xml: <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/NCT05974371</url>
    </required_header>
    <id_info>
      <org_study_id>MH134570</org_study_id>
      <nct_id>NCT05974371</nct_id>
    </id_info>
    <brief_title>Episodic Memory Integration and Interference</brief_title>
    <official_title>A Basic Science Study on Episodic Memory Integration and Interference in Healthy Adults</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Boston College</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Boston College</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>
        The purpose of this study is to assess how emotional memories integrate and interfere with&#xD;
        one another over time. We will be using a multi-session experimental paradigm consisting of&#xD;
        two encoding sessions and one retrieval session. Participants will either complete these&#xD;
        sessions online or in-person, with the latter collecting functional magnetic resonance&#xD;
        imaging during the two encoding sessions.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        After being informed about the study, all participants giving written informed consent will&#xD;
        complete three experimental sessions. On Day 1, participants will encode AB neutral word&#xD;
        pairs (e.g., Pencil - Car) shown alongside positive, negative, or neutral images.&#xD;
        Participants will also rate the images on valence and arousal. After encoding all stimuli,&#xD;
        participants will immediately complete a retrieval task, during which they will be presented&#xD;
        with the cue word (A; e.g., Pencil) and asked to recall the corresponding associate (B, e.g.,&#xD;
        Car). If incorrect, the correct word pair will be shown before the next trial. The complete&#xD;
        list of word pairs will be shown until at least 90% of the word associates are recalled. On&#xD;
        Day 2 (~24 h later), participants will return to encode new AC word pairs, where one of the&#xD;
        words is the same from the first encoding session and one is different (e.g., Pencil - Book).&#xD;
        These AC words pairs will be encoded alongside new images that either match the valence of&#xD;
        the first session or shift to a different valence. Again, participants will rate the valence&#xD;
        and arousal of each image and complete a subsequent memory test until they reach 90% accuracy&#xD;
        on all word pairs. On Day 3, participants will complete the final session of the study,&#xD;
        during which they will be shown a cue word (e.g., Pencil) and asked to freely recall the&#xD;
        corresponding associates from days 1 and 2 (e.g., Car and Book). Participants will also be&#xD;
        asked to remember the day each word associate was originally shown and the valence of the&#xD;
        paired image from that day. 100 participants will complete these sessions and their&#xD;
        corresponding behavioral tasks online (e.g., via Prolific). An additional 50 participants&#xD;
        will complete these sessions in-person, and functional magnetic resonance imaging will be&#xD;
        collected during Day 1 and Day 2 to examine how the blood oxygen-level dependent (BOLD)&#xD;
        signal is modulated by task conditions. Psychophysiological data such as respiration and&#xD;
        heart rate may also be collected. All participants (online and fMRI) will provide individual&#xD;
        difference metrics on mood and well-being, including the Beck Depression Inventory,&#xD;
        State-Trait Anxiety Inventory, NEO Personality Inventory, and Ruminative Responses Scale. On&#xD;
        each day prior to the start of the experimental task, participants will also complete the&#xD;
        Profile of Mood States, Positive and Negative Affect Scale, the Pittsburgh Sleep Quality&#xD;
        Index, and sleep logs for the night before to index the amount and quality of sleep.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2024</start_date>
    <completion_date type="Anticipated">August 2027</completion_date>
    <primary_completion_date type="Anticipated">August 2027</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>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Memory for the Associated Words</measure>
      <time_frame>Day 3</time_frame>
      <description>During the memory recall task on Day 3, participants will be shown a cue word (A) and asked to recall the corresponding associates from Day 1 (B) and Day 2 (C) by typing their response in a blank text field. Participants will also report their confidence in these memories from 1 (not at all confident) to 9 (extremely confident).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>fMRI Measured Neural Reactivity (Blood Oxygen-Level Dependent Signal)</measure>
      <time_frame>Day 2</time_frame>
      <description>fMRI data from Day 1 and Day 2 will be used to perform whole-brain analyses of neural response during encoding, as well as compute neural pattern similarity scores between AB and AC pairs from same- or differently-valenced contexts. Our primary hypothesis is that the similarity of neural patterns in the dorsomedial prefrontal cortex will predict memory performance on Day 3.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Source Memory</measure>
      <time_frame>Day 3</time_frame>
