认知行为疗法使重度抑郁症患者的社会学习正常化：一项单臂临床试验的研究方案
Cognitive-behavioral therapy to normalize social learning for patients with major depressive disorders: study protocol for a single-arm clinical trial.
作者信息
Jin Yuening, Zu Si, Wang Pengchong, Sheng Fangrui, Wang Xue, Wang Yun, Chen Qun, Zhong Jie, Yan Fang, Zhou Jia, Li Zhanjiang, Zhou Yuan
机构信息
State Key Laboratory of Cognitive Science and Mental Health, Institute of Psychology, Chinese Academy of Sciences, Beijing, 100101, China.
Department of Psychology, University of Chinese Academy of Sciences, Beijing, 100049, China.
出版信息
BMC Psychol. 2025 Apr 29;13(1):453. doi: 10.1186/s40359-025-02759-0.
BACKGROUND
The current study aims to explore the efficacy of cognitive behavioral therapy (CBT) in normalizing social learning capabilities and its underlying neural processes among patients with MDD, in terms of enhancing learning towards positive social feedback, and reducing excessive learning towards negative social feedback. This study also explores the potential for learning impairments in social contexts as a biomarker to predict the effectiveness of CBT.
METHODS
In a single-centre, single-arm, open-label trial, 60 outpatients with MDD will undergo 12 sessions of CBT in three months. Data collection of patients will be administered at baseline and at the endpoint of the treatment. Additionally, 60 heathy controls will be recruited as a comparative group to assess deviations from the normal functions in the patients with MDD before and after CBT. Data collection of the HC group will be administered at baseline. Data collection of the two groups comprises of demographic information, clinical assessments, psychological assessments, and behavioral experiments (i.e. the Door Game and the Trust Game) in conjuction with task-based function magnetic resonance imaging (fMRI) scanning. Data analysis comprises of an estimation of social learning capabilities by computational modeling, and identification of baseline abnormalities, treatment effects and endpoint abnormalities on social learning capabilities and its neural activities.
DISCUSSION
This trial aims to assess the efficacy of CBT in normalizing social learning capabilities among patients with MDD by leveraging high ecological validity paradigms and computational modeling. This trial also contributes to understanding psychosocial biomarkers of CBT treatment effectiveness in reducing depressive symptoms.
TRIAL REGISTRATION
ChiCTR2400094841 ( www.chictr.org.cn ; registration date: 12/29/2024) (retrospectively registered).
背景
本研究旨在探讨认知行为疗法（CBT）在使重度抑郁症（MDD）患者的社会学习能力及其潜在神经过程正常化方面的疗效，具体涉及增强对积极社会反馈的学习，以及减少对消极社会反馈的过度学习。本研究还探讨了社会情境中学习障碍作为预测CBT疗效的生物标志物的潜力。
方法
在一项单中心、单臂、开放标签试验中，60名MDD门诊患者将在三个月内接受12次CBT治疗。将在基线和治疗终点对患者进行数据收集。此外，将招募60名健康对照作为比较组，以评估MDD患者在CBT治疗前后与正常功能的偏差。将在基线时对健康对照组进行数据收集。两组的数据收集包括人口统计学信息、临床评估、心理评估以及结合基于任务的功能磁共振成像（fMRI）扫描的行为实验（即门游戏和信任游戏）。数据分析包括通过计算模型估计社会学习能力，以及识别社会学习能力及其神经活动的基线异常、治疗效果和终点异常。
讨论
本试验旨在通过利用高生态效度范式和计算模型来评估CBT在使MDD患者的社会学习能力正常化方面的疗效。本试验还有助于理解CBT治疗有效性在减轻抑郁症状方面的心理社会生物标志物。
试验注册
ChiCTR2400094841（www.chictr.org.cn；注册日期：2024年12月29日）（回顾性注册）
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