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

Official title

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

Overview

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.

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.

Interventions

• 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.

Primary outcome measures

• Decrease of Depression Symptoms [Time frame: 3 months]

Secondary outcome measures (12)

• BDNF, Interleukin, TNF [Time frame: 6 weeks]
• Decrease of Depression Symptoms [Time frame: 6 weeks]
• Decrease of Depression Symptoms [Time frame: 6 months]
• Decrease of Depression Symptoms [Time frame: 4 weeks]
• Decrease of Insomnia [Time frame: 3 months]
• Decrease of Insomnia [Time frame: 6 months]
• Decrease of Insomnia [Time frame: 4 weeks]
• Decrease of Insomnia [Time frame: 6 weeks]
• Decrease of Anxiety Symptoms [Time frame: 3 months]
• Decrease of Anxiety Symptoms [Time frame: 6 months]
• Decrease of Anxiety Symptoms [Time frame: 4 weeks]
• Decrease of Anxiety Symptoms [Time frame: 6 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Brazil · 1 center

• Universidade do Sul de Santa Catarina — Palhoça

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. PMID 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.

Identifiers

NCT: NCT05855421 · USantaCatarina · 2018/17469-5

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