Background Mental health issues are common and often overlooked in COPD patients. Digital psychological interventions might help, but their effectiveness in Chinese COPD patients hasn't been studied. This study aims to develop and evaluate EmoEase, a digital psychological intervention, for its effectiveness and cost-effectiveness in improving mental wellbeing in Chinese COPD patients.
Methods This multicenter, two-arm, randomized controlled trial (RCT) will enroll at least 420 COPD patients over 35 years old. Participants will receive either usual care (control group) or usual care plus EmoEase (intervention group). Assessments will occur at baseline (T0), 4 weeks (T1), 8 weeks (T2), and 16 weeks (T3). Participants will complete questionnaires and undergo physical measurements. The primary outcome will be mental wellbeing measured by the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS). Secondary outcomes will assess mental and physical health, COPD symptoms, health risk behaviors, socioeconomic factors, and healthcare use and costs. Analyses will use an intention-to-treat approach.
Discussion This is the first RCT to evaluate EmoEase for COPD patients. If effective and cost-effective, EmoEase could be scaled up to provide mental health support to COPD patients in China.
Age 35 years or older;
Post-bronchodilator FEV1/FVC ≤70% or confirmed COPD patients;
Literate and able to type;
Have a smartphone;
Patients with a physician diagnosis of asthma or asthma-COPD overlap syndrome;
Patients hospitalized for COPD within the previous one year;
Having severe cognitive dysfunction and being unable to communicate;
Severely ill with less than 12-month life expectancy.