Posted

October 7, 2014

Study Start

October 1, 2014

Primary Completion

March 1, 2020

Study Completion

November 1, 2020

Last Updated

December 4, 2018

Record last verified: 2018-12

Locations

ES(1)