Effects of cognitive remediation on cognitive dysfunction in partially or fully remitted patients with bipolar disorder: study protocol for a randomized controlled trial
Effects of cognitive remediation on cognitive dysfunction in partially or fully remitted patients with bipolar disorder: study protocol for a randomized controlled trial
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DOI：
10.1186/1745-6215-14-378
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发表时间：
2013-11-10
期刊：
影响因子：
2.5
通讯作者：
Miskowiak, Kamilla W.
中科院分区：
文献类型：
--
作者：
Demant, Kirsa M.;Almer, Glennie Marie;Miskowiak, Kamilla W.
背景资料：大部分双相情感障碍患者经历持续的认知功能障碍，如记忆、注意力和计划困难，即使在完全缓解期间也是如此。本试验的目的是调查是否认知补救，一种新的心理治疗，提高认知功能，反过来，在双相情感障碍患者的心理社会功能在部分或完全restriction.Methods/设计：该试验有一个评估盲，随机，组间设计。招募了40名双相情感障碍患者，年龄在18至50岁之间，完全或部分缓解，报告中度至重度认知困难。除了标准治疗或单独的标准治疗之外，患者被随机分配接受每周一次的基于组的认知补救治疗，持续12周。两组均在基线、治疗后（第12周）和随访（第26周）进行神经认知测试和功能性磁共振成像（fMRI）。主要结果是改善言语记忆，如从基线到治疗后的雷伊听觉言语学习测试（RAVLT）所测量的。通过纳入40名患者，我们获得了86%的把握度来检测各组之间言语记忆的临床相关差异。次要结果是注意力、执行功能和心理社会功能的改善，分别通过快速视觉信息处理测试、连线测试部分B和功能评估简短测试（FAST）进行测量。第三个结果是记忆力、注意力、执行功能和面部表情识别的额外神经心理学测试的分数提高，以及测量主观认知困难、压力、应对策略、人格特质、抑郁症状和生活质量的问卷调查。这是第一个随机对照试验，以评估认知补救对双相情感障碍患者认知功能的影响尽管完全或部分缓解，但仍有持续的认知困难。
Background: A large proportion of patients with bipolar disorder experience persistent cognitive dysfunction, such as memory, attention and planning difficulties, even during periods of full remission. The aim of this trial is to investigate whether cognitive remediation, a new psychological treatment, improves cognitive function and, in turn, psychosocial function in patients with bipolar disorder in partial or full remission.Methods/Design: The trial has an evaluator-blind, randomized, between-groups design. Forty patients with bipolar disorder in full or partial remission, aged 18 to 50 years, who report moderate to severe cognitive difficulties, are recruited. Patients are randomized to receive weekly group-based cognitive remediation treatment over 12 weeks in addition to standard treatment or standard treatment alone. Both groups undergo neurocognitive testing and functional magnetic resonance imaging (fMRI) at baseline, post-treatment (week 12) and follow-up (week 26). The primary outcome is improved verbal memory, as measured with the Rey Auditory Verbal Learning Test (RAVLT) from baseline to post-treatment. With inclusion of 40 patients we obtain 86% power to detect a clinically relevant difference in verbal memory between groups. Secondary outcomes are improved attention, executive function and psychosocial function, as measured with the Rapid Visual Information Processing test, the Trail Making Test part B and the Functional Assessment Short Test (FAST), respectively. Tertiary outcomes are improved scores for additional neuropsychological tests of memory, attention, executive function and facial expression recognition, as well as in questionnaires measuring subjective cognitive difficulties, stress, coping strategies, personality traits, depressive symptoms and quality of life.Discussion: This is the first randomized controlled trial to evaluate the effects of cognitive remediation on cognitive function in patients with bipolar disorder who experience persistent cognitive difficulties despite being in full or partial remission.