NCT05855421

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: Universidade do Sul de Santa Catarina · Other Government
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-03-01
• Primary completion: 2025-12-15
• Completion: 2025-12-30
• First posted: 2023-05-11
• Last updated: 2025-01-20

Locations

1 site across 1 country: Brazil