酒精使用障碍心理治疗后神经认知和神经行为机制的变化 (ABQTREAT)
2023年5月12日 更新者:Barbara S McCrady, PhD、University of New Mexico
心理变化后的神经认知和神经行为机制
酒精使用障碍 (AUD) 是一个重大的公共卫生问题,当前诊断的患病率为 13.9%,终生诊断的患病率为 29.1%(Grant 等人,2015 年)。 澳元在个人、家庭和社会层面造成伤害,估计每年的社会成本为 2490 亿美元(Sacks 等人,2015 年)。 AUD 的病程通常以问题饮酒的复发期为特征(Maisto 等人,2014 年),表明需要更好的治疗和了解行为改变的机制。
本研究的目的是对 140 名患有酒精使用障碍 (AUD) 的参与者进行随机临床试验。 每个参与者将在接受心理治疗治疗前后完成行为评估、自我报告调查和脑成像,以改变他们的饮酒行为。 将研究行为改变的各个方面,以更好地了解当某人改变饮酒模式时大脑功能和情绪反应的变化。 已发现本研究中使用的两种治疗方法有助于减少饮酒。 参与者将被随机分配到基于正念的复发预防 (MBRP) 或认知行为疗法 (CBT),这将在每周 12 次治疗中完成。
预计当某人在完成 12 周的治疗后减少或停止饮酒时,大脑功能会发生许多变化。
研究概览
详细说明
尽管存在针对酒精使用障碍 (AUD) 的药理学和社会心理治疗,可以改善自然恢复的结果(Finney 等人,2013 年),但结果仍然有限。
确定导致成功结果的行为改变机制 (MOBC) 可能对于改进现有治疗或更好地将患者与特定治疗相匹配的努力至关重要。
拟议研究的目标是进行一项随机临床试验,以系统地检查治疗前的神经认知和行为特征以及在两种经验支持的 AUD 治疗期间大脑功能随时间的变化。
140 名患有 AUD 的寻求治疗的人将在接受 4 周的平台治疗后随机接受 8 周的认知行为治疗 (CBT) 或基于正念的治疗 (MBT),该平台治疗的重点是增强改变的动力。
将使用神经影像学、综合行为评估和患者自我报告来测量神经认知和行为特征。
为确定饮酒变化与这些 MOBC 变化之间的时间关系,将在以下时间对患者进行评估:(a) 基线; (b) 接受治疗四个星期; (c) 治疗后立即; (d) 基线后 9 个月和 15 个月。
自我报告措施和行为任务将在治疗期间每月进行一次;和 fMRI 将在基线、基线后 3 个月和 9 个月收集。
该研究的主要目的是检查治疗对三种假设机制的影响:渴望/渴望的调节、认知和行为控制以及影响/唤醒的调节。
次要目标将确定神经认知和行为基线特征,这些特征可预测随着时间的推移饮酒减少以及对 CBT 或 MBT 的不同反应模式。
研究类型
介入性
注册 (预期的)
140
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Barbara McCrady, PhD
- 电话号码:505-925-2833
- 邮箱:bmccrady@unm.edu
研究联系人备份
- 姓名:Eric Claus, PhD
- 邮箱:eclaus@mrn.org
学习地点
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New Mexico
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Albuquerque、New Mexico、美国、87106
- The University of New Mexico
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Albuquerque、New Mexico、美国、87106
- The Mind Research Network
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
20年 至 83年 (成人、年长者)
接受健康志愿者
不
描述
纳入标准:
- 年龄 22-85 岁
- 自我认定为重度/狂饮/每周饮酒者
- 根据男性 > 8 分和女性 > 7 分的 AUDIT 分数,从事“危险和有害的酒精使用”(Babor 等人,2001 年)
- 亲自筛查时呼吸酒精浓度为 0.00
- 右撇子
- 明确寻求饮酒帮助
- 过去 30 天内饮酒
排除标准:
- 脑损伤史或神经系统诊断
- 当前精神病的证据
- 过去一年对尼古丁或大麻以外的物质依赖
- 最近在尿液筛查中使用非法药物(大麻除外)的证据
- MRI 的禁忌症(例如体内的医疗设备)
- 认为自己可能怀孕的女性参与者必须在每次 MRI 扫描之前通过尿液妊娠筛查
- 估计智商 < 80
- 无法流利地阅读或说英语
- 严重戒酒史
- 目前正在接受酒精使用治疗(或在过去 6 个月内)
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:认知行为疗法
CBT 条件将包括每周 8 次、每次 60 分钟的课程,并将根据 Epstein & McCrady (2009) 认知行为治疗手册进行,不包括平台治疗中提供的材料。
治疗手册和随附的客户工作簿为每个疗程、客户练习、工作表和家庭作业提供了详细的治疗师说明。
治疗侧重于认知和行为应对技能训练,并强调将解决问题作为应对饮酒的整体方法。
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CBT 条件将包括每周 8 次、每次 60 分钟的课程,并将根据 Epstein & McCrady (2009) 认知行为治疗手册进行,不包括平台治疗中提供的材料。
治疗手册和随附的客户工作簿为每个疗程、客户练习、工作表和家庭作业提供了详细的治疗师说明。
治疗侧重于认知和行为应对技能训练,并强调将解决问题作为应对饮酒的整体方法。
治疗过程可能会被录音以供监督并确保治疗按预期进行。
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有源比较器:基于正念的复发预防
MBT 条件将改编自基于正念的复发预防 (MBRP) 手册的 8 周版本(Bowen 等人,2011 年;Witkiewitz 等人,2005 年)。
主要的调整将是消除复发预防/CBT 组件,并将注意力集中在正念练习上。
MBT 中的正念练习旨在提高对触发因素的认识,并在触发因素存在的情况下减少对痛苦或不适的反应 (Witkiewitz & Bowen, 2010)。
专注于正念工具的相关工作表和家庭作业将从 MBRP 手册中保留下来。
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MBT 条件将改编自基于正念的复发预防 (MBRP) 手册的 8 周版本(Bowen 等人,2011 年;Witkiewitz 等人,2005 年)。
主要的调整将是消除复发预防/CBT 组件,并将注意力集中在正念练习上。
MBT 中的正念练习旨在提高对触发因素的认识,并在存在触发因素的情况下减少对痛苦或不适的反应 (Witkiewitz & Bowen, 2010)。
专注于正念工具的相关工作表和家庭作业将从 MBRP 手册中保留下来。
治疗过程可能会被录音以供监督并确保治疗按预期进行。
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
MOBC:渴望 - 自我报告
大体时间:长达 15 个月
