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

December 24, 2025 updated by: Shrouk Alaa-eldein Abdallah, Assiut University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

60

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adult
Procedure: Cardiac interventions
surgical or catheter-based, Corrective or palliative.
Child
Procedure: Cardiac interventions
surgical or catheter-based, Corrective or palliative.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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.
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).
At baseline, pre-procedure visit (within 4 weeks of intervention).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2028

Study Registration Dates

First Submitted

September 30, 2025

First Submitted That Met QC Criteria

December 24, 2025

First Posted (Actual)

January 8, 2026

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

December 24, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Interventions in CHD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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