Clinical trial NCT05291429: Study to Identify if OVR Health's VR-Kit is Safe to Use and Helps to Improve Focus, Attention and Reduce Worry & Rumination.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression, Anxiety
Keywords: Virtual reality
Lead sponsor: Oxford VR
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2022-03-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Safety of virtual reality device and reduction in worry and rumination (PHQ9)
timeFrame: 5 weeks
measure: Safety of virtual reality device and reduction in worry and rumination (Perseverative Thinking score )
timeFrame: 5 weeks
Secondary outcomes:
measure: Impact of coaching on virtual reality intervention effectiveness (PHQ9)
timeFrame: 5 weeks
measure: Impact of coaching on virtual reality intervention effectiveness (Perseverative Thinking scor)
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
affiliation: Citruslabs
name: Susanne Mitschke
role: PRINCIPAL_INVESTIGATOR
References: