<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/NCT03781921</url>
  </required_header>
  <id_info>
    <org_study_id>1819/IRASLR-V/1</org_study_id>
    <nct_id>NCT03781921</nct_id>
  </id_info>
  <brief_title>The Neural Bases of Emotion Regulation in Bulimia Nervosa</brief_title>
  <official_title>Disentangling Emotional Processing From Regulation in Bulimia Nervosa</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bournemouth University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bournemouth University</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 project aims to explore emotional processing and regulation in individuals with Bulimia&#xD;
      Nervosa (BN) with a view to better understand its underlying causes. Previous research&#xD;
      suggests that binge eating and purging behaviours may be linked to difficulties with emotions&#xD;
      and impulses. However, most of the research has been conducted using self-report methods,&#xD;
      despite the fact that these individuals have difficulties identifying and describing their&#xD;
      emotions (known as alexithymia), making the use of self-report questionable. This project is&#xD;
      the first to use electroencephalography (EEG) as an objective method to disentangle emotional&#xD;
      processing and regulation in these individuals. A combination of three tasks and&#xD;
      questionnaires will be used to measure various aspects of an emotional response and its link&#xD;
      to impulsive behaviours in individuals with BN (N=35) and healthy controls (N=35). This study&#xD;
      has the potential to inform future treatment for these individuals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Relevance:&#xD;
&#xD;
      Over 1.6 million people in the UK are affected by an eating disorder and approximately 40% of&#xD;
      these - 640,000 - suffer from bulimia nervosa (BN). Research shows that at 10 years after&#xD;
      diagnosis, only about half the people with BN will have recovered fully, demonstrating the&#xD;
      importance of developing new and more effective treatment. A recently published study&#xD;
      suggests that training emotion regulation skills may work as an alternative treatment. This&#xD;
      is because difficulties with emotions have been shown to contribute to eating disorder&#xD;
      pathologies. However, most studies looking at emotional difficulties in this population have&#xD;
      used self-report methods, despite the fact that high levels of alexithymia (difficulties with&#xD;
      identifying and describing emotions) characterise this population, indicating that these&#xD;
      findings are potentially flawed. In addition, self-report data show that two processes seem&#xD;
      involved in eating disorders, namely emotional intensity and emotional dysregulation.&#xD;
      However, experiencing emotions with higher intensity also makes it harder to reappraise&#xD;
      emotions so it is not clear whether individuals with BN actually have a real deficit in&#xD;
      emotion regulation, because self-reports cannot distinguish the two. The current project is&#xD;
      proposing to use an objective way to disentangle these aspects of emotional processing by&#xD;
      looking at two brain activities. The first is called the N1 because it appears about 100 ms&#xD;
      after the presentation of a stimulus and is of negative amplitude; the second is called the&#xD;
      LPP for Late Positive Potential.&#xD;
&#xD;
      This proposal also aims to investigate the mechanisms behind the observed link between&#xD;
      negative urgency (acting impulsively under distress) and binge eating by exploring the&#xD;
      brain's ability to filter out irrelevant stimuli in the environment -also called sensory&#xD;
      gating. Whilst individuals are constantly being stimulated by information, the brain usually&#xD;
      filters irrelevant information to prevent the cortex from being overloaded. However, if too&#xD;
      much attention is directed towards a stimulus (such as a negative event or food stimuli),&#xD;
      sensory gating deficits may occur, which could lead to cognitive deficits such as negative&#xD;
      urgency. In a previous study, the investigators have shown impaired sensory gating in bipolar&#xD;
      disorders and due to similarities in affective processing between bipolar disorder and BN as&#xD;
      well as high comorbidity between these disorders, the investigators suggest similar&#xD;
      mechanisms may be in place in BN.&#xD;
&#xD;
      This project has strong implications for treatment, because different approaches could be&#xD;
      used depending on what processes are affected (e.g. training to reallocate attention vs&#xD;
      helping with emotion regulation strategies).&#xD;
&#xD;
      Research Questions:&#xD;
&#xD;
      This research aims to answer the following four research questions using three tasks to&#xD;
      measure emotional processing and regulation (Task 1), emotional sensory gating (Task 2), and&#xD;
      negative urgency (Task 3).&#xD;
&#xD;
        1. Is binge eating associated with higher emotional intensity, as indicated by larger N1&#xD;
           amplitudes in BN compared to controls?&#xD;
&#xD;
        2. Do individuals with BN show poor emotion regulation skills, as indicated by larger LPP&#xD;
           amplitudes in the reappraisal condition compared to controls?&#xD;
&#xD;
        3. Do individuals with BN show impaired emotional sensory gating, as indicated by lower P50&#xD;
           ratio compared to controls? 3.1. If so, can deficits in emotional sensory gating explain&#xD;
           the emotional difficulties seen in BN, including negative urgency?&#xD;
&#xD;
        4. To what extent do emotional intensity, emotion regulation deficits and emotional sensory&#xD;
           gating deficits predict binge eating in BN?&#xD;
&#xD;
      Participant selection Since there are no similar studies conducted in participants with&#xD;
      Bulimia Nervosa, the investigators calculated our sample size based on power analysis from&#xD;
      other studies. Sample size varied between 13 and 33 participants to have an 80% chance of&#xD;
      finding an effect and a level of significance of 5%. The investigators will recruit 35&#xD;
