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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: Completed NA study, sponsored by Boston University Charles River Campus.
NCT04430543 is a NA study that has completed, run by Boston University Charles River Campus. The registered enrollment target is 11 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
decreased signal indicates better outcomes for amygdala, NAcc, and mPFC; increased signal indicates better outcomes for dlPFC
Interventions
- BEHAVIORAL Sham Training
- BEHAVIORAL Cognitive Bias Modification
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2019-08-21 |
| Est. Completion | 2021-08-31 |
| Phase | NA |
What the finished NCT04430543 record still lists
NCT04430543 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Sham Training is the first listed.
NCT04430543 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04430543's enrollment target sits among peer trials
11 1927th of 2000 higher than 74 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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