Discussion
depression, COPD, anxiety, ’
COPD, DISEASE, RECRUITMENT
Following careful intervention development based on previous work [Overall, our study suggests that psychological interventions with a cognitive behavioural approach do not improve symptoms of anxiety or depression in patients with advanced COPD, nor do these interventions improve disease-related quality of life or uptake or completion of pulmonary rehabilitation, although they could help with other important symptoms not assessed in this study. Despite these negative results, our study underlines the very high unmet need resulting from psychological distress in people with moderate to very severe COPD; 42% of those we screened for eligibility had symptoms of mild to moderate anxiety or depression.This is by far the largest randomised controlled trial of any psychological intervention for people with COPD, and one of the few to include only those with symptoms of anxiety and/or depression at baseline [A Cochrane review of psychological therapies for the treatment of anxiety in COPD identified only three studies, all of which included patients with anxiety and depression [Our study was adequately powered with very good retention at 12-month follow-up. Allocation was fully concealed and participants were randomised after collection of baseline data. Although we could not mask the participants or facilitators to allocation, all healthcare professionals involved in their care were unaware of participants’ allocation. Outcome assessors were masked and accidental unmasking was rare. Trial statisticians were masked prior to the statistical analysis plan being signed off and the database being locked. Patient and Public Involvement colleagues were involved throughout the trial [The trial had some limitations. Only half of the nearly 4500 people contacted by their clinical team as potentially eligible responded. Although written English was not a requirement, we required sufficient fluency in English to consent to the study and to participate in the intervention. Our recruitment sites covered areas with geographically and ethnically diverse populations, but we did not formally collect participants’ ethnicity so are unable to comment on the mix within our study.The question arises why the TANDEM intervention was not effective. It may be difficult for any relatively brief cognitive behavioural intervention to influence psychological comorbidities that have developed alongside a multicomponent condition which has developed across the life course [This trial indicates that cognitive behavioural interventions may not improve symptoms of anxiety or depression in patients with advanced COPD. Further research is needed to develop and evaluate alternative approaches to relieve the disease burden for this patient group. We suggest that three different approaches should be investigated. First, respiratory healthcare professional-delivered psychological approaches might be effective if delivered much earlier in the trajectory of this condition and could then make a lasting change to patients. Second, although pulmonary rehabilitation is known to improve mood and confers many other benefits for people with COPD, we found only 50% of those eligible for referral to pulmonary rehabilitation were actually referred and only 30% of those who attended completed a course. There is an urgent need to identify why patients are not being referred to pulmonary rehabilitation. Alongside this we need more research around supporting individuals to take up and complete a course of pulmonary rehabilitation, and we need to identify effective, alternative interventions for those individuals who will never be able to attend conventional pulmonary rehabilitation. Finally, we have identified considerable unmet need in a group of people with advanced COPD. There should be research in how to support this group more effectively, 