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A Neuro-Technological Intervention for Adolescents With GAD

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ClinicalTrials.gov Identifier: NCT03813290
Recruitment Status : Not yet recruiting
First Posted : January 23, 2019
Last Update Posted : January 23, 2019
Sponsor:
Collaborators:
Duke-NUS Graduate Medical School
Singapore General Hospital
Nanyang Technological University
Information provided by (Responsible Party):
Lim Choon Guan, National Healthcare Group, Singapore

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.

Condition or disease Intervention/treatment Phase
Generalised Anxiety Disorder Device: Neuro-technological Intervention Not Applicable

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.


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Study Type : Interventional
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: A Neuro-Technological Intervention for Adolescents With Generalised Anxiety Disorder (GAD): A Feasibility Trial
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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])

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03813290


Contacts
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Contact: Poh Xue Wei Wendy +65 6435 3969 xue_wei_poh@imh.com.sg
Contact: Teo Sze-Hui Jane +65 6435 3967 jane_sh_teo@imh.com.sg

Locations
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Singapore
Child Guidance Clinic Not yet recruiting
Singapore, Singapore, 168937
Contact: Poh Xue Wei Wendy    +65 6435 3969    xue_wei_poh@imh.com.sg   
Contact: Teo Sze-Hui Jane    +65 6435 3967    jane_sh_teo@imh.com.sg   
Principal Investigator: Lim Choon Guan         
Sponsors and Collaborators
National Healthcare Group, Singapore
Duke-NUS Graduate Medical School
Singapore General Hospital
Nanyang Technological University
Investigators
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Principal Investigator: Lim Choon Guan Institute of Mental Health, Singapore

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Responsible Party: Lim Choon Guan, Senior Consultant and Deputy Chief, National Healthcare Group, Singapore
ClinicalTrials.gov Identifier: NCT03813290     History of Changes
Other Study ID Numbers: DSRB A/2018/00693
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lim Choon Guan, National Healthcare Group, Singapore:
Brain Computer Interface
Neuro technological intervention
Neurofeedback

Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders