Assessment of Psychiatric Problems in Pre- and Post-Inter... | NCT07326384

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

NCT07326384

Sponsor

Assiut University

Status

Not yet recruiting

Last Update Posted

Jan 8, 2026Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Congenital Heart Disease

Interventions

Cardiac interventions

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2026Estimated

Primary Completion Date

Nov 1, 2027Estimated

Completion Date

Nov 1, 2028Estimated

First Submitted Date

Sep 30, 2025

First Submission Date that Met QC Criteria

Dec 24, 2025

First Posted Date

Jan 8, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 24, 2025

Last Update Posted Date

Jan 8, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shrouk Alaa-eldein Abdallah, Cardiology resident at Assiut University Heart Hospital, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adult			Procedure: Cardiac interventions
Child			Procedure: Cardiac interventions

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cardiac interventions	Procedure	surgical or catheter-based, Corrective or palliative.	Adult Child

Outcomes Module

Primary Outcomes

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.	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).

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D006330	Heart Defects, Congenital
D000092862	Psychological Well-Being
D002318	Cardiovascular Diseases

Ancestor Terms

ID	Term
D018376	Cardiovascular Abnormalities
D006331	Heart Diseases
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided