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Completed

NCT Number: NCT02340351

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

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.

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Key information

Conditions

Anxiety Disorders Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Auricular Acupuncture

Device

Auricular acupuncture according to the the NADA protocol includes the needling of five specific acupuncture points on both ears: point 51 (= Sympathetic point), point 55 (= Shen Men), point 95 (= Kidney point), point 97 (= Liver point) and point 101 (= Lung point). All points were acupunctured with fine sterile single use steel needles with the size of 0.25 x 20 millimetres. The needles were inserted about 2-3 millimetres, so that the needle point pierces the skin and is just positioned in the cartilage of the ear. They remained in position for 30 minutes.

Progressive muscle relaxation

Procedure

Progressive muscle relaxation was carried out by the method of Bernstein and Borkovec. All participants were asked to close eyes while sitting comfortably. Each group session included 16 main exercises of consciously tensing and relaxing specific groups of muscles.

Primary outcomes

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

    Time frame: 1 week

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

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

    Time frame: week 2

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

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

    Time frame: week 3

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

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

    Time frame: week 4

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

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2013
First posted
Jan 16, 2015
Registry last updated
Jan 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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