AnxietyNCT05291429
Study to Identify if OVR Health's VR-Kit is Safe to Use and Helps to Improve Focus, Attention and Reduce Worry & Rumination.
A study testing OVR Health's VR experience in people with Anxiety and Depression, Anxiety, run by Oxford VR at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Anxiety, Depression, Anxiety
- What is being tested?
- OVR Health's VR experience
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2021to 15 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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)
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- Receiving current alternative psychotherapy treatment
- Unwilling to provide consent
- Unwilling to follow the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
- Being tested
- OVR Health's VR experience
- Keywords
- Virtual reality
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OVR Health's VR experienceDevice
Virtual reality experience
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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) Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of virtual reality device and reduction in worry and rumination (PHQ9)
Changes in perceived safety using the PHQ9 questionnaire (Scale 0-3).
Measured: 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).
Measured: 5 weeks
Secondary outcomes (2)
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.
Measured: 5 weeks
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.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start15 Feb 2021
- Primary completion15 Jul 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford VR
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
- Investigators
- Susanne Mitschke, Principal investigator, Citruslabs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291429
- Sponsor's protocol ID
- 20213Oxford
- Status last verified
- Mar 2022
- First submitted
- 31 Jan 2022
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05291429
- Acronym / sponsor ID
- 20213Oxford
- Conditions
- Anxiety, Depression, Anxiety
- Keywords
- Virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Oxford VRIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 22 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VR - coaching arm | Active comparator | Device: OVR Health's VR experience30 individuals to be enrolled in the intervention arm that also includes coaching sessions to support and encourage VR use (VR+coaching arm). |
| VR only - no coaching | Active comparator | Device: OVR Health's VR experience30 individuals to be enrolled in the intervention arm without coaching (VR arm) |
| No intervention - control arm | No intervention | –30 individuals to be enrolled in the control arm with no active intervention (comparator 2; control arm) |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OVR Health's VR experienceVirtual reality experience | Device | VR - coaching arm, VR only - no coaching |
Primary outcome
Safety of virtual reality device and reduction in worry and rumination (PHQ9)
Time frame: 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 )
Time frame: 5 weeks
Changes in perceived safety using the Perseverative Thinking score (Scale 0-4).
2 secondary outcomes
Impact of coaching on virtual reality intervention effectiveness (PHQ9)
Time frame: 5 weeks
Impact of coaching on virtual reality intervention effectiveness (Perseverative Thinking scor)
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanne Mitschke principal investigator
Citruslabs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OVR Health's VR experience in people with Anxiety and Depression, Anxiety, run by Oxford VR at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of virtual reality device and reduction in worry and rumination (PHQ9) (time frame: 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.