Anxiety DepressionPOUIANCT06123325

Psychiatric Outcomes of Unruptured Intracranial Aneurysms (POUIA)

A study testing Clipping, Endovascular embolization and Surveillance imaging in people with Anxiety Depression and Aneurysm Cerebral, run by Montefiore Medical Center at 1 site in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Anxiety Depression, Aneurysm Cerebral, Mental Health Wellness 1
What is being tested?: Clipping, Endovascular embolization and Surveillance imaging
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteUnited States
Study dates: 1 Dec 2023to Dec 2028
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Montefiore Medical Center
The Bronx, New York, 10467

Other trials in United States

About this study

Official title: Impact of Observation Versus Treatment on The Psychiatric and Mental Outcomes of Patients With Unruptured Intracranial Aneurysms

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.

Read the detailed description

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.

Conditions: Anxiety Depression, Aneurysm Cerebral, Mental Health Wellness 1
Being tested: Clipping, Endovascular embolization, Surveillance imaging
Keywords: Cerebral aneurysm, Anxiety, Depression, Endovascular, Clipping
Medical subject headings: Intracranial Aneurysm, Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ClippingProcedure or 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 embolizationProcedure or 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 imagingDiagnostic 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.

Study groups in NCT06123325
Study group	Role	What they receive
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. Receives: 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. Receives: Diagnostic Test: Surveillance imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 months

Secondary outcomes (8)

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.
Measured: 18 months
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.
Measured: 6 months and 18 months
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.
Measured: 6 months and 18 months
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.
Measured: 6 months and 18 months
Change in Neurologic Status
The number of participants with change in neurologic status will be determined using the National Institute of Health (NIH) Stroke Scale/Score (NIHSS). The NIHSS is a 15-item neurological examination with each item scored on a 3- to 5-point scale, with 0 as normal. Scores range from 0-42 and there is an allowance for untestable items. Progressive increase in NIHSS score by 2 or more points after the procedure and through study completion will be considered as a bad outcome.
Measured: 6 months and 18 months
Functional Outcome Status
The number of participants demonstrating favorable functional outcome status will be assessed using a modified Rankin Scale (mRS) score. Participants with scores ranging from 0 (no disability) to 2 (slight disability) will be considered to have a favorable functional outcome status. Participants with mRS scores ranging from 3 (Moderate disability) to 5 (severe disability) will be considered to have an unfavorable functional outcome status.
Measured: 6 months and 18 months
Acute adverse events
The number of acute adverse events during hospital admission will be tabulated. Acute adverse events will encompass management and procedure-related complications. Increased incidence of procedure-related complications portends more unfavorable outcomes.
Measured: During admission
Delayed adverse events
The number of delayed adverse events will be tabulated. Delayed adverse events will encompass management and procedure-related complications. Increased incidence of procedure-related complications portends more unfavorable outcomes.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 2023Dec 2028

First posted8 Nov 2023
Study start1 Dec 2023
Primary completionDec 2027 (estimated)
Study completionDec 2028 (estimated)

Why it stopped: IRB approval has lapsed. Study has submitted continuing review report for re-certification. Awaiting IRB re-approval.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (18)Papers the sponsor has linked to this study.
Other trials for Anxiety DepressionStudies of the same condition, open and under way.
More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Controlled, non-randomized, prospective cohort study with parallel arms
Masking: None (open label)
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06123325
Sponsor's protocol ID: 2023-15285
Other IDs: 2023
Acronym: POUIA
Status last verified: Sep 2026
First submitted: 3 Nov 2023
Last updated: 23 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

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.
PubMed 22238841
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.
PubMed 32163437
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.
PubMed 9056628
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.
PubMed 9550514
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.
PubMed 30415386
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.
PubMed 11823649
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.
PubMed 14613562
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.
PubMed 25005549
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.
PubMed 32883243
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.
PubMed 16791435
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.
PubMed 22260815
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.
PubMed 28778800
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.
PubMed 21937934
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.
PubMed 9933290
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.
PubMed 9867550

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Observation Versus Treatment on The Psychiatric and Mental Outcomes of Patients With Unruptured Intracranial Aneurysms
ClinicalTrials.gov ID: NCT06123325
Acronym / sponsor ID: POUIA / 2023-15285
Conditions: Anxiety Depression, Aneurysm Cerebral, Mental Health Wellness 1
Keywords: Cerebral aneurysm, Anxiety, Depression, Endovascular, Clipping
Study type: Interventional
Recruitment status: SuspendedReason stopped: IRB approval has lapsed. Study has submitted continuing review report for re-certification. Awaiting IRB re-approval.
Enrolment: 120 participants (estimated)
Lead sponsor: Montefiore Medical CenterUniversity, hospital or other
Collaborators: The Bee Foundation
Study start: 1 Dec 2023 (actual)
Primary completion: Dec 2027 (estimated)
Study completion: Dec 2028 (estimated)
First posted: 8 Nov 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Controlled, non-randomized, prospective cohort study with parallel arms

Arm	Type	Receives
Treatment group	Experimental	Procedure: Clipping, Procedure: Endovascular embolizationPatients with unruptured intracranial aneurysms, opting for active intervention undergo microsurgical clipping or endovascular therapy to preemptively secure the aneurysm and prevent rupture.
Observation group	Other	Diagnostic Test: Surveillance imagingPatients 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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Unruptured intracranial aneurysms (UIA)
mRS scores between 0-1
Observation Group: All patients with UIAs that are eligible for conservative management
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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ClippingMicrosurgical 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 or surgery	Treatment group
Endovascular embolizationAny 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.	Procedure or surgery	Treatment group
Surveillance imagingSurveillance 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.	Diagnostic test	Observation group

Primary outcome

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.

8 secondary outcomes

Anxiety
Time frame: 18 months
Depression
Time frame: 6 months and 18 months
Aneurysm rupture
Time frame: 6 months and 18 months
Significant Aneurysm Growth
Time frame: 6 months and 18 months
Change in Neurologic Status
Time frame: 6 months and 18 months
Functional Outcome Status
Time frame: 6 months and 18 months
Acute adverse events
Time frame: During admission
Delayed adverse events
Time frame: 3 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
Background: PubMed 22238841Player 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.
Background: PubMed 32163437Lemos 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.
Background: PubMed 9056628Hop 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.
Background: PubMed 9550514Hop 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.
Background: PubMed 30415386Giordan 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.
Background: PubMed 11823649van 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.
Background: PubMed 14613562Burckhardt 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.
Background: PubMed 25005549Stern AF. The hospital anxiety and depression scale. Occup Med (Lond). 2014 Jul;64(5):393-4. doi: 10.1093/occmed/kqu024. No abstract available.
Background: PubMed 32883243Zhai 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.
Background: PubMed 16791435Solheim 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.
Background: PubMed 22260815Preiss 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.
Background: PubMed 28778800Li 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.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David J Altschul, MD principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Clipping, Endovascular embolization and Surveillance imaging in people with Anxiety Depression and Aneurysm Cerebral, run by Montefiore Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anxiety (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06123325, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.