Psychiatric Outcomes of Unruptured Intracranial Aneurysms (POUIA)
Recruiting · NCT06123325 · Interventional (participants receive a specific treatment) · Lead sponsor: Montefiore Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The impact of cerebrovascular procedures on patients experiencing anxiety and depression is not well studied despite the high prevalence of these mental health disorders. Unruptured Intracranial aneurysms (UIAs) have a prevalence of approximately 3% and an annual risk of 1-2% in the general population. Despite the high risk of fatality following aneurysm rupture with a rate of 40-50%, the overall aneurysm growth and rupture risks are rare (less than 3% per aneurysm per year) and many patients can be observed with serial follow-up imaging over years. Nevertheless, due to the gravity of the bad consequences of aneurysm rupture, simply informing many patients of UIA diagnosis has been found to result in worse outcomes of health-related quality of life. This study aims to investigate the impact of awareness of untreated UIA on the patients' mental health utilizing the Hospital Anxiety and Depression Scale (HADS) tool.
Who can take part
Inclusion criteria
- Unruptured intracranial aneurysms (UIA)
- mRS scores between 0-1
- Observation Group: All patients with UIAs that are eligible for conservative management
- Specific locations that are not good candidates for interventional treatment, such as cavernous internal carotid artery and very distally located aneurysms
- Aneurysm size (largest dimension) is less than 4 mm
- Treatment Group: All patients with UIAs that are decided to be treated either with endovascular or microsurgical treatments due to several reasons, such as aneurysm size above 4 mm, patient's decision
Exclusion criteria
- Prior history of Subarachnoid Hemorrhage (SAH)
- Prior history of intracranial aneurysm
- Severe comorbidities that impact the mental health of the patients, such severe psychiatric disease, and chronic end stage diseases
- Traumatic, mycotic, dissecting, or fusiform aneurysms
- Patients with communication barriers (does not include foreign language), developmental disability, or psychiatric illness that prevent understanding of the questions required to complete assessments
- Patients with any physical disabilities or handicaps
Where it is running
2 locations listed across 1 US state.
- Montefiore Medical Center - The Bronx, New York, United States
- Montefiore Medical Center - The Bronx, New York, United States