VR-GAD: Virtual Reality for Generalized Anxiety Disorders

Sponsor

Clinical Research Centre, Malaysia (Other)

Overall Status

Recruiting

CT.gov ID

NCT05895721

Collaborator

(none)

Enrollment

Locations

Arms

10.3

Anticipated Duration (Months)

26.7

Patients Per Site

2.6

Patients Per Site Per Month

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
Generalized Anxiety Disorder	Other: Virtual Reality	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

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

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

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)
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

Criteria

Ages Eligible for Study:

18 Years to 59 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 5.
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:

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

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

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Clinical Research Centre, Malaysia

ClinicalTrials.gov Identifier:

NCT05895721

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

GAD

Additional relevant MeSH terms:

Anxiety Disorders

Study Results

No Results Posted as of Jun 9, 2023