Clinical trial NCT05895721: Virtual Reality for Generalized Anxiety Disorders
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Generalized Anxiety Disorder
Keywords: GAD
VR
Lead sponsor: Clinical Research Centre, Malaysia
Sponsor class: OTHER
First posted: 2023-06-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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).

Primary outcomes:
measure: To determine the efficacy of VR modules as an adjunct therapy in improving GAD-7 scores among patients with generalized anxiety disorders.
timeFrame: Week 0 - Week 4
Secondary outcomes:
measure: To assess the acceptability of VR modules as an adjunct therapy to the standard of care among patients with generalized anxiety disorders.
timeFrame: Week 0 - Week 4
Other outcomes:
Locations:
city: Johor Bahru
country: Malaysia
facility: Hospital Sultanah Aminah
state: Johor
city: Johor Bahru
country: Malaysia
facility: Hospital Permai
state: Johor
city: Alor Setar
country: Malaysia
facility: Hospital Sultanah Bahiyah
state: Kedah
city: Kulim
country: Malaysia
facility: Hospital Kulim
state: Kedah
city: Kuala Terengganu
country: Malaysia
facility: Hospital Sultanah Nur Zahirah
state: Terengganu
Study officials:
References: