NCT03813290

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 23, 2019

Completed
1.9 years until next milestone

Study Start

First participant enrolled

December 8, 2020

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

May 22, 2025

Status Verified

November 1, 2024

Enrollment Period

5.1 years

First QC Date

January 18, 2019

Last Update Submit

May 19, 2025

Conditions

Generalised Anxiety Disorder

Keywords

Brain Computer InterfaceNeuro technological interventionNeurofeedback

Outcome Measures

Primary Outcomes (1)

  • Usability Questionnaire

    Usability questionnaire measures participants' experience with the neuro-technological intervention devices and software. Subscale with12 items asking about overall comfort and usability are included, with scale range of 1 to 4 (1 - very false for me, 2 - False, 3 - True, 4 - Very true for me). Subsequent 27-items subscale measures participants' experience with the software/virtual reality experience, with scale ranging from 1 to 7 (the lower the rating, the poorer the experience). Total score will be obtained from summing up the scores for each subscale. Higher score means better overall experience with the intervention.

    Week 4

Secondary Outcomes (2)

  • Multidimensional Anxiety Scale for Children (Parent-reported); 2nd Edition

    Week 0, 5

  • Multidimensional Anxiety Scale for Children (Adolescent-reported); 2nd Edition

    Week 0, 5

Study Arms (1)

Neuro-Technological Intervention

EXPERIMENTAL

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.

Device: Neuro-technological Intervention

Interventions

Neuro-technological InterventionDEVICE

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.

Also known as: Brain Computer Interface, Mindfulness based Intervention
Neuro-Technological Intervention

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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 \[MBCT\])

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Child Guidance Clinic

Singapore, Singapore, 168937, Singapore

RECRUITING

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Brain-Computer Interfaces

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electrical Equipment and SuppliesEquipment and Supplies

Study Officials

  • Lim Choon Guan

    Institute of Mental Health, Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lim Shernice Shi Yun

CONTACT

+65 6435 3969shernice_sy_lim@imh.com.sg

Poh Xue Wei Wendy

CONTACT

xue_wei_poh@imh.com.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant and Deputy Chief

Study Record Dates

First Submitted

January 18, 2019

First Posted

January 23, 2019

Study Start

December 8, 2020

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

May 22, 2025

Record last verified: 2024-11

Locations

SG(1)