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临床试验/NCT04053582
NCT04053582已完成不适用

Augmented Mindfulness Training for Resilience in Early Life

Laureate Institute for Brain Research, Inc.2 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2019年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
83
试验地点
2
主要终点
Percent signal change in the Posterior Cingulate Cortex (PCC) as assessed by fMRI

研究概览

简要总结

This project aims to determine whether neurofeedback augmented mindfulness intervention increases the plasticity in brain areas affected by exposure to early life adversity in youth. The study will first establish the augmented mindfulness training protocol targeting the posterior cingulate cortex (PCC) with real-time fMRI neurofeedback for use with healthy control and ELA-exposed youth. Next, in addition to ongoing data collection with healthy controls, ELA-exposed youth will be randomly assigned to either complete the neurofeedback augmented mindfulness training (AMT) or sham condition protocol. Effect of augmented mindfulness training on state measures of mindfulness, perceived stress, and affect will be examined.

详细描述

Early life adversity (ELA) is a major public health crisis that results in significant disruptions in neurobiological processes and long-term psychiatric and health consequences, yet very little is known about interventions that may prevent them and the optimal time to do so. Not only is ELA associated with earlier onset and greater severity and comorbidity of depression, anxiety, and substance abuse, these individuals also evidence significantly poorer responses to psychological and pharmacological interventions when treated for these conditions. Consequently, there is a dire need to develop preventive interventions that target individuals with ELA exposure. The first step in this process is to establish malleability of neural mechanisms disrupted by ELA exposure to acute interventions. We use augmented mindfulness training, that is, a standard mindfulness training combined with real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf) to influence and increase the plasticity of brain areas affected by ELA, in turn affecting state changes in symptoms in youth with ELA exposure. These fMRI tasks are designed to engage the PCC and mindfulness practice.

Over the course of three years, 120 eligible youth with early life adversity or healthy controls will be recruited into the study. All healthy controls will receive AMT, and ELA-exposed youth will be randomly assigned to AMT, consisting of real-time fMRI with neurofeedback during mindfulness practice, or Sham, consisting of artificially calculated neurofeedback signals during mindfulness practice. Adolescents will complete self-report measures to assess state affective symptoms before and after receiving mindfulness training and scanning, and again one week later.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
13 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Percent signal change in the Posterior Cingulate Cortex (PCC) as assessed by fMRI

时间窗: Through study completion (average: 2 weeks)

Percent signal change in the PCC for Focus - Describe condition contrast will be lower in the AMT relative to the Sham group during mindfulness practice.

次要结局

  • State Mindfulness Scale (SMS) scores(Through study completion (average: 2 weeks))
  • Positive and Negative Affect Schedule for Children (PANAS-C) scores(Through study completion (average: 2 weeks))
  • Perceived Stress Scale (PSS) scores(Through study completion (average: 2 weeks))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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