Functional Remediation for Bipolar Disorder

This study has been completed.
Sponsor:
Collaborators:
Hospital Clinic of Barcelona
Benito Menni
University of Valencia
Hospital Universitari de Bellvitge
Universidad de Oviedo
Hospital Universitario de la Princesa
Hospital General Universitario Gregorio Marañon
Hospital Santiago Apóstol de Vitoria
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Information provided by:
Centro de Investigación Biomédica en Red de Salud Mental
ClinicalTrials.gov Identifier:
NCT01370668
First received: March 10, 2011
Last updated: June 9, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Bipolar Disorder
Behavioral: Functional remediation
Behavioral: Psychoeducation
Behavioral: Treatment as usual

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Comparative Efficacy of Two Psychosocial Strategies of Intervention (Neurocognitive vs Psychoeducative) as add-on Therapy Versus Treatment as Usual in Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by Centro de Investigación Biomédica en Red de Salud Mental:

Primary Outcome Measures:
  • Functional Assessment Short Test (FAST) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The FAST is a valid and reliable instrument, easy to apply which requires a short period of time to administer. Evaluates functioning taking into account the last 15 days. It was developed for the clinical evaluation of the main difficulties presented by psychiatric patients, and has been validated in several languages for patients with bipolar disorder. The FAST scale consists of 24 items which allow the assessment of six specific areas of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships and leisure time.

  • Functional Assessment Short Test (FAST) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The FAST is a valid and reliable instrument, easy to apply which requires a short period of time to administer. Evaluates functioning taking into account the last 15 days. It was developed for the clinical evaluation of the main difficulties presented by psychiatric patients, and has been validated in several languages for patients with bipolar disorder. The FAST scale consists of 24 items which allow the assessment of six specific areas of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships and leisure time.

  • Functional Assessment Short Test (FAST) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The FAST is a valid and reliable instrument, easy to apply which requires a short period of time to administer. Evaluates functioning taking into account the last 15 days. It was developed for the clinical evaluation of the main difficulties presented by psychiatric patients, and has been validated in several languages for patients with bipolar disorder. The FAST scale consists of 24 items which allow the assessment of six specific areas of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships and leisure time.


Enrollment: 198
Study Start Date: January 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Functional remediation

Patients assigned to the experimental treatment will receive standard psychiatric care and will be enrolled in the neurocognitive intervention program composed of 21 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 8-to-10 patient group conducted by 2 experienced neuropsychologists. with previous experience with bipolar patients (at least 3 years) and specific training on patients' group management.

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.

Active Comparator: Psychoeducation
The group psychoeducation is a tested (Colom et al, 2003) and manualized intervention (Vieta and Colom, 2006) consisting on 21 sessions of 90 minutes, aimed at improving 4 main issues: illness awareness, treatment adherence, early detection of prodromal symptoms and recurrences and lifestyle regularity. The program will be performed in an 8-10 patient group conducted by 2 experienced psychologists with previous experience with bipolar patients and specific training on patients' group management. The structure of each session consists of a 30 to 40 minute speech on the topic of the day, followed by an exercise related to the issue (eg. drawing a life chart, writing a list of potential triggering factors) and a discussion.
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.
Active Comparator: Treatment as Usual
This arm will not receive any sort of add-on psychosocial intervention. All patients will keep on receiving standard psychiatric treatment.
Behavioral: Treatment as usual
The patients will not receive any add-on psychosocial intervention. All patients will keep on receiving standard psychiatric treatment.

Detailed Description:

The method consists of a randomized clinical trial with 3 arms: 1) one group (n=66) will receive a cognitive rehabilitation program + pharmacological treatment, 2) another group (n=66) will receive a psychoeducation program + pharmacological treatment, and 3) a control group (n=66) will only receive pharmacological treatment. A psychopathological, neuropsychological and functional assessment will be administered pre and post-intervention and a 12-month follow-up to assess the long term effects of the intervention.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Outpatients
  • Diagnosis of bipolar disorder type I or II, according to DSM-IV-TR 4ª Ed criteria
  • Adult patients, aged between 18 and 55 years old
  • Euthymic (YMRS < 6, HDRS < 8) for at least three months prior to study entry.
  • Signed inform consent
  • Severe or moderate functional impairment (FAST > 18)

Exclusion Criteria:

  • IQ < 85
  • Neurological illness
  • Present diagnosis of substance abuse or dependence according to DSM-IV criteria the last three months
  • Significant medical illness considered as severe by the study that may interfere with assessments
  • having been enrolled in any kind of cognitive rehabilitation intervention the last two years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01370668

Sponsors and Collaborators
Centro de Investigación Biomédica en Red de Salud Mental
Hospital Clinic of Barcelona
Benito Menni
University of Valencia
Hospital Universitari de Bellvitge
Universidad de Oviedo
Hospital Universitario de la Princesa
Hospital General Universitario Gregorio Marañon
Hospital Santiago Apóstol de Vitoria
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
Principal Investigator: Eduard Vieta, MD, PhD Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM)
  More Information

No publications provided by Centro de Investigación Biomédica en Red de Salud Mental

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eduard Vieta, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01370668     History of Changes
Other Study ID Numbers: PI08/90094, PI080180
Study First Received: March 10, 2011
Last Updated: June 9, 2011
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Centro de Investigación Biomédica en Red de Salud Mental:
functional remediation
psychoeducation
neurocognition

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014