Sex Differences, Cognitive Training & Emotion Processing

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Other: Affective Training; Other: Neutral Training

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida
    • Gainesville, Florida, United States, 32607
      • ASPIRE Healthcare Facilities
    • Gainesville, Florida, United States, 32608
      • The Sid Martin Bridge House
    • Gainesville, Florida, United States, 32608
      • UF Health Florida Recovery Center
    • Multiple Locations, Florida, United States, 32177
      • Steward-Marchman-Act (SMA) Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: 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.
Active Comparator: 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.	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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotional Stroop: Change From Baseline in Reaction Time	An interference task involving target words presented over non-target visual stimuli. The primary dependent measure is change in reaction time on trials with incongruent stimuli (e.g., a negative word presented over a "happy" face) from baseline to post-training assessment. Change scores are calculated by subtracting reaction time at post-training assessment from reaction time at baseline, thus positive values indicate improvements in processing speed from pre- to post-training (e.g., 500ms [baseline score] - 300ms [post-training score] = 200ms [positive change score]).	Baseline and Post-Training (3 weeks)
Trail-Making Task A: Change From Baseline in Task Completion Time	A psychomotor and visual perception task wherein participants connect numbered dots by drawing a continuous line. The primary dependent measure is change in task completion time from baseline to post--training assessment.	Baseline and Post-Training (3 weeks)
Trail-Making Task B: Change From Baseline in Task Completion Time	A psychomotor and visual perception task with a set-shifting component wherein participants connect numbered and lettered dots by drawing a continuous line. The primary dependent measure is change in task completion time from baseline to post-training assessment.	Baseline and Post-Training (3 weeks)
Digit Symbol Substitution: Change From Baseline in Translated Symbols	A psychomotor and set-shifting task involving translation between numbers and symbols. The primary dependent measure is the change in number of correctly translated symbols within 90 seconds from baseline to post-training assessment.	Baseline and Post-Training (3 weeks)
Little Man Task: Change From Baseline in Response Accuracy.	A visual perception task involving mental rotation. The primary dependent measure is the change in response accuracy from baseline to post-training assessment. This change was calculated as the difference between the proportion of correct responses at baseline and post-training asssessments. Positive values represent gains in accuracy. Negative values represent decreases in accuracy.	Baseline and Post-Training (3 weeks)
Wisconsin Card Sorting Task: Change From Baseline in Response Accuracy	A reasoning and set-shifting task. Participants must determine novel rule sets for stimuli matching through trial and error. Ss must match each 'Test Card' with a 'Key Card'. Criteria for a successful match shift throughout the testing session and may include color, shape, and number of symbols. The primary dependent measure is the change in response accuracy from baseline to post-training assessment.	Baseline and Post-Training (3 weeks)
Sternberg Working Memory Task: Change From Baseline in Response Accuracy	A working memory task involving numbers presented visually. Ss are presented with a list of digits, one at a time, followed by a probe digit. They must determine if the probe digit was in the original set of digits and recall the digits. The primary dependent measure is the change in response accuracy (proportion of correct responses) from baseline to post-training assessment. Positive values indicate greater proportions of correct responses at post-test, relative to baseline.	Baseline and Post-Training (3 weeks)
Stroop Color-Word Task: Change From Baseline in Response Time	An interference task involving target words (e.g., red) presented in interfering colors (e.g., blue). The primary dependent measure is change in reaction time from baseline to post-training assessment. Change scores are calculated by subtracting reaction time at post-training assessment from reaction time at baseline, thus positive values indicate improvements in processing speed from pre- to post-training (e.g., 500ms [baseline score] - 300ms [post-training score] = 200ms [positive change score]).	Baseline and Post-Training (3 weeks)
Visual-Perceptual Analysis Task: Change From Baseline in Response Time	A discrimination task in which participants are asked to determine which complex shape differs among a set of three. Outcomes reflect the difference in response times from baseline to post-test assessments, with negative values corresponding to improved speed at post-test.	Baseline and Post-Training (3 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timeline Follow-back	Measures frequency and quantity of daily alcohol use, measured as average ounces of alcohol consumed per day.	30 days following post-training assessment, up to 1.5 months
Moos Health and Daily Living Scale	Summarizes responses to 14 different topics that may cause disagreements in the participants' family. Response to each topic is binarized (Yes = 1; No = 0). Single summary score is generated by summing across all topics. The maximum score is 14; the minimum score is 0. Higher values represent a worse outcome.	30 days following post-training assessment, up to 1.5 months
Change in Profile of Mood States	Mood/affect assessment in which participants indicate whether presented words describe how they have felt during the past week on a scale from 0-4, where 0 indicates "not at all"; 1 indicates "a little"; 2 indicates "moderately"; 3 indicates "quite a bit"; and 4 indicates "extremely". The outcome reflects a difference in total score from pre- to post-test, with negative values reflecting improvements.	Approximately 30 days following post-training assessment, up to 1.5 months
Mini Alcohol Craving Experience Questionnaire	Indexes alcohol craving frequencies. Questions include: Over the past week, how often did you have a strong urge to drink?; Over the past week, how often did you picture alcohol or drinking?; Over the past week, how often did you imagine what it would taste like?; Over the past week, how often did you imagine how your body would feel if you had a drink?Higher scores reflect greater craving.; Over the past week, how often were these thoughts intrusive? Participants respond on a scale from 1-10 for each question. Responses are summed. Thus, scores range from 5-50.	30 days following post-training assessment, up to 1.5 months

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Ben Lewis, PhD, University of Florida; Principal Investigator: Sara Jo Nixon, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2017
• Primary Completion (Actual): February 8, 2021
• Study Completion (Actual): February 8, 2021

Study Registration Dates

• First Submitted: April 28, 2017
• First Submitted That Met QC Criteria: April 28, 2017
• First Posted (Actual): May 3, 2017

Study Record Updates

• Last Update Posted (Actual): May 31, 2025
• Last Update Submitted That Met QC Criteria: May 27, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Cognitive Training; Emotion Processing
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Alcoholism
• Other Study ID Numbers: IRB201700206-N; R03AA025430 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No