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自我指导型手机应用程序和电话提供的正念训练方案与重症幸存者教育方案相比对其效果:一项先导随机临床试验。

Effects of mindfulness training programmes delivered by a self-directed mobile app and by telephone compared with an education programme for survivors of critical illness: a pilot randomised clinical trial.

机构信息

Division of Pulmonary and Critical Care Medicine, Department of Medicine, Duke University, Durham, North Carolina, USA.

Program to Support People and Enhance Recovery, Duke University, Durham, North Carolina, USA.

出版信息

Thorax. 2019 Jan;74(1):33-42. doi: 10.1136/thoraxjnl-2017-211264. Epub 2018 May 23.

Abstract

BACKGROUND

Patients who are sick enough to be admitted to an intensive care unit (ICU) commonly experience symptoms of psychological distress after discharge, yet few effective therapies have been applied to meet their needs.

METHODS

Pilot randomised clinical trial with 3-month follow-up conducted at two academic medical centres. Adult (≥18 years) ICU patients treated for cardiorespiratory failure were randomised after discharge home to 1 of 3 month-long interventions: a self-directed mobile app-based mindfulness programme; a therapist-led telephone-based mindfulness programme; or a web-based critical illness education programme.

RESULTS

Among 80 patients allocated to mobile mindfulness (n=31), telephone mindfulness (n=31) or education (n=18), 66 (83%) completed the study. For the primary outcomes, target benchmarks were exceeded by observed rates for all participants for feasibility (consent 74%, randomisation 91%, retention 83%), acceptability (mean Client Satisfaction Questionnaire 27.6 (SD 3.8)) and usability (mean Systems Usability Score 89.1 (SD 11.5)). For secondary outcomes, mean values (and 95% CIs) reflected clinically significant group-based changes on the Patient Health Questionnaire depression scale (mobile (-4.8 (-6.6, -2.9)), telephone (-3.9 (-5.6, -2.2)), education (-3.0 (-5.3, 0.8)); the Generalized Anxiety Disorder scale (mobile -2.1 (-3.7, -0.5), telephone -1.6 (-3.0, -0.1), education -0.6 (-2.5, 1.3)); the Post-Traumatic Stress Scale (mobile -2.6 (-6.3, 1.2), telephone -2.2 (-5.6, 1.2), education -3.5 (-8.0, 1.0)); and the Patient Health Questionnaire physical symptom scale (mobile -5.3 (-7.0, -3.7), telephone -3.7 (-5.2, 2.2), education -4.8 (-6.8, 2.7)).

CONCLUSIONS

Among ICU patients, a mobile mindfulness app initiated after hospital discharge demonstrated evidence of feasibility, acceptability and usability and had a similar impact on psychological distress and physical symptoms as a therapist-led programme. A larger trial is warranted to formally test the efficacy of this approach.

TRIAL REGISTRATION NUMBER

Results, NCT02701361.

摘要

背景

在因心肺衰竭而住进重症监护病房(ICU)的患者中,常见出院后出现心理困扰症状,但针对这些需求,应用的有效疗法却寥寥无几。

方法

在两个学术医疗中心进行了为期 3 个月随访的试点随机临床试验。在出院回家后,将接受过心肺复苏治疗的成年(≥18 岁)ICU 患者随机分配至以下 3 种为期 1 个月的干预措施之一:自我指导的基于移动应用的正念课程;治疗师主导的基于电话的正念课程;或基于网络的重病教育计划。

结果

在 80 名被分配至移动正念(n=31)、电话正念(n=31)或教育(n=18)组的患者中,有 66 名(83%)完成了研究。对于主要结局,所有参与者的所有指标均超过了目标基准,其可行性指标(同意率 74%,随机化率 91%,保留率 83%)、可接受性(客户满意度问卷平均得分 27.6(SD 3.8))和可用性(系统可用性得分平均 89.1(SD 11.5))都达到了要求。对于次要结局,移动组(抑郁量表平均分(-4.8(-6.6,-2.9))、电话组(-3.9(-5.6,-2.2))、教育组(-3.0(-5.3,0.8))的患者在患者健康问卷抑郁量表、广泛性焦虑障碍量表、创伤后应激量表和患者健康问卷身体症状量表上的平均得分(和 95%CI)均反映了基于群组的、具有临床意义的变化。

结论

在 ICU 患者中,出院后启动移动正念应用程序具有可行性、可接受性和可用性的证据,且在心理困扰和身体症状方面与治疗师主导的项目具有相似的效果。需要更大规模的试验来正式检验该方法的疗效。

试验注册号

结果,NCT02701361。

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