Internet-delivered cognitive-behaviour therapy for anxiety related to asthma: study protocol for a randomised controlled trial.

IF 3.6 3区医学 Q1 RESPIRATORY SYSTEM

BMJ Open Respiratory Research Pub Date : 2024-05-27 DOI:10.1136/bmjresp-2023-002035

Marianne Bonnert, Stephen Nash, Erik M Andersson, Sten Erik Bergström, Christer Janson, Catarina Almqvist

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引用次数: 0

Abstract

Introduction: There is an established association between asthma and anxiety. The overlap between asthma symptoms and symptoms of anxiety may cause individuals to overestimate their asthma severity and restrict their daily activities leading to a low quality of life. There is currently weak evidence for treatments targeting anxiety related to asthma, but cognitive-behavioural therapy (CBT) has shown some promising but mixed results. The current randomised controlled trial will investigate if exposure-based internet-delivered CBT (Internet-CBT) is more effective than treatment as usual+medical education (TAU+ME) to relieve symptoms of anxiety and asthma control.

Methods and analysis: 90 participants will be randomised 1:1 to 8 weeks of Internet-CBT or TAU+ME. The primary outcome, the patient-reported Catastrophising Asthma Scale, will be analysed from baseline to the primary endpoint at 16 weeks using hierarchical linear mixed model of the slope over time. Secondary outcomes, such as asthma control, quality of life and forced expiratory volume in 1 s, will be analysed correspondingly.

Ethics and dissemination: All participants will be informed about the study and leave their consent before study entry. All results will be analysed at group level and reported through publication in a peer-reviewed scientific journal within the field. The study received ethical approval by the Swedish Ethical Review Authority in January 2020 (ID: 2019-05985; 2022-01117-02).

Trial registration number: Registered at ClinicalTrials.gov (ID: NCT04230369).

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针对哮喘相关焦虑症的互联网认知行为疗法：随机对照试验研究方案。

简介哮喘与焦虑之间存在关联。哮喘症状和焦虑症状的重叠可能会导致患者高估自己的哮喘严重程度，限制日常活动，从而降低生活质量。目前，针对与哮喘有关的焦虑症的治疗方法证据不足，但认知行为疗法（CBT）显示出了一些有希望的结果，但结果好坏参半。目前的随机对照试验将调查在缓解焦虑症状和控制哮喘方面，基于暴露的互联网CBT（Internet-CBT）是否比常规治疗+医学教育（TAU+ME）更有效。方法与分析：90名参与者将按1:1的比例随机接受为期8周的互联网CBT或TAU+ME治疗。将使用分层线性混合模型分析从基线到16周主要终点的主要结果，即患者报告的哮喘焦虑量表随时间变化的斜率。次要结果，如哮喘控制、生活质量和 1 秒用力呼气量，也将进行相应分析：伦理和传播：所有参与者都将被告知本研究的相关信息，并在进入研究前表示同意。所有结果都将在小组层面进行分析，并在该领域的同行评审科学杂志上发表。该研究于2020年1月获得瑞典伦理审查局的伦理批准（ID：2019-05985；2022-01117-02）：注册于 ClinicalTrials.gov（ID：NCT04230369）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

BMJ Open Respiratory Research RESPIRATORY SYSTEM-

CiteScore

6.60

自引率

2.40%

发文量

审稿时长

12 weeks

期刊介绍： BMJ Open Respiratory Research is a peer-reviewed, open access journal publishing respiratory and critical care medicine. It is the sister journal to Thorax and co-owned by the British Thoracic Society and BMJ. The journal focuses on robustness of methodology and scientific rigour with less emphasis on novelty or perceived impact. BMJ Open Respiratory Research operates a rapid review process, with continuous publication online, ensuring timely, up-to-date research is available worldwide. The journal publishes review articles and all research study types: Basic science including laboratory based experiments and animal models, Pilot studies or proof of concept, Observational studies, Study protocols, Registries, Clinical trials from phase I to multicentre randomised clinical trials, Systematic reviews and meta-analyses.