Tailored, psychological intervention for anxiety or depression in people with chronic obstructive pulmonary disease (COPD), TANDEM (Tailored intervention for ANxiety and DEpression Management in COPD): protocol for a randomised controlled trial

Trials

Hilary Pinnock¹  Sally Singh²  Moira Kelly³  Stephanie J. C. Taylor³  Stefan Priebe³  Melanie Smuk³  Ratna Sohanpal³  Liz Steed³  Sarah Saqi-Waseem³  C. Michael Roberts³  Claire Chan³  Andy Healey⁴  Chris Warburton⁵  Karen Heslop Marshall⁶  Patrick White⁷  Martin Underwood⁸ 

[1] Allergy and Respiratory Research Group, Usher Institute of Population Health Sciences and Informatics, Doorway 3, Medical School, Teviot Place, EH8 9AG, Edinburgh, UK;Department of Respiratory Sciences, College of Life Sciences, NIHR Leicester Biomedical Research Centre - Respiratory, Glenfield Hospital, University of Leicester, Groby Road, LE3 9QP, Leicester, UK;Institute for Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, 58 Turner Street, E1 2AB, London, UK;King’s Health Economics, Institute of Psychiatry, Psychology and Neuroscience, King’s College London, De Crespigny Park, Denmark Hill, SE5 8AF, London, UK;London, UK;Newcastle upon Tyne NHS Hospitals Foundation Trust, Chest Clinic, New Victoria Wing RVI Hospital, Queen Victoria Road, NE1 4LP, Newcastle upon Tyne, UK;School of Population Health and Environmental Sciences, King’s College London, Great Maze Pond, SE1 1UL, London, UK;Warwick CTU, Warwick Medical School, Gibbet Hill Road, Coventry, CV4 7AL and University Hospitals of Coventry and Warwickshire, Clifford Bridge Road, CV2 2DX, Coventry, UK;

关键词: COPD;    Co-morbidity;    Depression;    Anxiety;    Cognitive behavioural approach;    Pulmonary rehabilitation;    Complex intervention;    Pragmatic randomised controlled trial;    Clinical effectiveness;    Health economic evaluation;   

DOI  :  10.1186/s13063-019-3800-y

来源: Springer

【 摘 要 】

BackgroundPeople 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.MethodsWe 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.DiscussionThe 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.Trial registrationISRCTN, ID: ISRCTN59537391. Registered on 20 March 2017. Protocol version 6.0, 22 April 2018.

【 授权许可】

CC BY