      participants in each group. Thirty five control participants will be recruited through a&#xD;
      mailing list available at Bournemouth University (which includes students as well as&#xD;
      non-students).&#xD;
&#xD;
      Thirty five female participants with bulimia nervosa (BN) will be recruited from Kimmeridge&#xD;
      Court in Bournemouth. Dr Ciaran Newell (Consultant Nurse Eating Disorders) will advertise our&#xD;
      study to new patients diagnosed with BN. When patients are referred to Kimmeridge court, they&#xD;
      will be told about the current study. It will be emphasised that taking part in the study is&#xD;
      completely separate from their treatment and that whether or not they decide to participate&#xD;
      will not have any influence on their treatment. If participants decide to participate they&#xD;
      will be told to contact the PI (Dr Laura Vuillier) who will give them more information over&#xD;
      the phone or face to face, depending on their preferences.&#xD;
&#xD;
      Study Design If participants do agree to participate, participants will be sent a survey via&#xD;
      email. At the start of the study, participants will see a participant information sheet&#xD;
      detailing the study. Participants will then be asked to sign an electronic consent form if&#xD;
      they agree to participate. This survey will ask questions about their emotions and their&#xD;
      eating patterns. This survey will take approximately 30 minutes to complete. Their response&#xD;
      will be pseudonymous as participants will be asked to enter a pseudonymous code. At the end&#xD;
      of the survey participants will be asked to contact the experimenter to arrange a convenient&#xD;
      time for the laboratory session.&#xD;
&#xD;
      The laboratory session will take about 3 hours, including breaks and will take place in the&#xD;
      premises of Bournemouth University (Talbot campus). Thereparticipants will be given another&#xD;
      information sheet detailing this next part of the study. Participants will be asked to sign&#xD;
      another consent form before they can proceed. If participants agree to participate, the&#xD;
      researcher will administrate a structural interview (using the SCID short version) to confirm&#xD;
      their eating disorder diagnosis. After this, the electroencephalography (EEG) experiment will&#xD;
      start. All parts of the experiment (including the survey, the SCID and the three tasks) will&#xD;
      be pseudonymous and participants will not have to give any personal detail such as their&#xD;
      name. The only place the investigators will ask for their name is when participants sign the&#xD;
      consent form. However, these will be stored in a separate location and it will not be&#xD;
      possible to link these with their data.&#xD;
&#xD;
      For the purposes of the experiment, a cap with electrodes will be placed on their head to&#xD;
      record their brain activity. This will take about 30 minutes to set up. Then, participants&#xD;
      will be asked to complete 3 computer tasks: an emotion regulation task (task 1), a sensory&#xD;
      gating task (task 2) and a GoNogo task (task 3, all three are defined below). Each task will&#xD;
      take approximately 30 minutes to complete. Participants will be told they can take a break&#xD;
      during each task and also between tasks. Then the investigators will remove the cap with the&#xD;
      electrodes and the participants will be able to wash their hair (some gel is used on the&#xD;
      electrodes) before they leave.&#xD;
&#xD;
      Task 1: Emotional processing and regulation This task will show 50 emotional pictures from a&#xD;
      picture library accompanied by a neutral or negative description. For instance, a picture of&#xD;
      a woman dying will be either preceded by a neutral description (These doctors will save the&#xD;
      woman's life) or negative description (These workers have found a war victim). Reappraisal is&#xD;
      measured with the neutral description as participants will interpret the picture in a less&#xD;
      negative way. Previous work conducted in healthy participants show a reduction in one brain&#xD;
      activity (the LPP, or Late Positive Potential) in the reappraisal condition, and larger&#xD;
      amplitudes for another brain activity (the N1, for Negative activity appearing 100ms after a&#xD;
      stimulus) for stimuli with a negative valence reflecting higher attentional processes.&#xD;
&#xD;
      Task 2: Sensory gating The sensory gating deficit hypothesis will be tested in a paired-click&#xD;
      paradigm using 40 pictures of negative valence, 40 pictures of food, and 40 neutral pictures&#xD;
      from an affective picture library. Participants will be asked to passively watch the 120&#xD;
      pictures while the participants hear two clicks. Sensory gating will be measured as the&#xD;
      difference in amplitude in one brain activity (called the P50) between the first and second&#xD;
      click in all three conditions. This difference in amplitude shows that the brain filtered the&#xD;
      second stimuli.&#xD;
&#xD;
      Task 3: Negative urgency Negative urgency will be measured with our GoNogo task. This task&#xD;
      requires participants to 'go' (e.g. key press) when viewing a specific stimulus, but to 'not&#xD;
      go' (e.g. not key press) when viewing a different stimulus. To provide the emotional context&#xD;
      to our paradigm the task will use 50 negative emotional and 50 neutral pictorial stimuli. The&#xD;
      percentage of false alarms is considered an index of negative urgency, since it represents an&#xD;
      unsuccessful attempt at controlling an impulsive action.&#xD;
&#xD;
      Questionnaires:&#xD;
&#xD;
      The investigators will use validated questionnaires including the Eating Disorder Examination&#xD;
      Questionnaire, the Difficulties in Emotion Regulation Scale, the Toronto Alexithymia Scale,&#xD;
      and the Barratt Impulsiveness Scale to correlate self-report data with brain activity and&#xD;
      understand how these levels of explanation are related.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 30, 2019</start_date>
  <completion_date type="Anticipated">August 14, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 14, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>LPP</measure>
