<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/NCT03231488</url>
  </required_header>
  <id_info>
    <org_study_id>IRAS project ID: 213205</org_study_id>
    <nct_id>NCT03231488</nct_id>
  </id_info>
  <brief_title>The Effect of Mindfulness on Cognition and Emotion Following Acquired Brain Injury</brief_title>
  <official_title>The Effect of Mindfulness on Stimulus Over-selectivity and Selective Attention to Threat Following Acquired Brain Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of East Anglia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cambridge University Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cambridgeshire Community Services NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cambridgeshire and Peterborough NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>NORFOLK COMMUNITY HEALTH AND CARE NHS TRUST</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>NORTHAMPTONSHIRE HEALTHCARE NHS FOUNDATION TRUST</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Headway Cambridgeshire</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Headway Essex</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Headway Norfolk and Waveney</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Icanho, Livability</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Brain Injury Rehabilitation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>St Andrews Healthcare</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Partnerships in Care</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of East Anglia</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Can mindfulness help with attention and emotion difficulties after a brain injury?&#xD;
&#xD;
      People who have a brain injury often have problems with their attention and emotions. This&#xD;
      study will see if a short mindfulness task can help with these problems. So far, there are&#xD;
      not many studies looking at this and those that do show mixed results. When being mindful&#xD;
      someone is aware of their attention and focuses on the present moment without passing&#xD;
      judgement. This study focuses on over-selectivity and selective attention to threat after a&#xD;
      brain injury. These are two concepts involved in attention and emotion problems.&#xD;
      Over-selectivity is when someone focuses on only one thing around them and misses other key&#xD;
      things. Selective attention to threat is when someone's focus is drawn to something around&#xD;
      them that is seen as threatening. This has been shown to cause and keep anxious feelings&#xD;
      going. This research will see if a short mindfulness task can help those with a brain injury&#xD;
      by reducing overselectivity and selective attention to threat on two tasks. Participants will&#xD;
      be recruited from NHS and non-NHS brain injury services. The study will take around two hours&#xD;
      to complete for each participant. In summary, this study looks to see if a specific&#xD;
      mindfulness exercise can be helpful for specific attention and emotion problems. It could be&#xD;
      a first step in making treatment better and giving more treatment options for those with a&#xD;
      brain injury.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 31, 2017</start_date>
  <completion_date type="Anticipated">January 2018</completion_date>
  <primary_completion_date type="Anticipated">January 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Emotional Stroop</measure>
    <time_frame>Administered pre- and post- 10-minute intervention, so over a period of one hour</time_frame>
    <description>This will be a computer task that measures selective attention to threat.&#xD;
In the emotional Stroop, different coloured words are presented to participants and the emotional meaning of the words are manipulated. Participants are instructed to name the colour of the words as quickly as possible, whilst ignoring the meaning of the words. Selective attention to threat will be inferred when word colour-naming takes longer when the meaning of the word is threatening relative to neutral. So, the greater the difference between reaction times to neutral and threatening words, the greater the selective attention to threat.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Over-selectivity task.</measure>
    <time_frame>Administered pre- and post- 10-minute intervention, so over a period of one hour</time_frame>
    <description>This will be a computer task that measures over-selectivity.&#xD;
Practice phase - two cards, each with two images appear on the screen. One card is the correct one to select and the other is incorrect. This happens for two sets of two cards (pair 1 and pair 2). Test phase - participants are presented with two single stimuli simultaneously, one from the reinforced compound and one from the verbally punished compound (Figure 4). They are instructed to select one of the pictures on the screen.&#xD;
Over-selectivity will occur if participants fail to learn about one of the stimuli in the previously reinforced compound and therefore fail to select that stimuli they had not learned about in the practice phase.&#xD;
So, the higher the score on the over-selectivity task, the greater the difference between the most and least chosen stimuli, which means that the participant is demonstrating greater over-selectivity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>Pre-intervention (baseline measure)</time_frame>
    <description>A self-report measure consisting of 14 items. The measure gives an overall score, as well as separate scores for severity of anxiety and depression subscales.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Five Facet Mindfulness Questionnaire (FFMQ)</measure>
    <time_frame>Pre-intervention (baseline measure)</time_frame>
    <description>This will be used to characterise levels of mindfulness. This is a self-report measure, consisting of 39 items.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Test of Everyday Attention (TEA)</measure>
    <time_frame>Pre-intervention (baseline measure)</time_frame>
    <description>Subtests will be used to measure baseline measures of attention. Elevator counting is a measure of sustained attention and elevator counting with distraction is a measure of selective attention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weschler Test of Adult Reading (WTAR)</measure>
    <time_frame>Pre-intervention (baseline measure)</time_frame>
    <description>This will be used to measure a baseline measure of pre-morbid functioning. Participants read a list of 50 words with irregular pronunciations to assess previous learning of the words.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">46</enrollment>
  <condition>Injuries, Brain</condition>
  <arm_group>
    <arm_group_label>Mindfulness intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control intervention (unfocused attention)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mindfulness intervention</intervention_name>
