Intelligent Virtual Reality Therapy System and Testing Its Clinical Efficacy
Condition: Phobias; Acrophobia; Anxiety
MeSH terms: Phobic Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Objective: To take the existing VR technology to the next level, the investigators developed
      a novel Intelligent Virtual Reality Therapy System (IVRTS). The objective of this project had
      three aspects: Namely, development of the novel IVRTS technology involving the development of
      a hardware device, development of Artificially Intelligent Psychotherapeutic
      software-interface and testing it's clinical efficacy. Methods: It used a two-phased
      methodology; Development of the novel technology and testing its Clinical Efficacy. After
      development of Novel IVRTS. A 7-week intervention was designed for each subject. The sample
      of 500 patients, meeting the criteria of Acrophobia and Anxiety, underwent the interventions
      at The GTB hospital (The University of Delhi), for a total 3500 sessions, ranging 5250 hours
      for over 2 years. The subjects were randomly divided into 4 groups: IVRTS Group, Mindfulness
      group, CBT group and Control Group. The ethics committee and clinical trial registration
      number is 33011. Development of this technology would be a land-mark innovation.
    

Detailed description: 
      Many researchers have proved the usefulness of Virtual Reality Technology in the treatment of
      Psychological Disorders, and many studies have quoted efficacy of the treatment as well. The
      research in the VR field is progressing but still is at a very nascent stage10. However,
      despite some VR projects being worked upon in the current times, the technology is not being
      used widely, due to its limited proven efficacy. The current VR technology that exists is
      only limited to placing a patient in his or her phobic situation virtually and not beyond
      that. In this current project the investigators attempted to fill this gap by using two
      important novel technological developments. Firstly, the investigators moved beyond just the
      visual imaging and added haptic touch sensors as well as motion sensors to the device.
      Secondly, the investigators developed an automated intelligent interactive Psychotherapy
      software to compliment the virtual reality as a part of the device and finally the
      investigators tested its clinical efficacy to make sure the novel technology is effective.
      When the world is sitting on the verge of a Mental Health Crisis due to the global pandemic.
      The investigators need to revolutionize the Psychotherapy modality for two reasons, first
      being, the shortage of Mental Health Professionals compared the anticipated cases that would
      need help due to this unique global condition and secondly accessibility. When social
      isolation has become the norm for prevention, one needs innovative tools to be able to
      effectively handle the situation sitting at home, and yet be equally effective, if not more.
      This is the dire need of the society today and the project has immense potential as well has
      huge social impact for the treatment of Anxiety Disorders which currently effects 80% of the
      world population according to the World Health Organization, which is predicted to grow
      further due to the current global pandemic. The development of this novel technology would
      reduce the cost of treatment of Anxiety disorders, PTSD and Phobias considerably, which would
      make interventions viable for people across the world currently not being able to afford long
      term Psychological sessions. It would also reduce the treatment time by approximately half.
      It would make the accessibility of treatment widely available and more comfortable for the
      masses.

      The current Virtual Reality technology to treat Anxiety phobias and general stress was at a
      very nascent stage, where a subject was immersed into phobic situation and is expected to get
      stage-wise comfortable with it. The current existing Virtual Reality technology to treat
      phobia is still relatively new and lacks both theoretical and clinical research. VR
      applications need to go beyond only immersing the person into a phobic situation. This
      proposed research & development project aimed to integrate complex and proven effective
      psychotherapies (visual, auditory, interactive, kinesthetic, motion sensing and tactile),
      automated, intelligent and integrated with the Virtual Reality Technology, which the subject
      or patient will be able to control and undergo themselves, then it's initial clinical
      efficacy was examined. Keller and Bunnel explain, Virtual Reality being a technological
      system helps subjects to experience computer and machine generated situations in lab
      settings. The technology is being widely utilized in Psychological treatment and research.
      Rizzo, mentions that people totally experience Virtual reality when it mimics real life at
      the highest possible level and the users start believing that the situation simulates the
      real actual world experience that it is recreating. This project developed new technology,
      devices, and intelligent psychotherapeutic software programs in VR for curing phobias,
      anxiety, stress and even stress management. The current technology in this field that existed
      is only at a level of immersing a subject in a realistic VR image/scene and is not beyond
      that. Currently, this technology was not useful in the treatment, and that is the reason had
      not entered widely in clinical settings yet.

