Anxiety Clinical Trial
— IVRTSOfficial title:
Development of Intelligent Virtual Reality Therapy System (IVRTS) and Testing Its Clinical Efficacy: Revolutionizing Evidence-Based Psychotherapy
Verified date | November 2020 |
Source | University College of Medical Sciences, India |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 500 |
Est. completion date | March 1, 2020 |
Est. primary completion date | March 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
India | University College of Medical Sciences (UCMS) and GTB Hospital, Department of Psychiatry | New Delhi | Delhi |
Lead Sponsor | Collaborator |
---|---|
University College of Medical Sciences, India | Indraprastha Institute of Information Technology Delhi, Norwegian University of Science and Technology |
India,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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