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临床试验/NCT02447744
NCT02447744已完成不适用

Neural Changes Associated With a Mindfulness-based Intervention for Young Adults With Childhood Maltreatment

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2014年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
1
主要终点
Changes in Subjects' Perceived Stress Level

研究概览

简要总结

Childhood trauma is remarkably prevalent, and it has long lasting impact on mental health and neural development. This trial aims to see whether the 8-week mindfulness based intervention can reduce stress related psychological symptoms for young adults with childhood maltreatment, and whether it can promote neural plasticity.

详细描述

This study recruits young adults with childhood adversity; enrolled subjects either receive an 8-week mindfulness based intervention, or wait for 8 weeks before receiving the intervention. MRI and a battery of self report questionnaires will be administered before and after the intervention; subjects on the waiting list will undergo the same research procedures at the same time as subjects in the intervention group. Primary hypotheses include improved hippocampal plasticity, increased mindfulness and reduced stress and related psychological symptoms.

研究设计

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

入排标准

年龄范围
19 Years 至 35 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Experience of childhood maltreatment
  • •With current age between 19 to 35 years old
  • •With current symptoms of depression or anxiety or PTSD or significant general stress.

排除标准

  • •History of psychiatric disorders with psychotic features
  • •Suicidal attempts during the past six months
  • •Neurological disorders
  • •And common MRI exclusion criteria
  • •Prior history with the mindfulness based stress reduction program or other systematic meditation programs.

研究组 & 干预措施

Mindfulness group

Experimental

This arm receives an 8-week mindfulness based behavioral intervention program.

干预措施: Mindfulness based intervention (Behavioral)

Waitlist control group

Other

This arm waits while the mindfulness group receives their intervention, and then receives the mindfulness based intervention after their waiting period.

干预措施: Mindfulness based intervention (Behavioral)

结局指标

主要结局

Changes in Subjects' Perceived Stress Level

时间窗: After the 8-week intervention program compared to baseline measurement, or the same time as the intervention group for subjects on the waiting list.

Changes in the Perceived Stress Scale scores (post- intervention scores minus pre- intervention scores). Relevant time points used in the calculation include baseline scores at enrollment, and post-intervention/waiting period scores after 2 months of intervention or waiting period. Calculations of the change entail post-intervention/waiting period scores minus baseline scores for each individual subject. The Perceived Stress Scale is a 10 item scale (each responded with Likert scale 0-4), the scale score is the sum of all items, thus the full range of PSS scores is 0-40, with higher scores means worse stress. A reduction in PSS scores (i.e., the change scores being negative) indicates subjects have improved after the intervention by becoming less stressed.

次要结局

  • Changes of Mindfulness(After the 8-week intervention program compared to baseline measurement, or the same time as the intervention group for subjects on the waiting list.)

研究者

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

Sara W Lazar

Associate Research Scientist

Massachusetts General Hospital

研究点 (1)

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