TY - JOUR
T1 - Tailored psychological intervention for anxiety or depression in COPD (TANDEM)
T2 - a randomised controlled trial
AU - Taylor, Stephanie J C
AU - Sohanpal, Ratna
AU - Steed, Liz
AU - Marshall, Karen
AU - Chan, Claire
AU - Yaziji, Nahel
AU - Barradell, Amy C
AU - Font-Gilabert, Paulino
AU - Healey, Andrew
AU - Hooper, Richard
AU - Kelly, Moira J
AU - Mammoliti, Kristie-Marie
AU - Priebe, Stefan
AU - Rajasekaran, Arvind
AU - Roberts, C Michael
AU - Rowland, Vickie
AU - Singh, Sally J
AU - Smuk, Melanie
AU - Underwood, Martin
AU - Waseem, Sarah
AU - White, Patrick
AU - Wileman, Vari
AU - Pinnock, Hilary
N1 - We are deeply grateful to all the study participants and to the many health care professionals and managerial staff who contributed to the study. This study is independent research, funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (project number 13/146/02). ST and VW were supported by the NIHR Applied Research Collaboration (ARC) North Thames. PFG and AH were supported by the NIHR ARC South London at King’s College Hospital NHS Foundation Trust. SS is supported by the NIHR Leicester Biomedical Research Centre. MU is supported by University Hospitals Coventry and Warwickshire. The views expressed in this publication are those of the authors and not necessarily those of the National Institute for Health Research or the Department of Health and Social Care.
Copyright ©The authors 2023.
PY - 2023/11/2
Y1 - 2023/11/2
N2 - 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.
AB - 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.
U2 - 10.1183/13993003.00432-2023
DO - 10.1183/13993003.00432-2023
M3 - Article
C2 - 37620042
SN - 0903-1936
VL - 62
JO - European Respiratory Journal
JF - European Respiratory Journal
IS - 5
ER -