    <time_frame>Only once on the day of the electroencephalography task</time_frame>
    <description>Late Positive Potential differences in amplitude between the different groups and different conditions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>N1</measure>
    <time_frame>Only once on the day of the electroencephalography task</time_frame>
    <description>Differences in amplitude between the different groups and different conditions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>P50</measure>
    <time_frame>Only once on the day of the electroencephalography task</time_frame>
    <description>Differences in amplitude between the different groups and different conditions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>False alarm rate</measure>
    <time_frame>Only once on the day of the task</time_frame>
    <description>Differences in rate between the different groups and different conditions</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Bulimia Nervosa</condition>
  <condition>Emotions</condition>
  <condition>Emotional Impulsivity</condition>
  <arm_group>
    <arm_group_label>BN</arm_group_label>
    <description>Females with a current diagnosis of Bulimia Nervosa between 18 and 50 years old</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <description>Females with no current or past diagnosis of any eating disorder; between 18 and 50 years old</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>There is no intervention. Each group will conduct the same tasks and questionnaires and we will compare performances between groups.</description>
    <arm_group_label>BN</arm_group_label>
    <arm_group_label>Controls</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants will be identified as they come to be diagnosed at Kimmeridge Court in&#xD;
        Bournemouth, the local NHS clinic for people with eating disorders. Leaflets will be left&#xD;
        in the waiting room area and their clinician will also give individual leaflets to&#xD;
        individuals those patients meeting our inclusion criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Females&#xD;
&#xD;
          -  Fluent in English&#xD;
&#xD;
          -  With a diagnosis of bulimia nervosa for the BN group and without a diagnosis of any&#xD;
             eating disorder for the control group&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Males&#xD;
&#xD;
          -  Under 18 or over 50&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Only individuals being genetically females (As opposed to simply identifying as one) will be taking part in the study.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laura Renshaw-Vuillier, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bournemouth University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Laura Renshaw-Vuillier, PhD</last_name>
    <phone>01202964046</phone>
    <email>lrenshawvuillier@bournemouth.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Suzy Wignall, MA</last_name>
    <phone>01202961200</phone>
    <email>swignall@bournemouth.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Bournemouth University</name>
      <address>
        <city>Bournemouth</city>
        <zip>BH12 5BB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Laura Renshaw-Vuillier, PhD</last_name>
      <phone>01202964046</phone>
      <email>lrenshawvuillier@bournemouth.ac.uk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dorset Healthcare University NHS Foundation Trust</name>
      <address>
        <city>Bournemouth</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Natalie Goth</last_name>
      <email>natalie.goth@nhs.net</email>
    </contact>
    <contact_backup>
      <last_name>Laura Renshaw-Vuillier</last_name>
      <email>lrenshawvuillier@bournemouth.ac.uk</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>July 5, 2023</last_update_submitted>
  <last_update_submitted_qc>July 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>eating disorder</keyword>
  <keyword>Electroencephalography</keyword>
  <keyword>emotion regulation</keyword>
  <keyword>emotion processing</keyword>
  <keyword>negative urgency</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bulimia</mesh_term>
    <mesh_term>Bulimia Nervosa</mesh_term>
    <mesh_term>Impulsive Behavior</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Other researchers in the team will have access to the participant anonymised data for further analysis. This will be shared through a secure server.&#xD;
The anonymised data will also be saved on Bournemouth secured data repository for other researchers outside the research team to have access to it (requirement for publications etc)</ipd_description>
    <ipd_time_frame>The participant's anonymous data will be saved for 10 years on Bournemouth secured online data repository</ipd_time_frame>
    <ipd_access_criteria>Anyone with the link will be able to acess the data. The link will be distributed during the publication process.</ipd_access_criteria>
  </patient_data>
  <!-- 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/NCT03781921
org study id: 1819/IRASLR-V/1
nct id: NCT03781921
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This project aims to explore emotional processing and regulation in individuals with Bulimia
      Nervosa (BN) with a view to better understand its underlying causes. Previous research
      suggests that binge eating and purging behaviours may be linked to difficulties with emotions
      and impulses. However, most of the research has been conducted using self-report methods,
      despite the fact that these individuals have difficulties identifying and describing their
      emotions (known as alexithymia), making the use of self-report questionable. This project is
      the first to use electroencephalography (EEG) as an objective method to disentangle emotional
      processing and regulation in these individuals. A combination of three tasks and
      questionnaires will be used to measure various aspects of an emotional response and its link
      to impulsive behaviours in individuals with BN (N=35) and healthy controls (N=35). This study
      has the potential to inform future treatment for these individuals.
Relevance:

