Neuro-technological intervention for adolescents with anxiety
A Neuro-Technological Intervention for Adolescents With Generalised Anxiety Disorder (GAD): A Feasibility Trial
This study is testing a new virtual reality game that helps teenagers with anxiety learn to manage their feelings better while they continue their regular treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 13 Years to 18 Years |
| Sex | All |
| Sponsor | National Healthcare Group, Singapore Government |
| Locations | 1 site (Singapore, Singapore) |
| Trial ID | NCT03813290 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and acceptability of a neuro-technological intervention designed for adolescents diagnosed with Generalised Anxiety Disorder (GAD). Participants will engage in eight 30-minute sessions over four weeks, using a virtual reality game interface that incorporates mindfulness-based anxiety regulation techniques. The intervention is non-invasive and includes the use of a head-mounted VR display and a mobile EEG-biosensor. Participants will also continue their usual treatment prescribed by their psychiatrist, excluding psychotropic medications.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 13 to 18 who have been newly diagnosed with Generalised Anxiety Disorder.
Not a fit: Patients with other psychiatric disorders or neurological conditions may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could provide a novel, non-invasive treatment option for adolescents struggling with GAD.
How similar studies have performed: While the approach is innovative, similar neurofeedback interventions have shown promise in treating anxiety disorders, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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 \[MBCT\])
Where this trial is running
Singapore, Singapore
- Child Guidance Clinic — Singapore, Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Lim Choon Guan — Institute of Mental Health, Singapore
- Study coordinator: Lim Shernice Shi Yun
- Email: shernice_sy_lim@imh.com.sg
- Phone: +65 6435 3969
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.