Virtual Reality for Generalized Anxiety Disorders

Generalized Anxiety Disorder Clinical Trial

— VR-GAD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05895721
• Other study ID #: NMRR-22-00741-C75
• Status: Recruiting
• Phase: N/A
• Start date: February 21, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2023
• Source: Clinical Research Centre, Malaysia
• Contact: Dr. Mohd Aizuddin Abdul Rahman
• Phone: +60126877225
• Email: drmohdaizu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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).

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Other:
• Virtual Reality
Virtual Reality as adjunct treatment

Locations

Country	Name	City	State
Malaysia	Bangunan Lili Hospital Sultanah Aminah	Johor Bahru	Johor
Malaysia	Kompleks Psikiatri & Kesihatan Mental HSNZ	Kuala Terengganu	Terengganu
Malaysia	Klinik Halaman Minda Hospital Kulim	Kulim	Kedah

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Research Centre, Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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