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

NCT ID: NCT07326384

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2028-11-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Adult

Cardiac interventions

Intervention Type: PROCEDURE

surgical or catheter-based, Corrective or palliative.

Child

Cardiac interventions

Intervention Type: PROCEDURE

surgical or catheter-based, Corrective or palliative.

Interventions

Cardiac interventions

surgical or catheter-based, Corrective or palliative.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Shrouk Alaa-eldein Abdallah

Cardiology resident at Assiut University Heart Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Interventions in CHD

Identifier Type: -

Identifier Source: org_study_id