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NCT Number: NCT06239246

Association Between Cardiovascular Diseases and Mental Illness

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.

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Key information

Conditions

Cardiovascular Diseases Mental Disorder Mental Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Ningbo, Zhejiang, 315000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Outpatient and inpatient cardiology patients, diagnosed with at least one cardiovascular disease and at least one psychological disorder
  • Cardiovascular diseases: ACS (STEMI, non-STEMI, unstable angina), arrhythmia (atrial fibrillation, atrioventricular block), heart failure (stable/unstable), hypertension, cardiomyopathy (hypertrophic, dilated)
  • Psychological disorders: structured interview diagnosed as depression, anxiety, insomnia; PHQ-9/GAD-7 score ≥ 10 points.

4．18-70 years old

Exclusion criteria

  • Clear suicidal ideation: PHQ-9 item 9 suicide ideation ≥ 3 points
  • Severe mental illnesses such as bipolar disorder, schizophrenia
  • Currently under psychotherapy
  • Severe cardiovascular diseases or other severe chronic life-threatening diseases
  • Refusal to participate
  • Abuse of alcoholism and drugs
  • Pregnant or breastfeeding
  • Cognitive impairment

Treatment and study plan

Behavioral

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.);

Primary outcomes

  1. severity of depressive symptoms through CES-D

    Time frame: cross-sectional analyses in 2024

    severity of depressive symptoms through CES-D Include 20 questions, sum all points. Total points 60. Judgment critaria: ≤15 as no depressive symptoms, 16-19 as possible depressive symptoms, ≥20 as definite depressive symptoms.

  2. The Patient Health Questionnaire 9-item depression scale (PHQ-9)

    Time frame: cross-sectional analyses in 2024

    Total points 27. depression judgment criteria: 0-4 as no, 5-9 as mild, 10-14 as moderate, 15-19 as moderate to severe, 20-27 as severe.

    Framingham risk score,NYHA cardiac function classification, six-minute walk test

  3. 7-item Generalized Anxiety Disorder scale (GAD-7)

    Time frame: cross-sectional analyses in 2024

    Total points 21. Anxiety judgment criteria: 0-4 as no, 5-9 as mild, 10-14 as moderate, 15-21 as severe.

  4. Pittsburgh sleep quality index,PSQI

    Time frame: cross-sectional analyses in 2024

    Include 23 items. Total points 21. Sleep quality judgment criteria: 0-5 very good, 6-10 good, 11-15 fair, 16-21 poor.

  5. New York heart failure classification

    Time frame: cross-sectional analyses in 2024

    Judgment criteria:

    Class I: patients are not limited in daily activities; Class II: patients are mildly limited in physical activity; Class III: patients are significantly limited in physical activity; Class IV: patients can not be engaged in any physical activity.

  6. Six-minute walk test

    Time frame: cross-sectional analyses in 2024

    A 6-minute walking distance of less than 150 meters indicates severe heart failure, 150-450 meters indicates moderate heart failure, and>450 meters indicates mild heart failure.

Secondary outcomes

  1. Major Adverse Cardiac Events

    Time frame: 24 months

    Hospitalization or mortality from Major Adverse Cardiac Events

Sponsors and collaborators

Lead sponsor

Ningbo No. 1 Hospital

Other

Registry information

Official study title

Analyzing the Association Between Cardiovascular Diseases and Mental Illness Considering Environmental Risk Factors

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 2, 2024
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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