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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19-60
SponsorKangbuk Samsung Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

185 Participants
are divided into 2 treatment groups
Group A: Anxiety Behavior Group1 intervention
Group B: Healthy Control Group1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

7-item Generalized Anxiety Disorder Scale (GAD)

The GAD-7 (Generalized Anxiety Disorder-7) is a tool used to assess the severity of generalized anxiety disorder symptoms. It consists of 7 items that measure the frequency and intensity of anxiety-related symptoms. The scale uses a 4-point Likert scale, ranging from "Not at all" (0 points) to "Nearly every day" (3 points). The total score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms. A higher score suggests a worse outcome, meaning more frequent and intense anxiety.

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

Depression, Anxiety, Stress Scale (DASS)

The DASS-21 (Depression Anxiety Stress Scale-21) is a psychological tool developed by Henry and Crawford to assess the severity of depression, anxiety, and stress. It consists of 21 items, with 7 items for each symptom. The scale uses a 4-point Likert scale ranging from "Did not apply at all" (0 points) to "Applied very much or most of the time" (3 points). The depression, anxiety, and stress scores each range from 0 to 21, with higher scores indicating more severe symptoms. Depression severity is categorized as Normal (0-4), Mild Depression (5-6), Moderate Depression (7-10), Severe Depression (11-13), and Very Severe Depression (≥14). Anxiety and stress are similarly assessed, with higher scores indicating more severe symptoms.

Time frame
At the initial, 2-month, 6-month, and 12-month time points
3

Liebowits Social Anxiety Scale (LSAS)

The Liebowitz Social Anxiety Scale (LSAS) is a tool used to assess the severity of social anxiety disorder symptoms, consisting of 24 items divided into two sections: 13 items related to fear and 11 items related to avoidance in social situations. Each item is rated using a 4-point Likert scale: for fear, the scale ranges from 0 (Not at all) to 3 (Severely), and for avoidance, it ranges from 0 (Never) to 3 (Often). The total score ranges from 0 to 144, with higher scores indicating more severe symptoms. The score interpretation is as follows: 0-29 indicates no social anxiety, 30-49 represents mild social anxiety, 50-64 is moderate social anxiety, 65-79 is marked social anxiety, 80-94 is severe social anxiety, and ≥95 signifies very severe social anxiety.

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

Other outcomes

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