Cognitive Training for Emotion-Related Impulsivity and Rumination: Protocol for a Pilot Randomized Waitlist-Controlled Trial.

IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES JMIR Research Protocols Pub Date : 2025-02-19 DOI:10.2196/54221
K J D Allen, Matthew V Elliott, Eivind Haga Ronold, Liam Mason, Nandini Rajgopal, Åsa Hammar, Sheri L Johnson
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Abstract

Background: Inhibitory deficits are common in psychopathology. Emotion-related impulsivity (ERI) and rumination are general risk factors for psychiatric distress that are similarly associated with dysfunctional inhibition-particularly in affective contexts. A number of cognitive remediation procedures have been developed to improve inhibitory control; however, most remediation programs focus on "cold" cognition independent of affective processing. This pilot trial will gather preliminary evidence for a new cognitive training intervention targeting "hot" affective control (ie, inhibitory functions during elevated emotional arousal) in a transdiagnostic sample of adults who report heightened emotion dysregulation.

Objective: This manuscript describes a protocol for a pilot randomized waitlist-controlled trial to assess changes in ERI and rumination after neurobehavioral affective control training (N-ACT), an 8-week cognitive training intervention designed to improve emotional response inhibition and emotional working memory. Our primary aim is to evaluate the efficacy, feasibility, and acceptability of N-ACT in reducing rumination and ERI, which we respectively conceptualize as complementary cognitive and behavioral consequences of emotion dysregulation. Secondarily, we will examine whether N-ACT leads to improvements in inhibitory control and, more distally, psychopathology symptoms.

Methods: The final sample will comprise 80 adults who report high ERI or rumination. Participants will be randomized to (1) begin the N-ACT program without delay or (2) join a waitlist condition and then complete N-ACT. Exclusion criteria include active alcohol or substance use disorders, psychosis, and suicide risk. At the baseline and postintervention time points, participants will complete measures of emotion dysregulation and psychiatric symptoms, as well as a neuropsychological assessment of inhibitory control. Individuals assigned to the control group will undergo an identical assessment before joining the waitlist, followed by parallel assessments before and after N-ACT.

Results: This trial is funded by support from the University of California Board of Regents and the Peder Sather Foundation (funding period: October 2022-September 2025). Recruitment is scheduled to begin in spring 2025. We will begin data analysis once data collection is complete, which is planned to occur in fall 2025.

Conclusions: This pilot randomized waitlist-controlled trial is designed to assess the initial efficacy, feasibility, and acceptability of N-ACT, a novel cognitive remediation approach developed to address 2 key contributors to psychopathology: ERI and rumination. The N-ACT program uses computerized adaptive behavioral tasks to strengthen the affective control processes theoretically and empirically linked to ERI and rumination. We hope this work will help inform future studies with sufficient statistical power to ascertain whether enhancing affective control through cognitive training (N-ACT) produces downstream reductions in psychiatric symptoms via improved emotion regulation.

Trial registration: ClinicalTrials.gov NCT06226467; https://www.clinicaltrials.gov/study/NCT06226467; Open Science Framework Registry rak5z; https://osf.io/rak5z.

International registered report identifier (irrid): PRR1-10.2196/54221.

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情绪相关冲动和反刍的认知训练:一项随机候补对照试验的方案。
背景:抑制性缺陷在精神病理学中很常见。情绪相关冲动(ERI)和反刍是精神痛苦的一般危险因素,与功能失调抑制相似,特别是在情感环境中。已经开发了许多认知补救程序来改善抑制控制;然而,大多数补救方案侧重于独立于情感加工的“冷”认知。这项试点试验将为一种新的认知训练干预收集初步证据,该干预针对报告情绪失调加剧的成年人的跨诊断样本中的“热”情感控制(即情绪唤醒升高期间的抑制功能)。目的:本文描述了一项试点随机候补对照试验的方案,以评估神经行为情感控制训练(N-ACT)后ERI和反刍的变化,N-ACT是一项为期8周的认知训练干预,旨在改善情绪反应抑制和情绪工作记忆。我们的主要目的是评估N-ACT在减少反刍和ERI方面的有效性、可行性和可接受性,我们分别将其定义为情绪失调的互补认知和行为后果。其次,我们将研究N-ACT是否导致抑制控制的改善,以及更远的精神病理症状。方法:最后的样本将包括80名报告高ERI或反刍的成年人。参与者将被随机分配到(1)立即开始N-ACT计划或(2)加入等待名单条件,然后完成N-ACT。排除标准包括活动性酒精或物质使用障碍、精神病和自杀风险。在基线和干预后时间点,参与者将完成情绪失调和精神症状的测量,以及抑制性控制的神经心理学评估。被分配到对照组的个人在加入候补名单之前将接受相同的评估,然后在N-ACT之前和之后进行平行评估。结果:该试验由加州大学校董会和Peder Sather基金会资助(资助期:2022年10月至2025年9月)。招聘计划于2025年春季开始。一旦数据收集完成,我们将开始数据分析,计划在2025年秋季进行。结论:本试验旨在评估N-ACT的初步疗效、可行性和可接受性。N-ACT是一种新的认知修复方法,旨在解决精神病理学的两个关键因素:ERI和反刍。N-ACT计划使用计算机化的适应性行为任务来加强与ERI和反刍相关的情感控制过程的理论和经验。我们希望这项工作将有助于为未来的研究提供足够的统计能力,以确定通过认知训练(N-ACT)增强情感控制是否通过改善情绪调节来减少精神症状。试验注册:ClinicalTrials.gov NCT06226467;https://www.clinicaltrials.gov/study/NCT06226467;开放科学框架注册库;https://osf.io/rak5z.International注册报告标识符(irrid): PRR1-10.2196/54221。
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