Generalized Anxiety DisorderVR-GADNCT05895721
Virtual Reality for Generalized Anxiety Disorders
A study testing Virtual Reality in people with Generalized Anxiety Disorder, run by Clinical Research Centre, Malaysia at 5 sites in Malaysia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Virtual Reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 5 sitesMalaysia
- Study dates
- 21 Feb 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Malaysia5 sites
Hospital Sultanah Bahiyah
Alor Star, Kedah, 05460
Hospital Sultanah Aminah
Johor Bahru, Johor, 80100
Hospital Permai
Johor Bahru, Johor, 81200
Hospital Sultanah Nur Zahirah
Kuala Terengganu, Terengganu, 20400
Hospital Kulim
Kulim, Kedah, 09090
About this study
Official title: A Randomized Control Trial of the Use of Virtual Reality as an Adjunct in the Treatment for Generalized Anxiety Disorders
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
- Being tested
- Virtual Reality
- Keywords
- GAD, VR
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityOther
Virtual Reality as adjunct treatment
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard Of Care only |
| Intervention | Other | Standard Of Care + VR Modules Receives: Other: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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) .
Measured: 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.
Patient will assess with standard questionnaire on acceptability of VR technology (3 Times - Week 0, Week 2, Week 4).
Measured: Week 0 - Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start21 Feb 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Research Centre, Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895721
- Sponsor's protocol ID
- NMRR-22-00741-C75
- Acronym
- VR-GAD
- Status last verified
- Sep 2023
- First submitted
- 12 May 2023
- Last updated
- 8 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial of the Use of Virtual Reality as an Adjunct in the Treatment for Generalized Anxiety Disorders
- ClinicalTrials.gov ID
- NCT05895721
- Acronym / sponsor ID
- VR-GAD / NMRR-22-00741-C75
- Conditions
- Generalized Anxiety Disorder
- Keywords
- GAD, VR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Clinical Research Centre, MalaysiaUniversity, hospital or other
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard Of Care only |
| Intervention | Other | Other: Virtual RealityStandard Of Care + VR Modules |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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:
- The patient is under more than 1 center during follow up (e.g., patient is also receiving treatment from a private hospital for GAD).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityVirtual Reality as adjunct treatment | Other | Intervention |
Primary outcome
To determine the efficacy of VR modules as an adjunct therapy in improving GAD-7 scores among patients with generalized anxiety disorders.
Time frame: 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) .
1 secondary outcome
To assess the acceptability of VR modules as an adjunct therapy to the standard of care among patients with generalized anxiety disorders.
Time frame: Week 0 - Week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with Generalized Anxiety Disorder, run by Clinical Research Centre, Malaysia at 5 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the efficacy of VR modules as an adjunct therapy in improving GAD-7 scores among patients with generalized anxiety disorders. (time frame: Week 0 - Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.