Neuro-technological Intervention: During the intervention sessions, participants will don a head-mounted VR display set and a mobile EEG-biosensor. Each session will begin with a brief audio-guided mindfulness practice, follow by a 15 minutes VR game. Game performances will be influenced by individual's level of anxiety arousal and ability to regulate it.
Study summary
This study aims to evaluate the safety and acceptability of a basic neuro-technological intervention in the treatment of adolescents with Generalised Anxiety Disorder (GAD). Our technology will deliver a mindfulness-based anxiety regulation intervention through a neuro- / bio-feedback-based virtual reality (VR) game interface that is driven by a novel algorithm.
Eligibility
Sex
ALL
Min age
13 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria:
* 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
Exclusion Criteria:
* Diagnosis (as defined by DSM-5) of: anxiety disorder induced by medication, substance, or another medical condition; obsessive compulsive disorder; bipolar disorder; any psychotic disorder (lifetime); intellectual disability (i.e. IQ\<70); autism spectrum disorder; attention-deficit/hyperactivity disorder
* History of substance or drug use disorder (as per DSM-5 criteria) within the last 3 months
* Neurological disorders or insults (e.g. epilepsy, cerebrovascular accidents)
* Metal in the cranium, skull defects, or skin lesions on scalp (e.g. cuts, abrasion, rash) at proposed electrode sites
* Irregular heart rhythms or heart problems
* Severe visual or hearing impairment
* Prior experience with mindfulness-based therapy (e.g. mindfulness-based stress reduction \[MBSR\], mindfulness-based cognitive therapy \[MBCT\])
Primary outcome measure(s)
Usability Questionnaire — Week 4 Usability questionnaire measures participants' experience with the neuro-technological intervention devices and software. Subscale with12 items asking about overall comfort and usability are included, with scale range of 1 to 4 (1 - very false for me, 2 - False, 3 - True, 4 - Very true for me). Subsequent 27-items subscale measures participants' experience with the software/virtual reality experience, with scale ranging from 1 to 7 (the lower the rating, the poorer the experience). Total score will be obtained from summing up the scores for each subscale. Higher score means better overall experience with the intervention.
Trial sites (1)
Facility
City
Region
Status
Child Guidance Clinic
Singapore
Singapore
Recruiting
More National Healthcare Group, Singapore trials in Singapore
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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