Hui Victoria Ka-Ying, Wong Christy Yim-Fan, Ma Eric Ka-Yiu, Ho Fiona Yan-Yee, Chan Christian S
Department of Psychology, The University of Hong Kong, Pokfulam Road, Hong Kong SAR, Hong Kong.
Department of Psychology, The Chinese University of Hong Kong, Shatin, Hong Kong.
Trials. 2020 Oct 9;21(1):843. doi: 10.1186/s13063-020-04778-1.
Depression is a major public health concern. Emerging research has shown that cognitive behavioral therapy for insomnia (CBT-I) is effective in treating individuals with comorbid insomnia and depression. Traditional face-to-face CBT-I encounters many obstacles related to feasibility, accessibility, and help-seeking stigma. CBT-I delivered via smartphone application could be a potential solution. This paper reports a protocol designed to evaluate the efficacy of a self-help smartphone-based CBT-I, using a waitlist group as control, for people with major depression and insomnia.
A two-arm parallel randomized controlled trial is conducted in a target sample of 285 non-suicidal Hong Kong Chinese older than 17 years of age with major depression and insomnia. Participants complete an online rapid screening, followed by a telephone diagnostic interview. Those who meet the eligibility criteria are randomized in a ratio of 1:1 to receive either CBT-I immediately or to a waitlist control condition. The CBT-I consists of six weekly modules and is delivered through a smartphone application proACT-S. This smartphone app has been pilot tested and revamped to improve user experience. An online randomized algorithm is used to perform randomization to ensure allocation concealment. The primary outcomes are changes over the measurement points in sleep quality, insomnia severity, and depression severity. The secondary outcomes include changes over the measurement points in anxiety, subjective health, treatment expectancy, and acceptability of treatment. Assessments are administered at baseline, post-intervention, and 6-week follow-up. The recruitment is completed. Important adverse events, if any, are documented. Multilevel linear mixed model based on intention-to-treat principle will be conducted to examine the efficacy of the CBT-I intervention.
It is expected that proACT-S is an efficacious brief sleep-focused self-help treatment for people with major depression and insomnia. If proven efficacious, due to its self-help nature, proACT-S may be applicable as a community-based early intervention, thereby reducing the burden of the public healthcare system in Hong Kong.
ClinicalTrials.gov NCT04228146 . Retrospectively registered on 14 January 2020.
抑郁症是一个重大的公共卫生问题。新出现的研究表明，失眠的认知行为疗法（CBT-I）在治疗合并失眠和抑郁症的个体方面是有效的。传统的面对面CBT-I在可行性、可及性和求助污名方面遇到了许多障碍。通过智能手机应用程序提供的CBT-I可能是一个潜在的解决方案。本文报告了一项方案，旨在评估基于智能手机的自助式CBT-I对重度抑郁症和失眠患者的疗效，使用等待列表组作为对照。
对285名年龄在17岁以上、患有重度抑郁症和失眠的非自杀性香港华人进行双臂平行随机对照试验。参与者完成在线快速筛查，随后进行电话诊断访谈。符合入选标准的参与者按1:1的比例随机分组，立即接受CBT-I或进入等待列表对照组。CBT-I由六个每周一次的模块组成，通过智能手机应用程序proACT-S提供。这个智能手机应用程序已经进行了试点测试并进行了改进，以改善用户体验。使用在线随机算法进行随机化，以确保分配隐藏。主要结局是睡眠质量、失眠严重程度和抑郁严重程度在各测量点的变化。次要结局包括焦虑、主观健康、治疗预期和治疗可接受性在各测量点的变化。在基线、干预后和6周随访时进行评估。招募工作已完成。记录任何重要的不良事件。将基于意向性治疗原则进行多水平线性混合模型分析，以检验CBT-I干预的疗效。
预计proACT-S是一种对重度抑郁症和失眠患者有效的、以睡眠为重点的简短自助治疗方法。如果被证明有效，由于其自助性质，proACT-S可能适用于作为基于社区的早期干预，从而减轻香港公共医疗系统的负担。
ClinicalTrials.gov NCT04228146。于2020年1月14日进行回顾性注册。
