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

Primary Purpose

Depressive Symptoms, Depression, Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Auricular Acupuncture
Sponsored by
Universidade do Sul de Santa Catarina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Symptoms focused on measuring depression, auricular acupuncture, clinical trial, anxiety, insomnia, quality of life

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Universidade do Sul de Santa CatarinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Experimental: Specific Auricular Acupuncture

Inespecific Auricular Acupuncture

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Decrease of Depression Symptoms
The efficacy of auricular acupuncture to reduce depression symptoms compared to non-specific auricular acupuncture 3 months after study inclusion.

Secondary Outcome Measures

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)
Decrease of Depression Symptoms
The efficacy of auricular acupuncture to reduce depression symptoms compared to non-specific auricular acupuncture 6 weeks after study inclusion.
Decrease of Depression Symptoms
The efficacy of auricular acupuncture to reduce depression symptoms compared to non-specific auricular acupuncture 6 months after study inclusion.
Decrease of Depression Symptoms
The efficacy of auricular acupuncture to reduce depression symptoms compared to non-specific auricular acupuncture 4 weeks after study inclusion.
Decrease of Insomnia
The efficacy of auricular acupuncture to reduce insomnia compared to non-specific auricular acupuncture 3 months after study inclusion.
Decrease of Insomnia
The efficacy of auricular acupuncture to reduce insomnia compared to non-specific auricular acupuncture 6 months after study inclusion.
Decrease of Insomnia
The efficacy of auricular acupuncture to reduce insomnia compared to non-specific auricular acupuncture 4 weeks after study inclusion.
Decrease of Insomnia
The efficacy of auricular acupuncture to reduce insomnia compared to non-specific auricular acupuncture 6 weeks after study inclusion.
Decrease of Anxiety Symptoms
The efficacy of auricular acupuncture to reduce anxiety symptoms compared to non-specific auricular acupuncture 3 months after study inclusion.
Decrease of Anxiety Symptoms
The efficacy of auricular acupuncture to reduce anxiety symptoms compared to non-specific auricular acupuncture 6 months after study inclusion.
Decrease of Anxiety Symptoms
The eficacy of auricular acupuncture to reduce anxiety symptoms compared to non-specific auricular acupuncture 4 weeks after study inclusion.
Decrease of Anxiety Symptoms
The efficacy of auricular acupuncture to reduce anxiety symptoms compared to non-specific auricular acupuncture 6 weeks after study inclusion.
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.
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.
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.
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.

