Laureate Institute for Brain Research, 6655 South Yale Ave., Tulsa, OK, 74136, USA.
Institute for Cognitive Science Studies, Tehran, Iran.
Trials. 2021 May 7;22(1):330. doi: 10.1186/s13063-021-05268-8.
Neurocognitive deficits (NCDs) and associated meta-cognition difficulties associated with chronic substance use often delay the learning and change process necessary for addiction recovery and relapse prevention. However, very few cognitive remediation programs have been developed to target NCDs and meta-cognition for substance users. The study described herein aims to investigate the efficacy of a multi-component neurocognitive rehabilitation and awareness program termed "Neurocognitive Empowerment for Addiction Treatment" (NEAT). NEAT is a fully manualized, cartoon-based intervention involving psychoeducation, cognitive practice, and compensatory strategies relevant across 10 major cognitive domains, including aspects of attention, memory, executive functions, and decision-making.
METHOD/DESIGN: In a single-blind randomized controlled trial (RCT), 80 female opioid and/or methamphetamine users will be recruited from an addiction recovery program providing an alternative to incarceration for women with substance use-related offenses. Eight groups of 9-12 participants will be randomized into NEAT or treatment-as-usual (TAU). NEAT involves 14 90-min sessions, delivered twice weekly. The primary outcome is change in self-reported drug craving from before to after intervention using Obsessive Compulsive Drug Use Scale. Secondary and exploratory outcomes include additional psychological, neurocognitive, and structural and functional neuroimaging measures. Clinical measures will be performed at five time points (pre- and post-intervention, 3-, 6-, and 12-month follow-up); neuroimaging measures will be completed at pre- and post-intervention.
The present RCT is the first study to examine the efficacy of an adjunctive neurocognitive rehabilitation and awareness program for addiction. Results from this study will provide initial information concerning potential clinical efficacy of the treatment, as well as delineate neural mechanisms potentially targeted by this novel intervention.
ClinicalTrials.gov NCT03922646 . Registered on 22 April 2019.
与慢性物质使用相关的神经认知缺陷（NCD）和相关的元认知困难常常会延迟成瘾康复和预防复发所需的学习和改变过程。然而，针对物质使用者的 NCD 和元认知，很少有认知矫正计划被开发出来。本研究旨在调查一种名为“神经认知强化治疗”（NEAT）的多成分神经认知康复和意识计划的疗效。NEAT 是一种完全基于手册、基于卡通的干预措施，涉及心理教育、认知实践和与 10 个主要认知领域相关的补偿策略，包括注意力、记忆、执行功能和决策等方面。
方法/设计：在一项单盲随机对照试验（RCT）中，将从一个为有药物使用相关犯罪的女性提供替代监禁的戒毒康复计划中招募 80 名女性阿片类药物和/或甲基苯丙胺使用者。将 8 组 9-12 名参与者随机分为 NEAT 或常规治疗（TAU）组。NEAT 包括 14 个 90 分钟的课程，每周两次。主要结果是使用强迫性药物使用量表（Obsessive Compulsive Drug Use Scale），从干预前到干预后自我报告的药物渴求变化。次要和探索性结果包括其他心理、神经认知以及结构和功能神经影像学测量。临床测量将在五个时间点进行（干预前和干预后、3、6 和 12 个月随访）；神经影像学测量将在干预前和干预后进行。
本 RCT 是第一项研究辅助性神经认知康复和意识计划对成瘾的疗效的研究。这项研究的结果将提供有关该治疗潜在临床疗效的初步信息，并阐明该新干预措施可能针对的神经机制。
ClinicalTrials.gov NCT03922646。于 2019 年 4 月 22 日注册。
