search
Back to results

Functional Remediation for Bipolar Disorder

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Functional remediation
Psychoeducation
Treatment as usual
Sponsored by
Centro de Investigación Biomédica en Red de Salud Mental
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring functional remediation, psychoeducation, neurocognition

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    Functional remediation

    Psychoeducation

    Treatment as Usual

    Arm Description

    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.

    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.

    This arm will not receive any sort of add-on psychosocial intervention. All patients will keep on receiving standard psychiatric treatment.

    Outcomes

    Primary Outcome Measures

    Functional Assessment Short Test (FAST)
    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)
    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)
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 10, 2011
    Last Updated
    June 9, 2011
    Sponsor
    Centro de Investigación Biomédica en Red de Salud Mental
    Collaborators
    Hospital Clinic of Barcelona, Benito Menni, University of Valencia, Hospital Universitari de Bellvitge, Universidad de Oviedo, Fundación de Investigación Biomédica - 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
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01370668
    Brief Title
    Functional Remediation for Bipolar Disorder
    Official Title
    Comparative Efficacy of Two Psychosocial Strategies of Intervention (Neurocognitive vs Psychoeducative) as add-on Therapy Versus Treatment as Usual in Bipolar Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2009 (undefined)
    Primary Completion Date
    December 2010 (Actual)
    Study Completion Date
    December 2010 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Centro de Investigación Biomédica en Red de Salud Mental
    Collaborators
    Hospital Clinic of Barcelona, Benito Menni, University of Valencia, Hospital Universitari de Bellvitge, Universidad de Oviedo, Fundación de Investigación Biomédica - 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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bipolar Disorder
    Keywords
    functional remediation, psychoeducation, neurocognition

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    198 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Functional remediation
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Psychoeducation
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Treatment as Usual
    Arm Type
    Active Comparator
    Arm Description
    This arm will not receive any sort of add-on psychosocial intervention. All patients will keep on receiving standard psychiatric treatment.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Functional remediation
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Psychoeducation
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Treatment as usual
    Intervention Description
    The patients will not receive any add-on psychosocial intervention. All patients will keep on receiving standard psychiatric treatment.
    Primary Outcome Measure Information:
    Title
    Functional Assessment Short Test (FAST)
    Description
    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.
    Time Frame
    Baseline
    Title
    Functional Assessment Short Test (FAST)
    Description
    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.
    Time Frame
    6 months
    Title
    Functional Assessment Short Test (FAST)
    Description
    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.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eduard Vieta, MD, PhD
    Organizational Affiliation
    Centro de Investigación Biomédica en Red de Salud Mental
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26541692
    Citation
    Bonnin CM, Torrent C, Arango C, Amann BL, Sole B, Gonzalez-Pinto A, Crespo JM, Tabares-Seisdedos R, Reinares M, Ayuso-Mateos JL, Garcia-Portilla MP, Ibanez A, Salamero M, Vieta E, Martinez-Aran A; CIBERSAM Functional Remediation Group. Functional remediation in bipolar disorder: 1-year follow-up of neurocognitive and functional outcome. Br J Psychiatry. 2016 Jan;208(1):87-93. doi: 10.1192/bjp.bp.114.162123. Epub 2015 Nov 5.
    Results Reference
    derived
    PubMed Identifier
    24906790
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    23511717
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    Functional Remediation for Bipolar Disorder

    We'll reach out to this number within 24 hrs