A Neuro-Technological Intervention for Adolescents With GAD

  • STATUS
    Recruiting
  • End date
    Mar 15, 2023
  • participants needed
    30
  • sponsor
    National Healthcare Group, Singapore
Updated on 15 March 2021
anxiety disorder

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.

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.

Details
Condition Generalised Anxiety Disorder
Treatment Neuro-technological Intervention
Clinical Study IdentifierNCT03813290
SponsorNational Healthcare Group, Singapore
Last Modified on15 March 2021

Eligibility

Yes No Not Sure

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])
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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