正念减压对改善老年人注意力控制的随机对照试验方案（HealthyAgers 试验）。
Protocol for a randomized controlled trial of mindfulness-based stress reduction to improve attentional control in older adults (HealthyAgers trial).
机构信息
Department of Psychology, The Ohio State University, 62 Psychology Building, 1835 Neil Avenue, Columbus, OH, 43210, USA.
Center for Cognitive and Behavioral Brain Imaging, The Ohio State University, Columbus, OH, USA.
出版信息
BMC Geriatr. 2022 Aug 13;22(1):666. doi: 10.1186/s12877-022-03334-7.
BACKGROUND
Mindfulness meditation is a form of mind-body intervention that has increasing scientific support for its ability to reduce age-related declines in cognitive functioning, improve affective health, and strengthen the neural circuitry supporting improved cognitive and affective health. However, the majority of existent studies have been pilot investigations with small sample sizes, limited follow-up data, and a lack of attention to expectancy effects. Here, we present the study design of a Phase I/II, efficacy trial-HealthyAgers trial-that examines the benefits of a manualized mindfulness-based stress reduction program in improving attentional control and reducing mind-wandering in older adults.
METHODS
One hundred fifty older adults (ages 65-85 years) will be randomized into one of two groups: an eight-week mindfulness program or an eight-week, placebo-controlled, lifestyle education program. Behavioral and neuroimaging assessments are conducted before and after the training. Participants are then invited to booster sessions once every three months for a period of 12 months with post-intervention follow-up assessments conducted at 6-months and 12-months. The primary outcomes for the study are behavioral measures of attentional control and mind-wandering. Additional, secondary outcomes include network strength in an a priori defined neuromarker of attentional control, fluid and everyday cognition, emotion regulation strategy use, and markers of inflammation.
DISCUSSION
This study will establish the efficacy of a group-based, low-cost mind-body intervention for the inter-related facets of attentional control and mind-wandering in older adults. Strengths of this study include a well-designed, placebo-controlled comparison group, use of web/mobile application to track study adherence, and longitudinal follow-up.
TRIAL REGISTRATION
Clinicaltrials.gov (# NCT03626532 ). Registered August 4, 2018.
背景
正念冥想是一种身心干预形式，它越来越多地得到科学的支持，因为它能够减缓与年龄相关的认知功能下降，改善情感健康，并加强支持改善认知和情感健康的神经回路。然而，大多数现有的研究都是小规模的试点调查，随访数据有限，并且没有关注预期效应。在这里，我们介绍了一项 I/II 期功效试验——健康老年人试验的研究设计，该试验研究了一种规范化的正念减压方案对改善老年人注意力控制和减少思维漫游的益处。
方法
150 名老年人（65-85 岁）将被随机分为两组：八周正念课程组或八周、安慰剂对照、生活方式教育课程组。在训练前后进行行为和神经影像学评估。然后，参与者被邀请参加为期 12 个月的每月一次的强化课程，在干预后进行 6 个月和 12 个月的随访评估。该研究的主要结果是注意力控制和思维漫游的行为测量。此外，次要结果还包括预先定义的注意力控制神经标志物中的网络强度、流体和日常认知、情绪调节策略使用以及炎症标志物。
讨论
这项研究将确定基于群体的、低成本的身心干预对老年人注意力控制和思维漫游的相关方面的疗效。这项研究的优势包括精心设计的、安慰剂对照的比较组、使用网络/移动应用程序来跟踪研究依从性以及纵向随访。
试验注册
Clinicaltrials.gov（#NCT03626532）。于 2018 年 8 月 4 日注册。
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