    <description>A 10 minute mindfulness of breath exercise</description>
    <arm_group_label>Mindfulness intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control intervention (unfocused attention)</intervention_name>
    <description>A 10 minute unfocused attention intervention - participants are asked to let their mind wander on anything that comes to mind.</description>
    <arm_group_label>Control intervention (unfocused attention)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 years and over&#xD;
&#xD;
          -  Medical evidence of ABI with attention or executive functioning difficulties, such as&#xD;
             difficulties with planning, inhibition or attention&#xD;
&#xD;
          -  Time since ABI to be 9 months or greater • ABI severity to be moderate to severe,&#xD;
             determined by the Mayo classification system (Malec et al., 2007). This is&#xD;
             classification system is frequently used to determine ABI severity and is standard&#xD;
             practice to record at the acute stage of care when the individual is admitted to&#xD;
             hospital. This means there must be evidence of one or more of the following in medical&#xD;
             notes: the individual's lowest Glasgow Coma Scale (GCS) score is less than 13, there&#xD;
             is a loss of consciousness of at least 30 minutes immediately following ABI and post&#xD;
             traumatic amnesia (PTA) is at least 24 hours in length. If there is no evidence of&#xD;
             this in the medical notes, then there must be evidence that the individual has&#xD;
             clinically significant difficulties resulting from their ABI to have needed a referral&#xD;
             to brain injury services.&#xD;
&#xD;
          -  There are self-reported or clinician-identified emotional difficulties to adjusting to&#xD;
             circumstances post-ABI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant, severe and enduring presence of mental health difficulties or substance&#xD;
             misuse that would prevent valid engagement in experimental tasks&#xD;
&#xD;
          -  Perceptual, language, communication, reading or motor difficulties that would prevent&#xD;
             valid engagement in experimental tasks&#xD;
&#xD;
          -  The presence of developmental or acquired dyslexia affecting the automatic reading of&#xD;
             words in the emotional Stroop&#xD;
&#xD;
          -  Severe cognitive difficulties that would prevent valid engagement in experimental&#xD;
             tasks&#xD;
&#xD;
          -  Presence of pre-existing or comorbid disorders that may affect cognitive functioning&#xD;
             (other than ABI) that would prevent valid engagement in experimental tasks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Katrina Vicentijevic</last_name>
    <phone>07498045055</phone>
    <email>k.vicentijevic@uea.ac.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cambridge University Hospitals Nhs Foundation Trust</name>
      <address>
        <city>Cambridge</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Katrina Vicentijevic</last_name>
      <phone>07498045055</phone>
      <email>k.vicentijevic@uea.ac.uk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cambridgeshire Community Services Nhs Trust</name>
      <address>
        <city>Cambridge</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Katrina Vicentijevic</last_name>
      <phone>07498045055</phone>
      <email>k.vicentijevic@uea.ac.uk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Headway Cambridgeshire</name>
      <address>
        <city>Cambridge</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Katrina Vicentijevic</last_name>
      <phone>07498045055</phone>
      <email>k.vicentijevic@uea.ac.uk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Brain Injury Rehabilitation Trust</name>
      <address>
        <city>Ely</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Katrina Vicentijevic</last_name>
      <phone>07498045055</phone>
      <email>k.vicentijevic@uea.ac.uk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Headway Essex</name>
      <address>
        <city>Essex</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Katrina Vicentijevic</last_name>
      <phone>07498045055</phone>
      <email>k.vicentijevic@uea.ac.uk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Headway Norfolk &amp; Waveney</name>
      <address>
        <city>Norfolk</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Katrina Vicentijevic</last_name>
      <phone>07498045055</phone>
      <email>k.vicentijevic@uea.ac.uk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Norfolk Community Health and Care Nhs Trust</name>
      <address>
        <city>Norfolk</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Katrina Vicentijevic</last_name>
      <phone>07498045055</phone>
      <email>k.vicentijevic@uea.ac.uk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Northamptonshire Healthcare Nhs Foundation Trust</name>
      <address>
        <city>Northampton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Katrina Vicentijevic</last_name>
      <phone>07498045055</phone>
      <email>k.vicentijevic@uea.ac.uk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Partnerships in Care</name>
      <address>
        <city>Northampton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Katrina Vicentijevic</last_name>
      <phone>07498045055</phone>
      <email>k.vicentijevic@uea.ac.uk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>St Andrews Healthcare</name>
      <address>
        <city>Northampton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Katrina Vicentijevic</last_name>
      <phone>07498045055</phone>
      <email>k.vicentijevic@uea.ac.uk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cambridgeshire and Peterborough Nhs Foundation Trust</name>
      <address>
        <city>Peterborough</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Katrina Vicentijevic</last_name>
      <phone>07498045055</phone>
      <email>k.vicentijevic@uea.ac.uk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Icanho, Livability</name>
      <address>
        <city>Stowmarket</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Katrina Vicentijevic</last_name>
      <phone>07498045055</phone>
      <email>k.vicentijevic@uea.ac.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>August 9, 2017</last_update_submitted>
  <last_update_submitted_qc>August 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Wounds and 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/NCT03231488
org study id: IRAS project ID: 213205
nct id: NCT03231488
lead sponsor: 
collaborator: 
collaborator: 
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is fda regulated drug: No
is fda regulated device: No
Can mindfulness help with attention and emotion difficulties after a brain injury?

