Virtual Reality for Generalized Anxiety Disorders (VR-GAD)

July 5, 2024 updated by: Clinical Research Centre, Malaysia

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Johor
      • Johor Bahru, Johor, Malaysia, 80100
        • Hospital Sultanah Aminah
      • Johor Bahru, Johor, Malaysia, 81200
        • Hospital Permai
    • Kedah
      • Alor Setar, Kedah, Malaysia, 05460
        • Hospital Sultanah Bahiyah
      • Kulim, Kedah, Malaysia, 09090
        • Hospital Kulim
    • Terengganu
      • Kuala Terengganu, Terengganu, Malaysia, 20400
        • Hospital Sultanah Nur Zahirah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Standard Of Care only
Other: Intervention
Standard Of Care + VR Modules
Other: Virtual Reality
Virtual Reality as adjunct treatment

What is the study measuring?

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.
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) .
Week 0 - Week 4

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.
Time Frame: Week 0 - Week 4
Patient will assess with standard questionnaire on acceptability of VR technology (3 Times - Week 0, Week 2, Week 4).
Week 0 - Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinical Research Centre, Malaysia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2023

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

May 12, 2023

First Submitted That Met QC Criteria

June 6, 2023

First Posted (Actual)

June 9, 2023

Study Record Updates

Last Update Posted (Actual)

July 8, 2024

Last Update Submitted That Met QC Criteria

July 5, 2024

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMRR-22-00741-C75

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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