About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Clipping
Procedure/Surgery
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.
Endovascular embolization
Procedure/Surgery
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.
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.

Treatment groups

120 Participants

are divided into 2 treatment groups

Group A: Treatment groupExperimental treatment 2 interventions

Group B: Observation groupOther 1 intervention

Trial outcomes

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.

Time frame

6 months

Secondary 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.

Time frame

18 months

2

Depression

The number of participants demonstrating depression 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 depression 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 depression. The number of participants with HADS scores of 8 and above will be considered to demonstrate positive signs of depression.

Time frame

6 months and 18 months

3

Aneurysm rupture

The number of participants with any recorded event of aneurysm rupture during the follow-up periods of observed or treated Unruptured Intracranial Aneurysm (UIA) will be determined.

Time frame

6 months and 18 months

4

Significant Aneurysm Growth

The number of participants demonstrating significant aneurysm growth during the follow-up periods will be determined. Significant aneurysm growth is defined as any aneurysm growth of \>= 3 millimeters of observed or treated UIA.

Time frame

6 months and 18 months

Psychiatric Outcomes of Unruptured Intracranial Aneurysms (POUIA)

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts