Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03813290

A Neuro-Technological Intervention for Adolescents With GAD

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Child Guidance Clinic

Singapore, 168937

Location status: Recruiting

Location contact

Lim Choon Guan

PRINCIPAL_INVESTIGATOR

Lim Shernice Shi Yun

CONTACT

+65 6435 3969

Poh Xue Wei Wendy

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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])

Treatment and study plan

Neuro-technological Intervention

Device

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.

Other names: Brain Computer Interface, Mindfulness based Intervention

Primary outcomes

  1. Usability Questionnaire

    Time frame: Week 4

    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.

Secondary outcomes

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

    Time frame: Week 0, 5

    The MASC is a comprehensive, multi-rater assessment of anxiety dimensions in children and adolescents aged 8 to 19 years old. The MASC includes subscales scores for separation anxiety/phobias, GAD index, social anxiety, obsessions & compulsions, physical symptoms and harm avoidance. Raw scores from these subscales will be summed up to obtain the total score. Scale ranges from 0 to 3 (0 - Never, 1 - Rarely, 2 - Sometimes, 3 - Often). Higher raw scores indicate higher anxiety symptoms.

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

    Time frame: Week 0, 5

    The MASC is a comprehensive, multi-rater assessment of anxiety dimensions in children and adolescents aged 8 to 19 years old. The MASC includes subscales scores for separation anxiety/phobias, GAD index, social anxiety, obsessions & compulsions, physical symptoms and harm avoidance. Raw scores from these subscales will be summed up to obtain the total score. Scale ranges from 0 to 3 (0 - Never, 1 - Rarely, 2 - Sometimes, 3 - Often). Higher raw scores indicate higher anxiety symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Lim Shernice Shi Yun

CONTACT

[email protected]

+65 6435 3969

Poh Xue Wei Wendy

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

National Healthcare Group, Singapore

Other Gov

Collaborators

  • Duke-NUS Graduate Medical School
  • Nanyang Technological University
  • Singapore General Hospital

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2019
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.