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| ID | Type | Description | Link |
|---|---|---|---|
| 2018/17469-5 | Other Grant/Funding Number | Fundacao de Amparo a Pesquisa do Estado de Sao Paulo |
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| Name | Class |
|---|---|
| University of Sao Paulo | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 6 weeks |
| Decrease of Depression Symptoms |
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Inclusion Criteria:
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
Male; Female; Non-binary
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel MO Rodrigues, MSc | Contact | 5548 8825-1444 | danielmor7@gmail.com | |
| Alexandre F Cury, PhD | Contact | (15) 98107-3571 | faisal@usp.br |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade do Sul de Santa Catarina | Recruiting | Palhoça | Santa Catarina | 88101000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 29638213 |
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There is no IPD to be shared.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 10, 2023 | May 10, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 10, 2023 | May 10, 2023 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D020831 | Acupuncture, Ear |
| D055097 | Auriculotherapy |
| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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|
|
The efficacy of auricular acupuncture to reduce depression symptoms compared to non-specific auricular acupuncture 6 weeks after study inclusion.
| 6 weeks |
| 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 |
| 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 |
| Decrease of Insomnia | The efficacy of auricular acupuncture to reduce insomnia compared to non-specific auricular acupuncture 3 months after study inclusion. | 3 months |
| Decrease of Insomnia | The efficacy of auricular acupuncture to reduce insomnia compared to non-specific auricular acupuncture 6 months after study inclusion. | 6 months |
| Decrease of Insomnia | The efficacy of auricular acupuncture to reduce insomnia compared to non-specific auricular acupuncture 4 weeks after study inclusion. | 4 weeks |
| Decrease of Insomnia | The efficacy of auricular acupuncture to reduce insomnia compared to non-specific auricular acupuncture 6 weeks after study inclusion. | 6 weeks |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |