Intelligent Virtual Reality Therapy System and Testing Its Clinical Efficacy

NCT04620447 | Completed Phase 1 DMC

• 1 other identifier: 3/1/333011/HRD
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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

Phobias; Acrophobia; Anxiety

Keywords

Anxiety; Virtual Reality; Phobias; Clinical Intervention

Outcome Measures

Primary Outcomes (6)

• Change in of symptom intensity of acrophobia in the Intelligent Virtual Reality Therapy System Group as compared to Mindfulness Meditation and Cognitive Behavior Therapy Groups. As assessed on Hamilton Anxiety Inventory.

  Change in symptom intensity as assessed on Hamilton Anxiety Inventory. With lower score indicating higher effectiveness. 0 Being the lowest score and 56 being the highest.

  7 weeks

• Change in symptom intensity of acrophobia in the Intelligent Virtual Reality Therapy System Group as compared to Mindfulness Meditation and Cognitive Behavior Therapy Groups. As assessed on Subjective Units of Dysfunction Scale.

  Change in symptom intensity of symptoms as assessed on Subjective Units of Dysfunction Scale. With lower score indicating higher effectiveness. 0 being the lowest score and 5 being the highest.

  7 weeks

• Change in symptom intensity of acrophobia in the Intelligent Virtual Reality Therapy System Group as compared to Cognitive Behavior Therapy Group and Cognitive Behavior Therapy Groups. As assessed on World Health Organization Quality of Life Bref

  Change in symptom intensity level of Well-being as assessed on World Health Organization Quality of Life Bref Scale. Higher the score more the well-being levels. 26 being the lowest score and 120 being the highest score.

  7 weeks

• Change in symptom intensity of acrophobia Pre and Post Intervention in Intelligent Virtual Reality Therapy System as compared to the Control Group. As assessed on Hamilton Anxiety Inventory.

  Change in symptom intensity of symptoms as assessed on Hamilton Anxiety Inventory. With lower score indicating higher effectiveness. 0 Being the lowest score and 56 being the highest.

  7 weeks

• Change in symptom intensity of acrophobia Pre and Post Intervention in Intelligent Virtual Reality Therapy System as compared to the Control Group. As assessed on The Subjective Units of Dysfunction Scale.

  Reduction of symptoms as assessed on Subjective Units of Dysfunction Scale. With lower score indicating higher effectiveness. 0 being the lowest score and 5 being the highest.

  7 weeks

• Change in symptom intensity of acrophobia Pre and Post Intervention in Intelligent Virtual Reality Therapy System as compared to the Control Group. As assessed on World Health Organization Quality of Life - BREF

  Enhanced well-being as assessed on World Health Organization Quality of Life Bref Scale. Higher the score, better the well-being levels. Higher the score more the well-being levels. 26 being the lowest score and 120 being the highest score.

  7 weeks

Study Arms (4)

Mindfulness Meditation

ACTIVE COMPARATOR

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. Number of Participants: 125 Dropouts: 7 Final number of participants: 118 Mindfulness Meditation intervention was conducted on a sample of 118 patients diagnosed with Acrophobia co-morbid with generalized anxiety who underwent the intervention at The University College of Medical Sciences and GTB hospital. study carried out A-B-A research design 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.

Other: Intelligent Virtual Reality Therapy System (IVRTS)

Cognitive Behavior Therapy

ACTIVE COMPARATOR

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. Number of Participants: 125 Dropouts: 19 Final number of participants: 102 Cognitive Behavior Therapy intervention was conducted on a sample of 118 patients diagnosed with Acrophobia co-morbid with generalized anxiety who underwent the intervention at The University College of Medical Sciences and GTB hospital. study carried out A-B-A research design 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.

Other: Intelligent Virtual Reality Therapy System (IVRTS)

Novel 'Intelligent Virtual Reality Therapy System' (IVRTS)

ACTIVE COMPARATOR

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. Number of Participants: 125 Dropouts: 10 Final number of participants: 115 Novel 'Intelligent Virtual Reality Therapy System' (IVRTS) was conducted on a sample of 118 patients diagnosed with Acrophobia co-morbid with generalized anxiety who underwent the intervention at The University College of Medical Sciences and GTB hospital. study carried out A-B-A research design 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.

Other: Intelligent Virtual Reality Therapy System (IVRTS)

Control Group

NO INTERVENTION

A 7-week intervention course (In this case, no intervention) was designed for each subject to reduce symptoms and enhance quality of life as well as to establish clinical efficacy. Number of Participants: 125 Dropouts: 0 Final number of participants: 125 study carried out A-B-A research design 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.

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.

