Virtual Reality for Generalized Anxiety Disorders (VR-GAD)

Clinical Research Centre, Malaysia

Status: Active, not recruiting

Conditions: Generalized Anxiety Disorder

Treatments: Other: Virtual Reality

Study type: Interventional

Funder types: Other

Identifiers

NCT05895721

NMRR-22-00741-C75

Details and patient eligibility

About

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

Enrollment: 80 patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age between 18-59
2. The primary diagnosis is a generalized anxiety disorder
3. Agree to participate and consented as per study protocol.
4. 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.
5. GAD- 7 more than or equal to 5.
6. Able to come for the session as per scheduled.

Exclusion criteria

1. 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.

2. 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

3. The patient is under more than 1 center during follow up (e.g., patient is also receiving treatment from a private hospital for GAD).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Control

No Intervention group

Description:

Standard Of Care only

Intervention

Other group

Description:

Standard Of Care + VR Modules

Treatment:

Other: Virtual Reality