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

This multi-centre, 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 to usual care (UC).People with COPD and moderate to very severe airways obstruction and Hospital Anxiety and Depression Scale subscales scores indicating mild to moderate anxiety (HADS-A) and/or depression (HADS-D), were randomised 1.25:1, intervention (242): UC (181). Respiratory health professionals delivered the intervention face-to-face over 6-8 weeks. Co-primary outcomes were HADS-A and HADS-D measured six months post-randomisation. Secondary outcomes at six 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 5-level version, smoking status, completion of pulmonary rehabilitation (PR) and health and social care resource use.The intervention did not improve anxiety (HADS-A mean difference, 95% CI, -0.60, -1.40 to 0.21) or depression (HADS-D -0.66, -1.39 to 0.07) at six months. The intervention did not improve any secondary outcomes at either timepoint, nor did it influence completion of PR 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.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.