基于移动应用的认知行为疗法治疗失眠的疗效：多中心、单盲随机临床试验。

Efficacy of Mobile App-Based Cognitive Behavioral Therapy for Insomnia: Multicenter, Single-Blind Randomized Clinical Trial.

机构信息

Department of Psychiatry and Center for Sleep and Chronobiology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.

Department of Psychiatry, Uijeongbu Eulji Medical Center, Eulji University School of Medicine, Gyeonggi-do, Republic of Korea.

出版信息

J Med Internet Res. 2024 Jul 26;26:e50555. doi: 10.2196/50555.

DOI:10.2196/50555

PMID:39058549

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11316165/

Abstract

BACKGROUND

Cognitive behavioral therapy for insomnia (CBTi) is the first-line therapy for chronic insomnia. Mobile app-based CBTi (MCBTi) can enhance the accessibility of CBTi treatment; however, few studies have evaluated the effectiveness of MCBTi using a multicenter, randomized controlled trial design.

OBJECTIVE

We aimed to assess the efficacy of Somzz, an MCBTi that provides real-time and tailored feedback to users, through comparison with an active comparator app.

METHODS

In our multicenter, single-blind randomized controlled trial study, participants were recruited from 3 university hospitals and randomized into a Somzz group and a sleep hygiene education (SHE) group at a 1:1 ratio. The intervention included 6 sessions for 6 weeks, with follow-up visits over a 4-month period. The Somzz group received audiovisual sleep education, guidance on relaxation therapy, and real-time feedback on sleep behavior. The primary outcome was the Insomnia Severity Index score, and secondary outcomes included sleep diary measures and mental health self-reports. We analyzed the outcomes based on the intention-to-treat principle.

RESULTS

A total of 98 participants were randomized into the Somzz (n=49, 50%) and SHE (n=49, 50%) groups. Insomnia Severity Index scores for the Somzz group were significantly lower at the postintervention time point (9.0 vs 12.8; t=3.85; F=22.76; η=0.13; P<.001) and at the 3-month follow-up visit (11.3 vs 14.7; t=2.61; F=5.85; η=0.03; P=.01) compared to those of the SHE group. The Somzz group maintained their treatment effect at the postintervention time point and follow-ups, with a moderate to large effect size (Cohen d=-0.62 to -1.35; P<.01 in all cases). Furthermore, the Somzz group showed better sleep efficiency (t=-3.32; F=69.87; η=0.41; P=.001), wake after sleep onset (t=2.55; F=51.81; η=0.36; P=.01), satisfaction (t=-2.05; F=26.63; η=0.20; P=.04) related to sleep, and mental health outcomes, including depression (t=2.11; F=29.64; η=0.21; P=.04) and quality of life (t=-3.13; F=54.20; η=0.33; P=.002), compared to the SHE group after the intervention. The attrition rate in the Somzz group was 12% (6/49).

CONCLUSIONS

Somzz outperformed SHE in improving insomnia, mental health, and quality of life. The MCBTi can be a highly accessible, time-efficient, and effective treatment option for chronic insomnia, with high compliance.

TRIAL REGISTRATION

Clinical Research Information Service (CRiS) KCT0007292; https://cris.nih.go.kr/cris/search/detailSearch.do?seq=22214&search_page=L.

摘要

背景

认知行为疗法（CBTi）是慢性失眠症的一线治疗方法。基于移动应用程序的 CBTi（MCBTi）可以提高 CBTi 治疗的可及性；然而，很少有研究使用多中心、随机对照试验设计来评估 MCBTi 的有效性。

目的

我们旨在通过与活性对照应用程序比较，评估 Somzz 作为一种提供实时和定制反馈的 MCBTi 的疗效。

方法

在我们的多中心、单盲随机对照试验研究中，参与者从 3 家大学医院招募，并按 1:1 的比例随机分为 Somzz 组和睡眠卫生教育（SHE）组。干预包括 6 周的 6 个疗程，在 4 个月的随访期间进行随访。Somzz 组接受视听睡眠教育、放松疗法指导和睡眠行为的实时反馈。主要结局是失眠严重程度指数（Insomnia Severity Index，ISI）评分，次要结局包括睡眠日记测量和心理健康自我报告。我们根据意向治疗原则分析了结果。

结果

共有 98 名参与者被随机分配到 Somzz（n=49，50%）和 SHE（n=49，50%）组。在干预后时间点，Somzz 组的 ISI 评分明显低于 SHE 组（9.0 比 12.8；t=3.85；F=22.76；η=0.13；P<.001）和 3 个月随访时间点（11.3 比 14.7；t=2.61；F=5.85；η=0.03；P=.01）。与 SHE 组相比，Somzz 组在干预后时间点和随访中保持了治疗效果，具有中到大的效应量（Cohen d=-0.62 至-1.35；所有情况下 P<.01）。此外，Somzz 组的睡眠效率（t=-3.32；F=69.87；η=0.41；P=.001）、入睡后觉醒（t=2.55；F=51.81；η=0.36；P=.01）、与睡眠相关的满意度（t=-2.05；F=26.63；η=0.20；P=.04）以及心理健康结局，包括抑郁（t=2.11；F=29.64；η=0.21；P=.04）和生活质量（t=-3.13；F=54.20；η=0.33；P=.002），均优于 SHE 组。Somzz 组的失访率为 12%（6/49）。