Health TrialsbyHealthPanel

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

ConditionsDepressive SymptomsDepressionAnxietyInsomniaQuality of Life
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversidade do Sul de Santa Catarina

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age between 18 and 50 years old

PHQ-9 score between 10 and 19 (moderate depression)

Availability for sessions

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Auricular Acupuncture

    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.

Treatment groups

280 Participants
are divided into 2 treatment groups
Group A: Experimental: Specific Auricular AcupunctureExperimental treatment 1 intervention
Group B: Inespecific Auricular AcupunctureSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Decrease of Depression Symptoms

The efficacy of auricular acupuncture to reduce depression symptoms compared to non-specific auricular acupuncture 3 months after study inclusion.

Time frame
3 months

Secondary outcomes

1

BDNF, Interleukin, TNF

Levels of BDNF, Interleukin 1β, Interleukin-6 and TNF-α, evaluated at the beginning and end of auricular acupuncture applications (end of the sixth week of application)

Time frame
6 weeks
2

Decrease of Depression Symptoms

The efficacy of auricular acupuncture to reduce depression symptoms compared to non-specific auricular acupuncture 6 weeks after study inclusion.

Time frame
6 weeks
3

Decrease of Depression Symptoms

The efficacy of auricular acupuncture to reduce depression symptoms compared to non-specific auricular acupuncture 6 months after study inclusion.

Time frame
6 months
4

Decrease of Depression Symptoms

The efficacy of auricular acupuncture to reduce depression symptoms compared to non-specific auricular acupuncture 4 weeks after study inclusion.

Time frame
4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidade do Sul de Santa Catarina

Lead sponsor

University of Sao Paulo

Collaborator

Source ClinicalTrials.gov
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