A Multicenter Randomized Controlled Study on Brief Behavioral Therapy for Insomnia Integrated with Traditional Chinese Medicine in Chinese Community

Background:　Insomnia disorder is characterized by a high incidence rate, posing significant potential risks to both individual health and society. There is an urgent need within the country to undertake a graded medical system reform, aiming to establish a community-based initial diagnosis and treatment approach within community healthcare institutions. However, less mature community-based initial diagnosis and treatment models for insomnia disorder has yet to be observed in the domestic context. Objective:　The study aims to observe the effectiveness and compliance of integrating traditional Chinese external treatment techniques with simplified Brief Behavioral Treatment for Insomnia (BBT-I) in addressing insomnia disorder. Methods:　Between March 2021 and December 2022, a prospective study was conducted, selecting 84 insomnia disorder patients who sought outpatient care at multiple community health service centers in Yancheng City as the research subjects. The participants were randomly allocated into an experimental group (49 cases) and a control group (49 cases). The experimental group received personalized treatment integrating traditional Chinese exercises such as "Five Animal Frolics," massage, and traditional Chinese foot bathing into BBT-I therapy. The control group received BBT-I therapy, with the option of adjunctive treatment using Quetiapine Hydrochloride tablets (25-150mg/day) for 4 weeks, followed by a three-month follow-up. The primary endpoint for treatment comparison was the Insomnia Severity Index. Secondary outcomes included the Pittsburgh Sleep Quality Index, self-rating anxiety scale, self-rating depression scale, treatment compliance, and measurement of adverse events. Results:　Considering the dropouts as ineffective, the effective rate after 4 weeks of treatment was 26.53% in the experimental group with a relief rate of 53.06%, while in the control group, it was 22.45% with a relief rate of 24.49%. The difference was statistically significant (p<0.05). However, at the 3-month follow-up, the effective rate was 4.08% in the experimental group with a relief rate of 53.06%, and in the control group, it was 8.18% with a relief rate of 30.61%. The difference was not statistically significant (p>0.05). Regarding the compliance of the behavioral treatment "do not going to bed when not sleepy" under the combined regimen, the experimental group showed a significantly higher rate of being able to follow or mostly follow the behavior (98.23%) compared to the control group (67.79%) (P<0.05). No statistically significant differences were observed in the compliance of other behavioral treatments between the groups (P>0.05). Conclusion:　The combination of traditional Chinese external treatment techniques with BBT-I proves to be an effective initial treatment approach for insomnia disorder in community health institutions. When compared to the combined usage of Western medicine Quetiapine Hydrochloride, this approach demonstrates enhanced treatment compliance and efficacy.