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

NCT05855421 | Recruiting DMC

• 2 other identifiers: USantaCatarina2018/17469-5
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Symptoms; Depression; Anxiety; Insomnia; Quality of Life

Keywords

depression; auricular acupuncture; clinical trial; anxiety; insomnia; quality of life

Outcome Measures

Primary Outcomes (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.

  3 months

Secondary Outcomes (16)

• BDNF, Interleukin, TNF

  6 weeks

• Decrease of Depression Symptoms

  6 weeks

• Decrease of Depression Symptoms

  6 months

• Decrease of Depression Symptoms

  4 weeks

• Decrease of Insomnia

  3 months

Study Arms (2)

Experimental: Specific Auricular Acupuncture

EXPERIMENTAL

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

Inespecific Auricular Acupuncture

SHAM COMPARATOR

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

Interventions

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.

Also known as: Ear Acupuncture, Auriculotherapy

Experimental: Specific Auricular Acupuncture; Inespecific Auricular Acupuncture

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Male; Female; Non-binary
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade do Sul de Santa Catarina: lead
• University of Sao Paulo: collaborator

Study Sites (1)

Universidade do Sul de Santa Catarina

Palhoça, Santa Catarina, 88101000, Brazil

RECRUITING

Related Publications (57)

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

  BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

• 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.

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 29638213 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 25155878 BACKGROUND

• 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.

  PMID: 28181975 BACKGROUND

• 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.

  BACKGROUND

• COCHRANE COMPLEMENTARY MEDICINE. About us. 2018

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 17804354 BACKGROUND

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

  BACKGROUND

• Fu WB, Fan L, Zhu XP, He Q, Wang L, Zhuang LX, Liu YS, Tang CZ, Li YW, Meng CR, Zhang HL, Yan J. Depressive neurosis treated by acupuncture for regulating the liver--a report of 176 cases. J Tradit Chin Med. 2009 Jun;29(2):83-6. doi: 10.1016/s0254-6272(09)60037-6.

  PMID: 19663089 BACKGROUND

• Geib J, Rieger MA, Joos S, Eschweiler GW, Dresler T, Metzger FG. Introduction of auricular acupuncture in elderly patients suffering from major depression: protocol of a mixed methods feasibility study. Biomed Res Int. 2015;2015:678410. doi: 10.1155/2015/678410. Epub 2015 Apr 15.

  PMID: 25954756 BACKGROUND

• Guo N, Robakis T, Miller C, Butwick A. Prevalence of Depression Among Women of Reproductive Age in the United States. Obstet Gynecol. 2018 Apr;131(4):671-679. doi: 10.1097/AOG.0000000000002535.

  PMID: 29528926 BACKGROUND

• Hamilton JP, Farmer M, Fogelman P, Gotlib IH. Depressive Rumination, the Default-Mode Network, and the Dark Matter of Clinical Neuroscience. Biol Psychiatry. 2015 Aug 15;78(4):224-30. doi: 10.1016/j.biopsych.2015.02.020. Epub 2015 Feb 24.

  PMID: 25861700 BACKGROUND

• Huang W, Pach D, Napadow V, Park K, Long X, Neumann J, Maeda Y, Nierhaus T, Liang F, Witt CM. Characterizing acupuncture stimuli using brain imaging with FMRI--a systematic review and meta-analysis of the literature. PLoS One. 2012;7(4):e32960. doi: 10.1371/journal.pone.0032960. Epub 2012 Apr 9.

  PMID: 22496739 BACKGROUND

• Hendrick V, Altshuler L, Cohen L, Stowe Z. Evaluation of mental health and depression during pregnancy: position paper. Psychopharmacol Bull. 1998;34(3):297-9.

  PMID: 9803758 BACKGROUND

• King HC, Spence DL, Hickey AH, Sargent P, Elesh R, Connelly CD. Auricular acupuncture for sleep disturbance in veterans with post-traumatic stress disorder: a feasibility study. Mil Med. 2015 May;180(5):582-90. doi: 10.7205/MILMED-D-14-00451.

  PMID: 25939115 BACKGROUND

• Ibrahim AK, Kelly SJ, Adams CE, Glazebrook C. A systematic review of studies of depression prevalence in university students. J Psychiatr Res. 2013 Mar;47(3):391-400. doi: 10.1016/j.jpsychires.2012.11.015. Epub 2012 Dec 20.

  PMID: 23260171 BACKGROUND

• Irwin MR, Miller AH. Depressive disorders and immunity: 20 years of progress and discovery. Brain Behav Immun. 2007 May;21(4):374-83. doi: 10.1016/j.bbi.2007.01.010. Epub 2007 Mar 13.

  PMID: 17360153 BACKGROUND

• Jorm AF, Korten AE, Jacomb PA, Christensen H, Rodgers B, Pollitt P. "Mental health literacy": a survey of the public's ability to recognise mental disorders and their beliefs about the effectiveness of treatment. Med J Aust. 1997 Feb 17;166(4):182-6. doi: 10.5694/j.1326-5377.1997.tb140071.x.

