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临床试验/NCT03583060
NCT03583060已完成不适用

Interoceptive Engagement in Response to Mindful Awareness in Body-oriented Therapy: A Pilot Test Comparison

University of Washington2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2018年5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
21
试验地点
2
主要终点
interoceptive function

研究概览

简要总结

The proposed project is the first pilot test to examine interoceptive function as a mechanistic biomarker underlying Mindful Awareness in Body-oriented Therapy (MABT). MABT, an empirically-validated and manualized protocol is explicitly designed to teach interoceptive awareness skills for emotion regulation and is thus an ideal intervention approach in which to address this gap in research. This study uses a two group, randomized design to examine neural and physiological biomarkers in response to MABT. Twenty-four individuals reporting moderate stress will be recruited from the community and randomized to 8-week MABT intervention or the control condition. The study aims are to: 1) evaluate whether interoceptive training improves interoceptive function in the MABT vs control condition, and 2) explore whether changes in interoceptive function correlate with improved health outcomes. Analyses will include within and between-group ANOVA of brain activity with symptom change as a covariate. This is the first study to test whether a clinical intervention aimed specifically at cultivating interoceptive awareness effects change on interoceptive biomarkers. The results will support larger NIH proposals to more comprehensively validate neuro and behavioral biomarkers of interoceptive training to enhance mental health, particularly targeting depression and substance use disorder that have identified interoceptive dysfunction and poor emotion regulation.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult (over 18)
  • Perceived Stress Scale scores indicating moderate stress levels
  • naive to mindfulness-based approaches (no prior experience)
  • agrees to forgo (non-study) manual therapies (e.g., massage) and mind-body therapies (e.g., mindfulness meditation) for 3 months (baseline to post-test)
  • fluent in English
  • can attend MABT and assessment sessions
  • right-handed (for uniformity of neuroimaging results)

排除标准

  • lifetime diagnosis of mental health disorder
  • unable to complete study participation (includes planned relocation, pending inpatient treatment, planned extensive surgical procedures, etc.)
  • cognitive impairment, assessed by the Mini-Mental Status Exam (MMSE) if demonstrated difficulty comprehending the consent
  • use of medications in the past 30 days that affect hemodynamic response
  • lifetime head injuries or loss of consciousness longer than 5 min
  • currently pregnant
  • contraindications for MRI, e.g., claustrophobia, metal objects in body, etc.

结局指标

主要结局

interoceptive function

时间窗: 10 weeks

Functional magnetic resonance imaging (fMRI)

次要结局

未报告次要终点

研究者

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

Cynthia Price

Research Assoc. Professor

University of Washington

研究点 (2)

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