A Neuro-Technological Intervention for Adolescents With Generalised Anxiety Disorder (GAD): A Feasibility Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Generalised Anxiety Disorder
- Sponsor
- National Healthcare Group, Singapore
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Usability Questionnaire
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
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.
Investigators
Lim Choon Guan
Senior Consultant and Deputy Chief
National Healthcare Group, Singapore
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 \[MBCT\])
Outcomes
Primary Outcomes
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
- Multidimensional Anxiety Scale for Children (Parent-reported); 2nd Edition(Week 0, 5)
- Multidimensional Anxiety Scale for Children (Adolescent-reported); 2nd Edition(Week 0, 5)