Effectiveness and Cost-effectiveness of an Integrated Psychological Internet Intervention (MindWellness) in Chinese COPD Patients: Study Protocol of a Randomized Controlled Trial
Study Details
Study Description
Brief Summary
Background Mental health problems in chronic obstructive pulmonary disease (COPD) patients are prominent and neglected. Web-based self-help therapies may effectively reduce mental health problems, but their effectiveness has not been evaluated in Chinese COPD patients. We developed an integrated Internet-based psychological intervention (MindWellness). This study aims to evaluate the effectiveness and cost-effectiveness of MindWellness in enhancing the mental wellbeing of COPD patients.
Methods This study is a multicenter, two-arm, randomized controlled trial (RCT) with a parallel-group design to enroll at least 420 COPD patients over 35 years. Participants will be assigned to receive either usual care group or the usual care + MindWellness group. Assessments will take place at baseline (T0), 4 weeks (T1), 8 weeks (T2), and 16 weeks (T3) after baseline, and participants will be asked to complete questionnaires and take physical measurements. The primary outcome measure will assess mental well-being using the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS). Secondary outcome measures will assess mental health, physical health, COPD symptoms, health risk behaviors, socio-economic indicators, and healthcare utilization and expenditure. Analyses will utilize an intention-to-treat analysis.
Discussion This study is the first RCT to examine the value of MindWellness, the internet-based psychological intervention for COPD patients. If this low-cost intervention is effective, it could be rapidly scaled up for providing mental health care of COPD patients in China.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: usual care + MindWellness group
|
Behavioral: MindWellness
The online intervention "MindWellness" 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.
|
| No Intervention: usual care
|
Outcome Measures
Primary Outcome Measures
- the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) [at baseline (T0), 4 weeks (T1), 8 weeks (T2), and 16 weeks (T3) after baseline]
Patients'mental wellbeing
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 35 years or older;
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Post-bronchodilator FEV1/FVC ≤70% or confirmed COPD patients;
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Literate and able to type;
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Have a smartphone;
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Be proficient in using the WeChat applet;
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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;
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Receive three follow-up visits within four months (2 offline, 1 online) and complete a physical exam and online questionnaire; and
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Willingness to provide the hospital with their usual cell phone number.
Exclusion Criteria:
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Patients with a physician diagnosis of asthma or asthma-COPD overlap syndrome;
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Patients hospitalized for COPD within the previous one year;
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Having severe cognitive dysfunction and being unable to communicate;
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Severely ill with less than 12-month life expectancy.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Peking Union Medical College
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CAMS&PUMC-IEC-2023-018