<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03813290</url>
  </required_header>
  <id_info>
    <org_study_id>DSRB A/2018/00693</org_study_id>
    <nct_id>NCT03813290</nct_id>
  </id_info>
  <brief_title>A Neuro-Technological Intervention for Adolescents With GAD</brief_title>
  <official_title>A Neuro-Technological Intervention for Adolescents With Generalised Anxiety Disorder (GAD): A Feasibility Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Healthcare Group, Singapore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Duke-NUS Graduate Medical School</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Singapore General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nanyang Technological University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Healthcare Group, Singapore</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to evaluate the safety and acceptability of a basic neuro-technological&#xD;
      intervention in the treatment of adolescents with Generalised Anxiety Disorder (GAD). Our&#xD;
      technology will deliver a mindfulness-based anxiety regulation intervention through a neuro-&#xD;
      / bio-feedback-based virtual reality (VR) game interface that is driven by a novel algorithm.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a single-arm open-label test of feasibility. The recruitment target is 30.&#xD;
      Outpatient adolescents diagnosed with GAD will be recruited to undergo 8 x 30 minutes&#xD;
      intervention sessions over 4 weeks. Participants who are enrolled will continue to receive&#xD;
      treatment-as-usual prescribed by their treating psychiatrist, except for the use of&#xD;
      psychotropics. This population is selected as they could elucidate whether our intervention&#xD;
      can be beneficial as an early intervention program for GAD.&#xD;
&#xD;
      During the 8 bi-weekly intervention sessions, participants will don a head-mounted VR display&#xD;
      set and a mobile EEG-biosensor. The hardwares are non-invasive.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 8, 2020</start_date>
  <completion_date type="Anticipated">April 2024</completion_date>
  <primary_completion_date type="Anticipated">April 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Usability Questionnaire</measure>
    <time_frame>Week 4</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Multidimensional Anxiety Scale for Children (Parent-reported); 2nd Edition</measure>
    <time_frame>Week 0, 5</time_frame>
    <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 &amp; 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multidimensional Anxiety Scale for Children (Adolescent-reported); 2nd Edition</measure>
    <time_frame>Week 0, 5</time_frame>
    <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 &amp; 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.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Generalised Anxiety Disorder</condition>
  <arm_group>
    <arm_group_label>Neuro-Technological Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.&#xD;
Participants will also be required to fill up some questionnaires at baseline and post-intervention visits.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Neuro-technological Intervention</intervention_name>
    <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.</description>
    <arm_group_label>Neuro-Technological Intervention</arm_group_label>
    <other_name>Brain Computer Interface</other_name>
    <other_name>Mindfulness based Intervention</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between 13 to 18 years of age inclusive&#xD;
&#xD;
          -  Literate in English Language&#xD;
&#xD;
          -  Newly diagnosed with Generalised Anxiety Disorder: current episode, based on&#xD;
             Computerised Diagnostic Interview Schedule for Children (C-DISC)&#xD;
&#xD;
          -  If on medication, dosage stable or unchanged for at least preceding 8 weeks&#xD;
&#xD;
          -  Has parental consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis (as defined by DSM-5) of: anxiety disorder induced by medication, substance,&#xD;
             or another medical condition; obsessive compulsive disorder; bipolar disorder; any&#xD;
             psychotic disorder (lifetime); intellectual disability (i.e. IQ&lt;70); autism spectrum&#xD;
             disorder; attention-deficit/hyperactivity disorder&#xD;
&#xD;
          -  History of substance or drug use disorder (as per DSM-5 criteria) within the last 3&#xD;
             months&#xD;
&#xD;
          -  Neurological disorders or insults (e.g. epilepsy, cerebrovascular accidents)&#xD;
&#xD;
          -  Metal in the cranium, skull defects, or skin lesions on scalp (e.g. cuts, abrasion,&#xD;
             rash) at proposed electrode sites&#xD;
&#xD;
          -  Irregular heart rhythms or heart problems&#xD;
&#xD;
          -  Severe visual or hearing impairment&#xD;
&#xD;
          -  Prior experience with mindfulness-based therapy (e.g. mindfulness-based stress&#xD;
             reduction [MBSR], mindfulness-based cognitive therapy [MBCT])&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lim Choon Guan</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Mental Health, Singapore</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Poh Xue Wei Wendy</last_name>
    <phone>+65 6435 3969</phone>
    <email>xue_wei_poh@imh.com.sg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Soh Chui Pin</last_name>
    <phone>+65 6435 3967</phone>
    <email>chui_pin_soh@imh.com.sg</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Child Guidance Clinic</name>
      <address>
        <city>Singapore</city>
        <zip>168937</zip>
        <country>Singapore</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Poh Xue Wei Wendy</last_name>
      <phone>+65 6435 3969</phone>
      <email>xue_wei_poh@imh.com.sg</email>
    </contact>
    <contact_backup>
      <last_name>Soh Chui Pin</last_name>
      <phone>+65 6435 3967</phone>
      <email>chui_pin_soh@imh.com.sg</email>
    </contact_backup>
    <investigator>
      <last_name>Lim Choon Guan</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>April 4, 2022</last_update_submitted>
  <last_update_submitted_qc>April 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Healthcare Group, Singapore</investigator_affiliation>
    <investigator_full_name>Lim Choon Guan</investigator_full_name>
    <investigator_title>Senior Consultant and Deputy Chief</investigator_title>
  </responsible_party>
  <keyword>Brain Computer Interface</keyword>
  <keyword>Neuro technological intervention</keyword>
  <keyword>Neurofeedback</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03813290
org study id: DSRB A/2018/00693
nct id: NCT03813290
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Usability Questionnaire
time frame: Week 4
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.
measure: Multidimensional Anxiety Scale for Children (Parent-reported); 2nd Edition
time frame: Week 0, 5
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.
measure: Multidimensional Anxiety Scale for Children (Adolescent-reported); 2nd Edition
time frame: Week 0, 5
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.
arm group label: Neuro-Technological Intervention
arm group type: Experimental
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: Neuro-technological 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.
arm group label: Neuro-Technological Intervention
other name: Brain Computer Interface
other name: Mindfulness based Intervention
criteria: 
gender: All
minimum age: 13 Years
maximum age: 18 Years
healthy volunteers: No
last name: Lim Choon Guan
role: Principal Investigator
affiliation: Institute of Mental Health, Singapore
last name: Poh Xue Wei Wendy
phone: +65 6435 3969
email: xue_wei_poh@imh.com.sg
last name: Soh Chui Pin
phone: +65 6435 3967
email: chui_pin_soh@imh.com.sg
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Singapore
responsible party type: Principal Investigator
investigator affiliation: National Healthcare Group, Singapore
investigator full name: Lim Choon Guan
investigator title: Senior Consultant and Deputy Chief
mesh term: Anxiety Disorders