Institute for Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, 58 Turner Street, London, E1 2AB, UK.
Allergy and Respiratory Research Group, Usher Institute of Population Health Sciences and Informatics, Doorway 3, Medical School, Teviot Place, Edinburgh, EH8 9AG, UK.
Trials. 2020 Jan 6;21(1):18. doi: 10.1186/s13063-019-3800-y.
People with chronic obstructive pulmonary disease (COPD) are at increased risk of depression and anxiety, which greatly reduces their quality of life and is associated with worse outcomes; but these psychological co-morbidities are under-recognised and undertreated in COPD patients. Pulmonary rehabilitation (PR) improves mood for up to 6 months but health practitioners under-refer, and patients commonly fail to attend/complete PR. Research suggests that complex non-pharmacological interventions, including both psychological and exercise components, may reduce anxiety and depression in COPD. We have developed a tailored, cognitive behavioural approach (CBA) intervention for patients with COPD and co-morbid anxiety and/or depression ('TANDEM'), which precedes and optimises the benefits of currently offered PR. We hypothesise that such a psychological intervention, delivered by supervised, trained respiratory healthcare professionals, will improve mood in patients with mild to moderate anxiety and/or depression and encourage uptake and completion of PR.
We will conduct a multi-centre, pragmatic, randomised controlled trial of the TANDEM intervention compared to usual care across the Midlands, London, the South East and Bristol, UK. We will train healthcare professionals familiar with COPD to deliver the manualised, tailored, face-to-face, one-to-one intervention weekly for 6-8 weeks. We will recruit 430 participants from primary, community and secondary care with confirmed COPD and moderate to very severe airflow limitation, who are eligible for assessment for PR, and who screen positive for symptoms of mild/moderate depression and/or anxiety using the Hospital Anxiety and Depression scale (HADS). Participants will be randomised 1.25:1 (intervention: usual care). The co-primary outcomes are the HADS anxiety and depression subscale scores at 6 months; participants will be followed up to 12 months. Secondary outcomes include uptake and completion of PR and healthcare resource use. There will be a parallel process evaluation and a health economic evaluation.
The TANDEM intervention has the potential to optimise the unrealised synergy between a psychological intervention and PR. The CBA sessions will precede PR and target individuals' cognitions, behaviours and symptoms associated with anxiety and depression to decrease psychological morbidity and increase effective self-management amongst patients with COPD.
ISRCTN, ID: ISRCTN59537391. Registered on 20 March 2017. Protocol version 6.0, 22 April 2018.
患有慢性阻塞性肺疾病（COPD）的人患抑郁和焦虑症的风险增加，这大大降低了他们的生活质量，并与更差的结果相关；但是这些心理合并症在 COPD 患者中被低估和治疗不足。肺康复（PR）可改善情绪长达 6 个月，但健康从业者推荐不足，患者经常未能参加/完成 PR。研究表明，包括心理和运动成分在内的复杂非药物干预措施可能会降低 COPD 患者的焦虑和抑郁。我们为患有 COPD 和共病焦虑和/或抑郁的患者开发了一种针对个体的认知行为方法（CBA）干预措施（“TANDEM”），该方法先于并优化了目前提供的 PR 的益处。我们假设，由经过监督和培训的呼吸保健专业人员提供的这种心理干预措施将改善轻度至中度焦虑和/或抑郁患者的情绪，并鼓励他们接受和完成 PR。
我们将在英国中部、伦敦、东南部和布里斯托尔进行一项多中心、实用、随机对照试验，比较 TANDEM 干预与常规护理。我们将培训熟悉 COPD 的医疗保健专业人员，每周进行一次为期 6-8 周的个体化、量身定制、面对面的一对一干预。我们将从初级、社区和二级保健中招募 430 名确诊为 COPD 且气流受限中度至重度的患者，他们有资格接受 PR 评估，并且使用医院焦虑和抑郁量表（HADS）筛查出轻度/中度抑郁和/或焦虑症状。参与者将以 1.25:1（干预：常规护理）的比例随机分组。主要结局是 6 个月时 HADS 焦虑和抑郁分量表评分；参与者将随访 12 个月。次要结局包括 PR 的参与和完成情况以及医疗保健资源的使用。将进行平行的过程评估和健康经济评估。
TANDEM 干预有可能优化心理干预和 PR 之间未实现的协同作用。CBA 课程将在 PR 之前进行，针对的是与焦虑和抑郁相关的个人认知、行为和症状，以降低 COPD 患者的心理发病率并增强其有效的自我管理能力。
ISRCTN，ID：ISRCTN59537391。于 2017 年 3 月 20 日注册。方案版本 6.0，2018 年 4 月 22 日。
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