Effectiveness and Cost-effectiveness of Digital Psychological Intervention (EmoEase) in Chinese COPD Patients

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.

NCT Number	NCT06026709
Lead Sponsor	Peking Union Medical College
Conditions	Chronic Obstructive Pulmonary Disease, Depression, Anxiety
Enrollment	1,200 participants
Start Date	2025-10-01
Primary Completion	2025-12-30 (estimated)
Study Completion	2026-01-30 (estimated)
Updated on ClinicalTrials.gov	2025-08-13