Anxiety, Depression, Anxiety
Conditions
Keywords
Virtual reality
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.
Interventions
DEVICEOVR Health's VR experience
Virtual reality experience
Sponsors
Citruslabs
Oxford VR
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of virtual reality device and reduction in worry and rumination (PHQ9) | 5 weeks | Changes in perceived safety using the PHQ9 questionnaire (Scale 0-3). |
| Safety of virtual reality device and reduction in worry and rumination (Perseverative Thinking score ) | 5 weeks | Changes in perceived safety using the Perseverative Thinking score (Scale 0-4). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of coaching on virtual reality intervention effectiveness (PHQ9) | 5 weeks | 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. |
| Impact of coaching on virtual reality intervention effectiveness (Perseverative Thinking scor) | 5 weeks | 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. |
Countries
United States
Outcome results
None listed