<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/NCT04430543</url>
  </required_header>
  <id_info>
    <org_study_id>4633E</org_study_id>
    <secondary_id>1F31AA025522-01A1</secondary_id>
    <nct_id>NCT04430543</nct_id>
  </id_info>
  <brief_title>Neural and Behavioral Effects of Cognitive Bias Modification (CBM)</brief_title>
  <official_title>Addressing Problem Drinking From the Bottom-Up: An Investigation of the Neural and Behavioral Effects of Cognitive Bias Modification (CBM)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston University Charles River Campus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Alcohol Abuse and Alcoholism (NIAAA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston University Charles River Campus</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 seeks to better understand mechanisms of behavior change for heavy drinkers who&#xD;
      are interested in changing their drinking. The study will examine the effects of CBM as an&#xD;
      adjunctive treatment on neurocognitive processes related to alcohol use in a sample of&#xD;
      heavy/at-risk drinkers using functional magnetic resonance imaging (fMRI). The primary aim of&#xD;
      this project is to examine the effects of CBM on neurocognitive approach tendencies and&#xD;
      control processes, among heavy/at-risk drinkers interested in changing their alcohol use. As&#xD;
      a secondary aim, this project will investigate associations between neural and cognitive&#xD;
      changes and changes in alcohol use to better understand how CBM might lead to successful&#xD;
      changes in drinking behavior. Either CBM (treatment group) or sham computer task (control&#xD;
      group) will be paired with a motivational web-based intervention for alcohol use. Brain&#xD;
      activity will be measures twice via fMRI--pre-treatment and 1-week post-treatment. The&#xD;
      experimental tasks completed in the fMRI scans include 2 alcohol cue reactivity (CR)&#xD;
      tasks--one standard and one in which participants are told to either inhibit (INHIBIT) or&#xD;
      engage in (INDULGE) their reaction to images of alcohol and neutral beverages. Follow-up&#xD;
      drinking behavior will be measured also at 1-week and online via 1- and 6-month follow-ups.&#xD;
      Brain activity at baseline and follow-up will be measured in pre-defined regions of interest&#xD;
      including amygdala, NAcc, mPFC, and dlPFC. It is hypothesized that the CBM group will exhibit&#xD;
      changes in approach biases as exhibited by reductions in brain activity in the amygdala,&#xD;
      NAcc, mPFC in response to alcohol cues in both CR tasks (alcohol CR, INDULGE CR, and INHIBIT&#xD;
      CR) compared to sham. In addition, those in the CBM group will show increased dlPFC brain&#xD;
      activity during alcohol CR and INHIBIT trials of the cued-CR task as evidence strengthened&#xD;
      control abilities in response to alcohol cues. Finally, as a secondary hypothesis, those in&#xD;
      the CBM group will show greater reductions in drinking and craving at follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Forty heavy/at-risk drinkers (ages 18-34) who report an interest in changing their drinking&#xD;
      behavior will be recruited for this proposed project. &quot;Interest&quot; will be operationalized as&#xD;
      an affirmative answer on an item adapted (for past-month) from the CAGE questionnaire: &quot;In&#xD;
      the past month, have you felt you should cut down or stop drinking?&quot; (Mayfield, McLeod, &amp;&#xD;
      Hall, 1974). Heavy/at-risk drinking will be defined in terms of consumption (7+/14+ drinks&#xD;
      per week and/or 3+/4+ drinks on one occasion over the past week for women and men,&#xD;
      respectively; USDHHS, 2005) and score on the Alcohol Use Disorders Identification Test (AUDIT&#xD;
      score of 8-19; Babor, Higgins-Biddle, Saunders, &amp; Monteiro, 2001). A score between 8-19 on&#xD;
      the AUDIT is indicative of heavy use while scores 20 and above are indicative of a more&#xD;
      severe alcohol use disorder (i.e., &quot;dependence&quot;, DSM-IV; APA, 2013; APA, 2000). Participants&#xD;
      will be recruited through online advertisements on Craigslist, social media websites, and&#xD;
      &quot;Quickie Job Board&quot; listings on student websites as well as via flyers in community and&#xD;
      student health centers. Upon responding to advertisements participants will be administered a&#xD;
      phone screen or complete online screening survey to determine study eligibility.&#xD;
&#xD;
