Association Between Cardiovascular Diseases and Mental Illness

NCT06239246 | Completed

• 1 other identifier: 2022-R062
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Mental Disorder

Outcome Measures

Primary Outcomes (6)

• severity of depressive symptoms through CES-D

  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.

  cross-sectional analyses in 2024

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

  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

  cross-sectional analyses in 2024

• 7-item Generalized Anxiety Disorder scale (GAD-7)

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

  cross-sectional analyses in 2024

• Pittsburgh sleep quality index,PSQI

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

  cross-sectional analyses in 2024

• New York heart failure classification

  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.

  cross-sectional analyses in 2024

• Six-minute walk test

  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.

  cross-sectional analyses in 2024

Secondary Outcomes (1)

• Major Adverse Cardiac Events

  24 months

Study Arms (2)

2000 hospitalized patients

hospitalized patients with heart diseases

Other: Behavioral

10000 community population

Interventions

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.);

2000 hospitalized patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals aged 18 to 75 years old who had normal cognition.

You may qualify if:

• 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.
• ．18-70 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Ningbo No. 1 Hospital: lead

Study Sites (1)

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

Ningbo, Zhejiang, 315000, China

Location

Related Publications (1)

• Wu Y, Mi Y, Cui H, Song Q, Ruan L. Relationship between recurrently elevated hsCRP and adverse cardiovascular events among depressed patients in China: a time-to-event analysis. Front Cardiovasc Med. 2025 Oct 17;12:1554897. doi: 10.3389/fcvm.2025.1554897. eCollection 2025.

  PMID: 41179571 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Mental Disorders

Study Officials

• Ruan Liemin

  Department of Psychosomatic Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2023
• First Posted: February 2, 2024
• Study Start: October 1, 2022
• Primary Completion: December 25, 2025
• Study Completion: December 25, 2025
• Last Updated: April 13, 2026

Record last verified: 2024-01

Locations

CN (1)