Efficacy of Traditional Chinese Medicine Supportive Treatment on the Adherence of Behavioral Therapy for Insomnia: Study Protocol for a Randomized Controlled Trial

Abstract

Background: Brief behavioral therapy (BBT-I) for insomnia has been proven to be a simple and effective alternative to cognitive behavioral therapy. However, low adherence limits the application in Chinese primary medical institutions, resulting in delayed or irregular treatment for many patients. This study aimed to explore the efficacy of traditional Chinese medicine supportive treatments on the adherence to behavioral therapy for insomnia in Chinese primary healthcare institutions, with a particular focus on patients who live in regions with weak healthcare systems.Methods: This randomized controlled clinical trial will be conducted in primary medical institutions and will recruit 98 adult participants with insomnia. BBT-I will be used as the base treatment. The participants will be divided into experimental (combined with traditional Chinese medicine supportive treatment n = 49) and control (combined with trazodone treatment, n = 49) groups, and each group will be treated for 4 consecutive weeks. The severity index of insomnia will be used as the main indicator of disease evaluation, with an 8-point reduction in the score considered as effective and a score < 8 considered as cured. The secondary indicators of the disease evaluation will include the Pittsburgh sleep quality index (PSQI), Zung’s self-rating anxiety scale, Zung’s self-rating depression scale, treatment adherence, and adverse event reports. All participants will be followed up at the time of enrollment, 4 weeks after treatment, and 3 months after the end of treatment.Discussion: This clinical trial will provide evidence for the efficacy of traditional Chinese medicine supportive treatment on the adherence to behavioral therapy for insomnia in primary medical institutions. This cheap and accessible model may benefit insomnia patients in medically underserved areas.Trial registration: Chinese Clinical Trial Registry ChiCTR2100042845. Registered on 30 January 2021, dataset: http://www.chictr.org.cn/edit.aspx?pid=65691&htm=4