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NCT04430543 · ClinicalTrials.gov registry record · NA

Neural and Behavioral Effects of Cognitive Bias Modification (CBM)

A NA study, sponsored by Boston University Charles River Campus.

Completed
Registry status
NA
Development phase
11
Enrollment target

NCT04430543 is a NA study that has completed, run by Boston University Charles River Campus. The registered enrollment target is 11 participants.

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The verdict

NCT04430543, a NA study, has completed, sponsored by Boston University Charles River Campus.

COMPLETED
Registry status
NA
Development phase
11 participants
Enrollment target

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 w

Interventions

  • BEHAVIORAL Sham Training
  • BEHAVIORAL Cognitive Bias Modification

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2019-08-21
Est. Completion 2021-08-31
Phase NA

What the Registry Record Tells You About NCT04430543

The ClinicalTrials.gov registry entry for NCT04430543 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston University Charles River Campus, which has 104 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Sham Training is the first listed.

NCT04430543 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04430543 about?

NCT04430543 is a clinical study titled "Neural and Behavioral Effects of Cognitive Bias Modification (CBM)". 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 fu...

What is the current status of trial NCT04430543?

This trial is currently completed. It is a NA study. The enrollment target is 11 participants. The study started on 2019-08-21. Estimated completion is 2021-08-31.

What interventions are being tested in trial NCT04430543?

The interventions under investigation include: Sham Training (BEHAVIORAL), Cognitive Bias Modification (BEHAVIORAL).

Who is sponsoring clinical trial NCT04430543?

This trial is sponsored by Boston University Charles River Campus, which has 104 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.