Back to resultsA Validation Study of Mobile Virtual Reality-Based Self-Care and Exposure Therapy Contents for the Treatment of Panic Disorder
Primary Purpose
Panic Disorder
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Arm I (Prepectoral)
Arm II (Subpectoral)
Sponsored by
About this trial
This is an interventional treatment trial for Panic Disorder
Eligibility Criteria
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
Sites / Locations
- Gangnam Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
I (Prepectoral)
II (Subpectoral)
Arm Description
VR treatment group Participants received the Self-Guided Virtual Reality-based Cognitive Behavioral Therapy for panic disorder.
Waiting list Participants in a waiting list.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
The heart rate variability
The heart rate variability is the physiological recordings of the variation in the time interval between consecutive heartbeats in milliseconds
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
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
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
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
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
The Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale is a 14-item scale that has anxiety and depression subscales;
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
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.
Full Information
NCT ID
NCT04985019
First Posted
July 26, 2021
Last Updated
July 26, 2021
Sponsor
Gangnam Severance Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04985019
Brief Title
A Validation Study of Mobile Virtual Reality-Based Self-Care and Exposure Therapy Contents for the Treatment of Panic Disorder
Official Title
A Validation Study of Mobile Virtual Reality-Based Self-Care and Exposure Therapy Contents for the Treatment of Panic Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
November 14, 2018 (Actual)
Primary Completion Date
January 4, 2021 (Actual)
Study Completion Date
January 4, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gangnam Severance Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
I (Prepectoral)
Arm Type
Experimental
Arm Description
VR treatment group Participants received the Self-Guided Virtual Reality-based Cognitive Behavioral Therapy for panic disorder.
Arm Title
II (Subpectoral)
Arm Type
No Intervention
Arm Description
Waiting list Participants in a waiting list.
Intervention Type
Procedure
Intervention Name(s)
Arm I (Prepectoral)
Intervention Description
Participants followed the Self-Guided Virtual Reality-based Cognitive Behavioral Therapy for 4 weeks.
Intervention Type
Other
Intervention Name(s)
Arm II (Subpectoral)
Intervention Description
Participants followed the Self-Guided Virtual Reality-based Cognitive Behavioral Therapy for 4 weeks.
Primary Outcome Measure Information:
Title
The Panic Disorder Severity Scale
Description
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
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
The heart rate variability
Description
The heart rate variability is the physiological recordings of the variation in the time interval between consecutive heartbeats in milliseconds
Time Frame
4 weeks
Title
The Hamilton Rating Scale for Depression
Description
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
Time Frame
4 weeks
Title
The State and Trait Anxiety questionnaire
Description
The State and Trait Anxiety questionnaire is has 20 items for assessing trait anxiety and 20 for state anxiety
Time Frame
4 weeks
Title
The Korean Inventory of Depressive Symptomatology
Description
The Korean Inventory of Depressive Symptomatology is a self-report questionnaire that comprises symptoms of depression including melancholic, atypical and anxious symptoms
Time Frame
4 weeks
Title
The Perceived Stress Scale
Description
The Perceived Stress Scale is is a measure of the degree to which situations in one's life are appraised as stressful
Time Frame
4 weeks
Title
The Albany Panic and Phobia Questionnaire
Description
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
Time Frame
4 weeks
Title
The Hospital Anxiety and Depression Scale
Description
The Hospital Anxiety and Depression Scale is a 14-item scale that has anxiety and depression subscales;
Time Frame
4 weeks
Title
The Body Sensations Questionnaire
Description
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
Time Frame
4 weeks
Title
The Anxiety Sensitivity Index
Description
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.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
34813486
Citation
Shin B, Oh J, Kim BH, Kim HE, Kim H, Kim S, Kim JJ. Effectiveness of Self-Guided Virtual Reality-Based Cognitive Behavioral Therapy for Panic Disorder: Randomized Controlled Trial. JMIR Ment Health. 2021 Nov 22;8(11):e30590. doi: 10.2196/30590.
Results Reference
derived
Learn more about this trial
A Validation Study of Mobile Virtual Reality-Based Self-Care and Exposure Therapy Contents for the Treatment of Panic Disorder
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