Neural and Behavioral Effects of Cognitive Bias Modification (CBM)

NCT04430543 | Completed

• 2 other identifiers: 4633E1F31AA025522-01A1
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

motivation; alcohol-related disorders; self-control

Outcome Measures

Primary Outcomes (3)

• BOLD signal change in ROIs (amygdala, NAcc, mPFC, dlPFC) during alcohol cue-reactivity

  decreased signal indicates better outcomes for amygdala, NAcc, and mPFC; increased signal indicates better outcomes for dlPFC

  1-week

• BOLD signal change in ROIs (amygdala, NAcc, mPFC, dlPFC) during INHIBIT cue-reactivity

  decreased signal indicates better outcomes for amygdala, NAcc, and mPFC; increased signal indicates better outcomes for dlPFC

  1-week

• BOLD signal change in ROIs (amygdala, NAcc, mPFC) during INDULGE cue-reactivity

  decreased signal indicates better outcomes for amygdala, NAcc, and mPFC

  1-week

Secondary Outcomes (6)

• Drinking Behavior

  1-week

• Drinking Behavior

  1-month

• Drinking Behavior

  6-months

• Alcohol Craving

  1-week

• Alcohol Craving

  1-month

Study Arms (2)

CBM Group

EXPERIMENTAL

This group will receive Cognitive Bias Modification training

Behavioral: Cognitive Bias Modification

Control Group

SHAM COMPARATOR

This group will receive Sham (control) training

Behavioral: Sham Training

Interventions

Cognitive Bias Modification BEHAVIORAL

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%).

CBM Group

Sham Training BEHAVIORAL

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)

Control Group

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• current hazardous drinking (score of 8+ on USAUDIT-C)
• interest in changing drinking
• English-speaking
• able to provide informed consent

You may not qualify if:

• Score of 25+ on USAUDIT
• current or past treatment for alcohol or drug use
• lifetime diagnosis of other substance use disorder
• self-reported weekly or more other drug use as indicated on the NIDA-modified Alcohol, Smoking, and Substance Involvement Screening Test
• history of head injury or loss of consciousness
• lifetime diagnosis of bipolar disorder, psychotic symptomatology, organic mental disorder, seizure disorder, or central nervous system disease
• pregnancy
• current use of psychotropic medication
• history of delirium tremens and/or seizures as a result of alcohol withdrawal
• contraindications to fMRI (claustrophobia, pregnancy, metal, pacemaker, etc.).

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Rajen Kilachand Center for Integrated Life Sciences and Engineering at Boston University

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Alcohol Drinking; Alcohol-Related Disorders; Self-Control

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Social Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 12, 2020
• Study Start: August 21, 2019
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: September 10, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)