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

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.

Informations de copyright

Copyright ©The authors 2023.

Déclaration de conflit d'intérêts

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.