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Study to Identify if OVR Health's VR-Kit is Safe to Use and Helps to Improve Focus, Attention and Reduce Worry & Rumination.

Primary Purpose

Anxiety, Depression, Anxiety

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

OVR Health's VR experience

About this trial

This is an interventional other trial for Anxiety focused on measuring Virtual reality

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female over 18 years old
Must be in good general health
Self-reported with the following symptoms (as assessed by questions and questionnaires in study material):
Finding it hard to let go of difficult thoughts.
Looking out for signs of a potential threat in their environment (or in their body) that unhelpfully maintains their problem.
Engaging in repetitive, unhelpful patterns of negative thinking (worry & rumination). • These may be due to a diagnosis of a mental health condition, but this is not required for entry into the study.
Good understanding of written and spoken English
Willing and able to give informed consent
Willing and able to follow the study protocol
Willing and able to use VR headset at home
WiFi connection to connect VR headset at home
Willing and able to return VR headset

Exclusion Criteria:

Current diagnosis of epilepsy, dementia, or another neurological disease that may prevent the use of VR hardware and software
Individuals with suicidal or self-harm thoughts
Significant visual, auditory, or balance impairment
Insufficient comprehension of English
Primary diagnosis of alcohol or substance abuse disorder, or personality disorder • Significant learning disability
Current active suicidal plans or self-harm (in which case participant will be referred to appropriate crisis service)
Receiving current alternative psychotherapy treatment
Unwilling to provide consent
Unwilling to follow the study protocol

Sites / Locations

Citruslabs

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Arm Label

VR - coaching arm

VR only - no coaching

No intervention - control arm

Arm Description

30 individuals to be enrolled in the intervention arm that also includes coaching sessions to support and encourage VR use (VR+coaching arm).

30 individuals to be enrolled in the intervention arm without coaching (VR arm)

30 individuals to be enrolled in the control arm with no active intervention (comparator 2; control arm)

Outcomes

Primary Outcome Measures

Safety of virtual reality device and reduction in worry and rumination (PHQ9)

Changes in perceived safety using the PHQ9 questionnaire (Scale 0-3).

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).

Secondary Outcome Measures

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.

Impact of coaching on virtual reality intervention effectiveness (Perseverative Thinking scor)

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.

Full Information

NCT ID

NCT05291429

First Posted

January 31, 2022

Last Updated

March 18, 2022

Sponsor

Oxford VR

Collaborators

Citruslabs

1. Study Identification

Unique Protocol Identification Number

NCT05291429

Brief Title

Study to Identify if OVR Health's VR-Kit is Safe to Use and Helps to Improve Focus, Attention and Reduce Worry & Rumination.

Official Title

Study to Identify if OVR Health's VR-Kit is Safe to Use and Helps Individuals to Improve Focus, Attention and Reduce Worry & Rumination.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

February 15, 2021 (Actual)

Primary Completion Date

July 15, 2021 (Actual)

Study Completion Date

July 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Oxford VR

Collaborators

Citruslabs

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety, Depression, Anxiety

Keywords

Virtual reality

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VR - coaching arm

Arm Type

Active Comparator

Arm Description

30 individuals to be enrolled in the intervention arm that also includes coaching sessions to support and encourage VR use (VR+coaching arm).

Arm Title

VR only - no coaching

Arm Type

Active Comparator

Arm Description

30 individuals to be enrolled in the intervention arm without coaching (VR arm)

Arm Title

No intervention - control arm

Arm Type

No Intervention

Arm Description

30 individuals to be enrolled in the control arm with no active intervention (comparator 2; control arm)

Intervention Type

Device

Intervention Name(s)

OVR Health's VR experience

Intervention Description

Virtual reality experience

Primary Outcome Measure Information:

Title

Safety of virtual reality device and reduction in worry and rumination (PHQ9)

Description

Changes in perceived safety using the PHQ9 questionnaire (Scale 0-3).

Time Frame

5 weeks

Title

Safety of virtual reality device and reduction in worry and rumination (Perseverative Thinking score )

Description

Changes in perceived safety using the Perseverative Thinking score (Scale 0-4).

Time Frame

5 weeks

Secondary Outcome Measure Information:

Title

Impact of coaching on virtual reality intervention effectiveness (PHQ9)

Description

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.

Time Frame

5 weeks

Title

Impact of coaching on virtual reality intervention effectiveness (Perseverative Thinking scor)

Description

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.

Time Frame

5 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female over 18 years old Must be in good general health Self-reported with the following symptoms (as assessed by questions and questionnaires in study material): Finding it hard to let go of difficult thoughts. Looking out for signs of a potential threat in their environment (or in their body) that unhelpfully maintains their problem. Engaging in repetitive, unhelpful patterns of negative thinking (worry & rumination). • These may be due to a diagnosis of a mental health condition, but this is not required for entry into the study. Good understanding of written and spoken English Willing and able to give informed consent Willing and able to follow the study protocol Willing and able to use VR headset at home WiFi connection to connect VR headset at home Willing and able to return VR headset Exclusion Criteria: Current diagnosis of epilepsy, dementia, or another neurological disease that may prevent the use of VR hardware and software Individuals with suicidal or self-harm thoughts Significant visual, auditory, or balance impairment Insufficient comprehension of English Primary diagnosis of alcohol or substance abuse disorder, or personality disorder • Significant learning disability Current active suicidal plans or self-harm (in which case participant will be referred to appropriate crisis service) Receiving current alternative psychotherapy treatment Unwilling to provide consent Unwilling to follow the study protocol

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Susanne Mitschke

Organizational Affiliation

Citruslabs

Official's Role

Principal Investigator

Facility Information:

Facility Name

Citruslabs

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Study to Identify if OVR Health's VR-Kit is Safe to Use and Helps to Improve Focus, Attention and Reduce Worry & Rumination.

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