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随机对照临床试验:整体认知矫正方案治疗重度抑郁症(INCREM)。

Randomized clinical trial of integral cognitive remediation program for major depression (INCREM).

机构信息

Sant Pau Mental Health Group, Institut d'Investigació Biomèdica Sant Pau (IBB-Sant Pau), Hospital de la Sant Creu i Sant Pau, Centro de Investigación Biomédica en Red de Salut Mental (CIBERSAM), Universitat Autònoma de Barcelona (UAB), Barcelona, Catalonia, Spain.

Estadística Aplicada, Universitat Autònoma de Barcelona (UAB), Barcelona, Catalonia, Spain.

出版信息

J Affect Disord. 2022 Aug 1;310:189-197. doi: 10.1016/j.jad.2022.05.016. Epub 2022 May 8.

DOI:10.1016/j.jad.2022.05.016
PMID:35545155
Abstract

BACKGROUND

Despite achieving clinical remission, patients with depression encounter difficulties to return to their premorbid psychosocial functioning. Cognitive dysfunction has been proposed to be a primary mediator of functional impairment. Therefore, the new non-pharmacological procognitive strategy INtegral Cognitive REMediation for Depression (INCREM) has been developed with the aim of targeting cognitive and psychosocial functioning.

METHODS

This is a single-blind randomized controlled clinical trial with three treatment arms. Fifty-two depressed patients in clinical remission, with psychosocial difficulties and cognitive impairment, were randomly assigned to receive INCREM intervention, Psychoeducation programme, or treatment as usual. Patients were assessed before and after the study period, and six months after. The primary outcome was the change from baseline of patients' psychosocial functioning. Changes in cognitive functioning and other variables were considered secondary outcomes.

RESULTS

The analysis showed a significant improvement in psychosocial functioning in the INCREM group, especially six months after the intervention, compared to patients who received the psychoeducation programme. An improvement in cognitive performance was also observed in the INCREM group.

LIMITATIONS

This study includes a small sample size due to the anticipated end of the clinical trial because of the COVID-19 pandemic.

DISCUSSION

These results provide preliminary evidence on the feasibility and potential efficacy of the INCREM program to improve not only cognitive performance but also psychosocial functioning in clinically remitted depressed patients, and such improvement is maintained six months after. It can be speculated that the maintenance is mediated by the cognitive enhancement achieved with INCREM.

摘要

背景

尽管抑郁症患者达到了临床缓解,但他们在恢复到发病前的社会心理功能方面仍存在困难。认知功能障碍被认为是功能障碍的主要介导因素。因此,新的非药物认知促进策略——抑郁的综合认知康复(INCREM)已经被开发出来,旨在针对认知和社会心理功能。

方法

这是一项单盲随机对照临床试验,有三个治疗组。52 名处于临床缓解期、有社会心理困难和认知障碍的抑郁症患者被随机分配接受 INCREM 干预、心理教育计划或常规治疗。患者在研究期间前后和六个月后进行评估。主要结果是患者社会心理功能从基线的变化。认知功能和其他变量的变化被视为次要结果。

结果

分析显示,与接受心理教育计划的患者相比,INCREM 组的社会心理功能有显著改善,尤其是在干预六个月后。INCREM 组的认知表现也有所改善。

局限性

由于 COVID-19 大流行,预计临床试验将结束,因此本研究的样本量较小。

讨论

这些结果提供了初步证据,证明 INCREM 计划不仅可以改善认知表现,还可以改善临床缓解的抑郁症患者的社会心理功能,而且这种改善在六个月后仍能维持。可以推测,这种维持是通过 INCREM 实现的认知增强来介导的。

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