Neural and Behavioral Effects of Cognitive Bias Modification (CBM)

NCT04430543 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2022-09-10

No results posted yet for this study

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.

Conditions

  • Alcohol Drinking

Interventions

BEHAVIORAL

Cognitive Bias Modification

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%).

BEHAVIORAL

Sham Training

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)

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH
  • Boston University Charles River Campus

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
34 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-21
Primary Completion
2021-08-31
Completion
2021-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04430543 on ClinicalTrials.gov