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

March 10, 2011
June 9, 2011
January 2009
December 2010   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01370668 on ClinicalTrials.gov Archive Site
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Not Provided
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Not Provided
 
Functional Remediation for Bipolar Disorder
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Bipolar Disorder
  • 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.
  • 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.

    Intervention: Behavioral: Functional remediation
  • 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.
    Intervention: Behavioral: Psychoeducation
  • 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.
    Intervention: Behavioral: Treatment as usual
Torrent C, Bonnin Cdel M, Martínez-Arán A, Valle J, Amann BL, González-Pinto A, Crespo JM, Ibáñez Á, Garcia-Portilla MP, Tabarés-Seisdedos R, Arango C, Colom F, Solé B, Pacchiarotti I, Rosa AR, Ayuso-Mateos JL, Anaya C, Fernández P, Landín-Romero R, Alonso-Lana S, Ortiz-Gil J, Segura B, Barbeito S, Vega P, Fernández M, Ugarte A, Subirà M, Cerrillo E, Custal N, Menchón JM, Saiz-Ruiz J, Rodao JM, Isella S, Alegría A, Al-Halabi S, Bobes J, Galván G, Saiz PA, Balanzá-Martínez V, Selva G, Fuentes-Durá 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 1;170(8):852-9. doi: 10.1176/appi.ajp.2012.12070971. PubMed PMID: 23511717.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
198
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01370668
PI08/90094, PI080180
No
Eduard Vieta, Hospital Clinic of Barcelona
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
Principal Investigator: Eduard Vieta, MD, PhD Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM)
Centro de Investigación Biomédica en Red de Salud Mental
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP