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01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Trials 1/2017

Cognitive-behavioral rehabilitation vs. treatment as usual for bipolar patients: study protocol for a randomized controlled trial

Zeitschrift:
Trials > Ausgabe 1/2017
Autoren:
Bernardo Carramão Gomes, Cristiana Castanho Rocca, Gabriel Okawa Belizario, Beny Lafer
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​s13063-017-1896-5) contains supplementary material, which is available to authorized users.

Abstract

Background

Bipolar disorder (BD) is commonly associated with cognitive and functional impairments even during remission periods, and although a growing number of studies have demonstrated the benefits of psychotherapy as an add-on to pharmacological treatment, its effectiveness appears to be less compelling in severe presentations of the disorder. New interventions have attempted to improve cognitive functioning in BD patients, but results have been mixed.

Methods

The study consists of a clinical trial comparing a new structured group intervention, called “Cognitive-Behavioral Rehabilitation,” with treatment as usual (TAU) for bipolar patients. The new approach is a combination of cognitive behavioral strategies and cognitive remediation exercises, consisting of 12 weekly group sessions of 90 min each. To be included in the study, patients must be diagnosed with BD type I or II, aged 18–55 years, in full or partial remission, and have an IQ of at least 80. A comprehensive neuropsychological battery, followed by mood, social functioning, and quality of life assessments will occur in three moments: pre and post intervention and 12 months later. The primary outcome of the study is to compare the time, in weeks, that the first full mood episode appears in patients who participated in either group of the study. Secondary outcome will include improvement in cognitive functions.

Discussion

This is the first controlled trial assessing the validity and effectiveness of the new “Cognitive-Behavioral Rehabilitation” intervention in preventing new mood episodes and improving cognitive and functional impairments.

Trial registration

Clinicaltrial.gov, NCT02766361. Registered on 2 May 2016.
Zusatzmaterial
Additional file 1: We have included a copy of the SPIRIT checklist. (DOC 119 kb)
13063_2017_1896_MOESM1_ESM.doc
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