Virtual Reality for Generalized Anxiety Disorders

NCT ID: NCT05895721

Last Updated: 2024-07-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-21
• Study Completion Date: 2024-09-30

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

Conditions

Generalized Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control

Standard Of Care only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

Standard Of Care + VR Modules

Group Type: OTHER

Virtual Reality

Intervention Type: OTHER

Virtual Reality as adjunct treatment

Interventions

Virtual Reality

Virtual Reality as adjunct treatment

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinical Research Centre, Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Sultanah Aminah

Johor Bahru, Johor, Malaysia

Hospital Permai

Johor Bahru, Johor, Malaysia

Hospital Sultanah Bahiyah

Alor Star, Kedah, Malaysia

Hospital Kulim

Kulim, Kedah, Malaysia

Hospital Sultanah Nur Zahirah

Kuala Terengganu, Terengganu, Malaysia

Countries

Malaysia

Other Identifiers

NMRR-22-00741-C75

Identifier Type: -

Identifier Source: org_study_id