      <description>During the memory recall task on Day 3, participants will also be asked to report which day each paired associate (B &amp; C) was shown by selecting &quot;1&quot;, &quot;2&quot;, or &quot;?&quot; if unsure. Additionally, participants will indicate the valence of the image that they remember being associated with each pair from 1 (very negative) to 9 (very positive), as well as their confidence in the remembered valence from 1 (not at all confident) to 9 (extremely confident).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Resting-State Functional Connectivity</measure>
      <time_frame>Day 2</time_frame>
      <description>Prior work from our lab has shown that increased amygdala-visuosensory connectivity after encoding predicts a memory bias for negatively-valenced stimuli, whereas increased amygdala-prefrontal connectivity predicts a memory bias for positively-valenced stimuli. In the current study, we will also examine whether changes in functional connectivity of the amygdala on Day 2 predict individual differences in memory performance on Day 3 (change = post - pre connectivity strength).</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Episodic Memory</condition>
    <arm_group>
      <arm_group_label>Emotional memory updating paradigm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All participants will encode AB/AC word pairs shown with images that have differing emotional valence (positive, negative, or neutral)</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>emotional context similarity</intervention_name>
      <description>On Day 1, all participants will encode AB neutral word pairs (e.g., Pencil - Car) shown with positive, negative, or neutral images. On Day 2, all participants will encode AC neutral words pairs (e.g., Pencil - Book) alongside images of either the same or different valence. The emotional similarity of AB (Day 1) and AC (Day 2) image contexts (i.e., the independent variable) will consist of the following conditions: positive-positive, positive-negative, negative-negative, negative-positive, neutral-neutral, neutral-positive, and neutral-negative.</description>
      <arm_group_label>Emotional memory updating paradigm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. All participants: willing and able to follow the protocol&#xD;
  &#xD;
            2. All participants: fluent in English&#xD;
  &#xD;
            3. Online participants: online account in the crowdsourcing platform that will be used&#xD;
               (e.g., Prolific)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. All participants: history of a psychiatric or neurological condition, and/or current&#xD;
               psychotropic drug use (indicated by the participant)&#xD;
  &#xD;
            2. fMRI participants: pregnant, metal in body (incl piercings or metallic makeup if&#xD;
               unwilling to remove), unable to lie still for duration of scan (e.g., due to pain),&#xD;
               Meniere's disease, claustrophobic, or other contraindication for MRI as determined my&#xD;
               MRI technician, left-handed&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>39 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Erin Sibley</last_name>
      <phone>617.552.1758</phone>
      <email>erin.sibley@bc.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Boston College</name>
        <address>
          <city>Chestnut Hill</city>
          <state>Massachusetts</state>
          <zip>02467</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Elizabeth Kensinger</last_name>
        <phone>617-552-1350</phone>
        <email>elizabeth.kensinger@bc.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>All IPD that underlie results in a publication.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>De-identified data will be available for access and sharing as soon as the final version of the manuscript is accepted for publication</ipd_time_frame>
      <ipd_access_criteria>Because data will be de-identified, these data will be posted on an open access website.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05974371
  org study id: MH134570
  nct id: NCT05974371
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to assess how emotional memories integrate and interfere with
        one another over time. We will be using a multi-session experimental paradigm consisting of
        two encoding sessions and one retrieval session. Participants will either complete these
        sessions online or in-person, with the latter collecting functional magnetic resonance
        imaging during the two encoding sessions.
  After being informed about the study, all participants giving written informed consent will
        complete three experimental sessions. On Day 1, participants will encode AB neutral word
        pairs (e.g., Pencil - Car) shown alongside positive, negative, or neutral images.
        Participants will also rate the images on valence and arousal. After encoding all stimuli,
        participants will immediately complete a retrieval task, during which they will be presented
        with the cue word (A; e.g., Pencil) and asked to recall the corresponding associate (B, e.g.,
        Car). If incorrect, the correct word pair will be shown before the next trial. The complete
        list of word pairs will be shown until at least 90% of the word associates are recalled. On
        Day 2 (~24 h later), participants will return to encode new AC word pairs, where one of the
        words is the same from the first encoding session and one is different (e.g., Pencil - Book).
