Panic DisorderNCT04985019
A Validation Study of Mobile Virtual Reality-Based Self-Care and Exposure Therapy Contents for the Treatment of Panic Disorder
A study testing Arm I (Prepectoral) and Arm II (Subpectoral) in people with Panic Disorder, run by Gangnam Severance Hospital at 1 site in South Korea.
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 Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Panic Disorder
- What is being tested?
- Arm I (Prepectoral) and Arm II (Subpectoral)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Nov 2018to 4 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meet Diagnostic Statistical Manual criteria for panic disorder(with or without agoraphobia) .
- No change in drug dosage during the study period
Who cannot join
- Patients with a history of major neurological or significant medical illness, or met the diagnostic criteria of current substance misuse
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Panic Disorder
- Being tested
- Arm I (Prepectoral), Arm II (Subpectoral)
- Medical subject headings
- Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm I (Prepectoral)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| I (Prepectoral) | Experimental | VR treatment group Participants received the Self-Guided Virtual Reality-based Cognitive Behavioral Therapy for panic disorder. Receives: Procedure: Arm I (Prepectoral); Other: Arm II (Subpectoral) |
| II (Subpectoral) | No intervention | Waiting list Participants in a waiting list. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (9)
The heart rate variability
The heart rate variability is the physiological recordings of the variation in the time interval between consecutive heartbeats in milliseconds
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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;
Measured: 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
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start14 Nov 2018
- Primary completion4 Jan 2021
- Study completion4 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Panic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jooyoung Oh, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04985019
- Sponsor's protocol ID
- 3-2018-0292
- Status last verified
- Jul 2021
- First submitted
- 26 Jul 2021
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 34813486
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Validation Study of Mobile Virtual Reality-Based Self-Care and Exposure Therapy Contents for the Treatment of Panic Disorder
- ClinicalTrials.gov ID
- NCT04985019
- Acronym / sponsor ID
- 3-2018-0292
- Conditions
- Panic Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 14 Nov 2018 (actual)
- Primary completion
- 4 Jan 2021 (actual)
- Study completion
- 4 Jan 2021 (actual)
- First posted
- 2 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I (Prepectoral) | Experimental | Procedure: Arm I (Prepectoral), Other: Arm II (Subpectoral)VR treatment group Participants received the Self-Guided Virtual Reality-based Cognitive Behavioral Therapy for panic disorder. |
| II (Subpectoral) | No intervention | –Waiting list Participants in a waiting list. |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Meet Diagnostic Statistical Manual criteria for panic disorder(with or without agoraphobia) .
- No change in drug dosage during the study period
Key exclusion criteria (1 listed)
- Patients with a history of major neurological or significant medical illness, or met the diagnostic criteria of current substance misuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm I (Prepectoral)Participants followed the Self-Guided Virtual Reality-based Cognitive Behavioral Therapy for 4 weeks. | Procedure or surgery | I (Prepectoral) |
| Arm II (Subpectoral)Participants followed the Self-Guided Virtual Reality-based Cognitive Behavioral Therapy for 4 weeks. | Other | I (Prepectoral) |
Primary outcome
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
9 secondary outcomes
The heart rate variability
Time frame: 4 weeks
The Hamilton Rating Scale for Depression
Time frame: 4 weeks
The State and Trait Anxiety questionnaire
Time frame: 4 weeks
The Korean Inventory of Depressive Symptomatology
Time frame: 4 weeks
The Perceived Stress Scale
Time frame: 4 weeks
The Albany Panic and Phobia Questionnaire
Time frame: 4 weeks
The Hospital Anxiety and Depression Scale
Time frame: 4 weeks
The Body Sensations Questionnaire
Time frame: 4 weeks
The Anxiety Sensitivity Index
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- Derived from this study: PubMed 34813486Shin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm I (Prepectoral) and Arm II (Subpectoral) in people with Panic Disorder, run by Gangnam Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Panic Disorder Severity Scale (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04985019, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2021.