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

Panic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04985019
• Other study ID #: 3-2018-0292
• Status: Completed
• Phase: N/A
• Start date: November 14, 2018
• Est. completion date: January 4, 2021

Study information

• Verified date: July 2021
• Source: Gangnam Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 4, 2021
• Est. primary completion date: January 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Panic Disorder

Intervention

Procedure:
• Arm I (Prepectoral)
Participants followed the Self-Guided Virtual Reality-based Cognitive Behavioral Therapy for 4 weeks.

Other:
• Arm II (Subpectoral)
Participants followed the Self-Guided Virtual Reality-based Cognitive Behavioral Therapy for 4 weeks.

Locations

Country	Name	City	State
Korea, Republic of	Gangnam Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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