NCT06123325 · Montefiore Medical Center
Psychiatric Outcomes of Unruptured Intracranial Aneurysms (POUIA)
(POUIA)
What this study 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.
View original scientific 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.
Interventions
PROCEDURE
Clipping
Microsurgical clipping of intracranial aneurysms involves craniotomy to access the brain, locating the aneurysm, and placing a small metal clip across its neck, thereby isolating it from normal blood circulation to prevent rupture.
PROCEDURE
Endovascular embolization
Any endovascular embolization of intracranial aneurysms that involves navigating microcatheters through the vascular system to the site of the aneurysm and deploying materials like coils, flow-diverting stents, or endosaccular flow disruptors to occlude the aneurysm and reduce the risk of rupture.
DIAGNOSTIC_TEST
Surveillance imaging
Surveillance imaging for brain aneurysms is a diagnostic approach that uses imaging techniques such as MRI, MRA, CTA, or DSA to regularly monitor the status of detected brain aneurysms. The goal is to track changes in the aneurysm's size, shape, or structure over time, which may indicate an increased risk of rupture. This ongoing assessment helps healthcare providers decide whether to continue monitoring or to consider treatment options, such as surgical clipping or endovascular coiling, based on the aneurysm's characteristics and the patient's risk factors.
Primary outcome measures
Anxiety
Time frame: 6 months
The number of participants demonstrating anxiety will be determined using the Hospital Anxiety and Depression Scale (HADS) assessment tool. HADS is a widely used tool to evaluate anxiety and depression levels and is composed of 14 items in total, 7 items for anxiety and 7 for depression. The 7 anxiety subscale items are to be answered subjectively by patients using a four-point Likert scale (0-3) with a possible scoring range of 0-21 for anxiety. The number of participants with HADS scores of 8 and above will be considered to demonstrate positive signs of anxiety.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- The Bronx, New York
Collaborators
The Bee Foundation
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 19, 2025 · Source of record for eligibility and locations