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

Primary Purpose

Anxiety Disorders, Depressive Disorder, Major

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Auricular acupuncture
Progressive muscle relaxation
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring acupuncture, auricular acupuncture, NADA, anxiety, depression

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Auricular acupuncture

    Progressive muscle relaxation

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 13, 2015
    Last Updated
    January 15, 2015
    Sponsor
    Universitätsklinikum Hamburg-Eppendorf
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02340351
    Brief Title
    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

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2007 (undefined)
    Primary Completion Date
    March 2009 (Actual)
    Study Completion Date
    August 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Universitätsklinikum Hamburg-Eppendorf

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety Disorders, Depressive Disorder, Major
    Keywords
    acupuncture, auricular acupuncture, NADA, anxiety, depression

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    136 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Auricular acupuncture
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Progressive muscle relaxation
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Auricular acupuncture
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Progressive muscle relaxation
    Intervention Description
    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 Outcome Measure Information:
    Title
    Mean VAS scores of anxiety, tension, anger/aggression and mood before and after treatment within each treatment group at week 1.
    Description
    VAS are rated as follows: ´tension´, ´anxiety´, ´anger/aggression´: VAS 0 = none, 100 = most imaginable; ´mood´: VAS 0 = bad, 100 = good.
    Time Frame
    1 week
    Title
    Mean VAS scores of anxiety, tension, anger/aggression and mood before and after treatment within each treatment group at week 2.
    Description
    VAS are rated as follows: ´tension´, ´anxiety´, ´anger/aggression´: VAS 0 = none, 100 = most imaginable; ´mood´: VAS 0 = bad, 100 = good.
    Time Frame
    week 2
    Title
    Mean VAS scores of anxiety, tension, anger/aggression and mood before and after treatment within each treatment group at week 3.
    Description
    VAS are rated as follows: ´tension´, ´anxiety´, ´anger/aggression´: VAS 0 = none, 100 = most imaginable; ´mood´: VAS 0 = bad, 100 = good.
    Time Frame
    week 3
    Title
    Mean VAS scores of anxiety, tension, anger/aggression and mood before and after treatment within each treatment group at week 4.
    Description
    VAS are rated as follows: ´tension´, ´anxiety´, ´anger/aggression´: VAS 0 = none, 100 = most imaginable; ´mood´: VAS 0 = bad, 100 = good.
    Time Frame
    week 4

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Christoph Muhtz, MD
    Organizational Affiliation
    Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf & Schoen Klinik Hamburg-Eilbek, Hamburg, Germany
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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