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临床试验/NCT04503343
NCT04503343
已完成
不适用

Effects of Non-drug Therapy on Cognitive Function in Healthy Individuals and Patients With First Episode Depression

Central South University1 个研究点 分布在 1 个国家目标入组 120 人2020年7月30日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Depressive Disorder
发起方
Central South University
入组人数
120
试验地点
1
主要终点
The change of cerebellar electrical stimulation on cognitive function in healthy individuals
状态
已完成
最后更新
3年前

概览

简要总结

Mindfulness training, relaxation training, and cerebellar electrical stimulation were used to intervene in the cognitive function of healthy individuals and individuals with first episode depression

详细描述

In this proposed study,the investigators will evaluate the effects of different non-pharmacological interventions (physical/psychological) on emotion-related cognitive function.This project will use a variety of intervention methods to conduct research in healthy individuals and patients with mood disorders. The main intervention methods include: (1) mindfulness training;(2) relaxation training;(3) cerebellar electrical stimulation. The study will recruit 80 healthy subjects and 40 first-episode depression patients. The study consisted of three steps: First, subjects filled in personal data and completed the first screening, randomly assigned groups, and filled in the pre-intervention questionnaire;Second, give a one-time non-drug intervention (mindfulness training, relaxation training or cerebellar electrical stimulation);Step 3: After the intervention, the subjects filled in the post-intervention questionnaire and completed the cognitive task test.Clinical efficacy and safety assessment will be done at first time. The specific aims are to evaluate the effect of non-drug therapy on cognitive function in healthy individuals and patients with first episode depression. and the behavior was evaluated by cognitive function task.

注册库
clinicaltrials.gov
开始日期
2020年7月30日
结束日期
2022年6月30日
最后更新
3年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
Central South University
责任方
Principal Investigator
主要研究者

Jian-Jun Ou

Principal Investigator

Central South University

入排标准

入选标准

  • Healthy individuals group:
  • Aged between 16 and 34;
  • Does not meet the criteria of the DIAGNOSTIC and Statistical Manual of Mental Disorders, DSM-5,Does not meet the diagnosis of depression, bipolar disorder and other mental disorders.
  • First episode depression group:
  • Aged between 16 and 34;
  • Clinically diagnosed as having depression according to the DIAGNOSTIC and Statistical Manual of Mental Disorders (DSM-5);
  • First attack, not taking medicine, no risk of serious suicide NSSI.

排除标准

  • There are serious physical diseases, such as epilepsy, brain trauma, intracranial space-occupying lesions, severe audiovisual disorders, congenital heart disease, etc.;
  • Both Hamilton Depression Scale and Beck Depression Self-Rating Scale indicate severe depression or severe mental illness;
  • Affected by mental illness, it is difficult to conduct smooth and effective verbal communication and psychological measurement operation.

结局指标

主要结局

The change of cerebellar electrical stimulation on cognitive function in healthy individuals

时间窗: baseline

Cognitive function are measured by Emotional Recall Task

The change of mindfulness training on cognitive function in healthy individuals

时间窗: baseline

Cognitive function are measured by Faces Emotion Recognition Task

The change of mindfulness training on cognitive function in patients with first episode depression

时间窗: baseline

Cognitive function are measured by Emotional Categorisation Task

研究点 (1)

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