        These AC words pairs will be encoded alongside new images that either match the valence of
        the first session or shift to a different valence. Again, participants will rate the valence
        and arousal of each image and complete a subsequent memory test until they reach 90% accuracy
        on all word pairs. On Day 3, participants will complete the final session of the study,
        during which they will be shown a cue word (e.g., Pencil) and asked to freely recall the
        corresponding associates from days 1 and 2 (e.g., Car and Book). Participants will also be
        asked to remember the day each word associate was originally shown and the valence of the
        paired image from that day. 100 participants will complete these sessions and their
        corresponding behavioral tasks online (e.g., via Prolific). An additional 50 participants
        will complete these sessions in-person, and functional magnetic resonance imaging will be
        collected during Day 1 and Day 2 to examine how the blood oxygen-level dependent (BOLD)
        signal is modulated by task conditions. Psychophysiological data such as respiration and
        heart rate may also be collected. All participants (online and fMRI) will provide individual
        difference metrics on mood and well-being, including the Beck Depression Inventory,
        State-Trait Anxiety Inventory, NEO Personality Inventory, and Ruminative Responses Scale. On
        each day prior to the start of the experimental task, participants will also complete the
        Profile of Mood States, Positive and Negative Affect Scale, the Pittsburgh Sleep Quality
        Index, and sleep logs for the night before to index the amount and quality of sleep.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Memory for the Associated Words
  time frame: Day 3
  description: During the memory recall task on Day 3, participants will be shown a cue word (A) and asked to recall the corresponding associates from Day 1 (B) and Day 2 (C) by typing their response in a blank text field. Participants will also report their confidence in these memories from 1 (not at all confident) to 9 (extremely confident).
  measure: fMRI Measured Neural Reactivity (Blood Oxygen-Level Dependent Signal)
  time frame: Day 2
  description: fMRI data from Day 1 and Day 2 will be used to perform whole-brain analyses of neural response during encoding, as well as compute neural pattern similarity scores between AB and AC pairs from same- or differently-valenced contexts. Our primary hypothesis is that the similarity of neural patterns in the dorsomedial prefrontal cortex will predict memory performance on Day 3.
  measure: Source Memory
  time frame: Day 3
  description: During the memory recall task on Day 3, participants will also be asked to report which day each paired associate (B & C) was shown by selecting "1", "2", or "?" if unsure. Additionally, participants will indicate the valence of the image that they remember being associated with each pair from 1 (very negative) to 9 (very positive), as well as their confidence in the remembered valence from 1 (not at all confident) to 9 (extremely confident).
  measure: Change in Resting-State Functional Connectivity
  time frame: Day 2
  description: Prior work from our lab has shown that increased amygdala-visuosensory connectivity after encoding predicts a memory bias for negatively-valenced stimuli, whereas increased amygdala-prefrontal connectivity predicts a memory bias for positively-valenced stimuli. In the current study, we will also examine whether changes in functional connectivity of the amygdala on Day 2 predict individual differences in memory performance on Day 3 (change = post - pre connectivity strength).
  arm group label: Emotional memory updating paradigm
  arm group type: Experimental
  description: All participants will encode AB/AC word pairs shown with images that have differing emotional valence (positive, negative, or neutral)
  intervention type: Other
  intervention name: emotional context similarity
  description: On Day 1, all participants will encode AB neutral word pairs (e.g., Pencil - Car) shown with positive, negative, or neutral images. On Day 2, all participants will encode AC neutral words pairs (e.g., Pencil - Book) alongside images of either the same or different valence. The emotional similarity of AB (Day 1) and AC (Day 2) image contexts (i.e., the independent variable) will consist of the following conditions: positive-positive, positive-negative, negative-negative, negative-positive, neutral-neutral, neutral-positive, and neutral-negative.
  arm group label: Emotional memory updating paradigm
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 39 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Erin Sibley
  phone: 617.552.1758
  email: erin.sibley@bc.edu
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: Yes
  ipd description: All IPD that underlie results in a publication.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Analytic Code
  ipd time frame: De-identified data will be available for access and sharing as soon as the final version of the manuscript is accepted for publication
  ipd access criteria: Because data will be de-identified, these data will be posted on an open access website.