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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Quality of Life; Insomnia; Anxiety; Depressive Symptoms
• Intervention / Treatment: Device: Auricular Acupuncture

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 280
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel MO Rodrigues, MSc; Phone Number: 5548 8825-1444; Email: danielmor7@gmail.com
• Study Contact Backup: Name: Alexandre F Cury, PhD; Phone Number: (15) 98107-3571; Email: faisal@usp.br

Study Locations

• Brazil
  • Santa Catarina
    • Palhoça, Santa Catarina, Brazil, 88101000
      • Recruiting
      • Universidade do Sul de Santa Catarina
      • Principal Investigator: Daniel Maurício de Oliveira Rodrigues O Rodrigues, Msc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Specific Auricular Acupuncture; 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; 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.; Other Names: Auriculotherapy; Ear Acupuncture
Sham Comparator: Inespecific Auricular Acupuncture; 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; 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.; Other Names: Auriculotherapy; Ear Acupuncture

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidade do Sul de Santa Catarina
• Collaborators: University of Sao Paulo

Publications and helpful links

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Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): December 15, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: May 10, 2023
• First Submitted That Met QC Criteria: May 10, 2023
• First Posted (Actual): May 11, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 17, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: quality of life; depression; insomnia; anxiety; clinical trial; auricular acupuncture
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Mood Disorders; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Depression; Depressive Disorder
• Other Study ID Numbers: USantaCatarina; 2018/17469-5 (Other Grant/Funding Number: Fundacao de Amparo a Pesquisa do Estado de Sao Paulo)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no IPD to be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No