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

NCT ID: NCT05291429

Last Updated: 2022-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-15
• Study Completion Date: 2021-07-15

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.

Conditions

Anxiety; Depression, Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

OVR Health's VR experience

Intervention Type: DEVICE

Virtual reality experience

VR only - no coaching

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

Group Type: ACTIVE_COMPARATOR

OVR Health's VR experience

Intervention Type: DEVICE

Virtual reality experience

No intervention - control arm

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

OVR Health's VR experience

Virtual reality experience

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Citruslabs

INDUSTRY

Sponsor Role: collaborator

Oxford VR

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susanne Mitschke

Role: PRINCIPAL_INVESTIGATOR

Citruslabs

Locations

Citruslabs

Santa Monica, California, United States

Countries

United States

Other Identifiers

20213Oxford

Identifier Type: -

Identifier Source: org_study_id