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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.; Bárbara 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;:. 10.1176/appi.ajp.2012.12070971
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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.

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Abstract

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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