Sex Differences, Cognitive Training & Emotion Processing

NCT03137654 | Completed Results

• 2 other identifiers: IRB201700206-NR03AA025430
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Alcohol Use Disorder

Keywords

Cognitive Training; Emotion Processing

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (4)

• Timeline Follow-back

  30 days following post-training assessment, up to 1.5 months

• Moos Health and Daily Living Scale

  30 days following post-training assessment, up to 1.5 months

• Change in Profile of Mood States

  Approximately 30 days following post-training assessment, up to 1.5 months

• Mini Alcohol Craving Experience Questionnaire

  30 days following post-training assessment, up to 1.5 months

Study Arms (3)

Affective Training

ACTIVE COMPARATOR

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

Neutral Training

ACTIVE COMPARATOR

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

Control (Non-active)

NO INTERVENTION

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.

Interventions

Affective Training 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.

Affective Training

Neutral Training 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.

Neutral Training

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (5)

ASPIRE Healthcare Facilities

Gainesville, Florida, 32607, United States

Location

The Sid Martin Bridge House

Gainesville, Florida, 32608, United States

Location

UF Health Florida Recovery Center

Gainesville, Florida, 32608, United States

Location

University of Florida

Gainesville, Florida, 32611, United States

Location

Steward-Marchman-Act (SMA) Healthcare

Multiple Locations, Florida, 32177, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Ben Lewis, Assistant Professor, UF Department of Psychiatry
• Organization: UFlorida

benlewis@ufl.edu

3522948724

Study Officials

• Sara Jo Nixon, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

• Ben Lewis, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 28, 2017
• First Posted: May 3, 2017
• Study Start: August 16, 2017
• Primary Completion: February 8, 2021
• Study Completion: February 8, 2021
• Last Updated: May 31, 2025
• Results First Posted: May 31, 2025

Record last verified: 2025-05

Locations

US (5)