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

NCT02340351 | Completed

• 1 other identifier: UKE-Psych-Aku-08-14
• Study Type: interventional
• Target: 136
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anxiety Disorders; Depressive Disorder, Major

Keywords

acupuncture; auricular acupuncture; NADA; anxiety; depression

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Auricular acupuncture

ACTIVE COMPARATOR

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.

Device: Auricular acupuncture

Progressive muscle relaxation

ACTIVE COMPARATOR

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.

Procedure: Progressive muscle relaxation

Interventions

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.

Auricular acupuncture

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.

Progressive muscle relaxation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

MeSH Terms

Conditions

Anxiety Disorders; Depressive Disorder, Major; Depression

Interventions

Acupuncture, Ear; Autogenic Training

Condition Hierarchy (Ancestors)

Mental Disorders; Depressive Disorder; Mood Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics; Auriculotherapy; Hypnosis; Mind-Body Therapies; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Christoph Muhtz, MD

  Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf & Schoen Klinik Hamburg-Eilbek, Hamburg, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: January 16, 2015
• Study Start: July 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: August 1, 2013
• Last Updated: January 16, 2015

Record last verified: 2015-01