  PMID: 9066546 BACKGROUND

• Jorm AF, Medway J, Christensen H, Korten AE, Jacomb PA, Rodgers B. Public beliefs about the helpfulness of interventions for depression: effects on actions taken when experiencing anxiety and depression symptoms. Aust N Z J Psychiatry. 2000 Aug;34(4):619-26. doi: 10.1080/j.1440-1614.2000.00761.x.

  PMID: 10954393 BACKGROUND

• Karst M, Winterhalter M, Munte S, Francki B, Hondronikos A, Eckardt A, Hoy L, Buhck H, Bernateck M, Fink M. Auricular acupuncture for dental anxiety: a randomized controlled trial. Anesth Analg. 2007 Feb;104(2):295-300. doi: 10.1213/01.ane.0000242531.12722.fd.

  PMID: 17242083 BACKGROUND

• Kessler RC, Soukup J, Davis RB, Foster DF, Wilkey SA, Van Rompay MI, Eisenberg DM. The use of complementary and alternative therapies to treat anxiety and depression in the United States. Am J Psychiatry. 2001 Feb;158(2):289-94. doi: 10.1176/appi.ajp.158.2.289.

  PMID: 11156813 BACKGROUND

• Kober A, Scheck T, Schubert B, Strasser H, Gustorff B, Bertalanffy P, Wang SM, Kain ZN, Hoerauf K. Auricular acupressure as a treatment for anxiety in prehospital transport settings. Anesthesiology. 2003 Jun;98(6):1328-32. doi: 10.1097/00000542-200306000-00005.

  PMID: 12766639 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Kurebayashi LF, Silva MJ. Efficacy of Chinese auriculotherapy for stress in nursing staff: a randomized clinical trial. Rev Lat Am Enfermagem. 2014 May-Jun;22(3):371-8. doi: 10.1590/0104-1169.3239.2426.

  PMID: 25029046 BACKGROUND

• Leung MC, Yip KK, Ho YS, Siu FK, Li WC, Garner B. Mechanisms underlying the effect of acupuncture on cognitive improvement: a systematic review of animal studies. J Neuroimmune Pharmacol. 2014 Sep;9(4):492-507. doi: 10.1007/s11481-014-9550-4. Epub 2014 Jun 6.

  PMID: 24903518 BACKGROUND

• Liang Y, Xu B, Zhang XC, Zong L, Chen YL. [Comparative study on effects between electroacupuncture and auricular acupuncture for methamphetamine withdrawal syndrome]. Zhongguo Zhen Jiu. 2014 Mar;34(3):219-24. Chinese.

  PMID: 24843957 BACKGROUND

• Liu P, Qin W, Zhang Y, Tian J, Bai L, Zhou G, Liu J, Chen P, Dai J, von Deneen KM, Liu Y. Combining spatial and temporal information to explore function-guide action of acupuncture using fMRI. J Magn Reson Imaging. 2009 Jul;30(1):41-6. doi: 10.1002/jmri.21805.

  PMID: 19557845 BACKGROUND

• Lowe B, Unutzer J, Callahan CM, Perkins AJ, Kroenke K. Monitoring depression treatment outcomes with the patient health questionnaire-9. Med Care. 2004 Dec;42(12):1194-201. doi: 10.1097/00005650-200412000-00006.

  PMID: 15550799 BACKGROUND

• LUZ, M.T. Cultura Contemporânea e Medicinas Alternativas: Novos paradigmas em saúde no fim do século XX. Physis: Revista Saúde Coletiva. Rio de Janeiro, 15(Suplemento):145-176, 2005.

  BACKGROUND

• MacPherson H, Thomas K, Walters S, Fitter M. The York acupuncture safety study: prospective survey of 34 000 treatments by traditional acupuncturists. BMJ. 2001 Sep 1;323(7311):486-7. doi: 10.1136/bmj.323.7311.486. No abstract available.

  PMID: 11532841 BACKGROUND

• Molendijk ML, Spinhoven P, Polak M, Bus BA, Penninx BW, Elzinga BM. Serum BDNF concentrations as peripheral manifestations of depression: evidence from a systematic review and meta-analyses on 179 associations (N=9484). Mol Psychiatry. 2014 Jul;19(7):791-800. doi: 10.1038/mp.2013.105. Epub 2013 Aug 20.

  PMID: 23958957 BACKGROUND

• NATIONAL INSTITUTE OF MENTAL HEALTH. Depression and College Students. 2018. https://www.nimh.nih.gov/health/publications/depression-and-collegestudents/index.shtml

  BACKGROUND

• PRADO, J.M. Aplicação da acupuntura auricular verdadeira e sham no tratamento do estresse em enfermeiros. 2014. 98 p. Dissertação (Mestrado em Enfermagem na Saúde do adulto), Universidade de São Paulo, São Paulo, 2014.

