Impact of Observation Versus Treatment on The Psychiatric and Mental Outcomes of Patients With Unruptured Intracranial Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Anxiety
研究概览
简要总结
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.
详细描述
This is a controlled, non-randomized, prospective cohort study with parallel arms of treatment arm with microsurgical and endovascular treatment and comparison control arm with conservative management/observation of UIA. The goal of this study is to investigate the impact of the awareness of an untreated UIA on the psychiatric and mental status of the patients enrolled in the control arm compared to patients with a treated UIA. All patients presenting to the outpatient clinic upon the initiation of the trial and for 2 years ahead with UIA diagnosed on any of the angiographic imaging modalities including Computed Tomography Angiography (CTA), Magnetic Resonance Angiography (MRA), and Digital Subtraction Angiogram (DSA) will be included.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Anxiety
时间窗: 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.
次要结局
- 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)
- Functional Outcome Status(6 months and 18 months)
- Acute adverse events(During admission)
- Delayed adverse events(3 months)
- Anxiety(18 months)
- Aneurysm rupture(6 months and 18 months)
- Significant Aneurysm Growth(6 months and 18 months)
- Depression(6 months and 18 months)
- Change in Neurologic Status(6 months and 18 months)
- Functional Outcome Status(6 months and 18 months)
- Acute adverse events(During admission)
- Delayed adverse events(3 months)