NCT02481895

Brief Summary

Between 40% and 60% bipolar patients experience neurocognitive impairment not only during acute mood episodes but also during remission periods. These rates are quite similar to those reported as regards to functional impairment. In fact, it is estimated that only one third of patients achieve full social and occupational recovery and get back to their premorbid levels. Moreover, neurocognitive deficits, together with other clinical and sociodemographic variables are thought to contribute to functional impairment for bipolar disorder, similarly to that found in schizophrenia. Little is published with regard to neurocognitive remediation in bipolar disorder. The first open label study on bipolar disorder was published in 2010 with positive results. Recently, a multicenter randomized clinical trial coordinated showed efficacy of an innovative intervention at improving functioning and reducing disability of bipolar patients. There is a need of investigating novel and creative ways to work on cognitive deficits including new technologies in order to reduce costs and increasing benefits for patients. No study addressing computerized cognitive training in bipolar disorder has been developed so far. This project aims to test the efficacy of an e-neurocognitive module as an adjunct to functional remediation in bipolar patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 25, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 7, 2019

Status Verified

February 1, 2019

Enrollment Period

4.7 years

First QC Date

June 24, 2015

Last Update Submit

February 6, 2019

Conditions

Bipolar Disorder

Keywords

cognitionpsychosocial functioning

Outcome Measures

Primary Outcomes (1)

  • Psychosocial functioning measured by Functioning Assessment Short Test

    The scale is interviewer-administered, designed for the assessment of psychosocial functioning. The 24 items of the scale are divided among 6 specific areas of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships and leisure time. Each individual item is scored from 0 to 3. The global score (0-72) is obtained when the scores of each item are added up. The higher the score, the more serious the difficulties.

    15 days

Study Arms (2)

Experimental

EXPERIMENTAL

E-neurocognitive module training.

Behavioral: E-neurocognitive module

Control

NO INTERVENTION

The group will note receive any sort of add-on training, just the recommendations from the therapists.

Interventions

E-neurocognitive moduleBEHAVIORAL

The experimental group will take part of a 12-week extension with a total of 36 hours training with the e-neurocognitive module tailored for bipolar patients

Experimental

Eligibility Criteria

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

You may qualify if:

  • Bipolar I and II patients aged between 18 and 60.
  • Three months of clinical remission.
  • Patients will be required to present a moderate to severe degree of functional impairment (FAST\>18).

You may not qualify if:

  • IQ\<85.
  • Any medical condition that could affect neuropsychological performance.
  • The presence of any comorbid psychiatric condition.
  • Patients who received electroconvulsive therapy in the previous year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic of Barcelona

Barcelona, 08036, Spain

Location

Related Publications (4)

  • Sole B, Bonnin CM, Mayoral M, Amann BL, Torres I, Gonzalez-Pinto A, Jimenez E, Crespo JM, Colom F, Tabares-Seisdedos R, Reinares M, Ayuso-Mateos JL, Soria S, Garcia-Portilla MP, Ibanez A, Vieta E, Martinez-Aran A, Torrent C; CIBERSAM Functional Remediation Group. Functional remediation for patients with bipolar II disorder: improvement of functioning and subsyndromal symptoms. Eur Neuropsychopharmacol. 2015 Feb;25(2):257-64. doi: 10.1016/j.euroneuro.2014.05.010. Epub 2014 May 20.

    PMID: 24906790BACKGROUND

  • Torrent C, Bonnin Cdel M, Martinez-Aran A, Valle J, Amann BL, Gonzalez-Pinto A, Crespo JM, Ibanez A, Garcia-Portilla MP, Tabares-Seisdedos R, Arango C, Colom F, Sole B, Pacchiarotti I, Rosa AR, Ayuso-Mateos JL, Anaya C, Fernandez P, Landin-Romero R, Alonso-Lana S, Ortiz-Gil J, Segura B, Barbeito S, Vega P, Fernandez M, Ugarte A, Subira M, Cerrillo E, Custal N, Menchon JM, Saiz-Ruiz J, Rodao JM, Isella S, Alegria A, Al-Halabi S, Bobes J, Galvan G, Saiz PA, Balanza-Martinez V, Selva G, Fuentes-Dura I, Correa P, Mayoral M, Chiclana G, Merchan-Naranjo J, Rapado-Castro M, Salamero M, Vieta E. Efficacy of functional remediation in bipolar disorder: a multicenter randomized controlled study. Am J Psychiatry. 2013 Aug;170(8):852-9. doi: 10.1176/appi.ajp.2012.12070971.

    PMID: 23511717BACKGROUND

  • Martinez-Aran A, Torrent C, Sole B, Bonnin CM, Rosa AR, Sanchez-Moreno J, Vieta E. Functional remediation for bipolar disorder. Clin Pract Epidemiol Ment Health. 2011;7:112-6. doi: 10.2174/1745017901107010112. Epub 2011 Jun 6.

    PMID: 21687565BACKGROUND

  • Bonnin CM, Torrent C, Vieta E, Martinez-Aran A. Restoring functioning in bipolar disorder: functional remediation. Harv Rev Psychiatry. 2014 Nov-Dec;22(6):326-30. doi: 10.1097/HRP.0000000000000062.

    PMID: 25377603RESULT

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Carla Torrent Font, PhD

    Affiliated Postdoctoral Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2015

First Posted

June 25, 2015

Study Start

January 1, 2014

Primary Completion

September 1, 2018

Study Completion

December 1, 2018

Last Updated

February 7, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)