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OpenTrials
Completed

NCT Number: NCT05291429

Study to Identify if OVR Health's VR-Kit is Safe to Use and Helps 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.

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Key information

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Santa Monica, California, 90404, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OVR Health's VR experience

Device

Virtual reality experience

Primary outcomes

  1. 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).

  2. 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).

Secondary outcomes

  1. Impact of coaching on virtual reality intervention effectiveness (PHQ9)

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Oxford VR

Industry

Collaborators

  • Citruslabs

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 22, 2022
Registry last updated
Mar 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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