      Over 1.6 million people in the UK are affected by an eating disorder and approximately 40% of
      these - 640,000 - suffer from bulimia nervosa (BN). Research shows that at 10 years after
      diagnosis, only about half the people with BN will have recovered fully, demonstrating the
      importance of developing new and more effective treatment. A recently published study
      suggests that training emotion regulation skills may work as an alternative treatment. This
      is because difficulties with emotions have been shown to contribute to eating disorder
      pathologies. However, most studies looking at emotional difficulties in this population have
      used self-report methods, despite the fact that high levels of alexithymia (difficulties with
      identifying and describing emotions) characterise this population, indicating that these
      findings are potentially flawed. In addition, self-report data show that two processes seem
      involved in eating disorders, namely emotional intensity and emotional dysregulation.
      However, experiencing emotions with higher intensity also makes it harder to reappraise
      emotions so it is not clear whether individuals with BN actually have a real deficit in
      emotion regulation, because self-reports cannot distinguish the two. The current project is
      proposing to use an objective way to disentangle these aspects of emotional processing by
      looking at two brain activities. The first is called the N1 because it appears about 100 ms
      after the presentation of a stimulus and is of negative amplitude; the second is called the
      LPP for Late Positive Potential.

      This proposal also aims to investigate the mechanisms behind the observed link between
      negative urgency (acting impulsively under distress) and binge eating by exploring the
      brain's ability to filter out irrelevant stimuli in the environment -also called sensory
      gating. Whilst individuals are constantly being stimulated by information, the brain usually
      filters irrelevant information to prevent the cortex from being overloaded. However, if too
      much attention is directed towards a stimulus (such as a negative event or food stimuli),
      sensory gating deficits may occur, which could lead to cognitive deficits such as negative
      urgency. In a previous study, the investigators have shown impaired sensory gating in bipolar
      disorders and due to similarities in affective processing between bipolar disorder and BN as
      well as high comorbidity between these disorders, the investigators suggest similar
      mechanisms may be in place in BN.

