Randomized Controlled Trial

. 2023 Nov 2;62(5):2300432.

doi: 10.1183/13993003.00432-2023. Print 2023 Nov.

Tailored psychological intervention for anxiety or depression in COPD (TANDEM): a randomised controlled trial

Stephanie J C Taylor^{1

2}, Ratna Sohanpal^{3

2}, Liz Steed³, Karen Marshall⁴, Claire Chan³, Nahel Yaziji⁵, Amy C Barradell⁶, Paulino Font-Gilabert⁵, Andrew Healey⁵, Richard Hooper³, Moira J Kelly³, Kristie-Marie Mammoliti⁷, Stefan Priebe³, Arvind Rajasekaran⁸, C Michael Roberts⁹, Vickie Rowland¹⁰, Sally J Singh¹¹, Melanie Smuk¹², Martin Underwood^{13

14}, Sarah Waseem¹⁵, Patrick White¹⁰, Vari Wileman¹⁶, Hilary Pinnock¹⁷

Affiliations

¹ Wolfson Institute of Population Health, Queen Mary University of London, London, UK s.j.c.taylor@qmul.ac.uk.
² Joint first authors.
³ Wolfson Institute of Population Health, Queen Mary University of London, London, UK.
⁴ Chest Clinic, RVI Hospital, Newcastle upon Tyne NHS Foundation Trust, Newcastle upon Tyne, UK.
⁵ Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
⁶ NIHR Leicester Biomedical Research Centre - Respiratory, Glenfield Hospital, University Hospitals of Leicester NHS Trust, Leicester, UK.
⁷ WHO Collaborating Centre on Global Women's Health, Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.
⁸ Department of Respiratory Medicine, Sandwell and West Birmingham Hospitals NHS Trust, Birmingham, UK.
⁹ Centre for Digital Transformation of Health, University of Melbourne, Melbourne, Australia.
¹⁰ Department of Population Health, School of Life Course and Population Sciences, King's College London, London, UK.
¹¹ Department of Respiratory Sciences, Department of Health Sciences, University of Leicester, Leicester, UK.
¹² Blizard Institute, Queen Mary University of London, London, UK.
¹³ Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.
¹⁴ University Hospitals of Coventry and Warwickshire, Coventry, UK.
¹⁵ Women's Health Division, University College Hospital, London, UK.
¹⁶ Health Psychology, School of Mental Health and Psychological Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
¹⁷ Allergy and Respiratory Research Group, Usher Institute, The University of Edinburgh, Edinburgh, UK.

PMID: 37620042
PMCID: PMC10620475
DOI: 10.1183/13993003.00432-2023

Randomized Controlled Trial

Tailored psychological intervention for anxiety or depression in COPD (TANDEM): a randomised controlled trial

Stephanie J C Taylor et al. Eur Respir J. 2023.

. 2023 Nov 2;62(5):2300432.

doi: 10.1183/13993003.00432-2023. Print 2023 Nov.

Authors

Affiliations

¹ Wolfson Institute of Population Health, Queen Mary University of London, London, UK s.j.c.taylor@qmul.ac.uk.
² Joint first authors.
³ Wolfson Institute of Population Health, Queen Mary University of London, London, UK.
⁴ Chest Clinic, RVI Hospital, Newcastle upon Tyne NHS Foundation Trust, Newcastle upon Tyne, UK.
⁵ Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
⁶ NIHR Leicester Biomedical Research Centre - Respiratory, Glenfield Hospital, University Hospitals of Leicester NHS Trust, Leicester, UK.
⁷ WHO Collaborating Centre on Global Women's Health, Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.
⁸ Department of Respiratory Medicine, Sandwell and West Birmingham Hospitals NHS Trust, Birmingham, UK.
⁹ Centre for Digital Transformation of Health, University of Melbourne, Melbourne, Australia.
¹⁰ Department of Population Health, School of Life Course and Population Sciences, King's College London, London, UK.
¹¹ Department of Respiratory Sciences, Department of Health Sciences, University of Leicester, Leicester, UK.
¹² Blizard Institute, Queen Mary University of London, London, UK.
¹³ Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.
¹⁴ University Hospitals of Coventry and Warwickshire, Coventry, UK.
¹⁵ Women's Health Division, University College Hospital, London, UK.
¹⁶ Health Psychology, School of Mental Health and Psychological Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
¹⁷ Allergy and Respiratory Research Group, Usher Institute, The University of Edinburgh, Edinburgh, UK.

