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Virtual Reality for Generalized Anxiety Disorders (VR-GAD)

Primary Purpose

Generalized Anxiety Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Virtual Reality
Sponsored by
Clinical Research Centre, Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring GAD, VR

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept 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: 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 The patient is under more than 1 center during follow up (e.g., patient is also receiving treatment from a private hospital for GAD).

Sites / Locations

  • Bangunan Lili Hospital Sultanah AminahRecruiting
  • Klinik Halaman Minda Hospital KulimRecruiting
  • Kompleks Psikiatri & Kesihatan Mental HSNZRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

Control

Intervention

Arm Description

Standard Of Care only

Standard Of Care + VR Modules

Outcomes

Primary Outcome Measures

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) .

Secondary Outcome Measures

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

Full Information

First Posted
May 12, 2023
Last Updated
July 5, 2023
Sponsor
Clinical Research Centre, Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT05895721
Brief Title
Virtual Reality for Generalized Anxiety Disorders
Acronym
VR-GAD
Official Title
A Randomized Control Trial of the Use of Virtual Reality as an Adjunct in the Treatment for Generalized Anxiety Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 21, 2023 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinical Research Centre, Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
Keywords
GAD, VR

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard Of Care only
Arm Title
Intervention
Arm Type
Other
Arm Description
Standard Of Care + VR Modules
Intervention Type
Other
Intervention Name(s)
Virtual Reality
Intervention Description
Virtual Reality as adjunct treatment
Primary Outcome Measure Information:
Title
To determine the efficacy of VR modules as an adjunct therapy in improving GAD-7 scores among patients with generalized anxiety disorders.
Description
Patient will be access with GAD-7 questionnaire repeatedly at different time interval (3 Times - Day 0, Week 2, Week 4) .
Time Frame
4 Weeks
Secondary Outcome Measure Information:
Title
To assess the acceptability of VR modules as an adjunct therapy to the standard of care among patients with generalized anxiety disorders.
Description
Patient will assess with standard questionnaire on acceptability of VR technology
Time Frame
4 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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 The patient is under more than 1 center during follow up (e.g., patient is also receiving treatment from a private hospital for GAD).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Mohd Aizuddin Abdul Rahman
Phone
+60126877225
Email
drmohdaizu@gmail.com
Facility Information:
Facility Name
Bangunan Lili Hospital Sultanah Aminah
City
Johor Bahru
State/Province
Johor
ZIP/Postal Code
80000
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Marina Abd Rahman Sabri
Phone
+60127473577
Email
girlguardian@yahoo.com
Facility Name
Klinik Halaman Minda Hospital Kulim
City
Kulim
State/Province
Kedah
ZIP/Postal Code
09000
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Nurul Nadia Ismail
Phone
+60108783860
Email
nur.aidan@yahoo.com
Facility Name
Kompleks Psikiatri & Kesihatan Mental HSNZ
City
Kuala Terengganu
State/Province
Terengganu
ZIP/Postal Code
20400
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Chong Siew Koon
Phone
+60134890822
Email
chongsiewkoon85@gmail.com

12. IPD Sharing Statement

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Virtual Reality for Generalized Anxiety Disorders

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