Participants with moderate depressive symptoms measured by PHQ-9 will be randomized toreceive auricular acupuncture. The triple blinded procedure will be conducted in 12sessions (6 weeks). The primary outcome is the response to the treatment 3 months afterinclusion.
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.
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.
Other Name: Ear Acupuncture,Auriculotherapy
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
Universidade do Sul de Santa Catarina
Palhoça, Santa Catarina, Brazil
Investigator: Daniel Maurício de Oliveira Rodrigues O Rodrigues, Msc
Daniel MO Rodrigues, MSc
5548 8825-1444
danielmor7@gmail.com
Alexandre F Cury, PhD
(15) 98107-3571
faisal@usp.br
Not Provided