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针对慢性阻塞性肺疾病患者的基于数字正念的干预措施——一项多中心试点及可行性随机对照试验

Digital mindfulness-based intervention for people with COPD - a multicentre pilot and feasibility RCT.

作者信息

Tschenett Hannah, Vafai-Tabrizi Florian, Zwick Ralf Harun, Valipour Arschang, Funk Georg-Christian, Nater Urs M

机构信息

Department of Clinical and Health Psychology, Faculty of Psychology, University of Vienna, Vienna, Austria.

Karl Landsteiner Institute for Lung Research and Pulmonary Oncology, Vienna, Austria.

出版信息

Respir Res. 2025 May 26;26(1):199. doi: 10.1186/s12931-025-03243-4.

DOI:10.1186/s12931-025-03243-4
PMID:40420253
Abstract

BACKGROUND

Mindfulness-based interventions (MBIs) are effective in improving mental and physical health in various chronic conditions. While the GOLD 2024 report recommends MBIs for chronic obstructive pulmonary disease (COPD), scientific evidence in this specific population is scarce. This prospective randomised controlled pilot study investigated the feasibility of an 8-week digital MBI and its preliminary effects on mental and physical health in COPD.

METHODS

Psychologically burdened COPD patients (63 ± 7 years, 61% female, FEV1% 41 ± 19) were randomly allocated to the MBI group (n = 14; daily 10-15-minute audio-guided meditation via smartphone) or a waitlist control group (n = 16). Primary outcomes included the intervention's feasibility (dropouts, MBI usage rates, interview and questionnaire responses) and its preliminary effects on symptoms of anxiety and depression (Hospital Anxiety and Depression Scale, HADS). Secondary outcomes included its preliminary effects on the COPD Assessment Test (CAT), Chronic Respiratory Disease Questionnaire (CRQ-SAS), Perceived Stress Scale (PSS-10), and biological stress markers. Exploratory outcomes included momentary subjective stress, anxiety, and dyspnoea after meditating.

RESULTS

The results indicated that the intervention was feasible (81% usage rate; 93% and 71% found the MBI enjoyable and helpful, respectively), with 21% dropout. A statistically significant intervention (time x group) effect was found for anxiety (HADS-A, p =.010, η = 0.11) and emotional functioning (CRQ-SAS, p =.004, η = 0.14), but not for depression (HADS-D, p =.060, η = 0.06) or any other secondary outcome after 8 weeks. Momentary subjective stress (p <.001, η = 0.75), anxiety (p =.022, η = 0.75), and dyspnoea (p <.001, η = 0.70) were significantly reduced after meditating.

CONCLUSIONS

The digital MBI was feasible, with preliminary effects indicating improvements in anxiety and emotional functioning after 8 weeks as well as momentary outcomes after meditating. Future large-scale trials should further assess the effectiveness of digital MBIs in this context. However, the findings suggest that digital MBIs might be promising and effective low-threshold add-on treatments in clinical settings.

TRIAL REGISTRATION

The article has been preregistered at ClinicalTrials.gov (identifier: NCT04769505, date: 23rd February 2021).

摘要

背景

基于正念的干预措施(MBIs)在改善各种慢性病患者的身心健康方面具有显著效果。虽然《2024年慢性阻塞性肺疾病全球倡议(GOLD)报告》推荐将MBIs应用于慢性阻塞性肺疾病(COPD)患者,但针对这一特定人群的科学证据仍然较为匮乏。本项前瞻性随机对照试验研究了为期8周的数字化MBI干预在COPD患者中的可行性及其对身心健康的初步影响。

方法

心理负担较重的COPD患者(年龄63±7岁,女性占61%,第1秒用力呼气容积占预计值百分比[FEV1%]为41±19)被随机分为MBI组(n = 14;通过智能手机每天进行10 - 15分钟的音频引导冥想)或等待列表对照组(n = 16)。主要结局指标包括干预措施的可行性(退出率、MBI使用率、访谈和问卷调查回复情况)及其对焦虑和抑郁症状的初步影响(医院焦虑抑郁量表,HADS)。次要结局指标包括其对慢性阻塞性肺疾病评估测试(CAT)、慢性呼吸系统疾病问卷(CRQ - SAS)、感知压力量表(PSS - 10)和生物应激标志物的初步影响。探索性结局指标包括冥想后瞬间的主观压力、焦虑和呼吸困难情况。

结果

结果表明,该干预措施是可行的(使用率为81%;分别有93%和71%的患者认为MBI令人愉悦且有帮助),退出率为21%。在焦虑(HADS - A,p = 0.010,η = 0.11)和情绪功能(CRQ - SAS,p = 0.004,η = 0.14)方面发现了具有统计学意义的干预(时间×组间)效应,但在抑郁(HADS - D,p = 0.060,η = 0.06)或8周后的任何其他次要结局指标方面未发现该效应。冥想后瞬间的主观压力(p < 0.001,η = 0.75)、焦虑(p = 0.022,η = 0.75)和呼吸困难(p < 0.001,η = 0.70)均显著降低。

结论

数字化MBI是可行的,初步结果表明,8周后焦虑和情绪功能得到改善,且冥想后瞬间的结局指标也有所改善。未来的大规模试验应进一步评估数字化MBIs在此背景下的有效性。然而,研究结果表明,数字化MBIs在临床环境中可能是有前景且有效的低门槛辅助治疗方法。

试验注册

本文已在ClinicalTrials.gov上进行预注册(标识符:NCT04769505,日期:2021年2月23日)。

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