      If eligible, baseline assessments will be administered at an in person appointment, including&#xD;
      self-report assessments about alcohol use, drug use, consequences, and alcohol craving.&#xD;
      Participants will complete a baseline fMRI scan, which involves administration of two&#xD;
      versions of an alcohol cue reactivity (CR) task. Both CR tasks administered in the scanner&#xD;
      will consist of a block design. The first alcohol CR task consists of two types of blocks-1)&#xD;
      alcohol and 2) neutral beverage (i.e., soft drinks, juice, water). Subjects will be presented&#xD;
      with 40 alcohol images and 40 neutral beverage images, respectively. The second task, the&#xD;
      cued-CR task, involves 3 blocks utilizing the same images as the alcohol-CR task. Subjects&#xD;
      will receive instructions regarding their reaction to the photos-1) INHIBIT CR (alcohol&#xD;
      images), 2) INHIBIT NEUTRAL (neutral beverage images), and 3) INDULGE CR (alcohol images).&#xD;
      More specifically, participants will be given the instruction to imagine each image is&#xD;
      available to them and to either inhibit their natural reaction to the images presented&#xD;
      (alcohol in one block, neutral beverages in another block) or think about the possibility of&#xD;
      consuming, in this moment, each (alcohol-containing) beverage shown. This task was inspired&#xD;
      by fMRI studies using CR tasks and cognitive restraint strategies to inhibit cravings for&#xD;
      food and/or alcohol (Naqvi et al., 2015; Yokum &amp; Stice, 2013). For both tasks, each image&#xD;
      will be presented for 4 seconds followed by a 2 second inter-image interval. Participants&#xD;
      will be asked to rate their level of craving after each block for the first task only.&#xD;
      Following this baseline scan, participants will complete a brief web-based intervention for&#xD;
      alcohol use, Rethinking Drinking: Alcohol and Your Health (NIAAA, 2015), and will&#xD;
      subsequently be randomized to either cognitive bias modification (CBM) or sham training. They&#xD;
      will complete the first session of either CBM or sham training after randomization as well as&#xD;
      an additional 4 CBM/sham sessions at home (via web) over one week following baseline.&#xD;
      Participants will return to the lab one-week following their baseline appointment. At&#xD;
      follow-up assessment, participants will complete all baseline assessment measures in addition&#xD;
      to a second fMRI session consisting of the same CR tasks. Finally, participants will be&#xD;
      emailed a link to a web-based survey at 1- and 6-months following baseline to assess drinking&#xD;
      behavior. Data analysis will employ region of interest (ROI) analysis. Predefined ROIs&#xD;
      include the bilateral amygdala, nucleus accumbens (NAcc), and dorsolateral and medial&#xD;
      prefrontal cortex (dlPFC and mPFC). Anatomical ROIs will be generated using the Wake Forest&#xD;
      University (WFU) Pickatlas automatic anatomical labeling tool (Maldjian, Laurienti, Kraft, &amp;&#xD;
      Burdette, 2003) available for SPM. The analytic plan for testing study hypotheses are as&#xD;
      follows: Primary Aim 1-For the alcohol CR task, two within subject contrasts will be&#xD;
      calculated-1] alcohol CR &gt; neutral CR pre-CBM/sham and 2] (alcohol CR &gt; neutral CR)&#xD;
      pre-CBM/sham - (alcohol CR &gt; neutral CR) post-CBM/sham-in pre-defined ROIs. Primary Aim 2-as&#xD;
      with the alcohol CR task, the within subject contrasts will be 1] INDULGE CR &gt; INHIBIT CR&#xD;
      pre-CBM/sham and 2] (INDULGE CR &gt; INHIBIT CR) pre-CBM/sham - (INDULGE CR &gt; INHIBIT CR)&#xD;
      post-CBM/sham. Similar within subject contrasts will be explored for INHIBIT CR and INHIBIT&#xD;
      NEUTRAL CR as a control. T-tests will be used to compare within subject contrasts for each&#xD;
      task as well as to compare between-group contrasts (i.e., alcohol CR and INHIBIT CR pre-and&#xD;
      post- CBM/sham). Secondary Aim: Correlations will be run to determine whether BL BOLD&#xD;
      activity in each ROI significantly correlate with behavioral measures for both BL and 1-week&#xD;
      follow-up. For significant correlations, pre- and post-CBM/sham difference scores will be&#xD;
      calculated for behavioral measures and then correlated with significant BOLD contrasts&#xD;
      representing change in neural activity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 21, 2019</start_date>
  <completion_date type="Actual">August 31, 2021</completion_date>
