Effectiveness and Cost-effectiveness of an Integrated Psychological Internet Intervention (MindWellness) in Chinese COPD Patients: Study Protocol of a Randomized Controlled Trial

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness and Cost-effectiveness of an Integrated Psychological Internet Intervention (MindWellness) in Chinese COPD Patients: Study Protocol of a Randomized Controlled Trial

Conditions
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Chronic Obstructive Pulmonary Disease, Depression, Anxiety

Intervention / Treatment
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* Behavioral: MindWellness


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: usual care + MindWellness group<br> | Behavioral: MindWellness<br>* 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.<br>|
| No Intervention: usual care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) | Patients'mental wellbeing | at baseline (T0), 4 weeks (T1), 8 weeks (T2), and 16 weeks (T3) after baseline |