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

NCT06026709 | Not Yet Recruiting

• 1 other identifier: CAMS&PUMC-IEC-2023-018
• Study Type: interventional
• Target: 1,200
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Chronic Obstructive Pulmonary Disease; Depression; Anxiety

Outcome Measures

Primary Outcomes (1)

• 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).

  at baseline (T0), 4 weeks (T1), 8 weeks (T2), and 16 weeks (T3) after baseline

Study Arms (2)

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.

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.

Interventions

EmoEase BEHAVIORAL

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.

usual care + EmoEase group

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College: lead

Related Publications (1)

• 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.

  PMID: 39381816 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 7, 2023
• Study Start: October 1, 2025
• Primary Completion: December 30, 2025
• Study Completion: January 30, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share