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Intelligent Virtual Reality Therapy System and Testing Its Clinical Efficacy

NCT04620447 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2020-11-09

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Intelligent Virtual Reality Therapy System (IVRTS)

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.

Sponsors & Collaborators

  • Norwegian University of Science and Technology

    collaborator OTHER

  • Indraprastha Institute of Information Technology Delhi

    collaborator OTHER

  • University College of Medical Sciences, India

    lead INDIV

Principal Investigators

  • Manjit Singh Bhatia, MBBS; MD · University College Of Medical Sciences (UCMS) And GTB Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-05
Primary Completion
2020-03-01
Completion
2020-03-01

Countries

  • India

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04620447 on ClinicalTrials.gov