AnxietyNCT03636022
Virtual Reality System for Anxiety and OCD
A study testing VR System in people with Anxiety and Obsessive-Compulsive Disorder, run by Minnesota HealthSolutions at 1 site in United States.
Trial summary
Cognitive Behavioral Therapy with fear provoking exposures is the most effective therapy for anxiety disorders. The investigators aim to enhance this therapy with the use of virtual reality exposures. Read more about this study
- Who is it for?
- Ages 7 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Obsessive-Compulsive Disorder
- What is being tested?
- VR System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2020to 31 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 7 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 7 to 17
- Primary diagnosis of an anxiety disorder or obsessive compulsive disorder.
Who cannot join
- History of and/or current diagnosis of: psychosis, autism, bipolar disorder, mental retardation, oppositional defiant disorder, PTSD, selective mutism or major depressive disorder.
- Current sucidality or recent suicidal behavior.
- Parent to be involved in study who is unable to adequately participate due to intellectual or psychiatric difficulties.
- Starting or changing the dosage of psychiatric medications in the last 2 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low-Cost, Virtual Reality System to Increase Access to Exposure Therapy for Anxiety and Obsessive Compulsive Disorders
Cognitive Behavioral Therapy with fear provoking exposures is the most effective therapy for anxiety disorders. The investigators aim to enhance this therapy with the use of virtual reality exposures. The human subjects study will test the effects of using VR for exposures compared to traditional imaginal exposures on anxiety symptom improvement, functioning, child engagement in an response to exposures, completion of exposure homework between treatment sessions, and length of treatment in weeks and length of treatment among children with anxiety disorders and/or obsessive compulsive disorder.
The funding award supports the development of the technology and the human subjects study. The subcontract to Mayo supports expert input to identify clinically relevant content for therapeutic videos on the VR system and the human subjects study to test the VR system.
Read the detailed description
Seventy children with childhood anxiety disorders (CADs) or obsessive compulsive disorder (OCD) and a parent will be recruited to test the Phase II VR system with a randomized controlled mixed methods study. Participants will be identified through the Mayo Clinic Pediatric Anxiety Disorders Clinic (PADC). Participants will be randomly assigned to home exposure practice with or without the VR system, i.e., intervention or control, respectively. All participants in the study will participate in an introductory session in which participants complete two exposures related to content from their fear ladder, one with the VR system and analogous imaginal exposure. Each family will receive instructions for how to use the Mayo Clinic Anxiety Coach tablet app to record exposures during home practice. Participants will then be assigned one week of daily exposure homework for the intervention and control conditions. Participants randomized to the intervention condition will take home the VR system for homework completion and participants assigned to control will be instructed to complete imaginal exposures. One week after the introductory session, all participants will return for a session in which participants complete both types of exposure. Participants will also be assigned to a third generalization exposure, i.e., an exposure related to the baseline exposure that is higher on the fear ladder, to complete at their next anxiety clinic treatment sessions. SUDS ratings for each type of exposure will be recorded electronically via the Mayo Clinic Anxiety Coach. During the follow up session, an independent interviewer will observe participants' engagement during exposure and will interview participants and their parents about their experience with both types of exposure.
- Conditions
- Anxiety, Obsessive-Compulsive Disorder
- Being tested
- VR System, Control
- Keywords
- Anxiety, OCD, Obsessive Compulsive Disorder, Generalized Anxiety Disorder, Social Phobia, Separation Anxiety, GAD, Youth, Teen, Therapy, Specific Phobia, Children
- Medical subject headings
- Anxiety Disorders, Obsessive-Compulsive Disorder, Generalized Anxiety Disorder, Phobia, Social, Anxiety, Separation, Phobia, Specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR SystemOther
Use of virtual reality to deliver exposure therapy
ControlOther
Use of conventional delivery of exposure therapy
| Study group | Role | What they receive |
|---|---|---|
| VR System | Experimental | Participants will then be assigned one week of daily exposure homework. Patients randomized to the intervention condition will take home the VR system for homework. Receives: Other: VR System |
| Control Condition | Experimental | Participants will then be assigned one week of daily exposure homework. Participants assigned to control will be instructed to complete imaginal exposures. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Subjective Units of Distress Scale (SUDS) at End of Session 1
The SUDS - 0 to 10 ratings, where 0 indicates that participants feel no anxiety at all and 10 indicates that participants are experiencing maximum distress. The mean change in SUDS during the Session VR exposure versus mean change in SUDS during the conventional (control condition) verbal imaginal exposure.
Measured: Baseline and End of Session I, 2 hours
Maximum SUDS Rating During Crossover Exposure
Crossover exposure refers to the Session 2 virtual reality exposure for the control group and to the Session 2 imaginal exposure for the virtual reality group.
The SUDs Rating Scale, or Subjective Units of Distress Scale (SUDs) is used to measure the intensity of distress or anxiety. The SUDs is a self-assessment tool rated on a scale from 0 to 10. Ten represents the highest level of distress and 0 represents no distress.
