Neural and Behavioral Effects of Cognitive Bias Modification (CBM)
Condition: Alcohol Drinking
MeSH terms: Alcohol Drinking
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Cognitive Bias Modification; Sham Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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%).; 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)
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.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: motivation; alcohol-related disorders; self-control