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NCT06123325 · ClinicalTrials.gov registry record · NA
Psychiatric Outcomes of Unruptured Intracranial Aneurysms (POUIA)
A NA study of Mental Health Wellness 1 and Anxiety Depression, sponsored by Montefiore Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT06123325: Recruiting NA study of Mental Health Wellness 1 and Anxiety Depression, sponsored by Montefiore Medical Center.
NCT06123325 is a NA study of Mental Health Wellness 1 and Anxiety Depression that is actively recruiting participants, run by Montefiore Medical Center. The registered enrollment target is 120 participants, below the 723-participant average among 20 other Mental Health Wellness 1 trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06123325, a NA study of Mental Health Wellness 1 and Anxiety Depression, is actively recruiting participants, sponsored by Montefiore Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- PROCEDURE Clipping
- PROCEDURE Endovascular embolization
- DIAGNOSTIC_TEST Surveillance imaging
Study Locations (1)
New York
- Montefiore Medical Center - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2023-12-01 |
| Est. Completion | 2027-09 |
| Phase | NA |
What NCT06123325 shows while recruiting
NCT06123325 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 723-participant average among 20 other Mental Health Wellness 1 trials with a reported enrollment target (83% lower).
The record links to 3 conditions, with Mental Health Wellness 1 appearing as the primary indexed condition, and to 3 interventions - of which Clipping is the first listed.
NCT06123325 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06123325 about?
NCT06123325 is a clinical study titled "Psychiatric Outcomes of Unruptured Intracranial Aneurysms (POUIA)". 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 populati...
What is the current status of trial NCT06123325?
This trial is currently recruiting. It is a NA study. The enrollment target is 120 participants. The study started on 2023-12-01. Estimated completion is 2027-09.
What conditions does trial NCT06123325 study?
This clinical trial studies the following conditions: Mental Health Wellness 1, Anxiety Depression, Aneurysm Cerebral.
What interventions are being tested in trial NCT06123325?
The interventions under investigation include: Clipping (PROCEDURE), Endovascular embolization (PROCEDURE), Surveillance imaging (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06123325?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06123325 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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