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| Name | Class |
|---|---|
| Mayo Clinic | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VR System | Other | Use of virtual reality to deliver exposure therapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Homework Engagement | Number of homework exposures completed. | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bridget Biggs, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
Deidentified data will be made available through the National Database for Clinical Trials Related to Mental Illness
6 months following the study completion
To be determined by the National Institute of Mental Health
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| ID | Title | Description |
|---|---|---|
| FG000 | VR System | 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. VR System: Use of virtual reality to deliver exposure therapy |
| FG001 | Control Condition | Participants will then be assigned one week of daily exposure homework. Participants assigned to control will be instructed to complete imaginal exposures. Control: Use of conventional delivery of exposure therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | VR System | 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. VR System: Use of virtual reality to deliver exposure therapy |
| BG001 | Control Condition |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and End of Session I, 2 hours |
|
Procedures for the present study occurred over two study sessions, each approximately 60-minutes and spaced a week apart. Data on adverse events were collected for each participant for their approximately one week of participation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VR System | 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. VR System: Use of virtual reality to deliver exposure therapy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sara Seifert | Minnesota HealthSolutions | 6128036998 | sara@minnhealth.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 15, 2024 | May 15, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D009771 | Obsessive-Compulsive Disorder |
| D000098647 | Generalized Anxiety Disorder |
| D000072861 | Phobia, Social |
| D001010 | Anxiety, Separation |
| C562465 | Phobia, Specific |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D010698 | Phobic Disorders |
| D065886 | Neurodevelopmental Disorders |
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Participants will be randomly assigned to home exposure practice with or without the VR system, i.e., intervention or control
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| Control |
| Other |
Use of conventional delivery of exposure therapy |
|
Participants will then be assigned one week of daily exposure homework. Participants assigned to control will be instructed to complete imaginal exposures. Control: Use of conventional delivery of exposure therapy |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Participants will then be assigned one week of daily exposure homework. Participants assigned to control will be instructed to complete imaginal exposures. Control: Use of conventional delivery of exposure therapy |
|
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| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 2 hours |
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| Secondary | Homework Engagement | Number of homework exposures completed. | Posted | Mean | Standard Deviation | homework exposures completed | 1 week |
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| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Control Condition | Participants will then be assigned one week of daily exposure homework. Participants assigned to control will be instructed to complete imaginal exposures. Control: Use of conventional delivery of exposure therapy | 0 | 20 | 0 | 20 | 0 | 20 |
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