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

Anxiety Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02340351
• Other study ID #: UKE-Psych-Aku-08-14
• Status: Completed
• Phase: N/A
• First received: January 13, 2015
• Last updated: January 15, 2015
• Start date: July 2007
• Est. completion date: August 2013

Study information

• Verified date: January 2015
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: August 2013
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease

Intervention

Device:
• Auricular acupuncture
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.

Procedure:
• Progressive muscle relaxation
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean VAS scores of anxiety, tension, anger/aggression and mood before and after treatment within each treatment group at week 1.	VAS are rated as follows: ´tension´, ´anxiety´, ´anger/aggression´: VAS 0 = none, 100 = most imaginable; ´mood´: VAS 0 = bad, 100 = good.	1 week
Primary	Mean VAS scores of anxiety, tension, anger/aggression and mood before and after treatment within each treatment group at week 2.	VAS are rated as follows: ´tension´, ´anxiety´, ´anger/aggression´: VAS 0 = none, 100 = most imaginable; ´mood´: VAS 0 = bad, 100 = good.	week 2
Primary	Mean VAS scores of anxiety, tension, anger/aggression and mood before and after treatment within each treatment group at week 3.	VAS are rated as follows: ´tension´, ´anxiety´, ´anger/aggression´: VAS 0 = none, 100 = most imaginable; ´mood´: VAS 0 = bad, 100 = good.	week 3
Primary	Mean VAS scores of anxiety, tension, anger/aggression and mood before and after treatment within each treatment group at week 4.	VAS are rated as follows: ´tension´, ´anxiety´, ´anger/aggression´: VAS 0 = none, 100 = most imaginable; ´mood´: VAS 0 = bad, 100 = good.	week 4