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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05855421
• Other study ID #: USantaCatarina
• Secondary ID: 2018/17469-5
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: May 1, 2025

Study information

• Verified date: June 2023
• Source: Universidade do Sul de Santa Catarina
• Contact: Daniel MO Rodrigues, MSc
• Phone: 5548 8825-1444
• Email: danielmor7[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: May 1, 2025
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• COVID-19
• Depression
• Depressive Disorder
• Depressive Symptoms
• Insomnia
• Quality of Life
• Sleep Initiation and Maintenance Disorders

Intervention

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.

Locations

Country	Name	City	State
Brazil	Universidade do Sul de Santa Catarina	Palhoça	Santa Catarina

Sponsors (2)

Lead Sponsor	Collaborator
Universidade do Sul de Santa Catarina	University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

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* Note: There are 56 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	BDNF, Interleukin, TNF	Levels of BDNF, Interleukin 1ß, Interleukin-6 and TNF-a, evaluated at the beginning and end of auricular acupuncture applications (end of the sixth week of application)	6 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Decrease of Insomnia	The efficacy of auricular acupuncture to reduce insomnia compared to non-specific auricular acupuncture 3 months after study inclusion.	3 months
Secondary	Decrease of Insomnia	The efficacy of auricular acupuncture to reduce insomnia compared to non-specific auricular acupuncture 6 months after study inclusion.	6 months
Secondary	Decrease of Insomnia	The efficacy of auricular acupuncture to reduce insomnia compared to non-specific auricular acupuncture 4 weeks after study inclusion.	4 weeks
Secondary	Decrease of Insomnia	The efficacy of auricular acupuncture to reduce insomnia compared to non-specific auricular acupuncture 6 weeks after study inclusion.	6 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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