Digital Cognitive-Behavioural Therapy vs. Zolpidem for Insomnia Treatment
BMJ Open. 2024 Jun 25;14(6):e081205
Introduction: Insomnia is a common health issue, and cognitive-behavioural therapy (CBT) is a recommended treatment. Due to a shortage of CBT-trained therapists, we developed a digital CBT application (IIIP MED: Sleepy Med) for insomnia. This study outlines an exploratory trial to assess the effectiveness and safety of our digital CBT compared to zolpidem tartrate for patients with insomnia disorder.
Methods and Analysis: The multicentre exploratory trial will be conducted at Chiba University Hospital, Akita University Hospital, and Yoyogi Sleep Disorder Center, Japan. The study will include two groups (dCBT and zolpidem) with 15 participants each (n=30 in total) diagnosed with insomnia disorder. Effectiveness will be evaluated at baseline, week 5 (post-intervention), and week 10 (follow-up). The primary outcome will be the change in subjective sleep onset latency at week 5 from baseline. Secondary outcomes include objective sleep onset latency, functional improvement during the daytime, and quality of life.
Ethics and Dissemination: Ethics approval was granted by the Institutional Review Board of Chiba University Hospital (K2023001). All participants will provide written informed consent, and results will be published in international journals.
Trial Registration Number: jRCT2032230353
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