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

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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Depression, Anxiety
• Intervention / Treatment: Device: OVR Health's VR experience

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • Citruslabs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: VR - coaching arm; 30 individuals to be enrolled in the intervention arm that also includes coaching sessions to support and encourage VR use (VR+coaching arm).	Device: OVR Health's VR experience; Virtual reality experience
Active Comparator: VR only - no coaching; 30 individuals to be enrolled in the intervention arm without coaching (VR arm)	Device: OVR Health's VR experience; Virtual reality experience
No Intervention: No intervention - control arm; 30 individuals to be enrolled in the control arm with no active intervention (comparator 2; control arm)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Oxford VR
• Collaborators: Citruslabs

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2021
• Primary Completion (Actual): July 15, 2021
• Study Completion (Actual): July 15, 2021

Study Registration Dates

• First Submitted: January 31, 2022
• First Submitted That Met QC Criteria: March 18, 2022
• First Posted (Actual): March 22, 2022

Study Record Updates

• Last Update Posted (Actual): March 22, 2022
• Last Update Submitted That Met QC Criteria: March 18, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Virtual reality
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 20213Oxford

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No