CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 500 enrolled
Drug / intervention
Intelligent Virtual Reality Therapy System (IVRTS)other
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT04620447
NCT04620447Phase 2Completed

Development of Intelligent Virtual Reality Therapy System (IVRTS) and Testing Its Clinical Efficacy: Revolutionizing Evidence-Based Psychotherapy

University College of Medical Sciences, India·interventional·Posted Nov 9, 2020·Updated Nov 9, 2020

In Brief

A Phase 2 clinical trial evaluating Intelligent Virtual Reality Therapy System (IVRTS) for Phobias and 2 related conditions. Completed, enrolled 500 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIndia

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedNov 9, 2020
Enrollment StartFeb 5, 2018
Primary CompletionMar 1, 2020
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 5.6 years ago

Interventions

Intelligent Virtual Reality Therapy System (IVRTS)other

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.