Cognitive Enhancement Through Computerized Training

Alcohol Use Disorder Clinical Trial

Official title:

Cognitive Enhancement Through Computerized Training

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04244032
• Other study ID #: IRB201901330
• Secondary ID: K01AA026893
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 28, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: November 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 141
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]).	Baseline and up to 3 weeks
Primary	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]).	Baseline and up to 3 weeks
Primary	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]).	Baseline and up to 3 weeks