Functional Remediation for Bipolar Disorder

NCT01370668 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2011-06-10

No results posted yet for this study

Summary

Bipolar disorder is a severe, chronic and recurrent illness, that affects nearly the 5% of the population. Recent research point at the relevance and persistence of cognitive dysfunctions in bipolar patients even beyond the acute phases, although cognitive impairment has been classically associated with schizophrenia and not bipolar disorder. Current findings suggest that some intervention is needed in order to improve not only affective symptoms but also cognitive dysfunctions, so that patients could benefit from cognitive remediation techniques to improve cognitive impairment and the functional outcome. There is no previous research on the efficacy of cognitive remediation programs on bipolar disorder.

Conditions

Interventions

BEHAVIORAL

Functional remediation

The functional remediation program is composed of 21 weekly sessions of 90 minutes, each aimed at improving the following cognitive domains: attention, memory and executive functions and psychosocial functioning. The program will be performed in an 12- to 15-patient group conducted by 2 experienced neuropsychologists with previous experience with bipolar patients and specific training on patients' group management.

BEHAVIORAL

Psychoeducation

Group psychoeducation is a tested and manualized intervention consisting of 21 weekly sessions of 90 minutes aimed at improving 4 main issues: illness awareness, treatment adherence, early detection of prodromal symptoms and recurrences, and lifestyle regularity.

BEHAVIORAL

Treatment as usual

The patients will not receive any add-on psychosocial intervention. All patients will keep on receiving standard psychiatric treatment.

Sponsors & Collaborators

  • Hospital Clinic of Barcelona

    collaborator OTHER
  • Benito Menni

    collaborator UNKNOWN
  • University of Valencia

    collaborator OTHER
  • Hospital Universitari de Bellvitge

    collaborator OTHER
  • Universidad de Oviedo

    collaborator OTHER
  • Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

    collaborator OTHER
  • Hospital General Universitario Gregorio Marañon

    collaborator OTHER
  • Hospital Santiago Apóstol de Vitoria

    collaborator UNKNOWN
  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    collaborator OTHER
  • Centro de Investigación Biomédica en Red de Salud Mental

    lead NETWORK

Principal Investigators

  • Eduard Vieta, MD, PhD · Centro de Investigación Biomédica en Red de Salud Mental

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-12-31
Completion
2010-12-31

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01370668 on ClinicalTrials.gov