Efficacy and Safety of Auricular Acupuncture in Depression During the Covid 19 Pandemic

Study Overview
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Brief Summary
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Participants with moderate depressive symptoms measured by PHQ-9 will be randomized to receive auricular acupuncture. The triple blinded procedure will be conducted in 12 sessions (6 weeks). The primary outcome is the response to the treatment 3 months after inclusion.

Detailed Description
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Depression, often under-diagnosed and under-treated, is the leading cause of disability worldwide and contributes significantly to the global burden of diseases, with university students being a major risk group. There is a growing demand for non-pharmacological treatments for depression. In this sense, auricular acupuncture is considered a simple, low cost technique, well accepted by patients. The Unified Health System (Sistema Único de Saúde -SUS) incorporated this practice in 2006, but there is a lack of studies evaluating its efficacy and safety. The main objective of this study is to evaluate the efficacy of auricular acupuncture to reduce depressive symptoms in comparison with usual care and non-specific auricular acupuncture. This is a randomized clinical trial, blinded to the evaluator, participant and statistician. The study sample will be composed of 280 university students, divided equally into two groups: Experimental group - GE (auricular acupuncture) and Control group - GC (non-specific auricular acupuncture). The GE and GC participants will be submitted to 12 sessions of auricular acupuncture, 2 times a week. The primary outcome of the study will be the proportion of participants who present improvement of 50% or more in their symptoms, evaluated by the PHQ-9, three months after inclusion. The secondary outcomes will be: improvement of 50% or more in their symptoms, after six months; quality of life (SF-36), change in the use of antidepressant medication, events and adverse effects, levels of Brain-derived neurotrophic factor (BDNF), Interleukin 1β, Interleukin-6 and TNF-α in blood plasma. The data will be analyzed aiming at treating according to the principles of CONSORT.

Official Title
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Efficacy and Safety of Auricular Acupuncture in Depression During the Covid 19 Pandemic: a Multicenter Triple-blinded Randomized Clinical Trial

Conditions
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Anxiety, Depression, Depressive Symptoms, Insomnia, Quality of Life

Intervention / Treatment
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* Device: Auricular Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 50 years old PHQ-9 score between 10 and 19 (moderate depression) Availability for sessions Exclusion Criteria: Use complementary and integrative practices at the last 3 months; Suicidal risk evaluated by question number 9 in the PHQ-9 Severe depression score in the PHQ-9 Prior use of auricular acupuncture Pregnancy Menopause Tape and metal allergy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Specific Auricular Acupuncture<br>12 sessions in 6 weeks, 6 ear points of Chinese Tradicional Medicine - liver, kidney, shenmen, subcortex, heart and lung, with a semi-permanent needle (0,2x2,5mm). Participants will be instructed to stimulate the area 3 times a day. | Device: Auricular Acupuncture<br>* Aplication of semi-permanents needls in the ear by an experient and specialized professional using tradicional chinese maps and a specific device to find acupuncture points. There is a gap of one day minimum between sessions and two non-consecutive absences are allowed.<br>* Other names: Auriculotherapy;|
| Sham Comparator: Inespecific Auricular Acupuncture<br>12 sessions in 6 weeks, 6 ear points not related to chinese specific points - cheek, outer ear, 4 points non-reactive on the ear helix, with a semi-permanent needle (0,2x1,0mm). Participants will be instructed to stimulate the area 3 times a day. | Device: Auricular Acupuncture<br>* Aplication of semi-permanents needls in the ear by an experient and specialized professional using tradicional chinese maps and a specific device to find acupuncture points. There is a gap of one day minimum between sessions and two non-consecutive absences are allowed.<br>* Other names: Auriculotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease of Depression Symptoms | The efficacy of auricular acupuncture to reduce depression symptoms compared to non-specific auricular acupuncture 3 months after study inclusion. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BDNF, Interleukin, TNF | Levels of BDNF, Interleukin 1β, Interleukin-6 and TNF-α, evaluated at the beginning and end of auricular acupuncture applications (end of the sixth week of application) | 6 weeks | 
| Decrease of Depression Symptoms | The efficacy of auricular acupuncture to reduce depression symptoms compared to non-specific auricular acupuncture 6 weeks after study inclusion. | 6 weeks | 
| Decrease of Depression Symptoms | The efficacy of auricular acupuncture to reduce depression symptoms compared to non-specific auricular acupuncture 6 months after study inclusion. | 6 months | 
| Decrease of Depression Symptoms | The efficacy of auricular acupuncture to reduce depression symptoms compared to non-specific auricular acupuncture 4 weeks after study inclusion. | 4 weeks | 
| Decrease of Insomnia | The efficacy of auricular acupuncture to reduce insomnia compared to non-specific auricular acupuncture 3 months after study inclusion. | 3 months | 
| Decrease of Insomnia | The efficacy of auricular acupuncture to reduce insomnia compared to non-specific auricular acupuncture 6 months after study inclusion. | 6 months | 
| Decrease of Insomnia | The efficacy of auricular acupuncture to reduce insomnia compared to non-specific auricular acupuncture 4 weeks after study inclusion. | 4 weeks | 
| Decrease of Insomnia | The efficacy of auricular acupuncture to reduce insomnia compared to non-specific auricular acupuncture 6 weeks after study inclusion. | 6 weeks | 
| Decrease of Anxiety Symptoms | The efficacy of auricular acupuncture to reduce anxiety symptoms compared to non-specific auricular acupuncture 3 months after study inclusion. | 3 months | 
| Decrease of Anxiety Symptoms | The efficacy of auricular acupuncture to reduce anxiety symptoms compared to non-specific auricular acupuncture 6 months after study inclusion. | 6 months | 
| Decrease of Anxiety Symptoms | The eficacy of auricular acupuncture to reduce anxiety symptoms compared to non-specific auricular acupuncture 4 weeks after study inclusion. | 4 weeks | 
| Decrease of Anxiety Symptoms | The efficacy of auricular acupuncture to reduce anxiety symptoms compared to non-specific auricular acupuncture 6 weeks after study inclusion. | 6 weeks | 
| Increase of Quality of Life | The efficacy of auricular acupuncture to increase quality of life compared to non-specific auricular acupuncture 3 months after study inclusion. | 3 months | 
| Increase of Quality of Life | The efficacy of auricular acupuncture to increase quality of life compared to non-specific auricular acupuncture 6 months after study inclusion. | 6 months | 
| Increase of Quality of Life | The efficacy of auricular acupuncture to increase quality of life compared to non-specific auricular acupuncture 4 weeks after study inclusion. | 4 weeks | 
| Increase of Quality of Life | The efficacy of auricular acupuncture to increase quality of life compared to non-specific auricular acupuncture 6 weeks after study inclusion. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, auricular acupuncture, clinical trial, anxiety, insomnia, quality of life