Actively Recruiting
Psychiatric Outcomes of Unruptured Intracranial Aneurysms (POUIA)
Led by Montefiore Medical Center · Updated on 2025-11-19
120
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
Sponsors
M
Montefiore Medical Center
Lead Sponsor
T
The Bee Foundation
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Psychiatric Outcomes of Unruptured Intracranial Aneurysms (POUIA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with unruptured intracranial aneurysms (UIA)
- Modified Rankin Scale (mRS) score between 0 and 1
- For observation group: eligible for conservative management, with aneurysms in locations not suited for intervention or aneurysms smaller than 4 mm
- For treatment group: aneurysms larger than 4 mm or treatment decided by patient or doctor
You will not qualify if you...
- Prior history of subarachnoid hemorrhage (SAH)
- Prior history of intracranial aneurysm
- Severe psychiatric disease or chronic end stage diseases affecting mental health
- Traumatic, mycotic, dissecting, or fusiform aneurysms
- Communication barriers, developmental disability, or psychiatric illness preventing understanding of assessments
- Physical disabilities or handicaps
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
Research Team
M
Muhammed Amir Essibayi, MD
CONTACT
G
Genesis Liriano, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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