Virtual Reality for Generalized Anxiety Disorders

Study Overview
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Brief Summary
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The goal of this clinical trial is to apply Virtual Reality as an adjunct treatment for Generalized Anxiety Disorder. The main question it aims to answer are: Determination of the efficacy of VR modules as an adjunct therapy in improving GAD-7 scores Assessment of the acceptability of VR modules as an adjunct therapy to the standard of care Participants will randomized into two arms: Control Arm: Standard of Care only Intervention Arm: Standard of Care + VR Modules

Official Title
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A Randomized Control Trial of the Use of Virtual Reality as an Adjunct in the Treatment for Generalized Anxiety Disorders

Conditions
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Generalized Anxiety Disorder

Intervention / Treatment
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* Other: Virtual Reality


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18-59 The primary diagnosis is a generalized anxiety disorder Agree to participate and consented as per study protocol. There is no change in the standard of care within the past two months prior to enrollment into the study. If a patient is on any psychotherapy, then there is no change in the type of current psychotherapy intervention. GAD- 7 more than or equal to 5. Able to come for the session as per scheduled. Exclusion Criteria: Documented or known case of permanent hearing/visual impairment e.g., vestibular abnormalities that represent significant contraindications for the use of VR or visual impairment e.g., cataract. Documented Disorder as listed: A. Psychosis B. Psychosis disorder - previous case, known case of C. Claustrophobia D. Substance use E. Personality disorder F. Visual impairment that might hinder usage of virtual reality equipment G. Intellectual disabilities H. All types of seizures including febrile seizure The patient is under more than 1 center during follow up (e.g., patient is also receiving treatment from a private hospital for GAD).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Standard Of Care only | |
| Other: Intervention<br>Standard Of Care + VR Modules | Other: Virtual Reality<br>* Virtual Reality as adjunct treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the efficacy of VR modules as an adjunct therapy in improving GAD-7 scores among patients with generalized anxiety disorders. | Patient will be access with GAD-7 questionnaire repeatedly at different time interval (3 Times - Day 0, Week 2, Week 4) . | 4 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the acceptability of VR modules as an adjunct therapy to the standard of care among patients with generalized anxiety disorders. | Patient will assess with standard questionnaire on acceptability of VR technology | 4 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GAD, VR