Safety and Effectiveness of Auricular Acupuncture for Moderate Depression in Adults During the Covid-19 Pandemic A Multicenter Triple-Blinded Randomized Trial

What this Trial Is About

Researchers are evaluating the effectiveness and safety of auricular acupuncture to reduce depressive symptoms in university students during the Covid-19 pandemic. This randomized clinical trial involves participants with moderate depressive symptoms measured by PHQ-9 scores between 10 and 19. The study compares specific auricular acupuncture against non-specific auricular acupuncture and usual care. The trial is triple-blinded, meaning the evaluator, participant, and statistician do not know which treatment is given. Participants are randomly assigned to one of two groups the experimental group receiving auricular acupuncture at six traditional Chinese medicine ear points, and the control group receiving auricular acupuncture at non-specific ear points. Both groups receive 12 sessions over 6 weeks, with two sessions each week. Semi-permanent needles are used, and participants are instructed to stimulate the treated ear areas three times daily. A minimum one-day gap is maintained between sessions, and up to two non-consecutive absences are allowed. During the study, participants undergo assessments at multiple points including 3, 4, 6 weeks, and 6 months after starting treatment. Researchers evaluate improvement in depressive symptoms, quality of life, and other factors such as anxiety, insomnia, and biological markers in blood plasma. The primary outcome is the proportion of participants who improve their depressive symptoms by 50% or more at 3 months. Safety, adverse effects, and medication use are also monitored. The total participation duration covers at least six months of follow-up.

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