Functional Remediation for Bipolar Disorder

June 9, 2011 updated by: Centro de Investigación Biomédica en Red de Salud Mental

Comparative Efficacy of Two Psychosocial Strategies of Intervention (Neurocognitive vs Psychoeducative) as add-on Therapy Versus Treatment as Usual in Bipolar Disorder

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

198

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Assessment Short Test (FAST)
Time Frame: Baseline
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.
Baseline
Functional Assessment Short Test (FAST)
Time Frame: 6 months
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.
6 months
Functional Assessment Short Test (FAST)
Time Frame: 12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro de Investigación Biomédica en Red de Salud Mental

Collaborators

Hospital General Universitario Gregorio Marañon
Hospital Clinic of Barcelona
University of Valencia
Hospital Universitari de Bellvitge
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Benito Menni
Universidad de Oviedo
Hospital Santiago Apóstol de Vitoria

Investigators

  • Principal Investigator: Eduard Vieta, MD, PhD, Centro de Investigación Biomédica en Red de Salud Mental

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

March 10, 2011

First Submitted That Met QC Criteria

June 9, 2011

First Posted (Estimate)

June 10, 2011

Study Record Updates

Last Update Posted (Estimate)

June 10, 2011

Last Update Submitted That Met QC Criteria

June 9, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI08/90094
  • PI080180 (Other Grant/Funding Number: Fondo Investigaciones Sanitarias)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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