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临床试验/NCT06361953
NCT06361953已完成不适用

Comparing the Efficacy of Two Neurofeedback Protocols for Generalized Anxiety Disorder: Sensory Motor Rhythm and Alpha-Theta

Shahid Beheshti University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年6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
40
试验地点
1
主要终点
The Beck Anxiety Inventory

研究概览

简要总结

Generalized anxiety disorder (GAD) is one of the most prevalent mental disorders in adults, marked by excessive and uncontrollable worry about various events or activities. It is accompanied by symptoms such as restlessness, irritability, fatigue, difficulty concentrating, problems with sleep, and somatic symptoms.

In addition, a critical and up-to-date comparison of different treatments for GAD is crucial due to their high costs and unsatisfactory outcomes. EEG neurofeedback training has not reached the same level of evidence as more extensively validated non-pharmacological treatments, such as cognitive behavioral therapy.This study aimed to compare the efficacy of two protocols: one targeting alpha-theta amplitude increase and the other concentrating on SMR.

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Normal hearing and vision,
  • •had never undergone neurofeedback sessions,
  • •diagnosed as GAD by a psychiatrist,
  • •no history of neurological disorders
  • •undergoing other therapies

排除标准

  • •started other treatments during the study
  • •missed more than one session

研究组 & 干预措施

Alph-Theta

Experimental

15 sessions of alpha (8-12Hz) and theta (4-8Hz) push on Pz based on 10-20 international system

干预措施: EEG Neurofeedback (Device)

Sensory Motor Rhythm

Experimental

15 sessions of sensory-motor rhythm (12-15Hz) push on Cz based on 10-20 international system

干预措施: EEG Neurofeedback (Device)

结局指标

主要结局

The Beck Anxiety Inventory

时间窗: Pre-test, after 5 weeks and two month follow up

higher scores mean higher depression

Spielberger's state-trait anxiety test

时间窗: Pre-test, after 5 weeks and two month follow up

higher scores mean higher anxiety

The Perceived Stress Questionnaire

时间窗: Pre-test, after 5 weeks and two month follow up

higher scores mean higher stress

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

Abbas Masjedi Arani

Head of Clinical Psychology

Shahid Beheshti University of Medical Sciences

研究点 (1)

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