Full Information

First Posted
May 10, 2023
Last Updated
June 20, 2023
Sponsor
Universidade do Sul de Santa Catarina
Collaborators
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT05855421
Brief Title
Efficacy and Safety of Auricular Acupuncture in Depression During the Covid 19 Pandemic
Official Title
Efficacy and Safety of Auricular Acupuncture in Depression During the Covid 19 Pandemic: a Multicenter Triple-blinded Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade do Sul de Santa Catarina
Collaborators
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms, Depression, Anxiety, Insomnia, Quality of Life
Keywords
depression, auricular acupuncture, clinical trial, anxiety, insomnia, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Specific Auricular Acupuncture
Arm Type
Experimental
Arm Description
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.
Arm Title
Inespecific Auricular Acupuncture
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Auricular Acupuncture
Other Intervention Name(s)
Ear Acupuncture, Auriculotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Decrease of Depression Symptoms
Description
The efficacy of auricular acupuncture to reduce depression symptoms compared to non-specific auricular acupuncture 3 months after study inclusion.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
BDNF, Interleukin, TNF
Description
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)
Time Frame
6 weeks
Title
Decrease of Depression Symptoms
Description
The efficacy of auricular acupuncture to reduce depression symptoms compared to non-specific auricular acupuncture 6 weeks after study inclusion.
Time Frame
6 weeks
Title
Decrease of Depression Symptoms
Description
The efficacy of auricular acupuncture to reduce depression symptoms compared to non-specific auricular acupuncture 6 months after study inclusion.
Time Frame
6 months
Title
Decrease of Depression Symptoms
Description
The efficacy of auricular acupuncture to reduce depression symptoms compared to non-specific auricular acupuncture 4 weeks after study inclusion.
Time Frame
4 weeks
Title
Decrease of Insomnia
Description
The efficacy of auricular acupuncture to reduce insomnia compared to non-specific auricular acupuncture 3 months after study inclusion.
Time Frame
3 months
Title
Decrease of Insomnia
Description
The efficacy of auricular acupuncture to reduce insomnia compared to non-specific auricular acupuncture 6 months after study inclusion.
Time Frame
6 months
Title
Decrease of Insomnia
Description
The efficacy of auricular acupuncture to reduce insomnia compared to non-specific auricular acupuncture 4 weeks after study inclusion.
Time Frame
4 weeks
Title
Decrease of Insomnia
Description
The efficacy of auricular acupuncture to reduce insomnia compared to non-specific auricular acupuncture 6 weeks after study inclusion.
Time Frame
6 weeks
Title
Decrease of Anxiety Symptoms
Description
The efficacy of auricular acupuncture to reduce anxiety symptoms compared to non-specific auricular acupuncture 3 months after study inclusion.
Time Frame
3 months
Title
Decrease of Anxiety Symptoms
Description
The efficacy of auricular acupuncture to reduce anxiety symptoms compared to non-specific auricular acupuncture 6 months after study inclusion.
Time Frame
6 months
Title
Decrease of Anxiety Symptoms
Description
The eficacy of auricular acupuncture to reduce anxiety symptoms compared to non-specific auricular acupuncture 4 weeks after study inclusion.
Time Frame
4 weeks
Title
Decrease of Anxiety Symptoms
Description
The efficacy of auricular acupuncture to reduce anxiety symptoms compared to non-specific auricular acupuncture 6 weeks after study inclusion.
Time Frame
6 weeks
Title
Increase of Quality of Life
Description
The efficacy of auricular acupuncture to increase quality of life compared to non-specific auricular acupuncture 3 months after study inclusion.
Time Frame
3 months
Title
Increase of Quality of Life
Description
The efficacy of auricular acupuncture to increase quality of life compared to non-specific auricular acupuncture 6 months after study inclusion.
Time Frame
6 months
Title
Increase of Quality of Life
Description
The efficacy of auricular acupuncture to increase quality of life compared to non-specific auricular acupuncture 4 weeks after study inclusion.
Time Frame
4 weeks
Title
Increase of Quality of Life
Description
The efficacy of auricular acupuncture to increase quality of life compared to non-specific auricular acupuncture 6 weeks after study inclusion.
Time Frame
6 weeks

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Male; Female; Non-binary
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel MO Rodrigues, MSc
Phone
5548 8825-1444
Email
danielmor7@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandre F Cury, PhD
Phone
(15) 98107-3571
Email
faisal@usp.br
Facility Information:
Facility Name
Universidade do Sul de Santa Catarina
City
Palhoça
State/Province
Santa Catarina
ZIP/Postal Code
88101000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Maurício de Oliveira Rodrigues O Rodrigues, Msc

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no IPD to be shared.
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Lv X, Wang B, Chen Jianbin, Ye J. [Clinical observation of depression after breast cancer operation treated with aurieular point sticking therapy]. Zhongguo Zhen Jiu. 2015 May;35(5):447-50. Chinese.
Results Reference
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PubMed Identifier
27457720
Citation
Zhong LL, Kun W, Lam TF, Zhang SP, Yang JJ, Ziea TC, Ng B, Bian ZX. The combination effects of body acupuncture and auricular acupressure compared to sham acupuncture for body weight control: study protocol for a randomized controlled trial. Trials. 2016 Jul 25;17(1):346. doi: 10.1186/s13063-016-1458-2.
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Efficacy and Safety of Auricular Acupuncture in Depression During the Covid 19 Pandemic

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