<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/NCT03260335</url>
  </required_header>
  <id_info>
    <org_study_id>17/SS/0119</org_study_id>
    <nct_id>NCT03260335</nct_id>
  </id_info>
  <brief_title>A Biofeedback Intervention for the Prevention of Challenging Behaviour</brief_title>
  <official_title>A Biofeedback Intervention for the Prevention of Challenging Behaviour in People With Acquired Brain Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Glasgow</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Brain Injury Rehabilitation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Glasgow</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 explore whether feedback from a physical monitoring device (electronic&#xD;
      watch) to prompt patients to use an anxiety management strategy can help prevent challenging&#xD;
      behaviour.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A multiple baseline &quot;A-B-A&quot; single case experimental design will be adopted with baseline,&#xD;
      intervention, and return to baseline phases.&#xD;
&#xD;
      Participants will wear the portable monitoring device with heart rate monitor, pedometer and&#xD;
      global positioning system (GPS) functions. A pre-calculated algorithm, developed using&#xD;
      machine learning software will be used to predict challenging behaviour episodes 2-4 hours in&#xD;
      advance of the event. Recent research has developed a best predictor model with a sensitivity&#xD;
      of 82% and specificity of 42%, when averaged across two participants (in press). The device&#xD;
      will communicate with a smart phone, via Bluetooth connectivity, when an event has been&#xD;
      predicted.&#xD;
&#xD;
      Following enrolment in the study, participants will be randomly assigned to a treatment start&#xD;
      time, which will follow from an initial baseline phase. During the baseline phase,&#xD;
      participants will wear a commercially available smart watch with physiological monitoring&#xD;
      capability, for at least one month in order to gather behaviour frequency data, and&#xD;
      associated physiological data; no prompts will be provided. During this period, behavioural&#xD;
      and physiological data will be sent to a secure server where a machine learning algorithm&#xD;
      will examine the relationships between data streams and 'self-tune' to improve its prediction&#xD;
      of challenging behaviour episodes. In the treatment phase, participants and staff will&#xD;
      receive a biofeedback prompt in text, or graphic form (e.g. mood light), on the smart&#xD;
      watch/connected mobile phone, when an event has been predicted. This will prompt participants&#xD;
      to implement a proactive anxiety management strategy, and will prompt staff to support the&#xD;
      participant in completing this, if required. The strategy used will be predetermined in the&#xD;
      participant's standard care plan e.g. breathing relaxation, reframing the problem,&#xD;
      behavioural redirection. Details will be recorded using an adapted version of the Overt&#xD;
      Aggression Scale-Modified for Neurorehabilitation (OAS-MNR), describing the situation in&#xD;
      which the biofeedback prompt occurred, participant and staff responses to the biofeedback&#xD;
      prompt, and any resulting behaviours, including the occurrence of challenging behaviour.&#xD;
      Following the intervention phase, participants will return to a baseline phase for one month,&#xD;
      in which no prompts will be provided. Again, details of any challenging behaviour will be&#xD;
      recorded via the OAS-MNR.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Favourable ethical opinion not obtained&#xD;
  </why_stopped>
  <start_date type="Anticipated">November 2017</start_date>
  <completion_date type="Anticipated">June 2018</completion_date>
  <primary_completion_date type="Anticipated">June 2018</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>
    <intervention_model_description>Single Case Experimental Design combining withdrawal (ABA) and multiple baseline design,</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of incidents of challenging behaviour</measure>
    <time_frame>5 months</time_frame>
    <description>Score from Overt Aggression Scale-Modified for Neurorehabilitation (OAS-MNR)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Implementation of anxiety management strategy</measure>
    <time_frame>5 months</time_frame>
    <description>Number of times anxiety management strategy successfully employed</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Acquired Brain Injury</condition>
  <arm_group>
    <arm_group_label>Biofeedback intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Biofeedback prompt in text or graphic form to implement proactive anxiety management strategy, as per standard care plan</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Anxiety management strategy</intervention_name>
    <description>Anxiety management strategy as per standard care plan</description>
    <arm_group_label>Biofeedback intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  participants who have sustained a severe injury to the brain, as determined by length&#xD;
             of unconsciousness (greater than 24 hours), a Glasgow Coma Scale of 3 to 8 and a Post&#xD;
             Traumatic Amnesia period greater than 1 day&#xD;
&#xD;
          -  participants who are resident in the Graham Anderson House, Brain Injury&#xD;
             Rehabilitation (BIRT) Unit&#xD;
&#xD;
          -  participants presenting with challenging behaviour, during the recruitment period&#xD;
