Psychiatric Outcomes of Unruptured Intracranial Aneurysms (POUIA)

NCT06123325 | Recruiting

• 1 other identifier: 2023-15285
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Anxiety Depression; Aneurysm Cerebral; Mental Health Wellness 1

Keywords

Cerebral aneurysm; Anxiety; Depression; Endovascular; Clipping

Outcome Measures

Primary Outcomes (1)

• Anxiety

  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.

  6 months

Secondary Outcomes (8)

• Anxiety

  18 months

• Depression

  6 months and 18 months

• Aneurysm rupture

  6 months and 18 months

• Significant Aneurysm Growth

  6 months and 18 months

• Change in Neurologic Status

  6 months and 18 months

Study Arms (2)

Treatment group

EXPERIMENTAL

Patients with unruptured intracranial aneurysms, opting for active intervention undergo microsurgical clipping or endovascular therapy to preemptively secure the aneurysm and prevent rupture.

Procedure: Clipping; Procedure: Endovascular embolization

Observation group

OTHER

Patients with unruptured intracranial aneurysms, opting for conservative management undergo regular monitoring with serial imaging to track aneurysm stability, deferring interventional treatment unless changes indicate an increased risk of rupture.

Diagnostic Test: Surveillance imaging

Interventions

Clipping PROCEDURE

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.

Treatment group

Endovascular embolization PROCEDURE

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.

Treatment group

Surveillance imaging DIAGNOSTIC_TEST

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.

Observation group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead
• The Bee Foundation: collaborator

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

Related Publications (18)

• Player MS, Peterson LE. Anxiety disorders, hypertension, and cardiovascular risk: a review. Int J Psychiatry Med. 2011;41(4):365-77. doi: 10.2190/PM.41.4.f.

  PMID: 22238841 BACKGROUND

• Lemos M, Roman-Calderon JP, Calle G, Gomez-Hoyos JF, Jimenez CM. Personality and anxiety are related to health-related quality of life in unruptured intracranial aneurysm patients selected for non-intervention: A cross sectional study. PLoS One. 2020 Mar 12;15(3):e0229795. doi: 10.1371/journal.pone.0229795. eCollection 2020.

  PMID: 32163437 BACKGROUND

• Hop JW, Rinkel GJ, Algra A, van Gijn J. Case-fatality rates and functional outcome after subarachnoid hemorrhage: a systematic review. Stroke. 1997 Mar;28(3):660-4. doi: 10.1161/01.str.28.3.660.

  PMID: 9056628 BACKGROUND

• Hop JW, Rinkel GJ, Algra A, van Gijn J. Quality of life in patients and partners after aneurysmal subarachnoid hemorrhage. Stroke. 1998 Apr;29(4):798-804. doi: 10.1161/01.str.29.4.798.

  PMID: 9550514 BACKGROUND

• Giordan E, Sorenson TJ, Brinjikji W, Vine R, Lanzino G. Risk factors for growth of conservatively managed unruptured intracranial aneurysms. Acta Neurochir (Wien). 2018 Dec;160(12):2419-2423. doi: 10.1007/s00701-018-3729-z. Epub 2018 Nov 11.

  PMID: 30415386 BACKGROUND

• van der Schaaf IC, Brilstra EH, Rinkel GJ, Bossuyt PM, van Gijn J. Quality of life, anxiety, and depression in patients with an untreated intracranial aneurysm or arteriovenous malformation. Stroke. 2002 Feb;33(2):440-3. doi: 10.1161/hs0202.102335.

  PMID: 11823649 BACKGROUND

• Burckhardt CS, Anderson KL. The Quality of Life Scale (QOLS): reliability, validity, and utilization. Health Qual Life Outcomes. 2003 Oct 23;1:60. doi: 10.1186/1477-7525-1-60.

  PMID: 14613562 BACKGROUND

• Stern AF. The hospital anxiety and depression scale. Occup Med (Lond). 2014 Jul;64(5):393-4. doi: 10.1093/occmed/kqu024. No abstract available.

