# Impact of the Population Medicine Multimorbidity Intervention in Xishui County (POPMIX) on People at High Risk for Chronic Obstructive Pulmonary Disease Who Experience Mental Health Symptoms: Protocol for the POPMIX-MH Cluster Randomized Controlled Trial

## TL;DR

This study tests a new integrated health program in rural China to improve both COPD risk and mental health outcomes through community-based care.

## Contribution

The study introduces a novel, scalable intervention combining mental health support and chronic disease management in a low-resource setting.

## Key findings

- The POPMIX-MH trial is evaluating mental and physical health outcomes in high-COPD-risk individuals with mental health symptoms.
- Baseline and mid-term assessments have been completed, with final follow-up planned for March 2026.
- The intervention includes digital CBT, community screening, and team-based care to address multimorbidity.

## Abstract

Chronic obstructive pulmonary disease (COPD) and mental health conditions represent intersecting public health challenges, especially in resource-limited rural China. Existing care models often neglect the psychosocial needs of populations at high risk for COPD, resulting in limited effectiveness of prevention and management strategies. This study evaluates an integrated intervention designed to improve both mental and physical health outcomes among high-COPD-risk individuals with mental health symptoms, using a population medicine framework.

This study aims to evaluate the effect of an integrated, population medicine–based multimorbidity intervention package among high-COPD-risk individuals with mental health symptoms in Xishui County, Guizhou Province, China.

We are conducting a 12-month, 2-arm cluster randomized controlled trial across 26 townships in Xishui County, Guizhou, China. A total of 44,000 residents aged ≥35 years were screened using the Chronic Obstructive Pulmonary Disease Screening Questionnaire, identifying 10,000 individuals at high risk of COPD. Among them, 3807 individuals with Warwick-Edinburgh Mental Well-Being Scale scores below 45 were enrolled as participants. Intervention components include digital cognitive behavioral therapy–based mental health support, community screening, chronic disease management, patient education, digital follow-up, and team-based care. The primary outcomes are depressive symptoms (9-item Patient Health Questionnaire), anxiety symptoms (7-item General Anxiety Disorder), and mental well-being (Warwick-Edinburgh Mental Well-Being Scale). Secondary outcomes are control of chronic diseases, physiological and functional indicators such as lung function, health-related quality of life, mental and behavioral health, health care utilization, knowledge of COPD and asthma, productivity loss, and care cascade indicators for chronic conditions.

Data collection for the POPMIX-MH trial began in June 2024. Baseline, 3-month, and 6-month assessments have been completed, and the 12-month follow-up assessments are planned to be completed in March 2026.

This study is the first to integrate psychological support, chronic disease management, and community-based screening into a single scalable intervention package targeting multimorbidity in China. It tests the feasibility of applying population medicine principles, emphasizing integrated, preventive, and population-level care, within primary care systems in low-resource settings. By targeting both mental and physical health, it redefines chronic care beyond traditional organ-specific approaches.

ClinicalTrials.gov NCT06458218; https://clinicaltrials.gov/ct2/show/NCT06458218

DERR1-10.2196/85853