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

Abstract

BackgroundBipolar 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.MethodsThe 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.DiscussionThis 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 registrationClinicaltrial.gov, NCT02766361. Registered on 2 May 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-1896-5) contains supplementary material, which is available to authorized users.

Cognitive behavioral rehabilitation for bipolar disorder patients: A randomized controlled trial

“…Contrasting with previous studies, the CBR intervention did not improve functional impairment neither quality of life, which may be due to our small sample size. In fact, TP patients reported significant lower FAST scores in the work domain, which represents the patients´ perception about difficulties to perform their work.…”

“…Contrasting with previous studies, 22,35 It is important to describe the number of drop-outs in the trial (35%), which was compatible with previous studies, 48 but much higher than our previous experience with psychotherapy trials. 49 During the evaluation phase, many individuals have complained about the length of the cognitive evaluation, which took about 2 hours to complete.…”

“…We have written a manual describing 12 sessions in a group format and divided in three modules: (1) Memory and Attention, (2) Social Cognition and Solving Problems, and (3) Preventing Relapses. 35 The aim of the present study is to evaluate the effectiveness of CBR in improving divided and sustained attention, visual and working memory and emotional recognition (main outcome), and improving functionality and quality of life (secondary outcomes). 36 and had been followed in the outpatient service for at least one year previous to the beginning of this study.…”

“…The manual was briefly described previously. 35 To be included in the final analysis, individuals were required to have participated in more than six (50%) sessions.…”

“…The intervention focuses on behaviors from the daily routine which show potential prophylactic aspects. We have written a manual describing 12 sessions in a group format and divided in three modules: (1) Memory and Attention, (2) Social Cognition and Solving Problems, and (3) Preventing Relapses …”