      To take this technology to the next level, one needed to develop a novel VR
      technology/device, which is intelligent, as well as which would interact and stimulate "Whole
      brain activation" and help the subject overcome phobia/stress/anxiety effectively. This
      required developing a device which had motion sensors, interactive sensors which allowed the
      subject to feel and interact with the image, scenario, program real- time and other
      psychotherapeutic intelligent technological hardware components and intelligent interactive
      psychotherapeutic software programs fostering this process, all built in one integrated
      compact device.

      Furthermore, the main components of this project included -Hardware, software, system
      interfaces and data. The data being collected by the wireless sensor contains information
      about the health status of the user is stored in a database. Health status data included
      information about blood pressure, heart rate and other physiological parameters as well.

      This project is aimed to develop both hardware and software technology and finally test its
      clinical efficacy to treat Phobias, General Anxiety, Stress and PTSD. According to the DSM 5
      published by the American Psychiatry Association, specific phobias are associated with fear
      or Anxiety attached to a specific situation or Object Like water, animals, animals, public
      speaking, needles, heights, blood etc. DSM Also defines Generalized anxiety disorder (GAD) as
      a condition in which a person Feels intrusive, excessive, and persistent worrying to the
      extent that daily functioning becomes difficult.

      Anxiety and Stress is becoming a global epidemic, The World Health Organization, estimates
      that 1 in 3 from Clinical Anxiety and 1 in 5 individuals are suffering from Clinical
      Depression. About 80% of the world is suffering from general stress.

      It is said that situation improves with pumping in of resources and putting in efforts; but
      in this situation despite putting in huge funds, highest quality of resources, the best human
      minds and fierce efforts, the problem is only increasing. The development of this novel
      technology will be a landmark step towards the intervention of these conditions the world is
      battling in present times.

      NOVELTY OF THE PROJECT

      The approach of the Novel Intelligent Software interface approaches follows the basic premise
      that human beings think in terms of images rather than words. While the existing modes of
      treatment for phobias rely mainly on talk therapies and counseling; This novel intelligent
      software treatment methodology deals with the development of VR programs integrated with
      hardware for simulating various phobia-inducing situations, followed by novel automated
      integrated most effective psychotherapy; altering these images to reduce the anxiety
      experienced. Our treatment package includes a VR device integrated with easily comprehensible
      voice commands, along with a user manual and easy user interface, thereby reducing the effort
      of training required for operating the device. The framework is a combination of the therapy
      methodologies with VR, motion sensors, biofeedback and fNIRS. This would eliminate the need
      for a therapist by making the patient self-sufficient in handling the overall treatment
      themselves. In the long run, this would prove to be more cost-effective and socially
      accessible.
    

Intervention name(s): Intelligent Virtual Reality Therapy System (IVRTS)
Intervention type(s): Other
Intervention description(s): The approach of the Novel Intelligent Software interface approaches follows the basic premise that human beings think in terms of images rather than words. While the existing modes of treatment for phobias rely mainly on talk therapies and counseling; This novel intelligent software treatment methodology deals with the development of VR programs integrated with hardware for simulating various phobia-inducing situations, followed by novel automated integrated most effective psychotherapy; altering these images to reduce the anxiety experienced. Our treatment package includes a VR device integrated with easily comprehensible voice commands, along with a user manual and easy user interface, thereby reducing the effort of training required for operating the device. The framework is a combination of the therapy methodologies with VR, motion sensors and biofeedback.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: To achieve the stated objective, a two-fold approach comprising of qualitative and quantitative analysis was undertaken. A 7-week intervention course was designed for each subject to reduce symptoms and enhance quality of life as well as to establish clinical efficacy. .
The participants were assigned to three groups using circumstantial sampling methodology. Group 1: IVRTS, Group 2: Mindfulness, Group 3: Cognitive Behavior Therapy, Group 4: Control Group.
Further study carried out A-B-A research design (Pre and Post intervention) which mainly involved establishing a baseline condition, introducing an experimental treatment and then returning to the baseline. The subjects completed standardized self-report measures of Hamilton Anxiety Inventory (HAM-A), Subjective Units of Dysfunction (SUDS) and WHO Quality of Life - BREF Questionnaire (QOL-BREF) at baseline, after seven intervention sessions post assessments on the same scales were repeated to assess the efficacy.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anxiety; Virtual Reality; Phobias; Clinical Intervention