Psychiatric Outcomes of Unruptured Intracranial Aneurysms (POUIA)
Reason given: IRB approval has lapsed. Study has submitted continuing review report for re-certification. Awaiting IRB re-approval.
Key facts
- Where
- The Bronx, United StatesSee the site
Where in United States
- Montefiore Medical CenterThe Bronx, United StatesNo longer taking part
Trial details
- Who runs it
- Montefiore Medical Center
- Trial code
- NCT06123325
- Record updated
- 23 September 2026
- Original description
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.Read full original descriptionShow less
Impact of Observation Versus Treatment on The Psychiatric and Mental Outcomes of Patients With Unruptured Intracranial Aneurysms
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.
Inclusion: 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: 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; Patients with communication barriers (does not include foreign language), developmental disability, or psychiatric illness that prevent understanding of the questions required to complete assessments; Traumatic, mycotic, dissecting, or fusiform aneurysms; Patients with any physical disabilities or handicaps.