&#xD;
          -  participants will NOT be excluded on the basis of comorbid psychiatric disorders or&#xD;
             drug/alcohol use, in order to provide conclusions representative of the clinical&#xD;
             population&#xD;
&#xD;
          -  participants will NOT be excluded on the basis of being unable to provide informed&#xD;
             consent, in order to provide conclusions representative of the clinical population&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a level of cognitive impairment that would prevent individuals from understanding the&#xD;
             feedback obtained via digital or verbal prompts&#xD;
&#xD;
          -  participants without the capacity to consent, that do not provide verbal assent to&#xD;
             participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonathan Evans, BSc PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Glasgow</affiliation>
  </overall_official>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>March 26, 2018</last_update_submitted>
  <last_update_submitted_qc>March 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Glasgow</investigator_affiliation>
    <investigator_full_name>Professor Jon Evans</investigator_full_name>
    <investigator_title>Professor of Applied Neuropsychology</investigator_title>
  </responsible_party>
  <keyword>Challenging behaviour</keyword>
  <keyword>Biofeedback</keyword>
  <keyword>Anxiety management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</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/NCT03260335
org study id: 17/SS/0119
nct id: NCT03260335
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to explore whether feedback from a physical monitoring device (electronic
      watch) to prompt patients to use an anxiety management strategy can help prevent challenging
      behaviour.
A multiple baseline "A-B-A" single case experimental design will be adopted with baseline,
      intervention, and return to baseline phases.

      Participants will wear the portable monitoring device with heart rate monitor, pedometer and
      global positioning system (GPS) functions. A pre-calculated algorithm, developed using
      machine learning software will be used to predict challenging behaviour episodes 2-4 hours in
      advance of the event. Recent research has developed a best predictor model with a sensitivity
      of 82% and specificity of 42%, when averaged across two participants (in press). The device
      will communicate with a smart phone, via Bluetooth connectivity, when an event has been
      predicted.

      Following enrolment in the study, participants will be randomly assigned to a treatment start
      time, which will follow from an initial baseline phase. During the baseline phase,
      participants will wear a commercially available smart watch with physiological monitoring
      capability, for at least one month in order to gather behaviour frequency data, and
      associated physiological data; no prompts will be provided. During this period, behavioural
      and physiological data will be sent to a secure server where a machine learning algorithm
      will examine the relationships between data streams and 'self-tune' to improve its prediction
      of challenging behaviour episodes. In the treatment phase, participants and staff will
      receive a biofeedback prompt in text, or graphic form (e.g. mood light), on the smart
      watch/connected mobile phone, when an event has been predicted. This will prompt participants
      to implement a proactive anxiety management strategy, and will prompt staff to support the
      participant in completing this, if required. The strategy used will be predetermined in the
      participant's standard care plan e.g. breathing relaxation, reframing the problem,
      behavioural redirection. Details will be recorded using an adapted version of the Overt
      Aggression Scale-Modified for Neurorehabilitation (OAS-MNR), describing the situation in
      which the biofeedback prompt occurred, participant and staff responses to the biofeedback
      prompt, and any resulting behaviours, including the occurrence of challenging behaviour.
      Following the intervention phase, participants will return to a baseline phase for one month,
      in which no prompts will be provided. Again, details of any challenging behaviour will be
      recorded via the OAS-MNR.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single Case Experimental Design combining withdrawal (ABA) and multiple baseline design,
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of incidents of challenging behaviour
time frame: 5 months
description: Score from Overt Aggression Scale-Modified for Neurorehabilitation (OAS-MNR)
measure: Implementation of anxiety management strategy
time frame: 5 months
description: Number of times anxiety management strategy successfully employed
arm group label: Biofeedback intervention
arm group type: Experimental
description: Biofeedback prompt in text or graphic form to implement proactive anxiety management strategy, as per standard care plan
intervention type: Behavioral
intervention name: Anxiety management strategy
description: Anxiety management strategy as per standard care plan
arm group label: Biofeedback intervention
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Jonathan Evans, BSc PhD
role: Study Director
affiliation: University of Glasgow
responsible party type: Principal Investigator
investigator affiliation: University of Glasgow
investigator full name: Professor Jon Evans
investigator title: Professor of Applied Neuropsychology
mesh term: Brain Injuries