A Neuro-Technological Intervention for Adolescents With GAD
Recruiting · NCT03813290 · Interventional (participants receive a specific treatment) · Lead sponsor: National Healthcare Group, Singapore
View the official record on ClinicalTrials.gov →Interventions studied
Neuro-technological Intervention
What this trial is 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.
Who can take part
Age range
13 Years to 18 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 \[MBCT\])
Where it is running
1 location listed.
- Child Guidance Clinic - Singapore, Singapore, Singapore