Measured: 2 hours
Secondary outcomes (1)
Homework Engagement
Number of homework exposures completed.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start1 Nov 2020
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnxietyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to home exposure practice with or without the VR system, i.e., intervention or control
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minnesota HealthSolutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic
- Responsible party
- Sponsor
- Investigators
- Bridget Biggs, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636022
- Sponsor's protocol ID
- MinnesotaHealthSolutions
- Status last verified
- Oct 2024
- First submitted
- 14 Aug 2018
- Last updated
- 15 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be made available through the National Database for Clinical Trials Related to Mental Illness
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Cost, Virtual Reality System to Increase Access to Exposure Therapy for Anxiety and Obsessive Compulsive Disorders
- ClinicalTrials.gov ID
- NCT03636022
- Acronym / sponsor ID
- MinnesotaHealthSolutions
- Conditions
- Anxiety, Obsessive-Compulsive Disorder
- Keywords
- Anxiety, OCD, Obsessive Compulsive Disorder, Generalized Anxiety Disorder, Social Phobia, Separation Anxiety, GAD, Youth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Minnesota HealthSolutionsIndustry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 17 Aug 2018 (actual)
- Results
- Posted 15 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cognitive Behavioral Therapy with fear provoking exposures is the most effective therapy for anxiety disorders. The investigators aim to enhance this therapy with the use of virtual reality exposures. The human subjects study will test the effects of using VR for exposures compared to traditional imaginal exposures on anxiety symptom improvement, functioning, child engagement in an response to exposures, completion of exposure homework between treatment sessions, and length of treatment in weeks and length of treatment among children with anxiety disorders and/or obsessive compulsive disorder.
The funding award supports the development of the technology and the human subjects study. The subcontract to Mayo supports expert input to identify clinically relevant content for therapeutic videos on the VR system and the human subjects study to test the VR system.
Detailed description
Seventy children with childhood anxiety disorders (CADs) or obsessive compulsive disorder (OCD) and a parent will be recruited to test the Phase II VR system with a randomized controlled mixed methods study. Participants will be identified through the Mayo Clinic Pediatric Anxiety Disorders Clinic (PADC). Participants will be randomly assigned to home exposure practice with or without the VR system, i.e., intervention or control, respectively. All participants in the study will participate in an introductory session in which participants complete two exposures related to content from their fear ladder, one with the VR system and analogous imaginal exposure. Each family will receive instructions for how to use the Mayo Clinic Anxiety Coach tablet app to record exposures during home practice. Participants will then be assigned one week of daily exposure homework for the intervention and control conditions. Participants randomized to the intervention condition will take home the VR system for homework completion and participants assigned to control will be instructed to complete imaginal exposures. One week after the introductory session, all participants will return for a session in which participants complete both types of exposure. Participants will also be assigned to a third generalization exposure, i.e., an exposure related to the baseline exposure that is higher on the fear ladder, to complete at their next anxiety clinic treatment sessions. SUDS ratings for each type of exposure will be recorded electronically via the Mayo Clinic Anxiety Coach. During the follow up session, an independent interviewer will observe participants' engagement during exposure and will interview participants and their parents about their experience with both types of exposure.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to home exposure practice with or without the VR system, i.e., intervention or control
| Arm | Type | Receives |
|---|---|---|
| VR System | Experimental | Other: VR SystemParticipants will then be assigned one week of daily exposure homework. Patients randomized to the intervention condition will take home the VR system for homework. |
| Control Condition | Experimental | Other: ControlParticipants will then be assigned one week of daily exposure homework. Participants assigned to control will be instructed to complete imaginal exposures. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 7 to 17
- Primary diagnosis of an anxiety disorder or obsessive compulsive disorder.
Key exclusion criteria (4 listed)
- History of and/or current diagnosis of: psychosis, autism, bipolar disorder, mental retardation, oppositional defiant disorder, PTSD, selective mutism or major depressive disorder.
- Current sucidality or recent suicidal behavior.
- Parent to be involved in study who is unable to adequately participate due to intellectual or psychiatric difficulties.
- Starting or changing the dosage of psychiatric medications in the last 2 months.
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 |
|---|---|---|
| VR SystemUse of virtual reality to deliver exposure therapy | Other | VR System |
| ControlUse of conventional delivery of exposure therapy | Other | Control Condition |
Primary outcome
Mean Change From Baseline in Subjective Units of Distress Scale (SUDS) at End of Session 1
Time frame: Baseline and End of Session I, 2 hours
The SUDS - 0 to 10 ratings, where 0 indicates that participants feel no anxiety at all and 10 indicates that participants are experiencing maximum distress. The mean change in SUDS during the Session VR exposure versus mean change in SUDS during the conventional (control condition) verbal imaginal exposure.
Maximum SUDS Rating During Crossover Exposure
Time frame: 2 hours
Crossover exposure refers to the Session 2 virtual reality exposure for the control group and to the Session 2 imaginal exposure for the virtual reality group. The SUDs Rating Scale, or Subjective Units of Distress Scale (SUDs) is used to measure the intensity of distress or anxiety. The SUDs is a self-assessment tool rated on a scale from 0 to 10. Ten represents the highest level of distress and 0 represents no distress.
1 secondary outcome
Homework Engagement
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Deidentified data will be made available through the National Database for Clinical Trials Related to Mental Illness
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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.
Bridget Biggs, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR System in people with Anxiety and Obsessive-Compulsive Disorder, run by Minnesota HealthSolutions 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 2 inclusion and 4 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 15 Oct 2024. 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?
Yes. Results are posted in the registry (first posted 15 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change From Baseline in Subjective Units of Distress Scale (SUDS) at End of Session 1 (time frame: Baseline and End of Session I, 2 hours). The study lists 2 primary outcomes in all. 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 15 Oct 2024.