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Completed

NCT Number: NCT04985019

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

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Key information

Age range

19 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gangnam Severance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arm I (Prepectoral)

Procedure

Participants followed the Self-Guided Virtual Reality-based Cognitive Behavioral Therapy for 4 weeks.

Arm II (Subpectoral)

Other

Participants followed the Self-Guided Virtual Reality-based Cognitive Behavioral Therapy for 4 weeks.

Primary outcomes

  1. The Panic Disorder Severity Scale

    Time frame: 4 weeks

    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 outcomes

  1. The heart rate variability

    Time frame: 4 weeks

    The heart rate variability is the physiological recordings of the variation in the time interval between consecutive heartbeats in milliseconds

  2. The Hamilton Rating Scale for Depression

    Time frame: 4 weeks

    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

  3. The State and Trait Anxiety questionnaire

    Time frame: 4 weeks

    The State and Trait Anxiety questionnaire is has 20 items for assessing trait anxiety and 20 for state anxiety

  4. The Korean Inventory of Depressive Symptomatology

    Time frame: 4 weeks

    The Korean Inventory of Depressive Symptomatology is a self-report questionnaire that comprises symptoms of depression including melancholic, atypical and anxious symptoms

  5. The Perceived Stress Scale

    Time frame: 4 weeks

    The Perceived Stress Scale is is a measure of the degree to which situations in one's life are appraised as stressful

  6. The Albany Panic and Phobia Questionnaire

    Time frame: 4 weeks

    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

  7. The Hospital Anxiety and Depression Scale

    Time frame: 4 weeks

    The Hospital Anxiety and Depression Scale is a 14-item scale that has anxiety and depression subscales;

  8. The Body Sensations Questionnaire

    Time frame: 4 weeks

    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

  9. The Anxiety Sensitivity Index

    Time frame: 4 weeks

    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.

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 2, 2021
Registry last updated
Aug 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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