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

NCT05291429 | Completed

• 1 other identifier: 20213Oxford
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

Virtual reality

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Impact of coaching on virtual reality intervention effectiveness (PHQ9)

  5 weeks

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

  5 weeks

Study Arms (3)

VR - coaching arm

ACTIVE COMPARATOR

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

VR only - no coaching

ACTIVE COMPARATOR

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

Device: OVR Health's VR experience

No intervention - control arm

NO INTERVENTION

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

Interventions

OVR Health's VR experience DEVICE

Virtual reality experience

VR - coaching arm; VR only - no coaching

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oxford VR: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Susanne Mitschke

  Citruslabs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: March 22, 2022
• Study Start: February 15, 2021
• Primary Completion: July 15, 2021
• Study Completion: July 15, 2021
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)