  <primary_completion_date type="Actual">August 31, 2021</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>
    <intervention_model_description>There will be 2 groups- treatment group and control group. Both groups will receive a web-based motivational intervention then will be randomized to Cognitive Bias Modification or Sham (control) training. Participants will complete a total of 5 sessions of CBM or Sham over the course of a week.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>BOLD signal change in ROIs (amygdala, NAcc, mPFC, dlPFC) during alcohol cue-reactivity</measure>
    <time_frame>1-week</time_frame>
    <description>decreased signal indicates better outcomes for amygdala, NAcc, and mPFC; increased signal indicates better outcomes for dlPFC</description>
  </primary_outcome>
  <primary_outcome>
    <measure>BOLD signal change in ROIs (amygdala, NAcc, mPFC, dlPFC) during INHIBIT cue-reactivity</measure>
    <time_frame>1-week</time_frame>
    <description>decreased signal indicates better outcomes for amygdala, NAcc, and mPFC; increased signal indicates better outcomes for dlPFC</description>
  </primary_outcome>
  <primary_outcome>
    <measure>BOLD signal change in ROIs (amygdala, NAcc, mPFC) during INDULGE cue-reactivity</measure>
    <time_frame>1-week</time_frame>
    <description>decreased signal indicates better outcomes for amygdala, NAcc, and mPFC</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Drinking Behavior</measure>
    <time_frame>1-week</time_frame>
    <description>Daily Drinking Questionnaire quantity item &quot;most drinks on one occasion&quot;; range 0-31; higher score = more drinking/worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drinking Behavior</measure>
    <time_frame>1-month</time_frame>
    <description>Daily Drinking Questionnaire quantity item &quot;most drinks on one occasion&quot;; range 0-31; higher score = more drinking/worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drinking Behavior</measure>
    <time_frame>6-months</time_frame>
    <description>Daily Drinking Questionnaire quantity item &quot;most drinks on one occasion&quot;; range 0-31; higher score = more drinking/worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol Craving</measure>
    <time_frame>1-week</time_frame>
    <description>Score on Desire for Alcohol Questionnaire; range = 14-98; higher scores reflect higher desire for alcohol (worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol Craving</measure>
    <time_frame>1-month</time_frame>
    <description>Score on Desire for Alcohol Questionnaire; range = 14-98; higher scores reflect higher desire for alcohol (worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol Craving</measure>
    <time_frame>6-months</time_frame>
    <description>Score on Desire for Alcohol Questionnaire; range = 14-98; higher scores reflect higher desire for alcohol (worse outcome)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Alcohol Drinking</condition>
  <arm_group>
    <arm_group_label>CBM Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will receive Cognitive Bias Modification training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>This group will receive Sham (control) training</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Bias Modification</intervention_name>
    <description>CBM sessions are computer tasks that take 15 minutes each. CBM is similar to an alcohol approach avoidance task (AAT) in that they will involve moving their mouse forward to simulate an avoidance/push response and backward to simulate an approach/pull response in response to alcohol and neutral stimuli depending on photograph orientation. Photos will get larger as if coming toward the participant when &quot;pulled&quot; and will get smaller as if moving away when &quot;pushed&quot;. CBM will involve pushing 90% of alcohol stimuli (pulling 10%) and pulling 90% of neutral stimuli (pushing 10%).</description>
    <arm_group_label>CBM Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sham Training</intervention_name>
    <description>Sham training sessions are computer tasks that take 15 minutes each. Sham training is similar to an alcohol approach avoidance task (AAT) in that they will involve moving their mouse forward to simulate an avoidance/push response and backward to simulate an approach/pull response in response to alcohol and neutral stimuli depending on photograph orientation. Photos will get larger as if coming toward the participant when &quot;pulled&quot; and will get smaller as if moving away when &quot;pushed&quot;. Sham training will involve pushing and pulling 50% of each type of stimuli (alcohol and neutral)</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  current hazardous drinking (score of 8+ on USAUDIT-C)&#xD;
