Faculty of Health Sciences, Queen's University, Kingston, Ontario, Canada.
Faculty of Health Sciences, Department of Psychiatry, Queen's University, Kingston, Ontario, Canada.
PLoS One. 2023 May 16;18(5):e0285757. doi: 10.1371/journal.pone.0285757. eCollection 2023.
Insomnia is one of the most prevalent sleep disorders characterized by an inability to fall or stay asleep. Available treatments include pharmacotherapy and cognitive behavioural therapy for insomnia (CBTi). Although CBTi is the first-line treatment, it has limited availability. Therapist-guided electronic delivery of CBT for insomnia (e-CBTi) offers scalable solutions to enhance access to CBTi. While e-CBTi produces comparable outcomes to in-person CBTi, there is a lack of comparison to active pharmacotherapies. Therefore, direct comparisons between e-CBTi and trazodone, one of the most frequently prescribed medications for insomnia, is essential in establishing the effectiveness of this novel digital therapy in the health care system.
The aim of this study is to compare the effectiveness of a therapist-guided electronically-delivered cognitive behavioural therapy (e-CBTi) program to trazodone in patients with insomnia.
Patients (n = 60) will be randomly assigned to two groups: treatment as usual (TAU) + trazodone and TAU + e-CBTi for seven weeks. Each weekly sleep module will be delivered through the Online Psychotherapy Tool (OPTT), a secure, online mental health care delivery platform. Changes in insomnia symptoms will be evaluated throughout the study using clinically validated symptomatology questionnaires, Fitbits, and other behavioural variables.
Participant recruitment began in November 2021. To date, 18 participants have been recruited. Data collection is expected to conclude by December 2022 and analyses are expected to be completed by January 2023.
This comparative study will improve our understanding of the efficacy of therapist-guided e-CBTi in managing insomnia. These findings can be used to develop more accessible and effective treatment options and influence clinical practices for insomnia to further expand mental health care capacity in this population.
ClinicalTrials.gov (NCT05125146).
失眠是最常见的睡眠障碍之一，其特征是难以入睡或保持睡眠状态。现有的治疗方法包括药物治疗和失眠认知行为疗法（CBTi）。尽管 CBTi 是一线治疗方法，但它的可及性有限。治疗师指导的失眠电子 CBT（e-CBTi）提供了可扩展的解决方案，以增强 CBTi 的可及性。虽然 e-CBTi 的效果与面对面 CBTi 相当，但与活性药物治疗相比，缺乏比较。因此，在医疗保健系统中，确定这种新型数字疗法的有效性，将 e-CBTi 与治疗失眠最常用的药物之一曲唑酮进行直接比较至关重要。
本研究旨在比较治疗师指导的电子传递认知行为疗法（e-CBTi）方案与曲唑酮治疗失眠患者的疗效。
将患者（n=60）随机分为两组：常规治疗（TAU）+曲唑酮和 TAU+e-CBTi 共七周。每周的睡眠模块将通过在线心理治疗工具（OPTT）交付，这是一个安全的在线心理健康护理交付平台。整个研究过程中，将使用经过临床验证的症状问卷、Fitbit 和其他行为变量评估失眠症状的变化。
参与者招募于 2021 年 11 月开始。迄今为止，已经招募了 18 名参与者。预计数据收集将于 2022 年 12 月结束，分析预计将于 2023 年 1 月完成。
这项比较研究将提高我们对治疗师指导的 e-CBTi 治疗失眠的疗效的理解。这些发现可用于开发更易于获得和更有效的治疗方案，并影响失眠的临床实践，以进一步扩大该人群的心理健康护理能力。
ClinicalTrials.gov（NCT05125146）。
