A Validation Study of Mobile Virtual Reality-Based Self-Care and Exposure Therapy Contents for the Treatment of Panic Disorder
1 other identifier
interventional
40
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 4, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 4, 2021
CompletedFirst Submitted
Initial submission to the registry
July 26, 2021
CompletedFirst Posted
Study publicly available on registry
August 2, 2021
CompletedAugust 2, 2021
July 1, 2021
2.1 years
July 26, 2021
July 26, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
The heart rate variability
4 weeks
The Hamilton Rating Scale for Depression
4 weeks
The State and Trait Anxiety questionnaire
4 weeks
The Korean Inventory of Depressive Symptomatology
4 weeks
The Perceived Stress Scale
4 weeks
- +4 more secondary outcomes
Study Arms (2)
I (Prepectoral)
EXPERIMENTALVR treatment group Participants received the Self-Guided Virtual Reality-based Cognitive Behavioral Therapy for panic disorder.
II (Subpectoral)
NO INTERVENTIONWaiting list Participants in a waiting list.
Interventions
Participants followed the Self-Guided Virtual Reality-based Cognitive Behavioral Therapy for 4 weeks.
Participants followed the Self-Guided Virtual Reality-based Cognitive Behavioral Therapy for 4 weeks.
Eligibility Criteria
You may qualify if:
- \- Meet Diagnostic Statistical Manual criteria for panic disorder(with or without agoraphobia) .
- No change in drug dosage during the study period
You may not qualify if:
- \- Patients with a history of major neurological or significant medical illness, or met the diagnostic criteria of current substance misuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gangnam Severance Hospital
Seoul, South Korea
Related Publications (1)
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.
PMID: 34813486DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Assistant Professor
Study Record Dates
First Submitted
July 26, 2021
First Posted
August 2, 2021
Study Start
November 14, 2018
Primary Completion
January 4, 2021
Study Completion
January 4, 2021
Last Updated
August 2, 2021
Record last verified: 2021-07