Objectives To explore the effectiveness and safety of the health cloud headphones（ HCH） in patients with mild and moderate generalized anxiety disorder（ GAD）. Methods A total of 100 mild and moderate GAD outpatients who met the DSM-5 diagnostic criteria for GAD were recruited and randomly assigned into the experimental group and control group， with 50 cases in each group. The experimental group was treated using HCH while the control group was treated using duloxetine. All patients received an 8-week treatment. The effectiveness was evaluated by Hamilton Anxiety Rating Scale（ HAMA） and the safety of treatment was assessed by Treatment Emergent Symptom Scale（ TESS） before the treatment， 4 weeks into the treatment and at the end of the 8-week treatment. Results Two-factor repeated measure analysis of variance showed that there was no significant difference in the effects of group and time interaction on the HAMA scales of psychotic anxiety factors， somatic anxiety factors and total scores（ F=2.360，0.539，2.402，P＞ 0.05）. There was no significant difference in the main effect of group factors on the change of scale scores（ F=0.033，1.111，0.482，P＞0.05）， while the main effect of time factors was statistically significant（ F=133.260，52.091，121.092，P＜0.001）. Further comparison between the two groups showed that there were significant differences in the changes of psychotic anxiety factors， somatic anxiety factors and total scores between before the treatment and 4 weeks into the treatment（ P＜0.01）. There were significant differences in the scores between the 4 weeks into the treatment and at the end of the treatment（ P＜0.05）. There was no significant difference between the experimental group and the control group in terms of effectiveness rate（ 88.9% vs 92.9%） and marked effectiveness rate（ 53.3% vs 66.7%）（ χ2=0.410， 1.606， P＞ 0.05）. The incidence of adverse reactions in the experimental group was lower than that in the control group（ χ2=4.960， P＜ 0.05）. Conclusions The effectiveness of HCH in treatment of patients with mild and moderate GAD was similar to duloxetine， while the HCH therapy can improve symptoms with higher safety.