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Recruiting NCT03813290

A Neuro-Technological Intervention for Adolescents With GAD

No phase Interventional Generalised Anxiety Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Neuro-technological Intervention.
Who it may be relevant to
Registry conditions: Generalised Anxiety Disorder. Basic parameters: 13 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Singapore
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed 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.

Interventions

  • 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.

Primary outcome measures

  • Usability Questionnaire [Time frame: Week 4]
Secondary outcome measures (2)
  • Multidimensional Anxiety Scale for Children (Parent-reported); 2nd Edition [Time frame: Week 0, 5]
  • Multidimensional Anxiety Scale for Children (Adolescent-reported); 2nd Edition [Time frame: Week 0, 5]

Eligibility criteria

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 \[MBCT\])

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Singapore · 1 center
  • Child Guidance Clinic — Singapore

Identifiers

NCT: NCT03813290 · DSRB A/2018/00693

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