Efficacy and Safety of Auricular Acupuncture in Depression During the Covid 19 Pandemic
NCT ID: NCT05855421
Last Updated: 2025-01-20
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
280 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-03-01
Study Completion Date
2025-12-30
Brief Summary
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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.
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Detailed Description
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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
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Depressive Symptoms
Depression
Anxiety
Insomnia
Quality of Life
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Investigators
Outcome Assessors
Study Groups
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Experimental: Specific Auricular Acupuncture
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.
Group Type
EXPERIMENTAL
Auricular Acupuncture
Intervention Type
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.
Inespecific Auricular Acupuncture
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.
Group Type
SHAM_COMPARATOR
Auricular Acupuncture
Intervention Type
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.
Interventions
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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.
Intervention Type
DEVICE
Other Intervention Names
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Ear Acupuncture
Auriculotherapy
Eligibility Criteria
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Inclusion Criteria
* Age between 18 and 50 years old
* PHQ-9 score between 10 and 19 (moderate depression)
* Availability for sessions
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
50 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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University of Sao Paulo
OTHER
Sponsor Role
collaborator
Universidade do Sul de Santa Catarina
OTHER_GOV
Sponsor Role
lead
Responsible Party
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DANIEL MAURICIO DE OLIVEIRA RODRIGUES
ND, MSc.
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Universidade do Sul de Santa Catarina
Palhoça, Santa Catarina, Brazil
Site Status
RECRUITING
Countries
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Brazil
Central Contacts
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References
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DERIVED
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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2018/17469-5
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
USantaCatarina
Identifier Type: -
Identifier Source: org_study_id
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