Actively Recruiting
A Neuro-Technological Intervention for Adolescents With Generalised Anxiety Disorder (GAD): A Feasibility Trial
Led by National Healthcare Group, Singapore ยท Updated on 2025-05-22
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
N
National Healthcare Group, Singapore
Lead Sponsor
D
Duke-NUS Graduate Medical School
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a neuro-technological approach to help adolescents diagnosed with Generalised Anxiety Disorder (GAD). The study aims to test the safety and acceptability of delivering a mindfulness-based anxiety regulation intervention through a virtual reality (VR) game combined with neuro- and bio-feedback. This intervention uses a novel algorithm designed for early treatment of GAD in outpatient adolescents aged 13 to 18 years. Participants will take part in eight intervention sessions lasting 30 minutes each, held twice a week over four weeks. During these sessions, they will wear a head-mounted VR display and a mobile EEG-biosensor, both non-invasive devices. Each session starts with audio-guided mindfulness practice, followed by a 15-minute VR game that adapts to the participant's anxiety levels and their ability to manage it. Participants will continue their usual psychiatric treatment except for changes in psychotropic medications. Throughout the study, participants will complete questionnaires at the beginning and end of the intervention. Researchers will assess outcomes including usability of the intervention at week 4 and anxiety levels reported by both the adolescents and their parents at baseline and after five weeks. The study monitors participant safety and intervention feasibility over the four-week treatment period.
CONDITIONS
Brief Title
A Neuro-Technological Intervention for Adolescents With GAD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 13 to 18 years of age inclusive
- Literate in English Language
- Newly diagnosed with Generalised Anxiety Disorder: current episode, based on Computerised Diagnostic Interview Schedule for Children (C-DISC)
- If on medication, dosage stable or unchanged for at least preceding 8 weeks
- Has parental consent
You will not qualify if you...
- Diagnosis of anxiety disorder induced by medication, substance, or another medical condition
- Diagnosis of obsessive compulsive disorder, bipolar disorder, any psychotic disorder, intellectual disability (IQ <70), autism spectrum disorder, or attention-deficit/hyperactivity disorder
- History of substance or drug use disorder within the last 3 months
- Neurological disorders or insults such as epilepsy or cerebrovascular accidents
- Metal in the cranium, skull defects, or skin lesions on scalp at electrode sites
- Irregular heart rhythms or heart problems
- Severe visual or hearing impairment
- Prior experience with mindfulness-based therapy such as mindfulness-based stress reduction or mindfulness-based cognitive therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 4 weeks
Participants undergo 8 neuro-technological intervention sessions involving a head-mounted VR display and a mobile EEG-biosensor. Each session includes mindfulness practice followed by a VR game influenced by anxiety levels.
8 sessions (twice a week, 30 minutes each)
Duration - 1 week
Participants complete post-intervention questionnaires to assess usability and anxiety levels after the intervention period.
1 visit (in-person) for post-intervention assessment
Trial Site Locations
Total: 1 location
1
Child Guidance Clinic
Singapore, Singapore, Singapore, 168937
Actively Recruiting
Research Team
L
Lim Shernice Shi Yun
P
Poh Xue Wei Wendy
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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