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临床试验/NCT03571386
NCT03571386已完成不适用

Mechanisms of Mindfulness-Based Interventions (MBIs)

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2019年1月8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
136
试验地点
1
主要终点
Change in BOLD (Blood-oxygen-level-dependent) Mean Signal Change From Baseline to 12 Weeks in Response to Emotional (vs. Neutral) Word Stimuli

研究概览

简要总结

Mindfulness-based Interventions (MBIs) are a family of standardized cognitive and behavioral therapies that focus on cultivating mindfulness-related skills for improving maladaptive cognitive, emotional, and behavioral processes. MBIs have been developed for a wide range of problems, disorders, and populations and are increasingly available in a variety of health settings. This mixed methods study proposes to investigate proposed neurobiological, physiological, psycho-social-behavioral, and cognitive mechanisms by which MBIs may improve health outcomes.

详细描述

The state of mindfulness can be described as a form of meta-awareness in which attention is allocated to the present moment of external and internal sensory or mental experience, without reactivity, and without dwelling on any particular sensory or mental object with judgement or evaluation. Mindfulness-based Interventions (MBIs) are a family of standardized cognitive and behavioral therapies that focus on cultivating mindfulness-related skills for improving maladaptive cognitive, emotional, and behavioral processes.

MBIs have been developed for a wide range of problems, disorders, and populations and are increasingly available in a variety of health settings. Empirically supported MBIs include acceptance and commitment therapy (ACT; Hayes, Strosahl, & Wilson, 1999), dialectical behavior therapy (DBT; Linehan, 1993), mindfulness-based cognitive therapy (MBCT; Segal, Williams, & Teasdale, 2002), and mindfulness-based stress reduction (MBSR; Kabat-Zinn, 1982, 1990). Variations on these approaches, including integration of mindfulness training into individual psychotherapy from diverse perspectives, also have been described (Germer, Siegel, & Fulton, 2005). As the empirical evidence for the efficacy of these interventions continues to grow, the importance of investigating the mechanisms or processes by which they lead to beneficial outcomes is increasingly recognized. This mixed methods study proposes to investigate proposed neurobiological, physiological, psycho-social-behavioral, and cognitive mechanisms by which MBIs may improve health outcomes. Target (mechanism) engagement is expected to facilitate identification of individuals who are most likely to benefit (or not) from MBIs and further develop targeted interventions for optimization of delivery. Although there are very specific aims and hypotheses to be tested, this preliminary exploratory investigation will provide feasibility data and allow for refining existing hypotheses for larger research proposals to be submitted for extramural grant support.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 55 Years(Adult)
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

Change in BOLD (Blood-oxygen-level-dependent) Mean Signal Change From Baseline to 12 Weeks in Response to Emotional (vs. Neutral) Word Stimuli

时间窗: Baseline to 12 weeks

fMRI BOLD response to emotional word stimuli baseline to 12 weeks (post-MBCT). BOLD signal change (pre- to post-MBCT) is estimated from the contrast of emotional word vs neutral words, and extracted from voxels within the fronto-parietal and default mode areas at baseline and 12-weeks. Significant Voxel-wise BOLD activity is reported using z-scores from peak voxels. A mean score was calculated based on z-score and SD of 2 in the context of reporting fMRI BOLD data here. Z-scores is a statistical measure that describes how many standard deviations a data point (e.g., a voxel's signal) is from the mean of the distribution of that signal. The higher the reported mean, the less likely the observed activation is due to chance, thus indicating more significant activity or activation in that particular brain region.

次要结局

  • Amplitude of P1 Event-related Potentials (ERP) in Response to Threat (vs. Neutral) Face Cues Pre- to Post-MBCT(Baseline to 12 weeks (pre- to post-MBCT))
  • Response Time to Probes as a Function of Emotion and Congruency in the Dot Probe Task(Baseline to ~12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Vago

Research Director; Associate Professor

Vanderbilt University Medical Center

研究点 (1)

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