      People who have a brain injury often have problems with their attention and emotions. This
      study will see if a short mindfulness task can help with these problems. So far, there are
      not many studies looking at this and those that do show mixed results. When being mindful
      someone is aware of their attention and focuses on the present moment without passing
      judgement. This study focuses on over-selectivity and selective attention to threat after a
      brain injury. These are two concepts involved in attention and emotion problems.
      Over-selectivity is when someone focuses on only one thing around them and misses other key
      things. Selective attention to threat is when someone's focus is drawn to something around
      them that is seen as threatening. This has been shown to cause and keep anxious feelings
      going. This research will see if a short mindfulness task can help those with a brain injury
      by reducing overselectivity and selective attention to threat on two tasks. Participants will
      be recruited from NHS and non-NHS brain injury services. The study will take around two hours
      to complete for each participant. In summary, this study looks to see if a specific
      mindfulness exercise can be helpful for specific attention and emotion problems. It could be
      a first step in making treatment better and giving more treatment options for those with a
      brain injury.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Emotional Stroop
time frame: Administered pre- and post- 10-minute intervention, so over a period of one hour
description: This will be a computer task that measures selective attention to threat.
In the emotional Stroop, different coloured words are presented to participants and the emotional meaning of the words are manipulated. Participants are instructed to name the colour of the words as quickly as possible, whilst ignoring the meaning of the words. Selective attention to threat will be inferred when word colour-naming takes longer when the meaning of the word is threatening relative to neutral. So, the greater the difference between reaction times to neutral and threatening words, the greater the selective attention to threat.
measure: Over-selectivity task.
time frame: Administered pre- and post- 10-minute intervention, so over a period of one hour
description: This will be a computer task that measures over-selectivity.
Practice phase - two cards, each with two images appear on the screen. One card is the correct one to select and the other is incorrect. This happens for two sets of two cards (pair 1 and pair 2). Test phase - participants are presented with two single stimuli simultaneously, one from the reinforced compound and one from the verbally punished compound (Figure 4). They are instructed to select one of the pictures on the screen.
Over-selectivity will occur if participants fail to learn about one of the stimuli in the previously reinforced compound and therefore fail to select that stimuli they had not learned about in the practice phase.
So, the higher the score on the over-selectivity task, the greater the difference between the most and least chosen stimuli, which means that the participant is demonstrating greater over-selectivity.
measure: Hospital Anxiety and Depression Scale (HADS)
time frame: Pre-intervention (baseline measure)
description: A self-report measure consisting of 14 items. The measure gives an overall score, as well as separate scores for severity of anxiety and depression subscales.
measure: The Five Facet Mindfulness Questionnaire (FFMQ)
time frame: Pre-intervention (baseline measure)
description: This will be used to characterise levels of mindfulness. This is a self-report measure, consisting of 39 items.
measure: Test of Everyday Attention (TEA)
time frame: Pre-intervention (baseline measure)
description: Subtests will be used to measure baseline measures of attention. Elevator counting is a measure of sustained attention and elevator counting with distraction is a measure of selective attention.
measure: Weschler Test of Adult Reading (WTAR)
time frame: Pre-intervention (baseline measure)
description: This will be used to measure a baseline measure of pre-morbid functioning. Participants read a list of 50 words with irregular pronunciations to assess previous learning of the words.
arm group label: Mindfulness intervention
arm group type: Experimental
arm group label: Control intervention (unfocused attention)
arm group type: Active Comparator
intervention type: Other
intervention name: Mindfulness intervention
description: A 10 minute mindfulness of breath exercise
arm group label: Mindfulness intervention
intervention type: Other
intervention name: Control intervention (unfocused attention)
description: A 10 minute unfocused attention intervention - participants are asked to let their mind wander on anything that comes to mind.
arm group label: Control intervention (unfocused attention)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Katrina Vicentijevic
phone: 07498045055
email: k.vicentijevic@uea.ac.uk
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
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status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
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status: Recruiting
contact: 
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status: Recruiting
contact: 
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status: Recruiting
contact: 
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status: Not yet recruiting
contact: 
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status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
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status: Not yet recruiting
contact: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Wounds and Injuries