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Articles   |    
Efficacy of Functional Remediation in Bipolar Disorder: A Multicenter Randomized Controlled Study
Carla Torrent, Ph.D.; Caterina del Mar Bonnin, Ph.D.; Anabel Martínez-Arán, Ph.D.; Jesús Valle, M.D., Ph.D.; Benedikt L. Amann, M.D., Ph.D.; Ana González-Pinto, M.D., Ph.D.; José Manuel Crespo, M.D., Ph.D.; Ángela Ibáñez, M.D., Ph.D.; Mari Paz Garcia-Portilla, M.D., Ph.D.; Rafael Tabarés-Seisdedos, M.D., Ph.D.; Celso Arango, M.D., Ph.D.; Francesc Colom, Ph.D.; Brisa Solé, Psy.D.; Isabella Pacchiarotti, M.D., Ph.D.; Adriane R. Rosa, Ph.D.; Jose Luis Ayuso-Mateos, M.D., Ph.D.; Celia Anaya, Ph.D.; Patricia Fernández, Ph.D.; Ramon Landín-Romero, Ph.D.; Silvia Alonso-Lana, M.Sc.; Jordi Ortiz-Gil, Ph.D.; Bàrbara Segura, Ph.D.; Sara Barbeito, Ph.D.; Patricia Vega, Psy.D.; Miryam Fernández, Ph.D.; Amaia Ugarte, Ph.D.; Marta Subirà, M.B.B.S., M.D.; Ester Cerrillo, M.B.B.S., M.D.; Núria Custal, M.D., Ph.D.; José Manuel Menchón, M.D., Ph.D.; Jerónimo Saiz-Ruiz, M.D., Ph.D.; Jose Maria Rodao, Ph.D.; Sandra Isella, Ph.D.; Analucía Alegría, M.Sc.; Susana Al-Halabi, Ph.D.; Julio Bobes, M.D., Ph.D.; Gonzalo Galván, Ph.D.; Pilar A. Saiz, M.D., Ph.D.; Vicent Balanzá-Martínez, M.D., Ph.D.; Gabriel Selva, M.D., Ph.D.; Inmaculada Fuentes-Durá, Ph.D.; Patricia Correa, Psy.D.; María Mayoral, Ph.D.; Guadalupe Chiclana, Ph.D.; Jessica Merchan-Naranjo, M.Sc.; Marta Rapado-Castro, Ph.D.; Manel Salamero, M.D., Ph.D.; Eduard Vieta, M.D., Ph.D.
Am J Psychiatry 2013;170:852-859. doi:10.1176/appi.ajp.2012.12070971
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Dr. Amann has served as a speaker for Bristol-Myers Squibb. Dr. González-Pinto has received grants from or served as consultant, adviser, or CME speaker for Almirall, AstraZeneca, Bristol-Myers Squibb, Cephalon, Eli Lilly, GlaxoSmithKline, Janssen-Cilag, Lundbeck, Merck, Novartis, Otsuka, Pfizer, Sanofi-Aventis, Schering-Plough, and the Spanish Ministry of Science and Innovation (CIBERSAM). Dr. Crespo has served as a consultant or speaker for AstraZeneca, Bristol-Myers Squibb, Janssen, Eli Lilly, GlaxoSmithKline, Lundbeck, Novartis, Otsuka, Pfizer, Sanofi-Sinthelabo, and Wyatt and has received grant support from FIS, Health Ministry, IDIBELL Foundation, and CIBERSAM. Dr. Arango has served as a consultant for or has received honoraria or grants from Abbott, AMGEN, AstraZeneca, Bristol-Myers Squibb, Caja Navarra, CIBERSAM, Alicia Koplowitz Foundation, Carlos III Health Institute, Janssen-Cilag, Lundbeck, Merck, Ministry of Science and Innovation, Ministry of Health, Ministry of Economy and Competitiveness, Mutua Madrileña, Otsuka, Pfizer, Roche, Servier, Takeda, and Schering-Plough. Dr. Colom has served as a speaker for Adamed, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Lundbeck, Otsuka, Pfizer, Sanofi-Aventis, and Tecnifar and as an adviser for MSD-Merck and Shire, and he has received copyright fees from Cambridge University Press, Solal Ed., Ars Médica, Giovani Fioriti Ed., Medipage, La Esfera de Los Libros, Morales i Torres Ed, Panamericana, Mayo Ed. & Columna. Dr. Ayuso-Mateos has provided expert testimony for Sanofi-Aventis. Dr. Menchon has received research grants from or served as a consultant or speaker for AGAUR, Almirall, AstraZeneca, Boehringer-Ingelheim, Eli Lilly, Janssen, Lundbeck, Medtronic, Novartis, Otsuka, Rovi, Servier, the Spanish Ministry of Health, the Spanish Ministry of Science and Innovation, and Wyeth. Dr. Rapado has received a Sara Borrell Health Research Fellowship from the Spanish Ministry of Economy and Competitiveness and an Alicia Koplowitz Grant for Short-Term Placements from the Alicia Koplowitz Foundation. Dr. Vieta has received grants, CME-related honoraria, or consulting fees from Alexza, Almirall, AstraZeneca, Bristol-Myers Squibb, Cephalon, Eli Lilly, Ferrer, Forest Research Institute, Gedeon Richter, GlaxoSmithKline, Janssen, Janssen-Cilag, Jazz, Johnson & Johnson, Lundbeck, Merck, Novartis, Organon, Otsuka, Pfizer, Pierre-Fabre, Qualigen, Roche, Sanofi-Aventis, Schering-Plough, Servier, Shire, Solvay, Takeda, Teva, CIBERSAM, the Seventh European Framework Programme (ENBREC), the Stanley Medical Research Institute, United Biosource Corporation, and Wyeth. The other authors report no financial relationships with commercial interests.