      This project has strong implications for treatment, because different approaches could be
      used depending on what processes are affected (e.g. training to reallocate attention vs
      helping with emotion regulation strategies).

      Research Questions:

      This research aims to answer the following four research questions using three tasks to
      measure emotional processing and regulation (Task 1), emotional sensory gating (Task 2), and
      negative urgency (Task 3).

        1. Is binge eating associated with higher emotional intensity, as indicated by larger N1
           amplitudes in BN compared to controls?

        2. Do individuals with BN show poor emotion regulation skills, as indicated by larger LPP
           amplitudes in the reappraisal condition compared to controls?

        3. Do individuals with BN show impaired emotional sensory gating, as indicated by lower P50
           ratio compared to controls? 3.1. If so, can deficits in emotional sensory gating explain
           the emotional difficulties seen in BN, including negative urgency?

        4. To what extent do emotional intensity, emotion regulation deficits and emotional sensory
           gating deficits predict binge eating in BN?

      Participant selection Since there are no similar studies conducted in participants with
      Bulimia Nervosa, the investigators calculated our sample size based on power analysis from
      other studies. Sample size varied between 13 and 33 participants to have an 80% chance of
      finding an effect and a level of significance of 5%. The investigators will recruit 35
      participants in each group. Thirty five control participants will be recruited through a
      mailing list available at Bournemouth University (which includes students as well as
      non-students).

      Thirty five female participants with bulimia nervosa (BN) will be recruited from Kimmeridge
      Court in Bournemouth. Dr Ciaran Newell (Consultant Nurse Eating Disorders) will advertise our
      study to new patients diagnosed with BN. When patients are referred to Kimmeridge court, they
      will be told about the current study. It will be emphasised that taking part in the study is
      completely separate from their treatment and that whether or not they decide to participate
      will not have any influence on their treatment. If participants decide to participate they
      will be told to contact the PI (Dr Laura Vuillier) who will give them more information over
      the phone or face to face, depending on their preferences.

      Study Design If participants do agree to participate, participants will be sent a survey via
      email. At the start of the study, participants will see a participant information sheet
      detailing the study. Participants will then be asked to sign an electronic consent form if
      they agree to participate. This survey will ask questions about their emotions and their
      eating patterns. This survey will take approximately 30 minutes to complete. Their response
      will be pseudonymous as participants will be asked to enter a pseudonymous code. At the end
      of the survey participants will be asked to contact the experimenter to arrange a convenient
      time for the laboratory session.

      The laboratory session will take about 3 hours, including breaks and will take place in the
      premises of Bournemouth University (Talbot campus). Thereparticipants will be given another
      information sheet detailing this next part of the study. Participants will be asked to sign
      another consent form before they can proceed. If participants agree to participate, the
      researcher will administrate a structural interview (using the SCID short version) to confirm
      their eating disorder diagnosis. After this, the electroencephalography (EEG) experiment will
      start. All parts of the experiment (including the survey, the SCID and the three tasks) will
      be pseudonymous and participants will not have to give any personal detail such as their
      name. The only place the investigators will ask for their name is when participants sign the
      consent form. However, these will be stored in a separate location and it will not be
      possible to link these with their data.

