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
|Condition or disease||Intervention/treatment||Phase|
|Generalised Anxiety Disorder||Device: Neuro-technological Intervention||Not Applicable|
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.
|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|
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.
- 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.
- 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.
- 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.
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
|Contact: Poh Xue Wei Wendy||+65 6435 email@example.com|
|Contact: Teo Sze-Hui Jane||+65 6435 firstname.lastname@example.org|
|Child Guidance Clinic||Not yet recruiting|
|Singapore, Singapore, 168937|
|Contact: Poh Xue Wei Wendy +65 6435 3969 email@example.com|
|Contact: Teo Sze-Hui Jane +65 6435 3967 firstname.lastname@example.org|
|Principal Investigator: Lim Choon Guan|
|Principal Investigator:||Lim Choon Guan||Institute of Mental Health, Singapore|