[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100518143":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":18,"locations":18,"responsibleParty":25,"collaborators":18,"id":29,"slug":30,"hasResults":31,"nctId":32,"briefTitle":33,"officialTitle":34,"acronym":18,"eligibilityCriteria":35,"healthyVolunteers":31,"sex":36,"minAge":37,"maxAge":18,"enrollmentInfo":38,"targetDuration":18,"studyType":41,"phases":42,"briefSummary":44,"conditions":45,"keywords":18,"overallStatus":49,"whyStopped":18,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":18},{"fullName":5,"class":6},"Peking Union Medical College","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"usual care + EmoEase group","EXPERIMENTAL","EmoEase, the digital intervention, will be delivered through a WeChat Mini Program. It will integrate two main pieces of training for anxiety and depression. We will develop the training mainly based on CBT.",[13],"Behavioral: EmoEase",{"label":15,"type":16,"description":17,"interventionNames":18},"usual care","NO_INTERVENTION","We will distribute informational pamphlets to participants in both the intervention and control groups, which will include guidance on the following aspects of self-management of COPD:23\n\n1. Concise overview of COPD, encompassing its definition, prevalent risk factors, commonly observed symptoms, and disease progression;\n2. Minimizing exposure to high-risk factors, such as tobacco\u002Fsmoke exposure, air pollutants, household cooking emissions, and respiratory infections; .......\n\n(10) Receiving vaccinations for influenza and streptococcus pneumoniae.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","EmoEase","The online intervention\"EmoEase\" integrates two distinct trainings for anxiety and depression. Each training includes approximately twenty 10-minute sessions, and each are centered around different themes. These two trainings will be delivered through a WeChat Mini Program.",[9],{"type":26,"investigatorFullName":27,"investigatorTitle":28,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Simiao Chen","professor","100518143","effectiveness-and-cost-effectiveness-of-digital-psychological-intervention-emoease-in-chinese-copd-patients-100518143",false,"NCT06026709","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","Inclusion Criteria:\n\n1. Age 35 years or older;\n2. Post-bronchodilator FEV1\u002FFVC ≤70% or confirmed COPD patients;\n3. Literate and able to type;\n4. Have a smartphone;\n5. Be proficient in using the WeChat applet;\n6. 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;\n7. Receive three follow-up visits within four months (2 offline, 1 online) and complete a physical exam and online questionnaire; and\n8. Willingness to provide the hospital with their usual cell phone number.\n\nExclusion Criteria:\n\n1. Patients with a physician diagnosis of asthma or asthma-COPD overlap syndrome;\n2. Patients hospitalized for COPD within the previous one year;\n3. Having severe cognitive dysfunction and being unable to communicate;\n4. Severely ill with less than 12-month life expectancy.","ALL","35 Years",{"count":39,"type":40},1200,"ESTIMATED","INTERVENTIONAL",[43],"NA","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.\n\nMethods 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.\n\nDiscussion 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.",[46,47,48],"Chronic Obstructive Pulmonary Disease","Depression","Anxiety","NOT_YET_RECRUITING","2025-08-08",{"date":52,"type":53},"2025-08-13","ACTUAL",{"date":55,"type":40},"2025-10-01",{"date":57,"type":40},"2026-01-30",{"name":5,"class":6}]