Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
All Genders
Healthy Volunteers
ID05855421

Efficacy and Safety of Auricular Acupuncture for Depression During COVID-19 Pandemic A Multicenter Triple-Blinded Randomized Clinical Trial

Led by Universidade do Sul de Santa Catarina · Updated on 2025-01-20

280

Participants Needed

1

Research Sites

147 weeks

Total Duration

On this page

Sponsors

U

Universidade do Sul de Santa Catarina

Lead Sponsor

U

University of Sao Paulo

Collaborating Sponsor

AI-Summary

What this Trial Is About

Depression is a leading cause of disability worldwide, especially affecting university students. This research aims to evaluate the effectiveness and safety of auricular acupuncture as a non-drug treatment for moderate depressive symptoms during the Covid-19 pandemic. The study compares auricular acupuncture with usual care and non-specific auricular acupuncture in a randomized, triple-blinded clinical trial involving university students. Participants will be randomly assigned to one of two groups: an experimental group receiving auricular acupuncture and a control group receiving non-specific auricular acupuncture. Both groups will undergo 12 treatment sessions over 6 weeks, with sessions held twice a week. Auricular acupuncture involves applying semi-permanent needles to specific points on the ear using traditional Chinese maps and a specialized device. A minimum of one day is required between sessions, and participants are allowed up to two non-consecutive absences. During the study, participants will be assessed for changes in depressive symptoms using the PHQ-9 questionnaire, with the primary measure being a 50% or greater improvement in symptoms three months after starting treatment. Secondary outcomes include symptom improvement at six months, quality of life measurements, changes in antidepressant use, adverse events, and levels of certain blood markers. The study will monitor participants closely to evaluate the treatment's impact and safety over time.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 50Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 50 years old
  • PHQ-9 score between 10 and 19 indicating moderate depression
  • Availability to attend treatment sessions
Not Eligible

You will not qualify if you...

  • Use of complementary and integrative practices in the last 3 months
  • Suicidal risk as evaluated by question 9 of the PHQ-9
  • Severe depression score on the PHQ-9
  • Prior use of auricular acupuncture
  • Pregnancy
  • Menopause
  • Allergy to tape or metal

AI-Screening

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Trial Site Locations

Total: 1 location

1

Universidade do Sul de Santa Catarina

Palhoça, Santa Catarina, Brazil, 88101000

Actively Recruiting

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Research Team

D

Daniel MO Rodrigues, MSc

A

Alexandre F Cury, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Introduction of auricular acupuncture in elderly patients suffering from major depression: protocol of a mixed methods feasibility study.

Janina Geib, Monika A Rieger, Stefanie Joos...

https://pubmed.ncbi.nlm.nih.gov/25954756

Characterizing acupuncture stimuli using brain imaging with FMRI--a systematic review and meta-analysis of the literature.

Wenjing Huang, Daniel Pach, Vitaly Napadow...

https://pubmed.ncbi.nlm.nih.gov/22496739