Clinical trial NCT02340351: Auricular Acupuncture vs. Progressive Muscle Relaxation in Patients With Anxiety Disorders or Major Depressive Disorder.
Official title: Auricular Acupuncture Versus Progressive Muscle Relaxation in Patients With Anxiety Disorders or Major Depressive Disorder.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Depressive Disorder, Major
Keywords: acupuncture
auricular acupuncture
NADA
anxiety
depression
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2015-01-16
Enrollment: 136
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean VAS scores of anxiety, tension, anger/aggression and mood before and after treatment within each treatment group at week 1.
timeFrame: 1 week
measure: Mean VAS scores of anxiety, tension, anger/aggression and mood before and after treatment within each treatment group at week 2.
timeFrame: week 2
measure: Mean VAS scores of anxiety, tension, anger/aggression and mood before and after treatment within each treatment group at week 3.
timeFrame: week 3
measure: Mean VAS scores of anxiety, tension, anger/aggression and mood before and after treatment within each treatment group at week 4.
timeFrame: week 4
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf & Schoen Klinik Hamburg-Eilbek, Hamburg, Germany
name: Christoph Muhtz, MD
role: PRINCIPAL_INVESTIGATOR
References: