Virtual Reality for Generalized Anxiety Disorders

NCT05895721 | Unknown

• 1 other identifier: NMRR-22-00741-C75
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 5

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

Keywords

GAD; VR

Outcome Measures

Primary Outcomes (1)

• 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 - Week 0, Week 2, Week 4) .

  Week 0 - Week 4

Secondary Outcomes (1)

• 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

Study Arms (2)

Control

NO INTERVENTION

Standard Of Care only

Intervention

OTHER

Standard Of Care + VR Modules

Other: Virtual Reality

Interventions

Virtual Reality OTHER

Virtual Reality as adjunct treatment

Intervention

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Clinical Research Centre, Malaysia: lead

Study Sites (5)

Hospital Sultanah Aminah

Johor Bahru, Johor, 80100, Malaysia

Location

Hospital Permai

Johor Bahru, Johor, 81200, Malaysia

Location

Hospital Sultanah Bahiyah

Alor Star, Kedah, 05460, Malaysia

Location

Hospital Kulim

Kulim, Kedah, 09090, Malaysia

Location

Hospital Sultanah Nur Zahirah

Kuala Terengganu, Terengganu, 20400, Malaysia

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: June 9, 2023
• Study Start: February 21, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: July 8, 2024

Record last verified: 2023-09

Locations

MY (5)