Cognitive Behavior Therapy; Mindfulness Meditation; Novel 'Intelligent Virtual Reality Therapy System' (IVRTS)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients visiting the Psychiatry OPD of University College of Medical Sciences of the University of Delhi and the attached GTB Hospital.
• Patients who reported fear of heights and scored mild, moderate and Severe anxiety as assessed on Hamilton Anxiety Inventory.
• The patients in age group between 18 to 60 years of age.

You may not qualify if:

• Patients who had any Psychotic disorder were not selected for the study.
• Patients who had co-morbidity with any Psychiatry or medical illness other than Acrophobia and Anxiety were not selected for the study.
• Patients below 18 years of age and over 60 years of age were not selected for the study.

Sponsors & Collaborators

• University College of Medical Sciences, India: lead
• Norwegian University of Science and Technology: collaborator
• Indraprastha Institute of Information Technology Delhi: collaborator

Study Sites (1)

University College of Medical Sciences (UCMS) and GTB Hospital, Department of Psychiatry

New Delhi, National Capital Territory of Delhi, 110005, India

Location

Related Publications (10)

• Committee on Developing Evidence-Based Standards for Psychosocial Interventions for Mental Disorders; Board on Health Sciences Policy; Institute of Medicine; England MJ, Butler AS, Gonzalez ML, editors. Psychosocial Interventions for Mental and Substance Use Disorders: A Framework for Establishing Evidence-Based Standards. Washington (DC): National Academies Press (US); 2015 Sep 18. Available from http://www.ncbi.nlm.nih.gov/books/NBK305126/

  PMID: 26203478 RESULT

• Cartreine JA, Ahern DK, Locke SE. A roadmap to computer-based psychotherapy in the United States. Harv Rev Psychiatry. 2010 Mar-Apr;18(2):80-95. doi: 10.3109/10673221003707702.

  PMID: 20235773 RESULT

• Barnett JE. Utilizing technological innovations to enhance psychotherapy supervision, training, and outcomes. Psychotherapy (Chic). 2011 Jun;48(2):103-8. doi: 10.1037/a0023381.

  PMID: 21639653 RESULT

• Fairburn CG, Cooper Z. Therapist competence, therapy quality, and therapist training. Behav Res Ther. 2011 Jun;49(6-7):373-8. doi: 10.1016/j.brat.2011.03.005. Epub 2011 Mar 21.

  PMID: 21492829 RESULT

• Kobak KA, Craske MG, Rose RD, Wolitsky-Taylor K. Web-based therapist training on cognitive behavior therapy for anxiety disorders: a pilot study. Psychotherapy (Chic). 2013 Jun;50(2):235-47. doi: 10.1037/a0030568. Epub 2013 Feb 11.

  PMID: 23398031 RESULT

• Freeman D, Lister R, Waite F, Yu LM, Slater M, Dunn G, Clark D. Automated psychological therapy using virtual reality (VR) for patients with persecutory delusions: study protocol for a single-blind parallel-group randomised controlled trial (THRIVE). Trials. 2019 Jan 29;20(1):87. doi: 10.1186/s13063-019-3198-6.

  PMID: 30696471 RESULT

• Freeman D, Haselton P, Freeman J, Spanlang B, Kishore S, Albery E, Denne M, Brown P, Slater M, Nickless A. Automated psychological therapy using immersive virtual reality for treatment of fear of heights: a single-blind, parallel-group, randomised controlled trial. Lancet Psychiatry. 2018 Aug;5(8):625-632. doi: 10.1016/S2215-0366(18)30226-8. Epub 2018 Jul 11.

  PMID: 30007519 RESULT

• Maples-Keller JL, Bunnell BE, Kim SJ, Rothbaum BO. The Use of Virtual Reality Technology in the Treatment of Anxiety and Other Psychiatric Disorders. Harv Rev Psychiatry. 2017 May/Jun;25(3):103-113. doi: 10.1097/HRP.0000000000000138.

  PMID: 28475502 RESULT

• Garcia-Palacios A, Hoffman H, Carlin A, Furness TA 3rd, Botella C. Virtual reality in the treatment of spider phobia: a controlled study. Behav Res Ther. 2002 Sep;40(9):983-93. doi: 10.1016/s0005-7967(01)00068-7.

  PMID: 12296495 RESULT

• Miloff A, Lindner P, Hamilton W, Reuterskiold L, Andersson G, Carlbring P. Single-session gamified virtual reality exposure therapy for spider phobia vs. traditional exposure therapy: study protocol for a randomized controlled non-inferiority trial. Trials. 2016 Feb 2;17:60. doi: 10.1186/s13063-016-1171-1.

  PMID: 26833396 RESULT

MeSH Terms

Conditions

Phobic Disorders; Acrophobia; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Manjit Singh Bhatia, MBBS; MD

  University College Of Medical Sciences (UCMS) And GTB Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor and Clinical Consultant

Model Details: 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.

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: November 9, 2020
• Study Start: February 5, 2018
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: November 9, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)