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一项通过互联网提供的改善退伍军人失眠严重程度及功能的干预措施的疗效:随机对照试验。

Efficacy of an Internet-Delivered Intervention for Improving Insomnia Severity and Functioning in Veterans: Randomized Controlled Trial.

作者信息

Nazem Sarra, Barnes Sean M, Forster Jeri E, Hostetter Trisha A, Monteith Lindsey L, Kramer Emily B, Gaeddert Laurel A, Brenner Lisa A

机构信息

Dissemination & Training Division, National Center for Posttraumatic Stress Disorder, Menlo Park, CA, United States.

Veterans Affairs Rocky Mountain Mental Illness Research, Education and Clinical Center, Aurora, CO, United States.

出版信息

JMIR Ment Health. 2023 Nov 24;10:e50516. doi: 10.2196/50516.

DOI:10.2196/50516
PMID:37999953
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10709797/
Abstract

BACKGROUND

Despite a growing evidence base that internet-delivered cognitive behavioral therapy for insomnia (iCBT-I) is associated with decreased insomnia severity, its efficacy has been minimally examined in veterans.

OBJECTIVE

The objective of this study was to evaluate the efficacy of an unguided iCBT-I (Sleep Healthy Using the Internet [SHUTi]) among veterans.

METHODS

We conducted a single-blind, randomized controlled trial in Operation Enduring Freedom, Operation Iraqi Freedom, and Operation New Dawn veterans eligible for Veterans Health Administration care. Participants were randomly assigned (1:1) to receive SHUTi (a self-guided and interactive program) or an Insomnia Education Website (IEW) that provided nontailored and fixed insomnia information. Web-based assessments were administered at baseline, postintervention, 6 months postintervention, and 1 year postintervention. The primary outcome was self-reported insomnia severity (Insomnia Severity Index [ISI]). Secondary outcomes were self-reported mental and physical health functioning (Veterans RAND 36-item Health Survey). Exploratory outcomes comprised sleep diary parameters.

RESULTS

Of the 231 randomized participants (mean age 39.3, SD 7.8 years; 170/231, 73.5% male sex; 26/231, 11.3% Black; 172/231, 74.5% White; 10/231, 4.3% multiracial; and 17/231, 7.4% other; 36/231, 15.6% Hispanic) randomized between April 2018 and January 2019, a total of 116 (50.2%) were randomly assigned to SHUTi and 115 (49.8%) to the IEW. In intent-to-treat analyses, SHUTi participants experienced significantly larger ISI decreases compared with IEW participants at all time points (generalized η values of 0.13, 0.12, and 0.10, respectively; all P<.0001). These corresponded to estimated larger differences in changes of -3.47 (95% CI -4.78 to -2.16), -3.80 (95% CI -5.34 to -2.27), and -3.42 (95% CI -4.97 to 1.88) points on the ISI for the SHUTi group. SHUTi participants experienced significant improvements in physical (6-month generalized η=0.04; P=.004) and mental health functioning (6-month and 1-year generalized η=0.04; P=.009 and P=.005, respectively). Significant sleep parameter improvements were noted for SHUTi (all P<.05), though the pattern and magnitude of these reductions varied by parameter. No adverse events were reported.

CONCLUSIONS

Self-administered iCBT-I was associated with immediate and long-term improvements in insomnia severity. Findings suggest that leveraging technology to meet insomnia treatment demands among veterans may be a promising approach.

TRIAL REGISTRATION

ClinicalTrials.gov NCT03366870; https://clinicaltrials.gov/ct2/show/NCT03366870.

摘要

背景

尽管越来越多的证据表明,通过互联网提供的失眠认知行为疗法(iCBT-I)与失眠严重程度降低有关,但其在退伍军人中的疗效尚未得到充分研究。

目的

本研究的目的是评估一种无指导的iCBT-I(利用互联网实现健康睡眠[SHUTi])在退伍军人中的疗效。

方法

我们在符合退伍军人健康管理局护理条件的持久自由行动、伊拉克自由行动和新黎明行动退伍军人中进行了一项单盲随机对照试验。参与者被随机分配(1:1)接受SHUTi(一个自我指导的交互式项目)或失眠教育网站(IEW),该网站提供非个性化的固定失眠信息。在基线、干预后、干预后6个月和干预后1年进行基于网络的评估。主要结局是自我报告的失眠严重程度(失眠严重程度指数[ISI])。次要结局是自我报告的心理和身体健康功能(退伍军人兰德36项健康调查)。探索性结局包括睡眠日记参数。

结果

在2018年4月至2019年1月期间随机分组的231名参与者(平均年龄39.3岁,标准差7.8岁;170/231,73.5%为男性;26/231,11.3%为黑人;172/231,74.5%为白人;10/231,4.3%为多种族;17/231,7.4%为其他;36/231,15.6%为西班牙裔)中,共有116名(50.2%)被随机分配到SHUTi组,115名(49.8%)被分配到IEW组。在意向性分析中,与IEW组参与者相比,SHUTi组参与者在所有时间点的ISI降低幅度均显著更大(广义η值分别为0.13、0.12和0.10;所有P<.0001)。这相当于SHUTi组在ISI上的估计变化差异更大,分别为-3.47(95%CI -4.78至-2.16)、-3.80(95%CI -5.34至-2.27)和-3.42(95%CI -4.97至-1.88)分。SHUTi组参与者的身体(6个月广义η=0.04;P=.004)和心理健康功能(6个月和1年广义η=0.04;P=.009和P=.005)有显著改善。SHUTi组的睡眠参数有显著改善(所有P<.05),尽管这些减少的模式和幅度因参数而异。未报告不良事件。

结论

自我管理的iCBT-I与失眠严重程度的即时和长期改善有关。研究结果表明,利用技术满足退伍军人的失眠治疗需求可能是一种有前景的方法。

试验注册

ClinicalTrials.gov NCT03366870;https://clinicaltrials.gov/ct2/show/NCT03366870 。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3eab/10709797/9634e49d48f7/mental_v10i1e50516_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3eab/10709797/736b24d0e397/mental_v10i1e50516_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3eab/10709797/9634e49d48f7/mental_v10i1e50516_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3eab/10709797/736b24d0e397/mental_v10i1e50516_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3eab/10709797/9634e49d48f7/mental_v10i1e50516_fig2.jpg

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