Congenital Heart DiseaseNCT07326384
Assessment of Psychiatric Problems in Pre- and Post-Intervention in Patients With CHD
An observational study of Congenital Heart Disease, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Cardiac interventions
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Nov 2028
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with congenital heart disease presenting for palliative or corrective cardiac intervention (surgical or catheter-based).
- 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.
About this study
Official title: 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:
Read more
- 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
- Being tested
- Cardiac interventions
- Keywords
- Congenital heart disease, Psychiatric problems, Mental health and cardiovascular disease, Cardiac intervention
- Medical subject headings
- Heart Defects, Congenital, Psychological Well-Being, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac interventionsProcedure or surgery
surgical or catheter-based, Corrective or palliative.
| Study group | Role | What they receive |
|---|---|---|
| Adult | Not described Receives: Procedure: Cardiac interventions | |
| Child | Not described Receives: Procedure: Cardiac interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: At baseline, pre-procedure visit (within 4 weeks of intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shrouk Alaa-eldein Abdallah, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07326384
- Sponsor's protocol ID
- Interventions in CHD
- Status last verified
- Dec 2025
- First submitted
- 30 Sep 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Psychiatric Problems in Pre- and Post-Intervention in Patients With Congenital Heart Disease: A Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT07326384
- Acronym / sponsor ID
- Interventions in CHD
- Conditions
- Congenital Heart Disease
- Keywords
- Congenital heart disease, Psychiatric problems, Mental health and cardiovascular disease, Cardiac intervention
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adult | – | Procedure: Cardiac interventions |
| Child | – | Procedure: Cardiac interventions |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with congenital heart disease presenting for palliative or corrective cardiac intervention (surgical or catheter-based).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac interventionssurgical or catheter-based, Corrective or palliative. | Procedure or surgery | Adult, Child |
Primary outcome
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).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease, run by Assiut University.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.