Investigations of Factors Associated With Treatment Response and Prognosis in Anxiety Disorders

NCT06773585 | Not Yet Recruiting

• 1 other identifier: KBSMC IRB 2024-10-018-002
• Study Type: observational
• Target: 185
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to build a comprehensive brain and behavioral dataset on anxiety disorders and identify clinical factors related to treatment response and prognosis in patients with anxiety disorders. By conducting an integrated analysis of clinical features (phenotypes), comorbid conditions, virtual reality (VR)-based behavioral data, electroencephalogram (EEG) data, and MRI-based data in patients undergoing treatment for anxiety disorders and healthy controls, this study aims to enhance the understanding of the pathophysiology of anxiety disorders and establish a foundation for precision medicine. Anxiety disorders significantly impair quality of life by inducing irrational fear and apprehension even in everyday situations. Over the past few years, the prevalence of anxiety disorders and associated medical expenses have surged, escalating the societal and economic burden. However, the current diagnostic system, DSM-5, relies on symptom-based approaches, which often lead to heterogeneity within the same diagnostic category. This limitation hinders the accurate prediction of treatment response and the design of optimal therapeutic strategies. To address these issues, the U.S. National Institute of Mental Health (NIMH) proposed the Research Domain Criteria (RDoC). RDoC is a multidimensional framework that integrates behavioral, psychological, and neurological data to facilitate the development of treatment strategies rooted in pathophysiology. Nonetheless, the acquisition of objective and reliable assessment data remains a challenge due to the inherent characteristics of mental disorders. Virtual reality (VR) technology has emerged as a promising solution to overcome these limitations. VR enables the creation of immersive 3D environments that can elicit anxiety-related behaviors and precisely evaluate them in controlled settings. It also allows data collection in scenarios that closely resemble real-life situations while offering advantages such as repeatability and ease of use. Combining behavioral data collected in VR environments with EEG data can provide a more detailed understanding of the neurophysiological representations underlying anxiety behaviors. EEG, as a biomarker reflecting neural activity in real time, facilitates intuitive and effective analyses. Moreover, MRI-based brain imaging plays a critical role in identifying structural and functional connectivity differences between anxiety disorder patients and healthy controls. It offers crucial insights into the biomarkers that predict treatment outcomes and prognosis. By integrating these data, this study seeks to uncover the key factors influencing treatment response and prognosis in patients with anxiety disorders.

Conditions

Panic Disorder

Keywords

panic disorder; anxiety disorder; panic attack

Outcome Measures

Primary Outcomes (1)

• Panic Disorder Severity Scale (PDSS)

  The PDSS (Panic Disorder Severity Scale) is a tool used to assess the severity of panic disorder symptoms. It consists of 7 items that measure the frequency, intensity, and impact of panic attacks on daily life. The scale uses a 5-point Likert scale, ranging from "Not at all" (0 points) to "Severely" (4 points). The total score ranges from 0 to 28, with higher scores indicating more frequent and intense panic attacks. Participants will be classified into remission and no-remission groups based on a ≥40% reduction in the PDSS score at the 2-month, 6-month, and 12-month follow-up assessments.

  At the initial, 2-month, 6-month, and 12-month time points

Secondary Outcomes (3)

• 7-item Generalized Anxiety Disorder Scale (GAD)

  At the initial, 2-month, 6-month, and 12-month time points

• Depression, Anxiety, Stress Scale (DASS)

  At the initial, 2-month, 6-month, and 12-month time points

• Liebowits Social Anxiety Scale (LSAS)

  At the initial, 2-month, 6-month, and 12-month time points

Study Arms (2)

Anxiety Behavior Group

Participants diagnosed with an anxiety disorder based on DSM-5 diagnostic criteria, evaluated by a board-certified psychiatrist. The principal investigator, a board-certified psychiatrist, will conduct the following diagnostic assessments and differential diagnoses to screen eligible participants according to the inclusion and exclusion criteria. Anxiety disorders will be diagnosed using the Structured Clinical Interview for DSM-5 Disorders, Clinical Version (SCID-5-CV; First et al., 2016), and other major psychiatric conditions will be ruled out using the Mini International Neuropsychiatric Interview (MINI; Lecrubier et al., 1997). Participants will undergo four visits (initial evaluation, 2-month follow-up, 6-month follow-up, and 12-month follow-up).

Diagnostic Test: Psychiatric scale assessments, VR-Based Behavioral Assessment, Brain MRI

Healthy Control Group

Individuals who report no psychiatric symptoms and are not taking any psychotropic medications. Participants will undergo two visits (initial evaluation and 12-month follow-up).

Diagnostic Test: Psychiatric scale assessments, VR-Based Behavioral Assessment, Brain MRI

Interventions

Psychiatric scale assessments, VR-Based Behavioral Assessment, Brain MRI DIAGNOSTIC_TEST

This study is a minimal-risk study involving non-invasive, non-pharmacological interventions. Participants will continue receiving their usual medication or counseling treatments as part of their routine care during the study. When participants come to the hospital for assessments, they will engage in clinical assessments and complete questionnaires over a period of 1-2 hours, undergo MRI scans, and participate in virtual environment-based behavioral assessments. They will have the option to take breaks during the assessments and can withdraw from the study at any time without providing a reason.

Anxiety Behavior Group; Healthy Control Group

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of the anxiety behavior group and the healthy control group. 1. Anxiety Behavior Group Adults aged 19 to 60 who received a consultation at the Department of Psychiatry, Kangbuk Samsung Hospital, and were deemed eligible for study participation by the principal investigator. 2. Healthy Control Group Adults aged 19 to 60 voluntarily recruited through a notice posted on the bulletin board at Kangbuk Samsung Hospital.

You may qualify if:

• Anxiety Behavior Group
• Adults aged 19-60 years.
• Diagnosed with an anxiety disorder based on DSM-5 diagnostic criteria, evaluated by a board-certified psychiatrist.
• Individuals who fully understand the study's purpose and process and provide informed consent.
• Healthy Control Group
• Adults aged 19-60 years.
• Individuals who report no psychiatric symptoms and are not taking any psychotropic medications.
• Individuals who fully understand the study's purpose and process and provide informed consent.

You may not qualify if:

• Anxiety Behavior Group
• Individuals unable to read the consent form.
• Individuals with difficulty using virtual reality devices.
• Individuals with a history of epileptic seizures, brain injuries, or neurological disorders.
• Individuals with severe physical illnesses (e.g., cancer, tuberculosis, severe cardiovascular diseases).
• Individuals with substance or alcohol use disorders.
• Individuals with pacemakers or implanted metallic devices.
• Pregnant individuals or those in vulnerable environments, such as institutional employees.
• Healthy Control Group
• Additionally, individuals with any current or past psychiatric disorders are excluded.

Sponsors & Collaborators

• Kangbuk Samsung Hospital: lead

Study Sites (1)

Kangbuk Samsung Medical Center

Seoul, Jongno-gu, 03181, South Korea

Location

MeSH Terms

Conditions

Panic Disorder; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Junhyung Kim, Clinical Assistant Professor

CONTACT

+82-2-2001-2431; jihndy.kim@samsung.com

Jeongyeon Woo, Clinical Research Coordinator

CONTACT

+82-2-2001-1805

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 14, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): May 15, 2029
• Study Completion (Estimated): December 15, 2029
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)