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NCT Number: NCT05855421

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

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.

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Key information

Conditions

Depressive Symptoms Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Dyssomnias Insomnia Mental Disorders Nervous System Diseases Quality of Life Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade do Sul de Santa Catarina

Palhoça, Santa Catarina, 88101000, Brazil

Location status: Recruiting

Location contact

Daniel Maurício de Oliveira Rodrigues O Rodrigues, Msc

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Auricular Acupuncture

Device

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: Ear Acupuncture, Auriculotherapy

Primary outcomes

  1. Decrease of Depression Symptoms

    Time frame: 3 months

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

Secondary outcomes

  1. BDNF, Interleukin, TNF

    Time frame: 6 weeks

    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)

  2. Decrease of Depression Symptoms

    Time frame: 6 weeks

    The efficacy of auricular acupuncture to reduce depression symptoms compared to non-specific auricular acupuncture 6 weeks after study inclusion.

  3. Decrease of Depression Symptoms

    Time frame: 6 months

    The efficacy of auricular acupuncture to reduce depression symptoms compared to non-specific auricular acupuncture 6 months after study inclusion.

  4. Decrease of Depression Symptoms

    Time frame: 4 weeks

    The efficacy of auricular acupuncture to reduce depression symptoms compared to non-specific auricular acupuncture 4 weeks after study inclusion.

  5. Decrease of Insomnia

    Time frame: 3 months

    The efficacy of auricular acupuncture to reduce insomnia compared to non-specific auricular acupuncture 3 months after study inclusion.

  6. Decrease of Insomnia

    Time frame: 6 months

    The efficacy of auricular acupuncture to reduce insomnia compared to non-specific auricular acupuncture 6 months after study inclusion.

  7. Decrease of Insomnia

    Time frame: 4 weeks

    The efficacy of auricular acupuncture to reduce insomnia compared to non-specific auricular acupuncture 4 weeks after study inclusion.

  8. Decrease of Insomnia

    Time frame: 6 weeks

    The efficacy of auricular acupuncture to reduce insomnia compared to non-specific auricular acupuncture 6 weeks after study inclusion.

  9. Decrease of Anxiety Symptoms

    Time frame: 3 months

    The efficacy of auricular acupuncture to reduce anxiety symptoms compared to non-specific auricular acupuncture 3 months after study inclusion.

  10. Decrease of Anxiety Symptoms

    Time frame: 6 months

    The efficacy of auricular acupuncture to reduce anxiety symptoms compared to non-specific auricular acupuncture 6 months after study inclusion.

  11. Decrease of Anxiety Symptoms

    Time frame: 4 weeks

    The eficacy of auricular acupuncture to reduce anxiety symptoms compared to non-specific auricular acupuncture 4 weeks after study inclusion.

  12. Decrease of Anxiety Symptoms

    Time frame: 6 weeks

    The efficacy of auricular acupuncture to reduce anxiety symptoms compared to non-specific auricular acupuncture 6 weeks after study inclusion.

  13. Increase of Quality of Life

    Time frame: 3 months

    The efficacy of auricular acupuncture to increase quality of life compared to non-specific auricular acupuncture 3 months after study inclusion.

  14. Increase of Quality of Life

    Time frame: 6 months

    The efficacy of auricular acupuncture to increase quality of life compared to non-specific auricular acupuncture 6 months after study inclusion.

  15. Increase of Quality of Life

    Time frame: 4 weeks

    The efficacy of auricular acupuncture to increase quality of life compared to non-specific auricular acupuncture 4 weeks after study inclusion.

  16. Increase of Quality of Life

    Time frame: 6 weeks

    The efficacy of auricular acupuncture to increase quality of life compared to non-specific auricular acupuncture 6 weeks after study inclusion.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandre F Cury, PhD

CONTACT

[email protected]

(15) 98107-3571

Daniel MO Rodrigues, MSc

CONTACT

[email protected]

5548 8825-1444

Sponsors and collaborators

Lead sponsor

Universidade do Sul de Santa Catarina

Other Gov

Collaborators

  • University of Sao Paulo

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 11, 2023
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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