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Penn Alcohol Craving Scale 将用于检查治疗期间和之后发生的渴望变化。
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长达 15 个月
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MOBC:渴望 - 神经影像学
大体时间:长达 9 个月
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将使用提示任务评估腹侧纹状体酒精期间信号变化百分比与中性图片提示的差异,同时使用功能磁共振成像扫描参与者
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长达 9 个月
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MOBC:认知和行为控制 - 自我报告冲动
大体时间:长达 15 个月
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UPPS-P 冲动问卷将用于检查治疗期间和治疗后发生的冲动变化。
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长达 15 个月
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MOBC:认知和行为控制 - 行为
大体时间:长达 15 个月
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货币选择问卷将用于确定治疗期间和治疗后冲动选择的变化程度。
将为每个主管部门计算贴现率 (k)。
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长达 15 个月
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MOBC:认知和行为控制 - 神经影像学抑制
大体时间:长达 9 个月
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将使用停止信号任务评估右下额叶皮层成功抑制反应与成功非抑制试验期间信号变化百分比的差异,同时使用功能磁共振成像扫描参与者。
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长达 9 个月
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MOBC:认知和行为控制 - 神经影像学错误
大体时间:长达 9 个月
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在使用停止信号任务对参与者进行功能磁共振成像扫描时,将使用停止信号任务评估背侧前扣带皮层中反应抑制失败与成功的非抑制试验期间信号变化百分比的差异。
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长达 9 个月
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MOBC:影响/唤醒的调节 - 神经影像学
大体时间:长达 9 个月
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在使用功能磁共振成像扫描参与者时,将使用提示任务评估杏仁核中消极与中性图片提示期间信号变化百分比的差异。
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长达 9 个月
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MOBC:影响/唤醒的调节 - 负面影响自我报告
大体时间:长达 15 个月
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来自 NIH 工具箱的负面影响总结分数将用于评估治疗期间和之后的总体负面影响变化。
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长达 15 个月
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
饮酒天数百分比
大体时间:基线、4周治疗访视、8周治疗访视、3个月随访、9个月随访和15个月随访
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表格 90 将用于推导饮酒天数百分比的结果估计值。
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基线、4周治疗访视、8周治疗访视、3个月随访、9个月随访和15个月随访
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每个饮酒日的饮料
大体时间:基线、4周治疗访视、8周治疗访视、3个月随访、9个月随访和15个月随访
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表格 90 将用于得出结果的估计值:每个饮酒日的饮料(标准饮料 = 14 克纯酒精)。
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基线、4周治疗访视、8周治疗访视、3个月随访、9个月随访和15个月随访
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重度饮酒天数百分比
大体时间:基线、4周治疗访视、8周治疗访视、3个月随访、9个月随访和15个月随访
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表格 90 将用于得出结果的估计值:重度饮酒天数百分比,其中重度饮酒定义为女性每次饮酒 4 杯以上,男性每次饮酒 5 杯以上。
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基线、4周治疗访视、8周治疗访视、3个月随访、9个月随访和15个月随访
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Barbara McCrady, PhD、The University of New Mexico
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年11月14日
初级完成 (预期的)
2024年9月30日
研究完成 (预期的)
2024年9月30日
研究注册日期
首次提交
2019年2月6日
首先提交符合 QC 标准的
2019年2月12日
首次发布 (实际的)
2019年2月15日
研究记录更新
最后更新发布 (实际的)
2023年5月16日
上次提交的符合 QC 标准的更新
2023年5月12日
最后验证
2023年5月1日
更多信息
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