  PMID: 25005549 BACKGROUND

• Zhai XD, Yu JX, Ma YJ, Xiang SS, Li GL, He C, Hu P, Zhang HQ. Prevalence of and risk factors for anxiety and depression in Chinese patients with unruptured intracranial aneurysms treated by endovascular intervention. BMC Psychiatry. 2020 Sep 3;20(1):430. doi: 10.1186/s12888-020-02834-3.

  PMID: 32883243 BACKGROUND

• Solheim O, Eloqayli H, Muller TB, Unsgaard G. Quality of life after treatment for incidental, unruptured intracranial aneurysms. Acta Neurochir (Wien). 2006 Aug;148(8):821-30; discussion 830. doi: 10.1007/s00701-006-0804-7. Epub 2006 Jun 23.

  PMID: 16791435 BACKGROUND

• Preiss M, Netuka D, Koblihova J, Bernardova L, Charvat F, Benes V. Cognitive functions before and 1 year after surgical and endovascular treatment in patients with unruptured intracranial aneurysms. Br J Neurosurg. 2012 Aug;26(4):514-6. doi: 10.3109/02688697.2011.645915. Epub 2012 Jan 19.

  PMID: 22260815 BACKGROUND

• Li Y, Dai W, Zhang J. Anxiety, depression and quality of life in patients with a treated or untreated unruptured intracranial aneurysm. J Clin Neurosci. 2017 Nov;45:223-226. doi: 10.1016/j.jocn.2017.07.019. Epub 2017 Aug 1.

  PMID: 28778800 BACKGROUND

• Buijs JE, Greebe P, Rinkel GJ. Quality of life, anxiety, and depression in patients with an unruptured intracranial aneurysm with or without aneurysm occlusion. Neurosurgery. 2012 Apr;70(4):868-72. doi: 10.1227/NEU.0b013e3182367295.

  PMID: 21937934 BACKGROUND

• Brilstra EH, Rinkel GJ, van der Graaf Y, van Rooij WJ, Algra A. Treatment of intracranial aneurysms by embolization with coils: a systematic review. Stroke. 1999 Feb;30(2):470-6. doi: 10.1161/01.str.30.2.470.

  PMID: 9933290 BACKGROUND

• International Study of Unruptured Intracranial Aneurysms Investigators. Unruptured intracranial aneurysms--risk of rupture and risks of surgical intervention. N Engl J Med. 1998 Dec 10;339(24):1725-33. doi: 10.1056/NEJM199812103392401.

  PMID: 9867550 BACKGROUND

• Raaymakers TW, Rinkel GJ, Limburg M, Algra A. Mortality and morbidity of surgery for unruptured intracranial aneurysms: a meta-analysis. Stroke. 1998 Aug;29(8):1531-8. doi: 10.1161/01.str.29.8.1531.

  PMID: 9707188 BACKGROUND

• Curtis BM, O'Keefe JH Jr. Autonomic tone as a cardiovascular risk factor: the dangers of chronic fight or flight. Mayo Clin Proc. 2002 Jan;77(1):45-54. doi: 10.4065/77.1.45.

  PMID: 11794458 BACKGROUND

• Tada Y, Wada K, Shimada K, Makino H, Liang EI, Murakami S, Kudo M, Kitazato KT, Nagahiro S, Hashimoto T. Roles of hypertension in the rupture of intracranial aneurysms. Stroke. 2014 Feb;45(2):579-86. doi: 10.1161/STROKEAHA.113.003072. Epub 2013 Dec 26.

  PMID: 24370755 BACKGROUND

MeSH Terms

Conditions

Intracranial Aneurysm; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• David J Altschul, MD

  Associate Professor at The Leo M. Davidoff Department of Neurological Surgery at Montefiore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammed Amir Essibayi, MD

CONTACT

718-920-7498; muhammedamir.essibayi@einsteinmed.edu

Genesis Liriano, MD

CONTACT

718-920-2469; gliriano@montefiore.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Controlled, non-randomized, prospective cohort study with parallel arms

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 8, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

US (1)