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临床试验/NCT04071886
NCT04071886Unknown不适用

Effect of Short-Term Mindfulness-Based Training For Major Depression Disorder: An Eye-Tracking Study

Central South University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
Mean Change from Baseline in Eye Movement Performance During Free-View Task at 2 Weeks

研究概览

简要总结

The purpose of this study is to investigate the short-term effects of mindfulness-based training in individuals suffering from major depressive disorder (MDD) as assessed by clinical interviewing, self-report assessment, cognitive evaluation and eye-tracking task.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Meet Diagnostic and Statistical Manual (DSM-IV) diagnosis of depression
  • Consent to participate in the study and to be randomized to one of two groups

排除标准

  • Current or past substance abuse, psychotic disorder,obsessive compulsive disorder , Post-Traumatic Stress Disorder, in the past 6 months
  • History of epilepsy or head trauma
  • Eye disorders
  • History of electroconvulsive therapy in the past 4 weeks.

研究组 & 干预措施

Mindfulness-Based Training

Experimental

Participants in the Mindfulness-Based Training arm will receive 2 weeks of Mindfulness-Based Training for at least 30 minutes every day.

干预措施: Mindfulness-Based Training (Behavioral)

Relaxation Training

Active Comparator

Participants in the Relaxation Training arm will receive 2 weeks of Relaxation Training for at least 30 minutes every day.

干预措施: Relaxation Training (Behavioral)

结局指标

主要结局

Mean Change from Baseline in Eye Movement Performance During Free-View Task at 2 Weeks

时间窗: at baseline and in 2 weeks

The first fixated location and latency (msec) of each trial, the total dwell time (msec) in each interest area (IA) during the whole trial to assess the attentional bias in the experiment.

次要结局

  • Mean Change from Baseline in State Mindfulness at 2 Weeks(at baseline and in 2 weeks)
  • Mean Change from Baseline in Tendency to Engage in Ruminative Responses at 2 Weeks(at baseline and in 2 weeks)
  • Mean Change from Baseline in the Symptoms of Major Depression as Measured by BDI-II at 2 Weeks(at baseline and in 2 weeks)
  • Mean Change from Baseline in the Symptoms of Major Depression as Measured by HAM-D at 2 Weeks(at baseline and in 2 weeks)

研究者

发起方
Central South University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lingjiang Li

President of Chinese Psychiatry Society of Chinese Medical Association

Central South University

研究点 (1)

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