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

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

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

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.

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.

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.