摘要OBJECTIVE:To evaluate the efficacy of Traditional Chinese Medicine(TCM)psychosomatic integration therapy in treating subthreshold depression(SD).METHODS:A multicenter randomized controlled trial was conducted.Eligible participants were evaluated by physicians and randomly assigned to either the intervention or control group.The intervention group received group psychotherapy,Jue tune music therapy,and Yuleyin oral formula(郁乐饮).The control group received only group psychotherapy.The intervention period lasted 12 weeks,followed by a 12-week follow-up.The primary outcome was the Center for Epidemiologic Studies Depression Scale(CES-D)score at week 12.Secondary outcomes included dropout rate,scores of the Hamilton Anxiety Scale(HAMA)and the Hamilton Depression Rating Scale(HAMD-17)at week 12,and CES-D scores at weeks 4,8,16,20,and 24.RESULTS:A total of 505 patients were randomly allocated to the two groups,and 496 participants[77％female;(38±16)years]were included in the final analysis.The primary outcome showed no statistically significant difference in CES-D scores between the intervention and control groups at week 12(P＞0.05).However,the intervention group exhibited significant reductions in CES-D scores at weeks 4,8,12,16,20,and 24 compared to baseline,and at week 24 compared to week 12(P＜0.0001).The control group also showed significant reductions in CES-D scores at weeks 4 and 8 during the intervention period(P＜0.0001).Although no significant differences were observed between groups at each specific time point,the intervention group showed a more consistent downward trend.Additionally,both HAMD and HAMA scores significantly decreased from baseline to week 12 in both groups(P＜0.0001).CONCLUSIONS:TCM psychosomatic integration therapy,which includes group psychotherapy,Jue tune music therapy,and Yuleyin oral formula,may be effective in improving symptoms of SD,with good safety and feasibility.The complete TCM intervention demonstrated better long-term effectiveness than group psychotherapy alone.Further high-quality studies are needed to validate these findings.