Clinical trial NCT01370668: 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
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Keywords: functional remediation
psychoeducation
neurocognition
Lead sponsor: Centro de Investigación Biomédica en Red de Salud Mental
Sponsor class: NETWORK
Collaborators: name: Hospital Clinic of Barcelona
name: Benito Menni
name: University of Valencia
name: Hospital Universitari de Bellvitge
name: Universidad de Oviedo
name: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
name: Hospital General Universitario Gregorio Marañon
name: Hospital Santiago Apóstol de Vitoria
name: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
First posted: 2011-06-10
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Functional Assessment Short Test (FAST)
timeFrame: Baseline
measure: Functional Assessment Short Test (FAST)
timeFrame: 6 months
measure: Functional Assessment Short Test (FAST)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Centro de Investigación Biomédica en Red de Salud Mental
name: Eduard Vieta, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.