Gomes Bernardo Carramão, Rocca Cristiana Castanho, Belizario Gabriel Okawa, Lafer Beny
Department of Psychiatry, University of São Paulo School of Medicine, Rua Dr. Ovídio Pires de Campos, 785, São Paulo, 05403-010, Brazil.
Department and Institute of Psychiatry, Bipolar Research Program, University of São Paulo Medical School, Sao Paulo, Brazil.
Trials. 2017 Mar 28;18(1):142. doi: 10.1186/s13063-017-1896-5.
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.
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.
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.
Clinicaltrial.gov, NCT02766361 . Registered on 2 May 2016.
双相情感障碍（BD）即使在缓解期也常伴有认知和功能损害。尽管越来越多的研究表明心理治疗作为药物治疗的辅助手段具有益处，但在该疾病的严重表现中，其有效性似乎不那么令人信服。新的干预措施试图改善双相情感障碍患者的认知功能，但结果喜忧参半。
该研究包括一项临床试验，将一种名为“认知行为康复”的新型结构化团体干预措施与双相情感障碍患者的常规治疗（TAU）进行比较。新方法是认知行为策略和认知矫正练习的结合，包括每周12次、每次90分钟的团体课程。要纳入该研究，患者必须被诊断为I型或II型双相情感障碍，年龄在18至55岁之间，处于完全或部分缓解期，且智商至少为80。将在三个时间点进行全面的神经心理测试，随后进行情绪、社会功能和生活质量评估：干预前、干预后以及12个月后。该研究的主要结果是比较参与研究的两组患者首次出现完全情绪发作的时间（以周为单位）。次要结果将包括认知功能的改善。
这是第一项评估新型“认知行为康复”干预措施在预防新的情绪发作以及改善认知和功能损害方面的有效性和效果的对照试验。
Clinicaltrial.gov，NCT02766361。于2016年5月2日注册。
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