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Cognitive Enhancement Through Computerized Training

Primary Purpose

Alcohol Use Disorder

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Working Memory Training
Inhibitory Control Training
Bias Modification Training
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alcohol Use Disorder focused on measuring Cognitive Training, Alcohol Use Disorder

Eligibility Criteria

25 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Florida

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

No Intervention

Arm Label

Working Memory Training (WM)

Inhibitory Control Training (IC)

Bias Modification Training (BM)

Non-Trained control (NTC)

Arm Description

Participants complete training in a working memory task designed to utilize individually-adapted difficulty levels.

Participants complete training in an inhibitory control task designed to utilize individually-adapted difficulty levels.

Participants complete training in an active comparator task designed to weaken approach responses to alcohol-associated cues.

No active intervention is delivered beyond typical care.

Outcomes

Primary Outcome Measures

Working Memory
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]).
Inhibitory Control
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]).
General Executive Function
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]).

Secondary Outcome Measures

Full Information

First Posted
January 22, 2020
Last Updated
November 18, 2022
Sponsor
University of Florida
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT04244032
Brief Title
Cognitive Enhancement Through Computerized Training
Official Title
Cognitive Enhancement Through Computerized Training
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 28, 2021 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder
Keywords
Cognitive Training, Alcohol Use Disorder

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
141 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Working Memory Training (WM)
Arm Type
Experimental
Arm Description
Participants complete training in a working memory task designed to utilize individually-adapted difficulty levels.
Arm Title
Inhibitory Control Training (IC)
Arm Type
Experimental
Arm Description
Participants complete training in an inhibitory control task designed to utilize individually-adapted difficulty levels.
Arm Title
Bias Modification Training (BM)
Arm Type
Active Comparator
Arm Description
Participants complete training in an active comparator task designed to weaken approach responses to alcohol-associated cues.
Arm Title
Non-Trained control (NTC)
Arm Type
No Intervention
Arm Description
No active intervention is delivered beyond typical care.
Intervention Type
Behavioral
Intervention Name(s)
Working Memory Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Inhibitory Control Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Bias Modification Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Working Memory
Description
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]).
Time Frame
Baseline and up to 3 weeks
Title
Inhibitory Control
Description
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]).
Time Frame
Baseline and up to 3 weeks
Title
General Executive Function
Description
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]).
Time Frame
Baseline and up to 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ben Lewis, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Cognitive Enhancement Through Computerized Training

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