Back to resultsA Neuro-Technological Intervention for Adolescents With GAD
Primary Purpose
Generalised Anxiety Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Neuro-technological Intervention
Sponsored by
About this trial
This is an interventional other trial for Generalised Anxiety Disorder focused on measuring Brain Computer Interface, Neuro technological intervention, Neurofeedback
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])
Sites / Locations
- Child Guidance ClinicRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Neuro-Technological Intervention
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03813290
First Posted
January 18, 2019
Last Updated
April 4, 2022
Sponsor
National Healthcare Group, Singapore
Collaborators
Duke-NUS Graduate Medical School, Singapore General Hospital, Nanyang Technological University
1. Study Identification
Unique Protocol Identification Number
NCT03813290
Brief Title
A Neuro-Technological Intervention for Adolescents With GAD
Official Title
A Neuro-Technological Intervention for Adolescents With Generalised Anxiety Disorder (GAD): A Feasibility Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 8, 2020 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Healthcare Group, Singapore
Collaborators
Duke-NUS Graduate Medical School, Singapore General Hospital, Nanyang Technological University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalised Anxiety Disorder
Keywords
Brain Computer Interface, Neuro technological intervention, Neurofeedback
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Neuro-Technological Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Neuro-technological Intervention
Other Intervention Name(s)
Brain Computer Interface, Mindfulness based Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Usability Questionnaire
Description
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.
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Multidimensional Anxiety Scale for Children (Parent-reported); 2nd Edition
Description
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.
Time Frame
Week 0, 5
Title
Multidimensional Anxiety Scale for Children (Adolescent-reported); 2nd Edition
Description
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.
Time Frame
Week 0, 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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])
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Poh Xue Wei Wendy
Phone
+65 6435 3969
Email
xue_wei_poh@imh.com.sg
First Name & Middle Initial & Last Name or Official Title & Degree
Soh Chui Pin
Phone
+65 6435 3967
Email
chui_pin_soh@imh.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lim Choon Guan
Organizational Affiliation
Institute of Mental Health, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Child Guidance Clinic
City
Singapore
ZIP/Postal Code
168937
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Poh Xue Wei Wendy
Phone
+65 6435 3969
Email
xue_wei_poh@imh.com.sg
First Name & Middle Initial & Last Name & Degree
Soh Chui Pin
Phone
+65 6435 3967
Email
chui_pin_soh@imh.com.sg
First Name & Middle Initial & Last Name & Degree
Lim Choon Guan
12. IPD Sharing Statement
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A Neuro-Technological Intervention for Adolescents With GAD
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