  BACKGROUND

• Raison CL, Capuron L, Miller AH. Cytokines sing the blues: inflammation and the pathogenesis of depression. Trends Immunol. 2006 Jan;27(1):24-31. doi: 10.1016/j.it.2005.11.006. Epub 2005 Nov 28.

  PMID: 16316783 BACKGROUND

• SABBAG, S.H.F. et al. A. Origem e desenvolvimento da Naturologia no Brasil: aspectos conceituais, históricos e políticos. Cad. Naturol. Terap. Complem, v. 6, n. 11, p. 59-68, Set. /Abr., 2017.

  BACKGROUND

• Santos IS, Tavares BF, Munhoz TN, Almeida LS, Silva NT, Tams BD, Patella AM, Matijasevich A. [Sensitivity and specificity of the Patient Health Questionnaire-9 (PHQ-9) among adults from the general population]. Cad Saude Publica. 2013 Aug;29(8):1533-43. doi: 10.1590/0102-311x00144612. Portuguese.

  PMID: 24005919 BACKGROUND

• Set T, Cayir Y, Pirim AB. Effects of ear acupuncture therapy for obesity on the depression of obese women. Acupunct Med. 2014 Oct;32(5):427-9. doi: 10.1136/acupmed-2014-010626. Epub 2014 Aug 6.

  PMID: 25098839 BACKGROUND

• Simon NM, McNamara K, Chow CW, Maser RS, Papakostas GI, Pollack MH, Nierenberg AA, Fava M, Wong KK. A detailed examination of cytokine abnormalities in Major Depressive Disorder. Eur Neuropsychopharmacol. 2008 Mar;18(3):230-3. doi: 10.1016/j.euroneuro.2007.06.004. Epub 2007 Aug 3.

  PMID: 17681762 BACKGROUND

• Smith CA, Armour M, Lee MS, Wang LQ, Hay PJ. Acupuncture for depression. Cochrane Database Syst Rev. 2018 Mar 4;3(3):CD004046. doi: 10.1002/14651858.CD004046.pub4.

  PMID: 29502347 BACKGROUND

• SOUZA, F.G.M. Tratamento da depressão. Rev. Bras. Psiquiatr, v. 21, n.1, Maio.1999.

  BACKGROUND

• STUX, G. BIRCH, S. Padrões de tratamento por acupuntura propostos para estudos clínicos. In: STUX, G. BERMAN, B; POMERANZ, B. Basics of acupuncture. Berlin: Springer, 2005.

  BACKGROUND

• White A, Hayhoe S, Hart A, Ernst E; BMAS and AACP. British Medical Acupuncture Society and Acupuncture Association of Chartered Physiotherapists. Survey of adverse events following acupuncture (SAFA): a prospective study of 32,000 consultations. Acupunct Med. 2001 Dec;19(2):84-92. doi: 10.1136/aim.19.2.84.

  PMID: 11829164 BACKGROUND

• WORLD HEALTH ORGANIZATION. Benchmarks for training in traditional /complementary and alternative medicine: benchmarks for training in traditional Chinese medicine. 2010. Genebra: Who: 2010.

  BACKGROUND

• WORLD HEALTH ORGANIZATION. WHO Traditional Medicine Strategy 2014-2023. Genebra: WHO. 2013.

  BACKGROUND

• WORLD HEALTH ORGANIZATION. Atlas de Medicina Complementares e Tradicional. 2014. Genebra: OMS.

  BACKGROUND

• WORLD HEALTH ORGANIZATION. Depression and Other Common Mental Disorders: Global Health Estimates. Genebra: OMS, 2017a.

  BACKGROUND

• WORLD HEALTH ORGANIZATION. Mental Health. Depression: let's talk. 2017b

  BACKGROUND

• 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.

  PMID: 26255515 BACKGROUND

• 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.

  PMID: 27457720 BACKGROUND

• de Oliveira Rodrigues DM, Menezes PR, Machado Ribeiro Silotto AE, Heps A, Pereira Sanches NM, Schveitzer MC, Faisal-Cury A. Efficacy and Safety of Auricular Acupuncture for Depression: A Randomized Clinical Trial. JAMA Netw Open. 2023 Nov 1;6(11):e2345138. doi: 10.1001/jamanetworkopen.2023.45138.

  PMID: 38032640 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders; Sleep Initiation and Maintenance Disorders

Interventions

Acupuncture, Ear; Auriculotherapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics

Central Study Contacts

Daniel MO Rodrigues, MSc

CONTACT

5548 8825-1444; danielmor7@gmail.com

Alexandre F Cury, PhD

CONTACT

(15) 98107-3571; faisal@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ND, MSc.

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: May 11, 2023
• Study Start: March 1, 2023
• Primary Completion: December 15, 2025
• Study Completion: December 30, 2025
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)