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

Официальное название

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

Обзор

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.

Вмешательства

• Процедура Cardiac interventions
  surgical or catheter-based, Corrective or palliative.

Первичные конечные точки

• Prevalence of psychiatric disorders in adults with congenital heart disease, as assessed by the Symptom Checklist-90-Revised (SCL-90-R) Global Severity Index. [Срок оценки: 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. [Срок оценки: At baseline, pre-procedure visit (within 4 weeks of intervention).]

Критерии участия

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07326384 · Interventions in CHD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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