Chronic Obstructive Pulmonary DiseaseNCT06026709
Effectiveness and Cost-effectiveness of Digital Psychological Intervention (EmoEase) in Chinese COPD Patients
A study testing EmoEase in people with Chronic Obstructive Pulmonary Disease and Depression, run by Peking Union Medical College.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Depression, Anxiety
- What is being tested?
- EmoEase
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Effectiveness and Cost-effectiveness of an Integrated Digital Psychological Intervention (EmoEase) in Chinese COPD Patients: Study Protocol of a Randomized Controlled Trial
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.
Read the detailed description
Background Mental health problems in chronic obstructive pulmonary disease (COPD) patients are common and frequently neglected. Digital psychological interventions may reduce mental health problems, but their effectiveness has not been evaluated in the Chinese COPD population. In this study, we will develop an integrated digital psychological intervention (EmoEase) and evaluate its effectiveness and cost-effectiveness in enhancing the mental wellbeing of COPD patients in China.
Methods This study is a multicenter, two-arm, randomized controlled trial (RCT) with a parallel-group design to enroll at least 420 COPD patients with age over 35 years. Participants will be assigned to receive either usual care (control group) or usual care + EmoEase (intervention group). Assessments will take place at baseline (T0) and 4 weeks (T1), 8 weeks (T2), and 16 weeks (T3) after baseline, and participants will be asked to complete questionnaires and have physical measurements taken. The primary outcome measure will assess mental wellbeing using the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS). Secondary outcome measures will assess mental health, physical health, COPD symptoms, health risk behaviors, socioeconomic indicators, and healthcare utilization and expenditure. Analyses will utilize an intention-to-treat approach.
Discussion This is the first RCT to examine the value of EmoEase, a novel digital psychological intervention for COPD patients. If this intervention is effective and cost-effective, it could be rapidly scaled up to provide mental health care for COPD patients in China.
- Conditions
- Chronic Obstructive Pulmonary Disease, Depression, Anxiety
- Being tested
- EmoEase
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmoEaseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: EmoEase |
| 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 1. Concise overview of COPD, encompassing its definition, prevalent risk factors, commonly observed symptoms, and disease progression; 2. Minimizing exposure to high-risk factors, such as tobacco/smoke exposure, air pollutants, household cooking emissions, and respiratory infections; ....... (10) Receiving vaccinations for influenza and streptococcus pneumoniae. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS)
Patients' mental wellbeing at baseline, and each follow-up is assessed using the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS). The Chinese version of the scale shows good psychometric properties WEMWBS is a self-report measure comprising 14 short statements focusing on positive wellbeing. Each statement is rated on a 5-point Likert scale, resulting in scores ranging from 14 to 70 (a higher score indicates better mental wellbeing).
Measured: at baseline (T0), 4 weeks (T1), 8 weeks (T2), and 16 weeks (T3) after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start1 Oct 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simiao Chen, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026709
- Sponsor's protocol ID
- CAMS&PUMC-IEC-2023-018
- Status last verified
- Aug 2025
- First submitted
- 30 Aug 2023
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen S, Chen W, Li Y, Yu Y, Chen Q, Jiao L, Huang K, Tong X, Geldsetzer P, Bunker A, Fang X, Jing S, Liu Y, Li Y, He L, Wang C, Wang W, Zheng Z, Zhang S, Zhao J, Yang T, Barnighausen T, Wang C. Effectiveness and cost-effectiveness of an integrated digital psychological intervention (EmoEase) in Chinese chronic obstructive pulmonary disease patients: Study protocol of a randomized controlled trial. Digit Health. 2024 Oct 1;10:20552076241277650. doi: 10.1177/20552076241277650. eCollection 2024 Jan-Dec.
PubMed 39381816
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Cost-effectiveness of an Integrated Digital Psychological Intervention (EmoEase) in Chinese COPD Patients: Study Protocol of a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06026709
- Acronym / sponsor ID
- CAMS&PUMC-IEC-2023-018
- Conditions
- Chronic Obstructive Pulmonary Disease, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Peking Union Medical CollegeUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 7 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background Mental health problems in chronic obstructive pulmonary disease (COPD) patients are common and frequently neglected. Digital psychological interventions may reduce mental health problems, but their effectiveness has not been evaluated in the Chinese COPD population. In this study, we will develop an integrated digital psychological intervention (EmoEase) and evaluate its effectiveness and cost-effectiveness in enhancing the mental wellbeing of COPD patients in China.
Methods This study is a multicenter, two-arm, randomized controlled trial (RCT) with a parallel-group design to enroll at least 420 COPD patients with age over 35 years. Participants will be assigned to receive either usual care (control group) or usual care + EmoEase (intervention group). Assessments will take place at baseline (T0) and 4 weeks (T1), 8 weeks (T2), and 16 weeks (T3) after baseline, and participants will be asked to complete questionnaires and have physical measurements taken. The primary outcome measure will assess mental wellbeing using the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS). Secondary outcome measures will assess mental health, physical health, COPD symptoms, health risk behaviors, socioeconomic indicators, and healthcare utilization and expenditure. Analyses will utilize an intention-to-treat approach.
Discussion This is the first RCT to examine the value of EmoEase, a novel digital psychological intervention for COPD patients. If this intervention is effective and cost-effective, it could be rapidly scaled up to provide mental health care for COPD patients in China.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| usual care + EmoEase group | Experimental | Behavioral: EmoEaseEmoEase, 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. |
| 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 1. Concise overview of COPD, encompassing its definition, prevalent risk factors, commonly observed symptoms, and disease progression; 2. Minimizing exposure to high-risk factors, such as tobacco/smoke exposure, air pollutants, household cooking emissions, and respiratory infections; ....... (10) Receiving vaccinations for influenza and streptococcus pneumoniae. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmoEaseThe 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. | Behavioural | usual care + EmoEase group |
Primary outcome
the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS)
Time frame: at baseline (T0), 4 weeks (T1), 8 weeks (T2), and 16 weeks (T3) after baseline
Patients' mental wellbeing at baseline, and each follow-up is assessed using the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS). The Chinese version of the scale shows good psychometric properties WEMWBS is a self-report measure comprising 14 short statements focusing on positive wellbeing. Each statement is rated on a 5-point Likert scale, resulting in scores ranging from 14 to 70 (a higher score indicates better mental wellbeing).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Derived from this study: PubMed 39381816Chen S, Chen W, Li Y, Yu Y, Chen Q, Jiao L, Huang K, Tong X, Geldsetzer P, Bunker A, Fang X, Jing S, Liu Y, Li Y, He L, Wang C, Wang W, Zheng Z, Zhang S, Zhao J, Yang T, Barnighausen T, Wang C. Effectiveness and cost-effectiveness of an integrated digital psychological intervention (EmoEase) in Chinese chronic obstructive pulmonary disease patients: Study protocol of a randomized controlled trial. Digit Health. 2024 Oct 1;10:20552076241277650. doi: 10.1177/20552076241277650. eCollection 2024 Jan-Dec.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing EmoEase in people with Chronic Obstructive Pulmonary Disease and Depression, run by Peking Union Medical College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) (time frame: at baseline (T0), 4 weeks (T1), 8 weeks (T2), and 16 weeks (T3) after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06026709, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.