Assessment of Psychiatric Problems in Pre- and Post-Intervention in Patients With Congenital Heart Disease: A Prospective Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Prevalence of psychiatric disorders in adults with congenital heart disease, as assessed by the Symptom Checklist-90-Revised (SCL-90-R) Global Severity Index.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria:
- •patients of both gender.
- •Confirmed diagnosis of congenital heart disease requiring surgical or catheter-based intervention.
排除标准
- •current or a pre-existing psychiatric or neurological disorder.
结局指标
主要结局
Prevalence of psychiatric disorders in adults with congenital heart disease, as assessed by the Symptom Checklist-90-Revised (SCL-90-R) Global Severity Index.
时间窗: 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.
时间窗: 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).
次要结局
未报告次要终点
研究者
Shrouk Alaa-eldein Abdallah
Cardiology resident at Assiut University Heart Hospital
Assiut University