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

Clinical Research Centre, Malaysia5 sites in 1 country80 target enrollmentFebruary 21, 2023

ConditionsGeneralized Anxiety Disorder

Overview

Phase: N/A
Intervention: Not specified
Conditions: Generalized Anxiety Disorder
Sponsor: Clinical Research Centre, Malaysia
Enrollment: 80
Locations: 5
Primary Endpoint: To determine the efficacy of VR modules as an adjunct therapy in improving GAD-7 scores among patients with generalized anxiety disorders.
Status: Active, Not Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

February 21, 2023

End Date

September 30, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Clinical Research Centre, Malaysia

Responsible Party

Sponsor

Eligibility Criteria

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
•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

Outcomes

Primary Outcomes

To determine the efficacy of VR modules as an adjunct therapy in improving GAD-7 scores among patients with generalized anxiety disorders.

Time Frame: Week 0 - Week 4

Patient will be access with GAD-7 questionnaire repeatedly at different time interval (3 Times - Week 0, Week 2, Week 4) .

Secondary Outcomes

To assess the acceptability of VR modules as an adjunct therapy to the standard of care among patients with generalized anxiety disorders.(Week 0 - Week 4)