Department of Psychiatry, Hospital de la Santa Creu i Sant Pau, Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Institut d'Investigació Biomèdica Sant Pau (IBB-Sant Pau), Universitat Autònoma de Barcelona (UAB), Sant Antoni Ma Claret 167, 08025, Barcelona, Catalonia, Spain.
Mental Health Unit, Hospital Universitari Parc Taulí, Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Institut d'Investigació i Innovació Parc Taulí (I3PT), Universitat Autònoma de Barcelona (UAB), Sabadell, Barcelona, Catalonia, Spain.
BMC Psychiatry. 2019 May 6;19(1):135. doi: 10.1186/s12888-019-2117-4.
Given the limitation of pharmacological treatments to treat cognitive symptoms in patients with Major Depressive Disorder (MDD), cognitive remediation programs has been proposed as a possible procognitive intervention but findings are not conclusive. This study investigates the efficacy of an INtegral Cognitive REMediation (INCREM) that includes a combination of a Functional Remediation (FR) strategy plus a Computerized Cognitive Training (CCT) in order to improve not only cognitive performance but also the psychosocial functioning and the quality of life.
A single blind randomized controlled clinical trial in 81 patients with a diagnosis of MDD in clinical remission or in partial remission. Participants will be randomized to one of three conditions: INCREM (FR + CCT), Psychoeducation plus online games and Treatment As Usual (TAU). Intervention will consist in 12 group sessions, of approximately 110 min once a week. The primary outcome measure will be % of change in psychosocial functioning after treatment measured by the Functional Assessment Short Test (FAST); additionally, number of sick leaves and daily activities will also be recorded as pragmatic outcomes.
To our knowledge, this is the first randomized controlled clinical trial using a combination of two different approaches (FR + CCT) to treat the present cognitive deficits and to promote their improvements into a better psychosocial functioning.
Clinical Trials NCT03624621 . Date registered 10th of August 2018 and last updated 24th August 2018.
鉴于药物治疗在治疗重度抑郁症（MDD）患者认知症状方面的局限性，认知矫正计划已被提议作为一种可能的认知干预措施，但结果尚无定论。本研究调查了一种综合认知矫正（INCREM）的疗效，该方法包括功能矫正（FR）策略和计算机认知训练（CCT）的结合，以提高认知表现，改善社会心理功能和生活质量。
在 81 名临床缓解或部分缓解的 MDD 患者中进行了一项单盲随机对照临床试验。参与者将随机分为三组：INCREM（FR+CCT）、心理教育加在线游戏和常规治疗（TAU）。干预措施将包括 12 次团体课程，每周一次，每次约 110 分钟。主要的结局指标是治疗后社会心理功能的变化百分比，采用功能评估简短测试（FAST）进行测量；此外，还将记录病假和日常活动的次数作为实用结果。
据我们所知，这是首次使用两种不同方法（FR+CCT）联合治疗当前认知缺陷并促进其改善以获得更好的社会心理功能的随机对照临床试验。
临床试验 NCT03624621。注册日期为 2018 年 8 月 10 日，最后更新日期为 2018 年 8 月 24 日。
