Sex Differences, Cognitive Training & Emotion Processing

NCT ID: NCT03137654

Last Updated: 2025-05-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-16

Study Completion Date

2021-02-08

Brief Summary

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This pilot project addresses two understudied questions related to neurocognitive deficits observed in treatment-seeking alcoholics. First, whether cognitive training improves performance and outcomes in alcoholics, and whether men and women differ in their response to this training. The second is whether directed training using affective materials (e.g., emotional faces) is differentially effective compared to that using traditional (i.e., neutral) stimuli.

Detailed Description

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This pilot project leverages the team's expertise in neurobehavioral assessment and focus on sex differences to examine the potential efficacy of cognitive training in treatment-seeking men and women with alcohol use disorders (AUDs). Specifically, the ask whether cognitive training interventions derived from current methods and conceptual models has differential benefits for treatment-seeking women vs. men. Although neurocognitive improvement during training is desired, of practical import is whether gains achieved transfer to other tasks and settings. Therefore, transfer of gains to tasks/domains varying in their similarity to training are assessed. Given noted sex differences in emotional processing and the purported role of emotional factors in women's substance use, training engaging emotional processing via the use of affective stimuli (faces and words) is included, predicting that women may differentially benefit from such training. Equal numbers of treatment-seeking men and women with AUDs will be randomly assigned to one of two active training interventions (neutral or affective stimuli). To control for abstinence-related recovery, a third group of participants, meeting identical selection criteria, will complete pre and post-intervention testing, but will not undergo the training intervention. Ss will complete baseline, 3 wks training (for active groups) and post-intervention testing and will be contacted monthly for 3 months after discharge.

Conditions

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Alcohol Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The primary design is a 3 (Training Condition: Neutral, Affective, Control) by 2 (Time: Baseline, Post-training) repeated measures design.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Affective Training

Subjects complete baseline assessment, 3 wks of training with versions of the tasks using emotionally-laden stimuli, and a post-training assessment. Subjects will be contacted monthly for 3 months after discharge for follow-up interviews.

Group Type ACTIVE_COMPARATOR

Affective Training

Intervention Type OTHER

Intervention includes up to 12 training sessions (\~45 minutes each). Training sessions includes practice on cognitive tasks embedded with emotionally salient stimuli. Tasks include a dual modality n-back and a directed attend/ignore memory task.

Neutral Training

Subjects complete baseline assessment, 3 wks of training with versions of the tasks using neutral stimuli, and a post-training assessment. Subjects will be contacted monthly for 3 months after discharge for follow-up interviews.

Group Type ACTIVE_COMPARATOR

Neutral Training

Intervention Type OTHER

Intervention includes up to 12 training sessions (\~45 minutes each). Training sessions includes practice on cognitive tasks embedded with neutral stimuli. Tasks include a dual modality n-back and a directed attend/ignore memory task.

Control (Non-active)

Subjects complete a baseline assessment and a secondary assessment approximately three weeks later. No active intervention is delivered. Subjects will be contacted monthly for 3 months after discharge for follow-up interviews.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Affective Training

Intervention includes up to 12 training sessions (\~45 minutes each). Training sessions includes practice on cognitive tasks embedded with emotionally salient stimuli. Tasks include a dual modality n-back and a directed attend/ignore memory task.

Intervention Type OTHER

Neutral Training

Intervention includes up to 12 training sessions (\~45 minutes each). Training sessions includes practice on cognitive tasks embedded with neutral stimuli. Tasks include a dual modality n-back and a directed attend/ignore memory task.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Minimum of 10 years of education
* Subjects must have 20/40 or better corrected vision (determined by Snellen chart)
* have no significant hearing impairment as determined by self-report and audiometric testing
* must meet criteria for DSM-IV alcohol dependence using the computerized Diagnostic Interview Schedule - IV
* A craving index is also administered to allow discussion in terms of DSM 5 classification.
* Comorbid substance use including nicotine use is not exclusionary.

Exclusion Criteria

* May not have medical or psychiatric histories which would confound participation or data interpretation, e.g., epilepsy, stroke, untreated hypertension, psychotic disorders, anxiolytic medications.
* not be color blind (as determined by psuedoisochromatic plates)
* Endorsement of suicidal intent
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sara Jo Nixon, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Ben Lewis, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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ASPIRE Healthcare Facilities

Gainesville, Florida, United States

Site Status

The Sid Martin Bridge House

Gainesville, Florida, United States

Site Status

UF Health Florida Recovery Center

Gainesville, Florida, United States

Site Status

University of Florida

Gainesville, Florida, United States

Site Status

Steward-Marchman-Act (SMA) Healthcare

Multiple Locations, Florida, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R03AA025430

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB201700206-N

Identifier Type: -

Identifier Source: org_study_id

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