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Depressive SymptomsNCT05855421

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

A study testing Auricular Acupuncture in people with Depressive Symptoms and Depression, run by Universidade do Sul de Santa Catarina at 1 site in Brazil.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Depressive Symptoms, Depression, Anxiety
What is being tested?
Auricular Acupuncture
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
280 participants
Where
1 siteBrazil
Study dates
1 Mar 2023to 30 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age between 18 and 50 years old
  • PHQ-9 score between 10 and 19 (moderate depression)
  • Availability for sessions

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Daniel MO Rodrigues, MSc contact

5548 8825-1444

danielmor7@gmail.com

Alexandre F Cury, PhD contact

(15) 98107-3571

faisal@usp.br

Brazil1 site, 1 recruiting
  • Universidade do Sul de Santa Catarina

    Palhoça, Santa Catarina, 88101000

    Daniel Maurício de Oliveira Rodrigues O Rodrigues, Msc

    Recruiting

Other trials in Brazil

About this study

Official title: 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.

Read the 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.

Being tested
Auricular Acupuncture
Keywords
depression, auricular acupuncture, clinical trial, anxiety, insomnia, quality of life
Medical subject headings
Depression, Anxiety Disorders, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Auricular AcupunctureDevice

    Also called Ear Acupuncture, Auriculotherapy

    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.

Study groups in NCT05855421
Study groupRoleWhat they receive
Experimental: Specific Auricular AcupunctureExperimental12 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.
Receives: Device: Auricular Acupuncture
Inespecific Auricular AcupunctureSham comparator12 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.
Receives: Device: Auricular Acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Decrease of Depression Symptoms

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

    Measured: 3 months

Secondary outcomes (16)
  1. 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)

    Measured: 6 weeks

  2. Decrease of Depression Symptoms

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

    Measured: 6 weeks

  3. Decrease of Depression Symptoms

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

    Measured: 6 months

  4. Decrease of Depression Symptoms

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

    Measured: 4 weeks

  5. Decrease of Insomnia

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

    Measured: 3 months

  6. Decrease of Insomnia

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

    Measured: 6 months

  7. Decrease of Insomnia

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

    Measured: 4 weeks

  8. Decrease of Insomnia

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

    Measured: 6 weeks

  9. Decrease of Anxiety Symptoms

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

    Measured: 3 months

  10. Decrease of Anxiety Symptoms

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

    Measured: 6 months

  11. Decrease of Anxiety Symptoms

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

    Measured: 4 weeks

  12. Decrease of Anxiety Symptoms

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

    Measured: 6 weeks

  13. 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.

    Measured: 3 months

  14. 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.

    Measured: 6 months

  15. 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.

    Measured: 4 weeks

  16. 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.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2023
  2. Study start1 Mar 2023
  3. Primary completion15 Dec 2025 (estimated)
  4. Study completion30 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
280 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05855421
Sponsor's protocol ID
USantaCatarina
Other IDs
2018/17469-5, 2018
Status last verified
Jan 2025
First submitted
10 May 2023
Last updated
20 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no IPD to be shared.

Publications

  • AMERICAN PSYCHIATRIC ASSOCIATION. Diretrizes para o tratamento de transtornos psiquiátricos: compêndio 2006. Porto Alegre: Artmed, 2008.

  • AMERICAN PSYCHIATRIC ASSOCIATION. Manual diagnóstico e estatístico de transtornos mentais: DSM-5. Porto Alegre: Artmed, 2014.

  • BARLOW, D.H; DURAND, V.M. Psicopatologia: uma abordagem integrada. São Paulo: Cengage Learning, 2008.

  • BECK, A.T.; ALFORD, B.A. Depressão causas e tratamento. 2. ed. Porto Alegre: Artmed, 2011.

  • BRASIL. Ministério da Saúde. Secretaria de Atenção à Saúde. Departamento de Atenção Básica. Política Nacional de Práticas Integrativas e Complementares no SUS - PNPIC. Brasília: Ministério da Saúde, 2006.

  • BRASIL. Ministério da Saúde. Secretaria de Atenção à Saúde. Departamento de Atenção Básica. Portaria amplia oferta de PICS. 2019.

  • Brody DJ, Pratt LA, Hughes JP. Prevalence of Depression Among Adults Aged 20 and Over: United States, 2013-2016. NCHS Data Brief. 2018 Feb;(303):1-8.

    PubMed 29638213
  • BROWNER, W.S.; NEWMAN, T.B.; HULLEY, S.G. Estimando o tamanho da amostra e o poder estatístico: aplicações e exemplos. In: HULLER, S.G et al. Delineando a pesquisa clínica: uma abordagem epidemiológica. 3. ed. Porto Alegre: Artmed, 2008.

  • Bus BA, Molendijk ML, Tendolkar I, Penninx BW, Prickaerts J, Elzinga BM, Voshaar RC. Chronic depression is associated with a pronounced decrease in serum brain-derived neurotrophic factor over time. Mol Psychiatry. 2015 May;20(5):602-8. doi: 10.1038/mp.2014.83. Epub 2014 Aug 26.

    PubMed 25155878
  • Cha NH, Park YK, Sok SR. Effects of Auricular Acupressure Therapy on Stress and Sleep Disturbance of Middle-Aged Women in South Korea. Holist Nurs Pract. 2017 Mar/Apr;31(2):102-109. doi: 10.1097/HNP.0000000000000197.

    PubMed 28181975
  • CICONELLI, R.M. et al. Tradução para a língua portuguesa e validação do questionário genérico de avaliação de qualidade de vida SF-36 (Brasil SF-36). Rev Bras Reumatol., v. 29, n. 3, p. 154-50. 1997.

  • COCHRANE COMPLEMENTARY MEDICINE. About us. 2018

  • DAL MAS, Walter Douglas. Acupuntura auricular na doutrina brasileira. São Paulo: Roca, 2004.

  • Ell K, Unutzer J, Aranda M, Gibbs NE, Lee PJ, Xie B. Managing depression in home health care: a randomized clinical trial. Home Health Care Serv Q. 2007;26(3):81-104. doi: 10.1300/J027v26n03_05.

    PubMed 17804354
  • FOCKS, C. Atlas de acupuntura: com sequência de fotos e ilustrações, textos didáticos e indicações clínicas. Barueri: Manole, 2005.

Questions about this trial

What is this clinical trial studying?

A study testing Auricular Acupuncture in people with Depressive Symptoms and Depression, run by Universidade do Sul de Santa Catarina at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Daniel MO Rodrigues, MSc (5548 8825-1444, danielmor7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decrease of Depression Symptoms (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05855421, which also lists 57 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.

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