跳至主要内容
临床试验/NCT02340351
NCT02340351已完成不适用

Auricular Acupuncture Versus Progressive Muscle Relaxation in Patients With Anxiety Disorders or Major Depressive Disorder.

Universitätsklinikum Hamburg-Eppendorf0 个研究点目标入组 136 人开始时间: 2007年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
136
主要终点
Mean VAS scores of anxiety, tension, anger/aggression and mood before and after treatment within each treatment group at week 2.

研究概览

简要总结

The purpose of this study is to determine whether auricular acupuncture (AA) according to the NADA protocol and progressive muscle relaxation (PMR) differ in their effectiveness of treating people with anxiety disorders or major depressive disorder. We hypothesized, that both treatments show significant effects in alleviating the examined items (tension, anxiety, anger/aggression and state ofr mood) and that there is no significant difference between these two treatments.

详细描述

The purpose of this study is to determine whether auricular acupuncture according to the NADA protocol and progressive muscle relaxation differ in their effectiveness of treating people with anxiety disorders (AD) or major depressive disorder (MDD).

In this study, acupuncture was executed according to the NADA protocol: a standardized and comparable method of auricular acupuncture (AA) with ease of application and limited adverse reactions, which seems to have high acceptance among psychiatric patients. The NADA (National Acupuncture Detoxification Association) protocol includes the needling of five specific acupuncture points on both ears.

As a comparative relaxation treatment, progressive muscle relaxation (PMR) was applied in our study. It has been well established for many decades, especially for the treatment of severe states of physical and mental tension, which is a common symptom of anxiety disorders and depression. Many studies also suggest its potential utility in the treatment program of many other illnesses, which are associated with conditions of anxiety and depression, such as schizophrenia, sleeping disorders, endometriosis, atopic dermatitis or cancer.

The main aim of this study was to examine the effectiveness of AA according to the NADA protocol versus PMR in patients with AD or MDD. We hypothesized, that both treatments show significant effects in alleviating the examined items (tension, anxiety, anger/aggression and state ofr mood) and that there is no significant difference between these two treatments. In order to increase the patients´ treatment acceptance and compliance, this study was set up in an open design in which each patient was freely able to choose between both treatments.

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

性别
All
接受健康志愿者

入选标准

  • patient at our psychiatric ward or day-hospital
  • meeting the DSM-IV diagnostic criteria for the primary diagnosis of an anxiety disorder oder major depressive disorder

排除标准

  • ear infection
  • anamnestic substance abuse or positive drug screening
  • taking opioid analgesics
  • suffering from schizophrenic or organic cerebral psychosis

结局指标

主要结局

Mean VAS scores of anxiety, tension, anger/aggression and mood before and after treatment within each treatment group at week 2.

时间窗: week 2

VAS are rated as follows: ´tension´, ´anxiety´, ´anger/aggression´: VAS 0 = none, 100 = most imaginable; ´mood´: VAS 0 = bad, 100 = good.

Mean VAS scores of anxiety, tension, anger/aggression and mood before and after treatment within each treatment group at week 1.

时间窗: 1 week

VAS are rated as follows: ´tension´, ´anxiety´, ´anger/aggression´: VAS 0 = none, 100 = most imaginable; ´mood´: VAS 0 = bad, 100 = good.

Mean VAS scores of anxiety, tension, anger/aggression and mood before and after treatment within each treatment group at week 3.

时间窗: week 3

VAS are rated as follows: ´tension´, ´anxiety´, ´anger/aggression´: VAS 0 = none, 100 = most imaginable; ´mood´: VAS 0 = bad, 100 = good.

Mean VAS scores of anxiety, tension, anger/aggression and mood before and after treatment within each treatment group at week 4.

时间窗: week 4

VAS are rated as follows: ´tension´, ´anxiety´, ´anger/aggression´: VAS 0 = none, 100 = most imaginable; ´mood´: VAS 0 = bad, 100 = good.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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