Association Between Cardiovascular Diseases and Mental Illness

NCT ID: NCT06239246

Last Updated: 2024-02-02

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 7000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2024-12-31

Brief Summary

Cardiovascular diseases (CVD) are important public health concerns around the world and closely associated with the development and progression of mental illness, which in turn increases the risk of developing cardiovascular diseases. This study aimed (1) to explore the known or unknown protective and risk factors underlying this comorbidity using questionnaires; (2) to study the biomarkers (body fluid, imaging) of the participants, and to find the influence on the relationship between CVD and mental health; (3) to identify high-risk populations for mental disorders in CVD patients and to establish prediction models. (4) to establish a specialized medical database.

Detailed Description

Patients with depression and cardiovascular comorbidities have a worse prognosis, a sharply reduced quality of life, and a much higher incidence of fatal CVD events, such as acute infarction, than patients with a single disease. However, due to the variety of potential causative factors and clinical manifestations, population variability, long duration of the disease, as well as neurological disorders of the exact causative mechanism still unclear, the psychological assessment among patients with cardiovascular diseases is remarkably inadequate studied.

In this study, two cohorts are established that include 2000 hospitalized patients and 5000 of the entire population. All individuals are screened for depression and anxiety. Those who score positive will be advised to enroll in this study. Patients are then randomized to receive collaborative care involving the patient, the patient's primary care physician, cardiologist and nurse case manager, or usual care is defined for each patient. Whole blood and serum samples are obtained from all patients, which will be measured for a panel of metabolic and inflammatory indicators. Patients in both cohorts will be monitored for depression severity and duration at 6 and 12 months after enrollment. A statistical technique is applied to determine the effect size of potential risk factors.

Conditions

Cardiovascular Diseases; Mental Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

2000 hospitalized patients

hospitalized patients with heart diseases

Behavioral

Intervention Type: OTHER

Psychotherapy: Cognitive-behavioral therapy (CBT), Internet-based cognitive-behavioral therapy (I-CBT), cognitive-behavioral therapy for insomnia (CBT-I), self-management education for heart failure, "blended" intervention; Drug treatment (cardiovascular drugs: aspirin, clopidogrel, ticagrelor, statins; psychiatric drugs: SSRIs, SNRIs, etc.);

10000 community population

No interventions assigned to this group

Interventions

Behavioral

Psychotherapy: Cognitive-behavioral therapy (CBT), Internet-based cognitive-behavioral therapy (I-CBT), cognitive-behavioral therapy for insomnia (CBT-I), self-management education for heart failure, "blended" intervention; Drug treatment (cardiovascular drugs: aspirin, clopidogrel, ticagrelor, statins; psychiatric drugs: SSRIs, SNRIs, etc.);

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ningbo No. 1 Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ruan Liemin

Role: STUDY_DIRECTOR

Department of Psychosomatic Medicine

Locations

the first affliliated hospital of Ningbo University, Ningbo, Zhejiang Province, China

Ningbo, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ruan Liemin, MD

Role: CONTACT

lmruan@tom.com

0086057487085111

Song Qifa, Master

Role: CONTACT

qifasong@126.com

8613777056290

Facility Contacts

Ruan Liemin, MD

Role: primary

0086057487085111

Other Identifiers

2022-R062

Identifier Type: -

Identifier Source: org_study_id