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

Not Applicable

Completed

• Conditions: Depression, Anxiety; Anxiety
• Interventions: Device: OVR Health's VR experience

• Registration Number: NCT05291429
• Lead Sponsor: Oxford VR

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-15
• Primary Completion: 2021-07-15
• Study Completion: 2021-07-15
• Study First Submitted: 2022-01-31
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-18
• Last Update Submitted: 2022-03-18
• Study First Posted: 2022-03-22
• Last Update Posted: 2022-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VR - coaching arm	OVR Health's VR experience	30 individuals to be enrolled in the intervention arm that also includes coaching sessions to support and encourage VR use (VR+coaching arm).
VR only - no coaching	OVR Health's VR experience	30 individuals to be enrolled in the intervention arm without coaching (VR arm)

Primary Outcome Measures

Name	Time	Method
Safety of virtual reality device and reduction in worry and rumination (Perseverative Thinking score )	5 weeks	Changes in perceived safety using the Perseverative Thinking score (Scale 0-4).
Safety of virtual reality device and reduction in worry and rumination (PHQ9)	5 weeks	Changes in perceived safety using the PHQ9 questionnaire (Scale 0-3).

Secondary Outcome Measures

Name	Time	Method
Impact of coaching on virtual reality intervention effectiveness (PHQ9)	5 weeks	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)	5 weeks	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.

Trial Locations

Locations (1)

Citruslabs; 🇺🇸 Santa Monica, California, United States