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RECRUITINGINTERVENTIONAL

A Neuro-Technological Intervention for Adolescents With GAD

A Neuro-Technological Intervention for Adolescents With Generalised Anxiety Disorder (GAD): A Feasibility Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 \[MBCT\]) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 \[MBCT\])

Treatments Being Tested

DEVICE

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.

Locations (1)

Child Guidance Clinic
Singapore, Singapore, Singapore