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| Name | Class |
|---|---|
| Citruslabs | INDUSTRY |
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This is a randomized-controlled interventional treatment study with three arms of comparable demographics to evaluate the safety and efficacy of OVR Health's VR experience to improve control over the focus of attention and reduce worry and rumination in individuals who have reported problems with these issues.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR - coaching arm | Active Comparator | 30 individuals to be enrolled in the intervention arm that also includes coaching sessions to support and encourage VR use (VR+coaching arm). |
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| VR only - no coaching | Active Comparator | 30 individuals to be enrolled in the intervention arm without coaching (VR arm) |
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| No intervention - control arm | No Intervention | 30 individuals to be enrolled in the control arm with no active intervention (comparator 2; control arm) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OVR Health's VR experience | Device | Virtual reality experience |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of virtual reality device and reduction in worry and rumination (PHQ9) | Changes in perceived safety using the PHQ9 questionnaire (Scale 0-3). | 5 weeks |
| Safety of virtual reality device and reduction in worry and rumination (Perseverative Thinking score ) | Changes in perceived safety using the Perseverative Thinking score (Scale 0-4). | 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of coaching on virtual reality intervention effectiveness (PHQ9) | Changes in the PHQ9 questionnaire (0-3) in comparison to Group 2 (no coaching) and placebo arm (no intervention) with a lower score showing fewer symptoms. | 5 weeks |
| Impact of coaching on virtual reality intervention effectiveness (Perseverative Thinking scor) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susanne Mitschke | Citruslabs | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citruslabs | Santa Monica | California | 90404 | United States |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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Changes in the Perseverative Thinking score (0-4) in comparison to Group 2 (no coaching) and placebo arm (no intervention) with a lower score showing fewer symptoms. |
| 5 weeks |