Supported by an ETS grant from the Spanish Ministry of Economy and Competitiveness (PI080180 and PI08/90825, PI08/90327, PI08/90675, PI08/90224, PI08/90654, PI08/90189, PI08/90916, PI08/90416, PI08/90094) PN 2008–2011, Carlos III Health Institute, General Subdepartment for Evaluation and Research Promotion; European Regional Fund, European Union, “Una manera de hacer Europa”; CIBERSAM; and the Commissioner for Universities and Research, Ministry of Innovation, Universities and Enterprise, Catalan Government (2009 SGR 1022 to the Bipolar Disorders Group).

Clinicaltrials.gov identification number: NCT 01370668.

From the Centers for Biomedical Research Network on Mental Health (CIBERSAM), Barcelona, Madrid, Vitoria, Oviedo, and Valencia, Spain; the Bipolar Disorder Program, Clinical Institute of Neuroscience, Hospital Clinic of Barcelona, University of Barcelona, Barcelona; the August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona; the European Network of Bipolar Research Expert Centers (ENBREC), Barcelona; the Department of Psychiatry, Autonomous University of Madrid, Research Institute of the Hospital de La Princesa, Madrid; FIDMAG Research Foundation, Barcelona; General Hospital of Granollers, Barcelona; Álava University Hospital, University of the Basque Country, Kronikgune, Vitoria, Spain; the Department of Psychiatry, University Hospital of Bellvitge-Bellvitge Biomedical Research Institute (IDIBELL), Barcelona; the Department of Clinical Sciences, Bellvitge Campus, Barcelona University, Barcelona; the Department of Psychiatry, Ramon y Cajal Hospital, Ramon y Cajal Institute of Health Research (IRYCIS), University of Alcala, Madrid; the Department of Psychiatry, University of Oviedo, Oviedo; the Department of Medicine, University of Valencia, Valencia, Spain; and the Gregorio Marañón University General Hospital and Health Research Institute (IISGM), Madrid.

Address correspondence to Dr. Vieta (evieta@clinic.ub.es) and Dr. Martínez-Arán (amartiar@clinic.ub.es).

Copyright © 2013 by the American Psychiatric Association

Received July 25, 2012; Revised October 25, 2012; Accepted December 06, 2012.


Objective  The authors sought to assess the efficacy of functional remediation, a novel intervention program, on functional improvement in a sample of euthymic patients with bipolar disorder.

Method  In a multicenter, randomized, rater-blind clinical trial involving 239 outpatients with DSM-IV bipolar disorder, functional remediation (N=77) was compared with psychoeducation (N=82) and treatment as usual (N=80) over 21 weeks. Pharmacological treatment was kept stable in all three groups. The primary outcome measure was improvement in global psychosocial functioning, measured blindly as the mean change in score on the Functioning Assessment Short Test from baseline to endpoint.

Results  At the end of the study, 183 patients completed the treatment phase. Repeated-measures analysis revealed significant functional improvement from baseline to endpoint over the 21 weeks of treatment (last observation carried forward), suggesting an interaction between treatment assignment and time. Tukey’s post hoc tests revealed that functional remediation differed significantly from treatment as usual, but not from psychoeducation.

Conclusions  Functional remediation, a novel group intervention, showed efficacy in improving the functional outcome of a sample of euthymic bipolar patients as compared with treatment as usual.

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FIGURE 1. Changes in Functional Impairment Scores Before and After Intervention in Patients With Bipolar Disordera

a Functional impairment is measured with the Functioning Assessment Short Test; higher scores indicate greater impairment. Change for the functional remediation group was significantly different from change for the treatment-as-usual group (Pillai’s Trace=0.065; F=6.51, p=0.002). Error bars indicate standard error of the mean.

FIGURE 2. Within-Group Effect Sizes in Functional Improvement, by Domain of the Functioning Assessment Short Test
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TABLE 1.Content of the Functional Remediation Program
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TABLE 2.Baseline Clinical and Sociodemographic Characteristics of Euthymic Patients With Bipolar Disorder and Moderate to Severe Functional Impairment Randomly Assigned to Functional Remediation, Psychoeducation, or Treatment as Usuala
Table Footer Note

a No significant differences between groups, except when illness duration was compared between the treatment-as-usual and psychoeducation groups (F=3.27; p=0.04).



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