&#xD;
          -  interest in changing drinking&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
          -  able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Score of 25+ on USAUDIT&#xD;
&#xD;
          -  current or past treatment for alcohol or drug use&#xD;
&#xD;
          -  lifetime diagnosis of other substance use disorder&#xD;
&#xD;
          -  self-reported weekly or more other drug use as indicated on the NIDA-modified Alcohol,&#xD;
             Smoking, and Substance Involvement Screening Test&#xD;
&#xD;
          -  history of head injury or loss of consciousness&#xD;
&#xD;
          -  lifetime diagnosis of bipolar disorder, psychotic symptomatology, organic mental&#xD;
             disorder, seizure disorder, or central nervous system disease&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  current use of psychotropic medication&#xD;
&#xD;
          -  history of delirium tremens and/or seizures as a result of alcohol withdrawal&#xD;
&#xD;
          -  contraindications to fMRI (claustrophobia, pregnancy, metal, pacemaker, etc.).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>34 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Rajen Kilachand Center for Integrated Life Sciences and Engineering at Boston University</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>September 7, 2022</last_update_submitted>
  <last_update_submitted_qc>September 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston University Charles River Campus</investigator_affiliation>
    <investigator_full_name>Kelli Tahaney</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>motivation</keyword>
  <keyword>alcohol-related disorders</keyword>
  <keyword>self-control</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcohol Drinking</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>October 18, 2022</submitted>
    <returned>November 15, 2022</returned>
    <submitted>March 1, 2023</submitted>
    <returned>March 27, 2023</returned>
  </pending_results>
  <!-- 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/NCT04430543
org study id: 4633E
secondary id: 1F31AA025522-01A1
nct id: NCT04430543
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study seeks to better understand mechanisms of behavior change for heavy drinkers who
      are interested in changing their drinking. The study will examine the effects of CBM as an
      adjunctive treatment on neurocognitive processes related to alcohol use in a sample of
      heavy/at-risk drinkers using functional magnetic resonance imaging (fMRI). The primary aim of
      this project is to examine the effects of CBM on neurocognitive approach tendencies and
      control processes, among heavy/at-risk drinkers interested in changing their alcohol use. As
      a secondary aim, this project will investigate associations between neural and cognitive
      changes and changes in alcohol use to better understand how CBM might lead to successful
      changes in drinking behavior. Either CBM (treatment group) or sham computer task (control
      group) will be paired with a motivational web-based intervention for alcohol use. Brain
      activity will be measures twice via fMRI--pre-treatment and 1-week post-treatment. The
      experimental tasks completed in the fMRI scans include 2 alcohol cue reactivity (CR)
      tasks--one standard and one in which participants are told to either inhibit (INHIBIT) or
      engage in (INDULGE) their reaction to images of alcohol and neutral beverages. Follow-up
      drinking behavior will be measured also at 1-week and online via 1- and 6-month follow-ups.
      Brain activity at baseline and follow-up will be measured in pre-defined regions of interest
      including amygdala, NAcc, mPFC, and dlPFC. It is hypothesized that the CBM group will exhibit
      changes in approach biases as exhibited by reductions in brain activity in the amygdala,
      NAcc, mPFC in response to alcohol cues in both CR tasks (alcohol CR, INDULGE CR, and INHIBIT
      CR) compared to sham. In addition, those in the CBM group will show increased dlPFC brain
      activity during alcohol CR and INHIBIT trials of the cued-CR task as evidence strengthened
      control abilities in response to alcohol cues. Finally, as a secondary hypothesis, those in
      the CBM group will show greater reductions in drinking and craving at follow-up.
