A Validation Study of Mobile Virtual Reality-Based Self-Care and Exposure Therapy Contents for the Treatment of Panic Disorder

Study Overview
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Brief Summary
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The purpose of this study is to determine whether mobile-based virtual reality exposure treatement can reduce the symptoms of panic disorder and the symptoms of depression and anxiety than the waitlist group

Official Title
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A Validation Study of Mobile Virtual Reality-Based Self-Care and Exposure Therapy Contents for the Treatment of Panic Disorder

Conditions
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Panic Disorder

Intervention / Treatment
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* Procedure: Arm I (Prepectoral)
* Other: Arm II (Subpectoral)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Meet Diagnostic Statistical Manual criteria for panic disorder(with or without agoraphobia) . No change in drug dosage during the study period Exclusion Criteria: - Patients with a history of major neurological or significant medical illness, or met the diagnostic criteria of current substance misuse

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: II (Subpectoral)<br>Waiting list Participants in a waiting list. | |
| Experimental: I (Prepectoral)<br>VR treatment group Participants received the Self-Guided Virtual Reality-based Cognitive Behavioral Therapy for panic disorder. | Procedure: Arm I (Prepectoral)<br>* Participants followed the Self-Guided Virtual Reality-based Cognitive Behavioral Therapy for 4 weeks.<br>Other: Arm II (Subpectoral)<br>* Participants followed the Self-Guided Virtual Reality-based Cognitive Behavioral Therapy for 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Panic Disorder Severity Scale | The Panic Disorder Severity Scale consists of 7 items, each rated on a 5-point scale that assesses panic frequency, distress during panic, panic-focused anticipatory anxiety, phobic avoidance of situations, phobic avoidance of physical sensations, impairment in work functioning, and impairment in social functioning | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The heart rate variability | The heart rate variability is the physiological recordings of the variation in the time interval between consecutive heartbeats in milliseconds | 4 weeks | 
| The Hamilton Rating Scale for Depression | The Hamilton Rating Scale for Depression is a depression assessment scale and contains 17 items pertaining to symptoms of depression experienced over the past week | 4 weeks | 
| The State and Trait Anxiety questionnaire | The State and Trait Anxiety questionnaire is has 20 items for assessing trait anxiety and 20 for state anxiety | 4 weeks | 
| The Korean Inventory of Depressive Symptomatology | The Korean Inventory of Depressive Symptomatology is a self-report questionnaire that comprises symptoms of depression including melancholic, atypical and anxious symptoms | 4 weeks | 
| The Perceived Stress Scale | The Perceived Stress Scale is is a measure of the degree to which situations in one's life are appraised as stressful | 4 weeks | 
| The Albany Panic and Phobia Questionnaire | The Albany Panic and Phobia Questionnaire is a 27-item 9-point Likert scale that was designed to measure the distinct dimension of fear in various situations, and has three subscales: social phobia, agoraphobia, and interoceptive fear | 4 weeks | 
| The Hospital Anxiety and Depression Scale | The Hospital Anxiety and Depression Scale is a 14-item scale that has anxiety and depression subscales; | 4 weeks | 
| The Body Sensations Questionnaire | The Body Sensations Questionnaire is a 17-item 5-point Likert scale that evaluates how afraid and anxious a patient is when he/she feels the physical sensation of each item in an unstable state | 4 weeks | 
| The Anxiety Sensitivity Index | The Anxiety Sensitivity Index is a 16-item measure tapping the fear of anxiety sensations, which is known to be a risk factor for the development of panic. | 4 weeks |