Exploring the link between heart disease and mental health
Analyzing the Association Between Cardiovascular Diseases and Mental Illness Considering Environmental Risk Factors
This study looks at how heart disease and mental health issues, like depression and anxiety, are connected by checking both hospitalized patients and people from the general population to see if different types of care can help them feel better over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 7000 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Ningbo No. 1 Hospital Academic / other |
| Locations | 1 site (Ningbo, Zhejiang) |
| Trial ID | NCT06239246 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between cardiovascular diseases and mental disorders by analyzing both risk and protective factors through questionnaires and biomarker assessments. It includes two cohorts: 2000 hospitalized patients and 5000 individuals from the general population, all screened for depression and anxiety. Participants who test positive will be randomized to receive either collaborative care or usual care, while their mental health and cardiovascular status will be monitored over 6 and 12 months. The study aims to identify high-risk populations and establish a specialized medical database.
Who should consider this trial
Good fit: Ideal candidates include outpatient and inpatient cardiology patients aged 18-70 with at least one cardiovascular disease and one psychological disorder.
Not a fit: Patients with severe mental illnesses, clear suicidal ideation, or those currently undergoing psychotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management and treatment strategies for patients suffering from both cardiovascular diseases and mental health disorders.
How similar studies have performed: Previous studies have shown a correlation between cardiovascular diseases and mental health, but this specific approach of combining collaborative care with biomarker analysis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Outpatient and inpatient cardiology patients, diagnosed with at least one cardiovascular disease and at least one psychological disorder 2. Cardiovascular diseases: ACS (STEMI, non-STEMI, unstable angina), arrhythmia (atrial fibrillation, atrioventricular block), heart failure (stable/unstable), hypertension, cardiomyopathy (hypertrophic, dilated) 3. Psychological disorders: structured interview diagnosed as depression, anxiety, insomnia; PHQ-9/GAD-7 score ≥ 10 points. 4．18-70 years old Exclusion Criteria: 1. Clear suicidal ideation: PHQ-9 item 9 suicide ideation ≥ 3 points 2. Severe mental illnesses such as bipolar disorder, schizophrenia 3. Currently under psychotherapy 4. Severe cardiovascular diseases or other severe chronic life-threatening diseases 5. Refusal to participate 6. Abuse of alcoholism and drugs 7. Pregnant or breastfeeding 8. Cognitive impairment
Where this trial is running
Ningbo, Zhejiang
- the first affliliated hospital of Ningbo University, Ningbo, Zhejiang Province, China — Ningbo, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Ruan Liemin, MD
- Email: lmruan@tom.com
- Phone: 0086057487085111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.