Auricular Acupuncture vs. Progressive Muscle Relaxation in Patients With Anxiety Disorders or Major Depressive Disorder.
- Conditions
- Depressive Disorder, MajorAnxiety Disorders
- Interventions
- Procedure: Progressive muscle relaxationDevice: Auricular acupuncture
- Registration Number
- NCT02340351
- Lead Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 136
- 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
- ear infection
- anamnestic substance abuse or positive drug screening
- taking opioid analgesics
- suffering from schizophrenic or organic cerebral psychosis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Progressive muscle relaxation Progressive muscle relaxation Within this arm, patients were treated with who chose treatment with progressive muscle relaxation. Each setting involved not more than eight patients at a time and was performed in a sitting position. Each session lasted 30 minutes, took place twice a week over a period of 4 weeks. Auricular acupuncture Auricular acupuncture Within this arm, patients were treated with auricular acupuncture according to the NADA protocol. Each setting involved not more than eight patients at a time and was performed in a sitting position. Each session lasted 30 minutes and took place twice a week over a period of 4 weeks.
- Primary Outcome Measures
Name Time Method Mean VAS scores of anxiety, tension, anger/aggression and mood before and after treatment within each treatment group at week 2. 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. 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. 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. week 4 VAS are rated as follows: ´tension´, ´anxiety´, ´anger/aggression´: VAS 0 = none, 100 = most imaginable; ´mood´: VAS 0 = bad, 100 = good.
- Secondary Outcome Measures
Name Time Method