Specific PhobiaNCT04504773
Using Immersive Virtual Reality to Treat Pediatric Anxiety
A study testing Virtual Reality Exposure Therapy in people with Specific Phobia and Specific Phobia, Situational, run by Johns Hopkins University at 1 site in United States.
Trial summary
Anxiety is a common and impairing problem for children. The principle treatment for pediatric anxiety involves facing a child's fears in a stepwise approach through a therapeutic exercise called exposures. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Specific Phobia, Specific Phobia, Situational, Specific Phobia, Animal
- What is being tested?
- Virtual Reality Exposure Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2020to 14 Feb 2023
- 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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 8-17 years (inclusive),
- meet diagnostic criteria for one or more phobias on a structured diagnostic interview (ADIS-C/P). This specifically includes natural environments (e.g., storms, heights) and/or situational settings (e.g., airplanes, public speaking).
- be fluent in English.
Who cannot join
- unable to complete rating scales, or
- attend study visits.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205
About this study
Official title: Virtually Better: Using Immersive Virtual Reality to Treat Pediatric Anxiety
Anxiety is a common and impairing problem for children. The principle treatment for pediatric anxiety involves facing a child's fears in a stepwise approach through a therapeutic exercise called exposures. While exposures are effective, some feared situations cannot be confronted in a clinician's office (e.g., heights, public speaking, storms). This poses a logistical challenge in treatment that: (1) takes time away from patient care, (2) leads clinicians to rely on imagined exposures, and/or (3) requires families to complete exposures outside of the therapy visits. This creates a burden for clinicians and families, and impedes treatment success. Immersive virtual reality (VR) presents an innovative solution that allows children to face fears without leaving the clinician's office. While VR has been used to distract children during painful medical procedures, it has not been well examined as a primary treatment for pediatric anxiety. This study proposes to examine the effectiveness and acceptability of using immersive VR exposures to treat children and adolescents with specific phobias.
- Conditions
- Specific Phobia, Specific Phobia, Situational, Specific Phobia, Animal, Specific Phobia, Natural Environment, Childhood Anxiety Disorder
- Being tested
- Virtual Reality Exposure Therapy
- Keywords
- Exposure Therapy, Virtual Reality
- Medical subject headings
- Phobia, Specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Exposure TherapyBehavioural
Participants will receive a single session of virtual reality exposure therapy that targets the participant's specific phobia stimuli.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Exposure Therapy | Experimental | Participants will receive a single session of exposure therapy to address specific phobia that includes the use of virtual reality exposures. Receives: Behavioral: Virtual Reality Exposure Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Severity Rating (CSR) of Targeted Specific Phobia on Anxiety Disorder Interview Schedule for Children and Parents (ADIS-C/P)
The ADIS-C/P CSR for the Specific Phobia is a single item rating that is made by a clinician. Scores are made on a 9-point scale that ranges from 0 (Not at all) to 8 (Very, very much). A score of 4 or greater considered to be indicative of a psychiatric disorder.
Measured: 1 week after virtual reality exposure therapy session
Secondary outcomes (1)
Screen for Childhood Anxiety and Related Disorders-Parent Report (SCARED-P)
Parent-reported rating of child anxiety that consists of 41-items. Items are rated on a 3-point scale that ranges from 0 (Not True) to 2 (Very True). The total score ranges from 0 to 82, with a total score of 25 or greater may indicate the presence of an anxiety disorder.
Measured: 1 week after virtual reality exposure therapy session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start17 Sep 2020
- Primary completion12 Jan 2022
- Study completion14 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Specific PhobiaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph F. McGuire, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504773
- Sponsor's protocol ID
- IRB00210075
- Status last verified
- Dec 2022
- First submitted
- 5 Aug 2020
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtually Better: Using Immersive Virtual Reality to Treat Pediatric Anxiety
- ClinicalTrials.gov ID
- NCT04504773
- Acronym / sponsor ID
- IRB00210075
- Conditions
- Specific Phobia, Specific Phobia, Situational, Specific Phobia, Animal, Specific Phobia, Natural Environment, Childhood Anxiety Disorder
- Keywords
- Exposure Therapy, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 17 Sep 2020 (actual)
- Primary completion
- 12 Jan 2022 (actual)
- Study completion
- 14 Feb 2023 (actual)
- First posted
- 7 Aug 2020 (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.
Anxiety is a common and impairing problem for children. The principle treatment for pediatric anxiety involves facing a child's fears in a stepwise approach through a therapeutic exercise called exposures. While exposures are effective, some feared situations cannot be confronted in a clinician's office (e.g., heights, public speaking, storms). This poses a logistical challenge in treatment that: (1) takes time away from patient care, (2) leads clinicians to rely on imagined exposures, and/or (3) requires families to complete exposures outside of the therapy visits. This creates a burden for clinicians and families, and impedes treatment success. Immersive virtual reality (VR) presents an innovative solution that allows children to face fears without leaving the clinician's office. While VR has been used to distract children during painful medical procedures, it has not been well examined as a primary treatment for pediatric anxiety. This study proposes to examine the effectiveness and acceptability of using immersive VR exposures to treat children and adolescents with specific phobias.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Exposure Therapy | Experimental | Behavioral: Virtual Reality Exposure TherapyParticipants will receive a single session of exposure therapy to address specific phobia that includes the use of virtual reality exposures. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 8-17 years (inclusive),
- meet diagnostic criteria for one or more phobias on a structured diagnostic interview (ADIS-C/P). This specifically includes natural environments (e.g., storms, heights) and/or situational settings (e.g., airplanes, public speaking).
- be fluent in English.
Key exclusion criteria (2 listed)
- unable to complete rating scales, or
- attend study visits.
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 |
|---|---|---|
| Virtual Reality Exposure TherapyParticipants will receive a single session of virtual reality exposure therapy that targets the participant's specific phobia stimuli. | Behavioural | Virtual Reality Exposure Therapy |
Primary outcome
Clinical Severity Rating (CSR) of Targeted Specific Phobia on Anxiety Disorder Interview Schedule for Children and Parents (ADIS-C/P)
Time frame: 1 week after virtual reality exposure therapy session
The ADIS-C/P CSR for the Specific Phobia is a single item rating that is made by a clinician. Scores are made on a 9-point scale that ranges from 0 (Not at all) to 8 (Very, very much). A score of 4 or greater considered to be indicative of a psychiatric disorder.
1 secondary outcome
Screen for Childhood Anxiety and Related Disorders-Parent Report (SCARED-P)
Time frame: 1 week after virtual reality exposure therapy session
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 21 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Specific Phobia
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
Not yet recruiting
Effects of Dead Bug Exercises With and Without Diaphragmatic Breathing in Patients With Chronic Non-specific Low Back Pain.
Non-specific Chronic Low Back Pain
Not yet recruiting
Facing Fears From Home: Development, Feasibility and Maximization of FobiApp
Specific Phobia
Recruiting
Anxiety Skills Study
Anxiety, Anxiety Acute
Recruiting
Metacognitive Therapy Compared to Cognitive-behavioral Therapy
Generalized Anxiety Disorder, Social Anxiety Disorder
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.
Joseph F. McGuire, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Exposure Therapy in people with Specific Phobia and Specific Phobia, Situational, run by Johns Hopkins University at 1 site in United States.
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 3 inclusion and 2 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 21 Feb 2023. 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 United States. 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?
Clinical Severity Rating (CSR) of Targeted Specific Phobia on Anxiety Disorder Interview Schedule for Children and Parents (ADIS-C/P) (time frame: 1 week after virtual reality exposure therapy session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2023.