A Neuro-Technological Intervention for Adolescents With GAD

National Healthcare Group, Singapore

Status: Enrolling

Conditions: Generalised Anxiety Disorder

Treatments: Device: Neuro-technological Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03813290

DSRB A/2018/00693

Details and patient eligibility

About

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.

Full description

This study is a single-arm open-label test of feasibility. The recruitment target is 30. Outpatient adolescents diagnosed with GAD will be recruited to undergo 8 x 30 minutes intervention sessions over 4 weeks. Participants who are enrolled will continue to receive treatment-as-usual prescribed by their treating psychiatrist, except for the use of psychotropics. This population is selected as they could elucidate whether our intervention can be beneficial as an early intervention program for GAD.

During the 8 bi-weekly intervention sessions, participants will don a head-mounted VR display set and a mobile EEG-biosensor. The hardwares are non-invasive.

Enrollment: 30 estimated patients

Sex: All

Ages: 13 to 18 years old

Volunteers: No Healthy Volunteers

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])

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Neuro-Technological Intervention

Experimental group

Description:

Participants will attend a total of 8 x 30 minutes intervention sessions (twice a week) for four consecutive weeks, starting within 1 week after baseline assessment. Participants will also be required to fill up some questionnaires at baseline and post-intervention visits.

Treatment:

Device: Neuro-technological Intervention