NCT06026709Not yet recruiting
Effectiveness and Cost-effectiveness of Digital Psychological Intervention (EmoEase) in Chinese COPD Patients
Effectiveness and Cost-effectiveness of an Integrated Digital Psychological Intervention (EmoEase) in Chinese COPD Patients: Study Protocol of a Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 13 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 1200 (estimated)
- First submitted
- 30 Aug 2023
- Start date
- 1 Oct 2025
- Primary completion date
- 30 Dec 2025
- Lead sponsor
- Peking Union Medical College
- Diseases
- COPD
- NCT number
- NCT06026709
What you commit to
- Study type: Interventional
- Planned participants: 1200
- From 1 Oct 2025 to the primary completion date, 30 Dec 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients hospitalized for COPD within the previous one year;
Other illness
- Patients with a physician diagnosis of asthma or asthma-COPD overlap syndrome;
Other
- Having severe cognitive dysfunction and being unable to communicate;
- Severely ill with less than 12-month life expectancy.
Who the study is looking for
- Age 35 years or older;
- Post-bronchodilator FEV1/FVC ≤70% or confirmed COPD patients;
- Literate and able to type;
- Have a smartphone;
- Be proficient in using the WeChat applet;
- Willingness to self-help iCBT sessions for 8 weeks, 10-20 minutes of practice per session, roughly 1 hour per week, time and place flexible;
- Receive three follow-up visits within four months (2 offline, 1 online) and complete a physical exam and online questionnaire; and
- Willingness to provide the hospital with their usual cell phone number.
Age in the registry: 35 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.