Impact of Multi-component Interventions on Populations With Mental Health Symptoms and High-risk COPD

NCT06458218 | Active Not Recruiting

• 1 other identifier: CAMS&PUMC-IEC-2024-043
• Study Type: interventional
• Target: 7,400
• Locations: 1 country
• Sites: 1

Brief Summary

Study Participants: High-risk COPD population with mental health symptoms, defined as individuals whose score of COPD-SQ ≥ 16, whose age is 35 and above, and whose Warwick-Edinburgh Mental Well-being Scale \<45 . Intervention: We have constructed a pay-for-population mechanism for medical practitioners within the intervention townships to encourage them caring for population health. For study participants in the intervention arm, we will ask them to finish an online COPD-SQ questionnaire with notification of his or her COPD high risk status. For those with high-risk COPD population, we will provide face-to-face survey, simple physical examination, pulmonary function tests, and provide a multi-component intervention at baseline. For high-risk COPD population with mental health issues in the intervention arm, we provide community-based spirometry pulmonary function test (PFT) and education; If individuals whose post-bronchodilator FEV1/FVC\<0.7, they will be spirometry-defined COPD patients and will be encouraged to seek treatment and medication to the superior hospitals. A CBT-based digital health intervention program, EmoEase, will be provided to our study participants with an intelligent mobile phone. Also health education in terms of mental health issues will be given. Additionally, we provide (1) a digital health intervention programs to smokers; (2) CBT-based health education for study participants with abnormal BMI; (3) active recruitment into National Essential Public Health Program in China for those with abnormal blood pressure and blood glucose. Intensive follow-ups will be conducted at month 3 (telephone interview), month 6 (face-to-face with full steps of physical examination), and month 12. Comparison: Those who are assigned in the control arm, we will ask them to finish the same COPD-SQ online questionnaire with notification of his or her COPD high risk status and a face-to-face survey. No physical examinations, community-based pulmonary function tests will be given. Outcomes: The primary outcomes are PHQ-9 scores for depression symptoms, GAD-7 symptoms for anxiety symptoms, and WEM-WBS score at month 12.

Conditions

Multimorbidity; Mental Health Issue; Multi-component Interventions

Outcome Measures

Primary Outcomes (3)

• Depression Symptoms

  Definition: Emotional disorders, including sadness, loss, and anger; Variable type: Continuous; Measurement: PHQ-9; Introduction to PHQ-9: Patient Health Questionnaire- 9 items (PHQ-9), ranging from 0 to 27, the higher the score, the severer the depression symptoms for the respondents will be.

  1 year

• Anxiety Symptoms

  Definition: Unpleasant state of inner turmoil; Variable type: Continuous; Measurement: GAD-7; Introduction to GAD-7: General Anxiety Disorder - 7 (GAD-7), ranging from 0 to 21, the higher the score, the severer the anxiety symptoms for the respondents will be.

  1 year

• Warwick-Edinburgh Mental Well-being Scale, WEM -WBS

  Definition: Reflects overall mental health problems; Variable type: Continuous; Measurement: WEMWBS; Introduction to WEMWBS: Warwick-Edinburgh Mental Well-being Scale, ranging from 14 to 70, the lower the score, the worse one's general mental health will be.

  1 year

Secondary Outcomes (34)

• Number of chronic diseases controlled

  1 year

• Self-rated health status

  1 year

• FEV1 measurement

  1 year

• mMRC score

  1 year

• CAT score

  1 year

Study Arms (2)

Intervention arm

EXPERIMENTAL

We have constructed a pay-for-population mechanism to encourage medical workers caring for population health. We will ask study populations to finish online COPD-SQ questionnaire with notification of his or her COPD high risk status. For high-risk COPD population, we will provide a face-to-face survey and examination, and provide a multi-component intervention at baseline. We give community-based spirometry pulmonary function test and education; If individuals who are COPD patients, they will be encouraged to seek treatment to the superior hospitals. A CBT-based digital health program will be provided. Also health education will be given. Additionally, we provide (1) a digital health intervention programs to smokers; (2) CBT-based health education for the abnormal BMI; (3) active recruitment into National Essential Public Health Program for those with high blood pressure and blood glucose. Intensive follow-ups will be conducted at month 3, 6, 12.

Combination Product: Multi-component Interventions

Control Arm

NO INTERVENTION

Those who are assigned in the control arm, we will ask them to finish the same COPD-SQ online questionnaire with notification of his or her COPD high risk status and a face-to-face survey. No physical examinations, community-based pulmonary function tests will be given.

Interventions

Multi-component Interventions COMBINATION_PRODUCT

1. Community-based spirometry pulmonary function tests and result interpretations and health education for COPD; 2. A digital health intervention program, EmoEase, for individuals with mental health issues among high-risk COPD population(very familiar with intelligent mobile phone); 3. NicQuit, digital health intervention to smokers; 4. Health education to smokers and individuals with mental health issues; 5. Encouragement to seek professional medication treatment in superior hospitals for spirometry-defined COPD patients; 6. To actively include individuals whose blood pressure and glucose are higher than the normal value into the National Essential Public Health Service in China; 7. A CBT-based health education to the BMI abnormal; 8. Pay-for-performance incentives to medical workers.

Intervention arm

Eligibility Criteria

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

You may qualify if:

• Aged 35 and above;
• High-risk COPD population, defined by score of COPD-SQ ≥ 16;
• Mental health issues, defined by WEM-WBS scale \< 45;
• Local residents who stay within a township in the previous 3 months and plan to stay within the same township for the next 12 months.

You may not qualify if:

• Those who suffer from severe cognitive disorder or total loss of ability of daily living.

Sponsors & Collaborators

• Peking Union Medical College: lead
• China-Japan Friendship Hospital: collaborator

Study Sites (1)

Xishui County

Zunyi, Guizhou, China

Location

Related Publications (1)

• Liu Y, Chen W, Zhang S, Wang Y, Zheng Z, Huang K, Tang X, Cao Z, Tong X, Tang L, Zhao J, He L, Jiao L, Zhao T, Luo Y, Lai Q, Lyu X, Chen Q, Bunker A, Vollmer S, Geldsetzer P, Jamison D, Barnighausen T, Yang T, Chen S, Wang C; POPMIX Group. 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. JMIR Res Protoc. 2026 Mar 6;15:e85853. doi: 10.2196/85853.

  PMID: 41791105 DERIVED

Study Officials

• Simiao Chen, Ph.D.

  Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 9, 2024
• First Posted: June 13, 2024
• Study Start: June 17, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

CN (1)