Forty heavy/at-risk drinkers (ages 18-34) who report an interest in changing their drinking
      behavior will be recruited for this proposed project. "Interest" will be operationalized as
      an affirmative answer on an item adapted (for past-month) from the CAGE questionnaire: "In
      the past month, have you felt you should cut down or stop drinking?" (Mayfield, McLeod, &
      Hall, 1974). Heavy/at-risk drinking will be defined in terms of consumption (7+/14+ drinks
      per week and/or 3+/4+ drinks on one occasion over the past week for women and men,
      respectively; USDHHS, 2005) and score on the Alcohol Use Disorders Identification Test (AUDIT
      score of 8-19; Babor, Higgins-Biddle, Saunders, & Monteiro, 2001). A score between 8-19 on
      the AUDIT is indicative of heavy use while scores 20 and above are indicative of a more
      severe alcohol use disorder (i.e., "dependence", DSM-IV; APA, 2013; APA, 2000). Participants
      will be recruited through online advertisements on Craigslist, social media websites, and
      "Quickie Job Board" listings on student websites as well as via flyers in community and
      student health centers. Upon responding to advertisements participants will be administered a
      phone screen or complete online screening survey to determine study eligibility.

      If eligible, baseline assessments will be administered at an in person appointment, including
      self-report assessments about alcohol use, drug use, consequences, and alcohol craving.
      Participants will complete a baseline fMRI scan, which involves administration of two
      versions of an alcohol cue reactivity (CR) task. Both CR tasks administered in the scanner
      will consist of a block design. The first alcohol CR task consists of two types of blocks-1)
      alcohol and 2) neutral beverage (i.e., soft drinks, juice, water). Subjects will be presented
      with 40 alcohol images and 40 neutral beverage images, respectively. The second task, the
      cued-CR task, involves 3 blocks utilizing the same images as the alcohol-CR task. Subjects
      will receive instructions regarding their reaction to the photos-1) INHIBIT CR (alcohol
      images), 2) INHIBIT NEUTRAL (neutral beverage images), and 3) INDULGE CR (alcohol images).
      More specifically, participants will be given the instruction to imagine each image is
      available to them and to either inhibit their natural reaction to the images presented
      (alcohol in one block, neutral beverages in another block) or think about the possibility of
      consuming, in this moment, each (alcohol-containing) beverage shown. This task was inspired
      by fMRI studies using CR tasks and cognitive restraint strategies to inhibit cravings for
      food and/or alcohol (Naqvi et al., 2015; Yokum & Stice, 2013). For both tasks, each image
      will be presented for 4 seconds followed by a 2 second inter-image interval. Participants
      will be asked to rate their level of craving after each block for the first task only.
      Following this baseline scan, participants will complete a brief web-based intervention for
      alcohol use, Rethinking Drinking: Alcohol and Your Health (NIAAA, 2015), and will
      subsequently be randomized to either cognitive bias modification (CBM) or sham training. They
      will complete the first session of either CBM or sham training after randomization as well as
      an additional 4 CBM/sham sessions at home (via web) over one week following baseline.
      Participants will return to the lab one-week following their baseline appointment. At
      follow-up assessment, participants will complete all baseline assessment measures in addition
      to a second fMRI session consisting of the same CR tasks. Finally, participants will be
      emailed a link to a web-based survey at 1- and 6-months following baseline to assess drinking
      behavior. Data analysis will employ region of interest (ROI) analysis. Predefined ROIs
      include the bilateral amygdala, nucleus accumbens (NAcc), and dorsolateral and medial
      prefrontal cortex (dlPFC and mPFC). Anatomical ROIs will be generated using the Wake Forest
      University (WFU) Pickatlas automatic anatomical labeling tool (Maldjian, Laurienti, Kraft, &
      Burdette, 2003) available for SPM. The analytic plan for testing study hypotheses are as
      follows: Primary Aim 1-For the alcohol CR task, two within subject contrasts will be
      calculated-1] alcohol CR > neutral CR pre-CBM/sham and 2] (alcohol CR > neutral CR)
      pre-CBM/sham - (alcohol CR > neutral CR) post-CBM/sham-in pre-defined ROIs. Primary Aim 2-as
      with the alcohol CR task, the within subject contrasts will be 1] INDULGE CR > INHIBIT CR
      pre-CBM/sham and 2] (INDULGE CR > INHIBIT CR) pre-CBM/sham - (INDULGE CR > INHIBIT CR)
      post-CBM/sham. Similar within subject contrasts will be explored for INHIBIT CR and INHIBIT
      NEUTRAL CR as a control. T-tests will be used to compare within subject contrasts for each
      task as well as to compare between-group contrasts (i.e., alcohol CR and INHIBIT CR pre-and
      post- CBM/sham). Secondary Aim: Correlations will be run to determine whether BL BOLD
      activity in each ROI significantly correlate with behavioral measures for both BL and 1-week
      follow-up. For significant correlations, pre- and post-CBM/sham difference scores will be
      calculated for behavioral measures and then correlated with significant BOLD contrasts
      representing change in neural activity.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: There will be 2 groups- treatment group and control group. Both groups will receive a web-based motivational intervention then will be randomized to Cognitive Bias Modification or Sham (control) training. Participants will complete a total of 5 sessions of CBM or Sham over the course of a week.
