互联网提供的计算机化认知行为疗法对药物治疗后仍有症状的失眠患者的有效性：随机对照探索性试验。

Effectiveness of Internet-Delivered Computerized Cognitive Behavioral Therapy for Patients With Insomnia Who Remain Symptomatic Following Pharmacotherapy: Randomized Controlled Exploratory Trial.

作者信息

Sato Daisuke, Yoshinaga Naoki, Nagai Eiichi, Nagai Kazue, Shimizu Eiji

机构信息

Department of Cognitive Behavioral Physiology, Graduate School of Medicine, Chiba University, Chiba, Japan.

Department of Rehabilitation Sciences, Chiba Prefectural University of Health Sciences, Chiba, Japan.

出版信息

J Med Internet Res. 2019 Apr 11;21(4):e12686. doi: 10.2196/12686.

DOI:10.2196/12686

PMID:30973344

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6482403/

Abstract

BACKGROUND

In reality, pharmacotherapy still remains the most common treatment for insomnia.

OBJECTIVE

This study aimed to examine the effectiveness of our internet-delivered computerized cognitive behavioral therapy (ICBT) program as an adjunct to usual care (UC) compared with UC alone in patients with insomnia who remain symptomatic following hypnotics.

METHODS

We recruited 23 patients with insomnia who remained symptomatic following pharmacologic treatment including benzodiazepines, and we conducted an exploratory randomized controlled trial. The primary outcome was the Pittsburgh Sleep Quality Index (PSQI) at week 6 of the treatment. Secondary outcomes were sleep onset latency, total sleep time, sleep efficiency, number of awakenings, refreshment and soundness of sleep, anxiety by Hospital Anxiety and Depression Scale, depression measured by the Center for Epidemiologic Studies Depression Scale, and quality of life (QOL) measured by the EuroQol-5D. All parameters were measured at weeks 0 (baseline), 6 (postintervention), and 12 (follow-up).

RESULTS

The adjusted mean reduction (-6.11) in PSQI at week 6 from baseline in the ICBT plus UC group was significantly (P<.001) larger than the adjusted mean reduction (0.40) in the UC alone group. Significant differences were also found in favor of ICBT plus UC for PSQI, sleep onset latency, sleep efficiency, number of awakenings, and depression at all assessment points. Refreshment, soundness of sleep, anxiety, and QOL improved by week 6 in ICBT plus UC compared with UC alone. There were no reports of adverse events in either group during the study.

CONCLUSIONS

These results indicated that our 6-week ICBT program is an effective treatment adjunct to UC for improving insomnia and related symptoms even after unsuccessful pharmacotherapy.

TRIAL REGISTRATION

University Hospital Medical Information Network Clinical Trials Registry: UMIN000021509; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023545 (Archived by WebCite at http://www.webcitation. org/75tCmwnYt).

摘要

背景

在现实中，药物治疗仍然是失眠最常见的治疗方法。

目的

本研究旨在检验我们通过互联网提供的计算机化认知行为疗法（ICBT）方案作为常规护理（UC）辅助手段与单纯UC相比，对使用催眠药物后仍有症状的失眠患者的有效性。

方法

我们招募了23名在包括苯二氮䓬类药物在内的药物治疗后仍有症状的失眠患者，并进行了一项探索性随机对照试验。主要结局是治疗第6周时的匹兹堡睡眠质量指数（PSQI）。次要结局包括入睡潜伏期、总睡眠时间、睡眠效率、觉醒次数、睡眠恢复感和睡眠质量、医院焦虑抑郁量表测量的焦虑、流行病学研究中心抑郁量表测量的抑郁以及欧洲五维健康量表测量的生活质量（QOL）。所有参数均在第0周（基线）、第6周（干预后）和第12周（随访）进行测量。

结果

ICBT联合UC组第6周时PSQI较基线的调整后平均降低值（-6.11）显著（P<0.001）大于单纯UC组的调整后平均降低值（0.40）。在所有评估点，PSQI、入睡潜伏期、睡眠效率、觉醒次数和抑郁方面也发现有利于ICBT联合UC组的显著差异。与单纯UC相比，ICBT联合UC组在第6周时睡眠恢复感、睡眠质量、焦虑和QOL有所改善。研究期间两组均未报告不良事件。