Cognitive Enhancement Through Computerized Training

December 9, 2024 updated by: University of Florida
Alcohol use disorder is characterized by widespread neurocognitive impairments, however despite substantial advances in the intervention and treatment of alcohol use disorders, exceptionally few studies have been directed to improving these deficits. This project leverages computerized cognitive training, applied as an adjunct to inpatient treatment, to enhance neurocognitive recovery. This project informs public health and future intervention efforts by interrogating factors critical to intervention efficacy and clarifying relationships between neurocognitive recovery and treatment outcomes, including post-discharge alcohol consumption.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Programmatic investigation of neurocognitive functioning in alcohol use disorder (AUD) has revealed widespread and sustained impairments. Despite conceptual relevance to treatment efficacy, few AUD interventions have been directed to the remediation of these impairments. This project is responsive to this gap. It will answer critical questions regarding the potential of cognitive training (CT), applied as an adjunct to inpatient treatment, to improve cognitive recovery and post-discharge functional outcomes in AUD.

The current project will investigate the efficacy of two experimental cognitive training interventions in a sample of inpatients in treatment for AUD. While the effectiveness of CT to enhance function is supported by diverse literatures, it remains largely unexamined in AUD. The current project will interrogate the degree to which cognitive training interventions can "transfer" cognitive gains to untrained tasks/domains, and improve overall executive functioning. It will apply conceptual models from the CT and alcohol literatures to identify factors associated with CT efficacy. The impact of cognitive training on functional outcomes, including post-discharge drinking, will be investigated. Finally, relationships between cognitive recovery during treatment and post-discharge adaptation will be examined. Thus, the current work will be of substantial import to public health, alcohol science, and will inform future intervention efforts.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Minimum of 10 years of education
  • Meet DSM-5 criteria for alcohol use disorder

Exclusion Criteria:

  • Medical histories confounding interpretation regarding change in neuropsychological functioning (e.g., stroke)
  • Meet DSM-5 criteria for current/unremitted psychotic, panic, or bipolar disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Working Memory Training (WM)
Participants complete training in a working memory task designed to utilize individually-adapted difficulty levels.
Behavioral: Working Memory Training
Participants complete up to 12 sessions of computerized training (30-45 min each) in a working memory task designed to utilize individually-adapted difficulty levels.
Experimental: Inhibitory Control Training (IC)
Participants complete training in an inhibitory control task designed to utilize individually-adapted difficulty levels.
Behavioral: Inhibitory Control Training
Participants complete up to 12 sessions of computerized training (30-45 min each) in an inhibitory control task designed to utilize individually-adapted difficulty levels.
Active Comparator: Bias Modification Training (BM)
Participants complete training in an active comparator task designed to weaken approach responses to alcohol-associated cues.
Behavioral: Bias Modification Training
Participants complete up to 12 sessions of computerized training (30-45 min each) in a bias modification task designed to utilize individually-adapted difficulty levels.
No Intervention: Non-Trained control (NTC)
No active intervention is delivered beyond typical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Working Memory
Time Frame: Baseline and up to 3 weeks
Performance on neuropsychological measures indexing working memory capacity. Score range: 0-100 (scores <40 are poor [0-16th percentile]; scores >60 are good [84th-100th percentile]).
Baseline and up to 3 weeks
Inhibitory Control
Time Frame: Baseline and up to 3 weeks
Performance on neuropsychological measures indexing inhibitory control capacity. Score range: 0-100 (scores <40 are poor [0-16th percentile]; scores >60 are good [84th-100th percentile]).
Baseline and up to 3 weeks
General Executive Function
Time Frame: Baseline and up to 3 weeks
Performance on neuropsychological measures indexing general executive functioning. Score range: 0-100 (scores <40 are poor [0-16th percentile]; scores >60 are good [84th-100th percentile]).
Baseline and up to 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Ben Lewis, PhD, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2021

Primary Completion (Actual)

September 22, 2023

Study Completion (Actual)

September 15, 2024

Study Registration Dates

First Submitted

January 22, 2020

First Submitted That Met QC Criteria

January 24, 2020

First Posted (Actual)

January 28, 2020

Study Record Updates

Last Update Posted (Actual)

December 13, 2024

Last Update Submitted That Met QC Criteria

December 9, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB201901330
  • K01AA026893 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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