A Neuro-Technological Intervention for Adolescents With GAD

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

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.

Study Overview

• Status: Recruiting
• Conditions: Generalised Anxiety Disorder
• Intervention / Treatment: Device: Neuro-technological Intervention

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Poh Xue Wei Wendy; Phone Number: +65 6435 3969; Email: xue_wei_poh@imh.com.sg
• Study Contact Backup: Name: Soh Chui Pin; Phone Number: +65 6435 3967; Email: chui_pin_soh@imh.com.sg

Study Locations

• Singapore
  • Singapore, Singapore, 168937
    • Recruiting
    • Child Guidance Clinic
    • Contact: Poh Xue Wei Wendy; Phone Number: +65 6435 3969; Email: xue_wei_poh@imh.com.sg
    • Contact: Soh Chui Pin; Phone Number: +65 6435 3967; Email: chui_pin_soh@imh.com.sg
    • Principal Investigator: Lim Choon Guan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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])

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Neuro-Technological Intervention; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Multidimensional Anxiety Scale for Children (Parent-reported); 2nd Edition	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.	Week 0, 5
Multidimensional Anxiety Scale for Children (Adolescent-reported); 2nd Edition	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.	Week 0, 5

Collaborators and Investigators

• Sponsor: National Healthcare Group, Singapore
• Collaborators: Singapore General Hospital; Nanyang Technological University; Duke-NUS Graduate Medical School
• Investigators: Principal Investigator: Lim Choon Guan, Institute of Mental Health, Singapore

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2020
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: January 18, 2019
• First Submitted That Met QC Criteria: January 22, 2019
• First Posted (Actual): January 23, 2019

Study Record Updates

• Last Update Posted (Actual): April 6, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Neurofeedback; Brain Computer Interface; Neuro technological intervention
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: DSRB A/2018/00693

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No