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

Assessment of Psychiatric Problems in Pre- and Post-Intervention in Patients With Congenital Heart Disease: A Prospective Cohort Study.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07326384
Enrollment
60
Registered
2026-01-08
Start date
2026-01-01
Completion date
2028-11-01
Last updated
2026-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease

Keywords

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

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.

Interventions

PROCEDURECardiac interventions

surgical or catheter-based, Corrective or palliative.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

1. Inclusion criteria: * patients of both gender. * Confirmed diagnosis of congenital heart disease requiring surgical or catheter-based intervention. 2.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of psychiatric disorders in adults with congenital heart disease, as assessed by the Symptom Checklist-90-Revised (SCL-90-R) Global Severity Index.At baseline, Pre-procedure visit (within 4 weeks of intervention).* Measurement Tool: Symptom Checklist-90-Revised (SCL-90-R). * Unit of Measure: Units on a Scale (Global Severity Index T-score).
Prevalence of psychiatric disorders in children with congenital heart disease, as assessed by the Child Behavior Checklist (CBCL) Total Problems T-score.At baseline, pre-procedure visit (within 4 weeks of intervention).* Measurement Tool: Child Behavior Checklist (CBCL). * Unit of Measure: Units on a Scale (Total Problems T-score).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026