Virtual Reality for Generalized Anxiety Disorders

Not Applicable

Active, not recruiting

• Conditions: Generalized Anxiety Disorder
• Interventions: Other: Virtual Reality

• Registration Number: NCT05895721
• Lead Sponsor: Clinical Research Centre, Malaysia

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-21
• Study First Submitted: 2023-05-12
• Study First Submitted QC: 2023-06-06
• Study First Posted: 2023-06-09
• Status Verified: 2023-09
• Last Update Submitted: 2024-07-05
• Last Update Posted: 2024-07-08
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Virtual Reality	Standard Of Care + VR Modules

Primary Outcome Measures

Name	Time	Method
To determine the efficacy of VR modules as an adjunct therapy in improving GAD-7 scores among patients with generalized anxiety disorders.	Week 0 - Week 4	Patient will be access with GAD-7 questionnaire repeatedly at different time interval (3 Times - Week 0, Week 2, Week 4) .

Secondary Outcome Measures

Name	Time	Method
To assess the acceptability of VR modules as an adjunct therapy to the standard of care among patients with generalized anxiety disorders.	Week 0 - Week 4	Patient will assess with standard questionnaire on acceptability of VR technology (3 Times - Week 0, Week 2, Week 4).

Trial Locations

Locations (5)

Hospital Sultanah Bahiyah; 🇲🇾 Alor Setar, Kedah, Malaysia

Hospital Sultanah Aminah; 🇲🇾 Johor Bahru, Johor, Malaysia

Hospital Permai; 🇲🇾 Johor Bahru, Johor, Malaysia

Hospital Kulim; 🇲🇾 Kulim, Kedah, Malaysia

Hospital Sultanah Nur Zahirah; 🇲🇾 Kuala Terengganu, Terengganu, Malaysia