PMID: 37620042
PMCID: PMC10620475
DOI: 10.1183/13993003.00432-2023

Abstract

Background: The TANDEM multicentre, pragmatic, randomised controlled trial evaluated whether a tailored psychological intervention based on a cognitive behavioural approach for people with COPD and symptoms of anxiety and/or depression improved anxiety or depression compared with usual care (control).

Methods: People with COPD and moderate to very severe airways obstruction and Hospital Anxiety and Depression Scale subscale scores indicating mild to moderate anxiety (HADS-A) and/or depression (HADS-D) were randomised 1.25:1 (242 intervention and 181 control). Respiratory health professionals delivered the intervention face-to-face over 6-8 weeks. Co-primary outcomes were HADS-A and HADS-D measured 6 months post-randomisation. Secondary outcomes at 6 and 12 months included: HADS-A and HADS-D (12 months), Beck Depression Inventory II, Beck Anxiety Inventory, St George's Respiratory Questionnaire, social engagement, the EuroQol instrument five-level version (EQ-5D-5L), smoking status, completion of pulmonary rehabilitation, and health and social care resource use.

Results: The intervention did not improve anxiety (HADS-A mean difference -0.60, 95% CI -1.40-0.21) or depression (HADS-D mean difference -0.66, 95% CI -1.39-0.07) at 6 months. The intervention did not improve any secondary outcomes at either time-point, nor did it influence completion of pulmonary rehabilitation or healthcare resource use. Deaths in the intervention arm (13/242; 5%) exceeded those in the control arm (3/181; 2%), but none were associated with the intervention. Health economic analysis found the intervention highly unlikely to be cost-effective.

Conclusion: This trial has shown, beyond reasonable doubt, that this cognitive behavioural intervention delivered by trained and supervised respiratory health professionals does not improve psychological comorbidity in people with advanced COPD and depression or anxiety.

PubMed Disclaimer

Conflict of interest statement

Conflict of interest: L. Steed reports support for the present manuscript from the NIHR Health Technology Assessment programme (project number 13/146/02), and also reports lecture honoraria from the IPCRG, outside the submitted work. K. Marshall reports support for the present manuscript from the NIHR Health Technology Assessment programme (project number 13/146/02), and also reports lecture honoraria, outside the submitted work. S.J. Singh reports support for the present manuscript from the NIHR Health Technology Assessment programme (project number 13/146/02); in addition, S.J. Singh also reports grants from the NIHR (NIHR 202020 and senior investigator grant), Wellcome Doctoral Training Programme, HTA Project Grant (NIHR 131015), NIHR DHSC/UKRI COVID-19 Rapid Response Initiative, NIHR Global Research Group (NIHR 17/63/20) and Actegy Limited, lecture honoraria from GSK, Ministry of Justice, CIPLA and Sherbourne Gibbs, advisory board participation with NICE (Expert Adviser Panel – Long COVID) and the Wales Long COVID Advisory Board (expired), and leadership roles with the ATS (Pulmonary Rehabilitation Assembly Chair), RCP Pulmonary Rehabilitation Accreditation Scheme and NACAP Audit for Pulmonary Rehabilitation, outside the submitted work. M. Underwood is chief investigator or co-investigator on previous and current research grants from the UK NIHR, Arthritis Research UK and on grants funded by the Australian NHMRC and Norwegian MRC; he was an NIHR Senior Investigator until March 2021. He has received travel expenses for speaking at conferences from the professional organisations hosting the conferences. He is a director and shareholder of Clinvivo Ltd. He is part of an academic partnership with Serco Ltd, funded by the European Social Fund. He is a co-investigator studies that are, or have had, additional support from Stryker Ltd. Until March 2020 he received a fee as an NIHR journal editor and editors group member. V. Wileman reports support for the present manuscript from the NIHR Applied Research Collaboration (ARC) North Thames. P. White is a chief investigator or co-investigator on multiple previous and current research grants from the NIHR, and reports travel expenses for speaking at conferences from the professional organisations hosting the conferences. H. Pinnock reports support for the present manuscript from the NIHR Health Technology Assessment programme (project number 13/146/02), and also reports lecture honoraria from Sandoz, Teva and Boehringer Ingelheim, outside the submitted work. S.J.C. Taylor, R. Sohanpal, S. Priebe, A. Healey, S. Waseem, M.J. Kelly and C.M. Roberts report support for the present manuscript from the NIHR Health Technology Assessment programme (project number 13/146/02). All other authors have nothing to disclose.

