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

Oxford VR

Status: Completed

Conditions: Depression, Anxiety; Anxiety

Treatments: Device: OVR Health's VR experience

Study type: Interventional

Funder types: Industry

Identifiers

NCT05291429

20213Oxford

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

VR - coaching arm

Active Comparator group

Description:

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

Treatment:

Device: OVR Health's VR experience

VR only - no coaching

Active Comparator group

Description:

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

Treatment:

Device: OVR Health's VR experience

No intervention - control arm

No Intervention group

Description:

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