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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

Neuro-technological Intervention
Device
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.

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: Neuro-Technological InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Usability Questionnaire

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.

Time frame

Week 4

Secondary outcomes

1

Multidimensional Anxiety Scale for Children (Parent-reported); 2nd Edition

The MASC is a comprehensive, multi-rater assessment of anxiety dimensions in children and adolescents aged 8 to 19 years old. The MASC includes subscales scores for separation anxiety/phobias, GAD index, social anxiety, obsessions \& compulsions, physical symptoms and harm avoidance. Raw scores from these subscales will be summed up to obtain the total score. Scale ranges from 0 to 3 (0 - Never, 1 - Rarely, 2 - Sometimes, 3 - Often). Higher raw scores indicate higher anxiety symptoms.

Time frame

Week 0, 5

2

Multidimensional Anxiety Scale for Children (Adolescent-reported); 2nd Edition

The MASC is a comprehensive, multi-rater assessment of anxiety dimensions in children and adolescents aged 8 to 19 years old. The MASC includes subscales scores for separation anxiety/phobias, GAD index, social anxiety, obsessions \& compulsions, physical symptoms and harm avoidance. Raw scores from these subscales will be summed up to obtain the total score. Scale ranges from 0 to 3 (0 - Never, 1 - Rarely, 2 - Sometimes, 3 - Often). Higher raw scores indicate higher anxiety symptoms.

Time frame

Week 0, 5

A Neuro-Technological Intervention for Adolescents With GAD

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts