Clinical trial NCT03813290: A Neuro-Technological Intervention for Adolescents With GAD
Official title: A Neuro-Technological Intervention for Adolescents With Generalised Anxiety Disorder (GAD): A Feasibility Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Generalised Anxiety Disorder
Keywords: Brain Computer Interface
Neuro technological intervention
Neurofeedback
Lead sponsor: National Healthcare Group, Singapore
Sponsor class: OTHER_GOV
Collaborators: name: Duke-NUS Graduate Medical School
name: Singapore General Hospital
name: Nanyang Technological University
First posted: 2019-01-23
Enrollment: 30
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

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.

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 \[MBCT\])

Primary outcomes:
measure: Usability Questionnaire
timeFrame: Week 4
Secondary outcomes:
measure: Multidimensional Anxiety Scale for Children (Parent-reported); 2nd Edition
timeFrame: Week 0, 5
measure: Multidimensional Anxiety Scale for Children (Adolescent-reported); 2nd Edition
timeFrame: Week 0, 5
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Child Guidance Clinic
Study officials:
affiliation: Institute of Mental Health, Singapore
name: Lim Choon Guan
role: PRINCIPAL_INVESTIGATOR
References: