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临床试验/NCT02816502
NCT02816502已完成不适用

Hippocampal Plasticity of Young Adults With Childhood Adversity

Mclean Hospital2 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2017年6月15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
73
试验地点
2
主要终点
Changes in hippocampal subfield gray matter density measured with high resolution structural MRI at 3T

研究概览

简要总结

This study investigates the clinical and neural effects of stress management skill building programs for young adults with childhood adversity. The investigators will recruit a total of 60 young adults (21-35 years old) who will be randomized into two different stress management skill building programs, both of which are 8 weeks long. MRI and psychological assessments will be acquired from all subjects before and after the intervention programs in order to investigate changes in clinical symptoms (such as depression, anxiety and stress) and hippocampus structure and function as well as other neural changes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

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

入选标准

  • having childhood adversity
  • no history of psychiatric disorders of psychotic features or neurological disorders
  • verified age between 21-35 years old;
  • no suicidal attempts during the past six months;
  • being determined by the clinician to have the capability to comply with the program requirements and not detrimental to other participants in the group;
  • passing MRI eligibility criteria.
  • provided written informed consent to participate in this study;
  • committed to meeting the requirement of refraining from using marijuana or illicit drugs.

排除标准

  • psychosis
  • active suicidal attempts during the past 6 months
  • psychoactive substance abuse
  • MRI exclusion criteria

结局指标

主要结局

Changes in hippocampal subfield gray matter density measured with high resolution structural MRI at 3T

时间窗: before and after the 8-week intervention

次要结局

  • Changes in severity of depression symptom measured by Beck Depression Inventory (BDI)(before and after the 8-week intervention)
  • Changes in stress level measured by the Perceived Stress Scale (PSS)(before and after the 8-week intervention)
  • Changes in severity of anxiety symptom measured by State-Trait Anxiety Inventory (STAI)(before and after the 8-week intervention)

研究者

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

Diane Yan

Assistant Neuroscientist

Mclean Hospital

研究点 (2)

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