A Neuro-Technological Intervention for Adolescents With GAD

Generalised Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03813290
• Other study ID #: DSRB A/2018/00693
• Status: Recruiting
• Phase: N/A
• Start date: December 8, 2020
• Est. completion date: April 2024

Study information

• Verified date: April 2022
• Source: National Healthcare Group, Singapore
• Contact: Poh Xue Wei Wendy
• Phone: +65 6435 3969
• Email: xue_wei_poh[@]imh.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 2024
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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])

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalised Anxiety Disorder

Intervention

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.

Locations

Country	Name	City	State
Singapore	Child Guidance Clinic	Singapore

Sponsors (4)

Lead Sponsor	Collaborator
National Healthcare Group, Singapore	Duke-NUS Graduate Medical School, Nanyang Technological University, Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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