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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05291429
• Other study ID #: 20213Oxford
• Status: Completed
• Phase: N/A
• Start date: February 15, 2021
• Est. completion date: July 15, 2021

Study information

• Verified date: March 2022
• Source: Oxford VR
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 15, 2021
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression, Anxiety

Intervention

Device:
• OVR Health's VR experience
Virtual reality experience

Locations

Country	Name	City	State
United States	Citruslabs	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
Oxford VR	Citruslabs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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