TANDEM COPD Trial
Research type
Research Study
Full title
A tailored, cognitive behavioural approach intervention for mild to moderate anxiety and/or depression in people with chronic obstructive pulmonary disease (COPD): A randomised controlled trial
IRAS ID
216048
Contact name
Stephanie JC Taylor
Contact email
Sponsor organisation
Queen Mary University London
Duration of Study in the UK
2 years, 10 months, 31 days
Research summary
Research Summary
Many people with chronic obstructive pulmonary disease (COPD) are affected by anxiety and/or depression and their illness can feel burdensome both physically and emotionally. One main treatment for patients with COPD is pulmonary rehabilitation (PR); a package of exercise training and disease specific education. PR aims to help break the cycle of physical disability, associated anxiety, despondency, inactivity and isolation. Although PR is a well known effective treatment in COPD there is unfortunately poor patient uptake and programme completion, particularly in patients with anxiety and depression.
This study will evaluate a psychological cognitive behavioural approach (CBA) intervention, which links into and optimises the benefits of PR, with the aim of reducing mild/moderate anxiety and/or depression in people with moderate to severe COPD.
Eligible patients, following written consent, will be randomised to receive either the intervention (CBA intervention) or usual care. Those in the CBA intervention group will receive between five and eight 30-40 minute weekly sessions from trained respiratory health care professionals. 10-15 minute weekly telephone follow ups will also be scheduled with patients if they decide to attend the PR programme after completion of the CBA intervention.
The study duration is one year and all patient participants will be followed up at six and twelve months. The two groups will be compared to see if the intervention helped to reduce anxiety and/or depression among patient participants. Carers of patient participants will also be invited to the join the study (with patient permission). The intervention will not be targeted towards them but their well-being will also be assessed at 6 and 12 months.Summary of Results
People with long-standing lung problems such as chronic obstructive pulmonary disease (COPD) often also have anxiety and depression which further reduces their quality-of-life. Two existing treatments could help. Pulmonary rehabilitation (a programme of exercise and education) improves both the physical and mental health of people with COPD. Cognitive behavioural therapy (CBT) (a talking therapy) may reduce anxiety and depression. TANDEM linked these two treatments by providing talking therapy based on CBT during the waiting time following referral for pulmonary rehabilitation.
The TANDEM treatment was delivered by respiratory healthcare professionals (e.g. nurses or physiotherapists) trained to deliver the talking therapy in six to eight weekly sessions. The sessions were conducted in the participant’s home (or another convenient locality), with brief telephone support during the pulmonary rehabilitation.
Of 423 participants recruited to the study, 242 received the TANDEM talking therapy and 181 received usual care (including a referral to pulmonary rehabilitation). We measured mental health, quality-of-life, social life, attendance at pulmonary rehabilitation and healthcare use in both groups at 6-months and 12-months. 43 carers joined the study and we assessed their mental-wellbeing. We interviewed patients, carers and health professionals to find out their views and experience of the TANDEM treatment. We also examined whether the TANDEM treatment was good value for money.
The TANDEM treatment did not improve the mental or the physical health of people with COPD. It cost the NHS an extra £770 per patient, which was not good value for money. The TANDEM treatment was well received, and many participants told us how it had helped them. Professionals noted how participants did not just have COPD, but were coping with many physical, mental and social problems.
TANDEM was not effective: other strategies will be needed to help people with COPD and mental health problems live with their condition.REC name
London - Queen Square Research Ethics Committee
REC reference
17/LO/0095
Date of REC Opinion
27 Feb 2017
REC opinion
Further Information Favourable Opinion