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NCT Number: NCT07326384

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

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

  • Inclusion criteria:
  • patients of both gender.
  • Confirmed diagnosis of congenital heart disease requiring surgical or catheter-based intervention.
  • Exclusion criteria:
  • current or a pre-existing psychiatric or neurological disorder.

Treatment and study plan

Cardiac interventions

Procedure

surgical or catheter-based, Corrective or palliative.

Primary outcomes

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

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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 8, 2026
Registry last updated
Jan 8, 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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