Newcastle Chronic Obstructive Pulmonary Disease (COPD) Cognitive Behavioural Therapy (CBT) care study : a randomised controlled trial (funded by the National Institute for Health Research)

Abstract

Title - Randomised controlled trial (RCT) to identify if cognitive behavioural therapy (CBT) with respiratory nurses reduces anxiety in patients with chronic obstructive pulmonary disease (COPD). (Trial Registration - ISCRCTN55206395). Introduction Anxiety and depression are common comorbidities in COPD. The aim of this research is to identify if CBT delivered by respiratory nurses reduces anxiety in a large COPD population. Methods Study Design – Prospective RCT. Sample Size - 112 for each arm were required. Approach – 1,518 patients were approached: 279 were recruited. Randomisation –Electronic randomisation was used. Intervention – CBT with a respiratory nurse plus self-help leaflets. Comparison – Self- help leaflets. Main Outcomes -Primary outcome was symptoms of anxiety. Secondary outcomes were depression and quality of life. Data collection – was undertaken by nurses blinded to treatment allocation. Results The groups were well matched at baseline. The CBT intervention achieved clinical and statistically significant change for all outcomes: HADS-Anxiety group mean change of 3.4 (SD 4.20) p=<0.001 CI 2.62- 4.17; HADS-Depression 2.20 (SD 3.62) p=<001, CI 1.53 – 2.87; CAT 2.7 (SD 6.36) p=< 0.001, CI 1.49 – 3.88 and EQ-5D utility group mean change of 0.08 (SD 0.31) p=0.007, CI - 0.14 - -0.02 at 3 months. The leaflet group achieved a clinical and significant reduction in group mean change of 1.9 (SD 3.80) p= <0.001, CI 1.19 - 2.55 in HADS-Anxiety and CAT 2.06 (SD 5.34) p=<0.001, CI 1.09 – 3.04. The HADS-Depression group mean change was only statistically significant 1.07 (SD 3.55) p=0.001, CI 0.44 – 1.71. The EQ-5D utility scores group mean change of - 0.003 (SD 0.31) p= 0.09 CI -0.06 – 0.05 which did not reach statistical or clinical significance. Conclusion Overall the CBT intervention was superior to the leaflet intervention. Funded by: National Institute for Health Research (NIHR).