Abstract
Background
People with COPD are at increased risk of depression and anxiety, which greatly reduce quality of life and are associated with worse outcomes; but these psychological co-morbidities are under-recognised and undertreated in COPD. Pulmonary rehabilitation (PR) improves mood for up to six months but health practitioners under-refer, and patients commonly fail to attend/complete PR. Research suggests complex non-pharmacological interventions including both psychological and exercise components may reduce anxiety and depression in COPD.
We have developed a tailored, cognitive behavioural approach (CBA) intervention for patients with COPD and co-morbid anxiety and/or depression (“TANDEM”), which precedes and optimises the benefits of currently offered PR. We hypothesise that such a psychological intervention, delivered by supervised, trained respiratory health care professionals, will improve mood in patients with mild to moderate anxiety and/or depression and encourage uptake and completion of PR.
Methods
We will conduct a multi-centre, pragmatic, randomised controlled trial of the TANDEM intervention compared to usual care across the Midlands, London, the South East and Bristol, UK.
We will train health care professionals familiar with COPD to deliver the manualised, tailored, face-to-face, one-to-one intervention weekly for 6-8 weeks.
We will recruit 430 participants from primary, community and secondary care with confirmed COPD and moderate to very severe airflow limitation, who are eligible for assessment for PR, and who screen positive for symptoms of mild/moderate depression and/or anxiety using the Hospital Anxiety and Depression scale (HADS). Participants will be randomised 1.25:1 (intervention: usual care).
The co-primary outcomes are HADS anxiety and depression subscale scores at 6 months, participants will be followed up to 12 months. Secondary outcomes include uptake and completion of PR and healthcare resource use. There will be a parallel process evaluation and a health economic evaluation.
Discussion
The TANDEM intervention has the potential to optimise the unrealised synergy between a psychological intervention and PR. The CBA sessions will precede PR and target individuals’ cognitions, behaviours and symptoms associated with anxiety and depression to decrease psychological morbidity and increase effective self-management amongst patients with COPD.
People with COPD are at increased risk of depression and anxiety, which greatly reduce quality of life and are associated with worse outcomes; but these psychological co-morbidities are under-recognised and undertreated in COPD. Pulmonary rehabilitation (PR) improves mood for up to six months but health practitioners under-refer, and patients commonly fail to attend/complete PR. Research suggests complex non-pharmacological interventions including both psychological and exercise components may reduce anxiety and depression in COPD.
We have developed a tailored, cognitive behavioural approach (CBA) intervention for patients with COPD and co-morbid anxiety and/or depression (“TANDEM”), which precedes and optimises the benefits of currently offered PR. We hypothesise that such a psychological intervention, delivered by supervised, trained respiratory health care professionals, will improve mood in patients with mild to moderate anxiety and/or depression and encourage uptake and completion of PR.
Methods
We will conduct a multi-centre, pragmatic, randomised controlled trial of the TANDEM intervention compared to usual care across the Midlands, London, the South East and Bristol, UK.
We will train health care professionals familiar with COPD to deliver the manualised, tailored, face-to-face, one-to-one intervention weekly for 6-8 weeks.
We will recruit 430 participants from primary, community and secondary care with confirmed COPD and moderate to very severe airflow limitation, who are eligible for assessment for PR, and who screen positive for symptoms of mild/moderate depression and/or anxiety using the Hospital Anxiety and Depression scale (HADS). Participants will be randomised 1.25:1 (intervention: usual care).
The co-primary outcomes are HADS anxiety and depression subscale scores at 6 months, participants will be followed up to 12 months. Secondary outcomes include uptake and completion of PR and healthcare resource use. There will be a parallel process evaluation and a health economic evaluation.
Discussion
The TANDEM intervention has the potential to optimise the unrealised synergy between a psychological intervention and PR. The CBA sessions will precede PR and target individuals’ cognitions, behaviours and symptoms associated with anxiety and depression to decrease psychological morbidity and increase effective self-management amongst patients with COPD.
| Original language | English |
|---|---|
| Pages (from-to) | 1-38 |
| Number of pages | 38 |
| Journal | Trials |
| Publication status | Accepted/In press - 11 Oct 2019 |
Keywords
- COPD
- Co-morbidity
- Depression
- anxiety
- Cognitive Behavioural Approach
- Pulmonary rehabilitation
- Complex intervention
- Pragmatic Randomised Controlled Trial
- Clinical Effectiveness
- health Economic Evaluation