Assessment of Psychiatric Problems in Pre- and Post-Intervention in Patients With CHD

NCT07326384 | Not Yet Recruiting

• 1 other identifier: Interventions in CHD
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational study is to learn about the relationship between cardiac intervention and subsequent psychiatric symptoms in patients with CHD. Due to the known high prevalence of mental health issues-with up to 50% of adults and 35% of pediatric patients with CHD experiencing mood or anxiety disorders-this research is crucial for improving long-term psychosocial care. The main questions it aims to answer are:

• What is the prevalence of psychiatric problems in CHD patients?
• Do psychiatric problems change or evolve after a cardiac intervention?
• Who Can Take Part (Supporting Information) The study is actively recruiting patients who meet specific criteria:
• Diagnosed with CHD and scheduled for a palliative or corrective cardiac intervention (surgical or catheter-based).
• Patients of both genders can participate. Patients cannot take part if they have:
• A current or pre-existing psychiatric or neurological disorder. - How the Research Will Happen This is a prospective, longitudinal cohort study that tracks the same participants over time. Participants will be asked to complete a series of validated psychological and cognitive assessments at three specific time points:
• T0 (Baseline): Before the cardiac procedure.
• T1 (Short-term): Approximately 1 month after the procedure.
• T2 (Long-term): Approximately 3 months after the procedure. Participants will complete standardized measures covering a wide range of topics, including:
• Psychological symptoms (e.g., depression, anxiety).
• Cognitive function (e.g., memory and attention).
• Sleep quality.
• Eating attitudes.
• Suicidal ideation. Potential Benefits: This research is critical for identifying dynamic changes in mental health related to cardiac procedures and will help the medical community understand the psychological impact of these interventions, leading to better screening and long-term quality of life.

Conditions

Congenital Heart Disease

Keywords

Congenital heart disease; Psychiatric problems; Mental health and cardiovascular disease; Cardiac intervention

Outcome Measures

Primary Outcomes (2)

• Prevalence of psychiatric disorders in adults with congenital heart disease, as assessed by the Symptom Checklist-90-Revised (SCL-90-R) Global Severity Index.

  * Measurement Tool: Symptom Checklist-90-Revised (SCL-90-R). * Unit of Measure: Units on a Scale (Global Severity Index T-score).

  At baseline, Pre-procedure visit (within 4 weeks of intervention).

• Prevalence of psychiatric disorders in children with congenital heart disease, as assessed by the Child Behavior Checklist (CBCL) Total Problems T-score.

  * Measurement Tool: Child Behavior Checklist (CBCL). * Unit of Measure: Units on a Scale (Total Problems T-score).

  At baseline, pre-procedure visit (within 4 weeks of intervention).

Study Arms (2)

Adult

Procedure: Cardiac interventions

Child

Procedure: Cardiac interventions

Interventions

Cardiac interventions PROCEDURE

surgical or catheter-based, Corrective or palliative.

Adult; Child

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with congenital heart disease presenting for palliative or corrective cardiac intervention (surgical or catheter-based).

You may qualify if:

• patients of both gender.
• Confirmed diagnosis of congenital heart disease requiring surgical or catheter-based intervention.

You may not qualify if:

• current or a pre-existing psychiatric or neurological disorder.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Heart Defects, Congenital; Psychological Well-Being; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Personal Satisfaction; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiology resident at Assiut University Heart Hospital

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: January 8, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: January 8, 2026

Record last verified: 2025-12