primary purpose: Treatment
masking: Single (Participant)
measure: BOLD signal change in ROIs (amygdala, NAcc, mPFC, dlPFC) during alcohol cue-reactivity
time frame: 1-week
description: decreased signal indicates better outcomes for amygdala, NAcc, and mPFC; increased signal indicates better outcomes for dlPFC
measure: BOLD signal change in ROIs (amygdala, NAcc, mPFC, dlPFC) during INHIBIT cue-reactivity
time frame: 1-week
description: decreased signal indicates better outcomes for amygdala, NAcc, and mPFC; increased signal indicates better outcomes for dlPFC
measure: BOLD signal change in ROIs (amygdala, NAcc, mPFC) during INDULGE cue-reactivity
time frame: 1-week
description: decreased signal indicates better outcomes for amygdala, NAcc, and mPFC
measure: Drinking Behavior
time frame: 1-week
description: Daily Drinking Questionnaire quantity item "most drinks on one occasion"; range 0-31; higher score = more drinking/worse outcome
measure: Drinking Behavior
time frame: 1-month
description: Daily Drinking Questionnaire quantity item "most drinks on one occasion"; range 0-31; higher score = more drinking/worse outcome
measure: Drinking Behavior
time frame: 6-months
description: Daily Drinking Questionnaire quantity item "most drinks on one occasion"; range 0-31; higher score = more drinking/worse outcome
measure: Alcohol Craving
time frame: 1-week
description: Score on Desire for Alcohol Questionnaire; range = 14-98; higher scores reflect higher desire for alcohol (worse outcome)
measure: Alcohol Craving
time frame: 1-month
description: Score on Desire for Alcohol Questionnaire; range = 14-98; higher scores reflect higher desire for alcohol (worse outcome)
measure: Alcohol Craving
time frame: 6-months
description: Score on Desire for Alcohol Questionnaire; range = 14-98; higher scores reflect higher desire for alcohol (worse outcome)
arm group label: CBM Group
arm group type: Experimental
description: This group will receive Cognitive Bias Modification training
arm group label: Control Group
arm group type: Sham Comparator
description: This group will receive Sham (control) training
intervention type: Behavioral
intervention name: Cognitive Bias Modification
description: CBM sessions are computer tasks that take 15 minutes each. CBM is similar to an alcohol approach avoidance task (AAT) in that they will involve moving their mouse forward to simulate an avoidance/push response and backward to simulate an approach/pull response in response to alcohol and neutral stimuli depending on photograph orientation. Photos will get larger as if coming toward the participant when "pulled" and will get smaller as if moving away when "pushed". CBM will involve pushing 90% of alcohol stimuli (pulling 10%) and pulling 90% of neutral stimuli (pushing 10%).
arm group label: CBM Group
intervention type: Behavioral
intervention name: Sham Training
description: Sham training sessions are computer tasks that take 15 minutes each. Sham training is similar to an alcohol approach avoidance task (AAT) in that they will involve moving their mouse forward to simulate an avoidance/push response and backward to simulate an approach/pull response in response to alcohol and neutral stimuli depending on photograph orientation. Photos will get larger as if coming toward the participant when "pulled" and will get smaller as if moving away when "pushed". Sham training will involve pushing and pulling 50% of each type of stimuli (alcohol and neutral)
arm group label: Control Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 34 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston University Charles River Campus
investigator full name: Kelli Tahaney
investigator title: Principal Investigator
mesh term: Alcohol Drinking
sharing ipd: No
submitted: October 18, 2022
returned: November 15, 2022
submitted: March 1, 2023
returned: March 27, 2023