      For the purposes of the experiment, a cap with electrodes will be placed on their head to
      record their brain activity. This will take about 30 minutes to set up. Then, participants
      will be asked to complete 3 computer tasks: an emotion regulation task (task 1), a sensory
      gating task (task 2) and a GoNogo task (task 3, all three are defined below). Each task will
      take approximately 30 minutes to complete. Participants will be told they can take a break
      during each task and also between tasks. Then the investigators will remove the cap with the
      electrodes and the participants will be able to wash their hair (some gel is used on the
      electrodes) before they leave.

      Task 1: Emotional processing and regulation This task will show 50 emotional pictures from a
      picture library accompanied by a neutral or negative description. For instance, a picture of
      a woman dying will be either preceded by a neutral description (These doctors will save the
      woman's life) or negative description (These workers have found a war victim). Reappraisal is
      measured with the neutral description as participants will interpret the picture in a less
      negative way. Previous work conducted in healthy participants show a reduction in one brain
      activity (the LPP, or Late Positive Potential) in the reappraisal condition, and larger
      amplitudes for another brain activity (the N1, for Negative activity appearing 100ms after a
      stimulus) for stimuli with a negative valence reflecting higher attentional processes.

      Task 2: Sensory gating The sensory gating deficit hypothesis will be tested in a paired-click
      paradigm using 40 pictures of negative valence, 40 pictures of food, and 40 neutral pictures
      from an affective picture library. Participants will be asked to passively watch the 120
      pictures while the participants hear two clicks. Sensory gating will be measured as the
      difference in amplitude in one brain activity (called the P50) between the first and second
      click in all three conditions. This difference in amplitude shows that the brain filtered the
      second stimuli.

      Task 3: Negative urgency Negative urgency will be measured with our GoNogo task. This task
      requires participants to 'go' (e.g. key press) when viewing a specific stimulus, but to 'not
      go' (e.g. not key press) when viewing a different stimulus. To provide the emotional context
      to our paradigm the task will use 50 negative emotional and 50 neutral pictorial stimuli. The
      percentage of false alarms is considered an index of negative urgency, since it represents an
      unsuccessful attempt at controlling an impulsive action.

      Questionnaires:

      The investigators will use validated questionnaires including the Eating Disorder Examination
      Questionnaire, the Difficulties in Emotion Regulation Scale, the Toronto Alexithymia Scale,
      and the Barratt Impulsiveness Scale to correlate self-report data with brain activity and
      understand how these levels of explanation are related.
observational model: Cohort
time perspective: Cross-Sectional
measure: LPP
time frame: Only once on the day of the electroencephalography task
description: Late Positive Potential differences in amplitude between the different groups and different conditions
measure: N1
time frame: Only once on the day of the electroencephalography task
description: Differences in amplitude between the different groups and different conditions
measure: P50
time frame: Only once on the day of the electroencephalography task
description: Differences in amplitude between the different groups and different conditions
measure: False alarm rate
time frame: Only once on the day of the task
description: Differences in rate between the different groups and different conditions
arm group label: BN
description: Females with a current diagnosis of Bulimia Nervosa between 18 and 50 years old
arm group label: Controls
description: Females with no current or past diagnosis of any eating disorder; between 18 and 50 years old
intervention type: Other
intervention name: No intervention
description: There is no intervention. Each group will conduct the same tasks and questionnaires and we will compare performances between groups.
arm group label: BN
arm group label: Controls
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Only individuals being genetically females (As opposed to simply identifying as one) will be taking part in the study.
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Laura Renshaw-Vuillier, PhD
role: Principal Investigator
affiliation: Bournemouth University
last name: Laura Renshaw-Vuillier, PhD
phone: 01202964046
email: lrenshawvuillier@bournemouth.ac.uk
last name: Suzy Wignall, MA
phone: 01202961200
email: swignall@bournemouth.ac.uk
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Bulimia
mesh term: Bulimia Nervosa
mesh term: Impulsive Behavior
sharing ipd: Yes
ipd description: Other researchers in the team will have access to the participant anonymised data for further analysis. This will be shared through a secure server.
The anonymised data will also be saved on Bournemouth secured data repository for other researchers outside the research team to have access to it (requirement for publications etc)
ipd time frame: The participant's anonymous data will be saved for 10 years on Bournemouth secured online data repository
ipd access criteria: Anyone with the link will be able to acess the data. The link will be distributed during the publication process.