RCT Abstract - Tailored psychological intervention for anxiety/depression in people with COPD (TANDEM): a randomised controlled trial

Introduction: Systematic reviews suggest cognitive behaviour therapy may have a role in the management of people with COPD. We trained experienced respiratory healthcare professionals to deliver a cognitive behavioural approach talking therapy (TANDEM intervention) to people with moderate-very severe COPD and mild-moderate anxiety and/or depression. The intervention preceded commencement of routine pulmonary rehabilitation (PR). Aim: To determine effectiveness and cost effectiveness of the TANDEM intervention. Methods: Individual patient assessor-blind RCT comparing TANDEM with usual care (randomisation ratio 1.25:1). Usual care received routine PR referral. Primary outcome was Hospital Anxiety and Depression Scale anxiety and depression scores (HADS-A, HADS-D) six months post-randomisation. Secondary outcomes at 6m and 12m included: St George’s Respiratory Questionnaire (SGRQ), social engagement, healthcare resource use, completion of PR, smoking cessation and cost effectiveness. Results: We randomised 423 participants: intervention 242; control 181. Follow up at 6 and 12 months was 94% and 90%, respectively. Although the intervention was delivered with good fidelity, mean differences (MD) in HADS scores at 6 months ruled out clinically meaningful effect from the intervention (MD (95% CI): HADS-A -0.59 (-1.40; 0.21); HADS-D -0.66 (-1.39; 0.07)) with similar results at 12 months. There were no significant differences in quality of life (SGRQ MD: 0.06 (-3.33; 3.45). Conclusion: Our definitive RCT found that cognitive behavioural approaches delivered by respiratory professionals did not improve anxiety, depression or quality of life in people with COPD.