VR-GAD: Virtual Reality for Generalized Anxiety Disorders

Clinical Research Centre, Malaysia (Other)
Overall Status
CT.gov ID

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Virtual Reality

Study Design

Study Type:
Anticipated Enrollment :
80 participants
Intervention Model:
Parallel Assignment
Double (Participant, Investigator)
Primary Purpose:
Official Title:
A Randomized Control Trial of the Use of Virtual Reality as an Adjunct in the Treatment for Generalized Anxiety Disorders
Actual Study Start Date :
Feb 21, 2023
Anticipated Primary Completion Date :
Nov 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Generalized Anxiety Disorder - 7 (GAD-7) [1 - 6 Months]

    The GAD-7 is useful in primary care and mental health settings as a screening tool and symptom severity measure for the four most common anxiety disorders

Secondary Outcome Measures

  1. Acceptability [1 - 6 Months]

    Acceptability of VR modules as an adjunct therapy is measured by a multi- construct questionnaire developed and validated by Bryan JW et. al. (2017)

  2. WHO-5 Well-Being Index (WHO-5) [1 - 6 Months]

    The 5-item questionnaire is among the most widely used questionnaires assessing subjective psychological well-being

Eligibility Criteria


Ages Eligible for Study:
18 Years to 59 Years
Sexes Eligible for Study:
Accepts 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:

    1. Psychosis
    1. Psychosis disorder - previous case, known case of
    1. Claustrophobia
    1. Substance use
    1. Personality disorder
    1. Visual impairment that might hinder usage of virtual reality equipment
    1. Intellectual disabilities
    1. All types of seizures including febrile seizure
  1. The patient is under more than 1 center during follow up (e.g., patient is also receiving treatment from a private hospital for GAD).

Contacts and Locations


Site City State Country Postal Code
1 Bangunan Lili Hospital Sultanah Aminah Johor Bahru Johor Malaysia 80000
2 Klinik Halaman Minda Hospital Kulim Kulim Kedah Malaysia 09000
3 Kompleks Psikiatri & Kesihatan Mental HSNZ Kuala Terengganu Terengganu Malaysia 20400

Sponsors and Collaborators

  • Clinical Research Centre, Malaysia


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Clinical Research Centre, Malaysia
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • NMRR-22-00741-C75
First Posted:
Jun 9, 2023
Last Update Posted:
Jun 9, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Keywords provided by Clinical Research Centre, Malaysia
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 9, 2023