Anxiety DisordersNCT02340351
Auricular Acupuncture vs. Progressive Muscle Relaxation in Patients With Anxiety Disorders or Major Depressive Disorder.
A study testing Auricular acupuncture and Progressive muscle relaxation in people with Anxiety Disorders and Depressive Disorder, Major, run by Universitätsklinikum Hamburg-Eppendorf.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anxiety Disorders, Depressive Disorder, Major
- What is being tested?
- Auricular acupuncture and Progressive muscle relaxation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- ear infection
- anamnestic substance abuse or positive drug screening
- taking opioid analgesics
- suffering from schizophrenic or organic cerebral psychosis
About this study
Official title: Auricular Acupuncture Versus Progressive Muscle Relaxation in Patients With Anxiety Disorders or Major Depressive Disorder.
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.
Read the 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.
- Conditions
- Anxiety Disorders, Depressive Disorder, Major
- Being tested
- Auricular acupuncture, Progressive muscle relaxation
- Keywords
- acupuncture, auricular acupuncture, NADA, anxiety, depression
- Medical subject headings
- Anxiety Disorders, Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular acupunctureDevice
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.
Progressive muscle relaxationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Progressive muscle relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2015 (estimated)
- Study startJul 2007
- Primary completionMar 2009
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Muhtz, MD, Principal investigator, Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf & Schoen Klinik Hamburg-Eilbek, Hamburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02340351
- Sponsor's protocol ID
- UKE-Psych-Aku-08-14
- Status last verified
- Jan 2015
- First submitted
- 13 Jan 2015
- Last updated
- 16 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auricular Acupuncture Versus Progressive Muscle Relaxation in Patients With Anxiety Disorders or Major Depressive Disorder.
- ClinicalTrials.gov ID
- NCT02340351
- Acronym / sponsor ID
- UKE-Psych-Aku-08-14
- Conditions
- Anxiety Disorders, Depressive Disorder, Major
- Keywords
- acupuncture, auricular acupuncture, NADA, anxiety, depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 16 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auricular acupuncture | Active comparator | Device: Auricular acupunctureWithin 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. |
| Progressive muscle relaxation | Active comparator | Procedure: Progressive muscle relaxationWithin 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- ear infection
- anamnestic substance abuse or positive drug screening
- taking opioid analgesics
- suffering from schizophrenic or organic cerebral psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular acupunctureAuricular 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. | Device | Auricular acupuncture |
| Progressive muscle relaxationProgressive 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. | Procedure or surgery | Progressive muscle relaxation |
Primary outcome
Mean VAS scores of anxiety, tension, anger/aggression and mood before and after treatment within each treatment group at week 1.
Time frame: 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 2.
Time frame: 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.
Time frame: 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.
Time frame: week 4
VAS are rated as follows: ´tension´, ´anxiety´, ´anger/aggression´: VAS 0 = none, 100 = most imaginable; ´mood´: VAS 0 = bad, 100 = good.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2015.
Related trials for Anxiety Disorders
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Muhtz, MD principal investigator
Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf & Schoen Klinik Hamburg-Eilbek, Hamburg, Germany
Questions about this trial
What is this clinical trial studying?
A study testing Auricular acupuncture and Progressive muscle relaxation in people with Anxiety Disorders and Depressive Disorder, Major, run by Universitätsklinikum Hamburg-Eppendorf.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean VAS scores of anxiety, tension, anger/aggression and mood before and after treatment within each treatment group at week 1. (time frame: 1 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2015.