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

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

Study Overview

• Status: Completed
• Conditions: Panic Disorder
• Intervention / Treatment: Procedure: Arm I (Prepectoral); Other: Arm II (Subpectoral)

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Gangnam Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: I (Prepectoral); VR treatment group Participants received the Self-Guided Virtual Reality-based Cognitive Behavioral Therapy for panic disorder.	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.
NO_INTERVENTION: II (Subpectoral); Waiting list Participants in a waiting list.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 14, 2018
• Primary Completion (ACTUAL): January 4, 2021
• Study Completion (ACTUAL): January 4, 2021

Study Registration Dates

• First Submitted: July 26, 2021
• First Submitted That Met QC Criteria: July 26, 2021
• First Posted (ACTUAL): August 2, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 2, 2021
• Last Update Submitted That Met QC Criteria: July 26, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Panic Disorder
• Other Study ID Numbers: 3-2018-0292

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No