Figures

**FIGURE 1**
Trial profile. ^#: two participants were randomised (both to the intervention) in error as they did not meet the eligibility criteria. They were picked up during the ongoing data cleaning process for data monitoring and ethics committee reports and thus were found in an unbiased way. These two participants were excluded from all analyses.

See this image and copyright information in PMC

Comment in

Can the curse of mood disorders in COPD be lifted and enable pulmonary rehabilitation?
Evans R, Doe G. Evans R, et al. Eur Respir J. 2023 Nov 2;62(5):2301538. doi: 10.1183/13993003.01538-2023. Print 2023 Nov. Eur Respir J. 2023. PMID: 37918881 No abstract available.
Reply: Cognitive behavioural therapy sessions approach ineffective for anxiety and depression in COPD: is the door closed for good?
Taylor SJC, Sohanpal R, Steed L, Marshall K, Kelly MJ, Underwood M, White P, Pinnock H. Taylor SJC, et al. Eur Respir J. 2024 Jan 4;63(1):2302149. doi: 10.1183/13993003.02149-2023. Print 2024 Jan. Eur Respir J. 2024. PMID: 38176703 Free PMC article.
Cognitive behavioural therapy sessions approach ineffective for anxiety and depression in COPD: is the door closed for good?
Yohannes AM, Iyer AS, Hoth KF, Dransfield MT. Yohannes AM, et al. Eur Respir J. 2024 Jan 4;63(1):2301857. doi: 10.1183/13993003.01857-2023. Print 2024 Jan. Eur Respir J. 2024. PMID: 38176705 No abstract available.

References

1. Vanfleteren LEGW, Spruit MA, Wouters EFM, et al. . Management of chronic obstructive pulmonary disease beyond the lungs. Lancet Respir Med 2016; 4: 911–924. doi:10.1016/S2213-2600(16)00097-7 - DOI - PubMed
1. Tselebis A, Pachi A, Ilias I, et al. . Strategies to improve anxiety and depression in patients with COPD: a mental health perspective. Neuropsychiatr Dis Treat 2016; 12: 297–328. doi:10.2147/NDT.S79354 - DOI - PMC - PubMed
1. Yohannes AM, Alexopoulos GS. Depression and anxiety in patients with COPD. Eur Respir Rev 2014; 23: 345–349. doi:10.1183/09059180.00007813 - DOI - PMC - PubMed
1. Pooler A, Beech R. Examining the relationship between anxiety and depression and exacerbations of COPD which results in hospital admission: a systematic review. Int J COPD 2014; 9: 315–330. doi:10.2147/COPD.S53255 - DOI - PMC - PubMed
1. Pollok J, van Agteren JEM, Esterman AJ, et al. . Psychological therapies for the treatment of depression in chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2019; 3: CD012347. doi:10.1002/14651858.CD012347.pub2 - DOI - PMC - PubMed

Publication types

Actions
Actions
Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Tailored psychological intervention for anxiety or depression in COPD (TANDEM): a randomised controlled trial

Affiliations

Tailored psychological intervention for anxiety or depression in COPD (TANDEM): a randomised controlled trial

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

Comment in

References

Publication types

MeSH terms

Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

Medical