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Clinical Trials/NCT03137654
NCT03137654
Completed
Not Applicable

Sex Differences, Cognitive Training & Emotion Processing

University of Florida5 sites in 1 country82 target enrollmentAugust 16, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alcohol Use Disorder
Sponsor
University of Florida
Enrollment
82
Locations
5
Primary Endpoint
Emotional Stroop: Change From Baseline in Reaction Time
Status
Completed
Last Updated
11 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
August 16, 2017
End Date
February 8, 2021
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Emotional Stroop: Change From Baseline in Reaction Time

Time Frame: Baseline and Post-Training (3 weeks)

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 \[positive change score\]).

Trail-Making Task A: Change From Baseline in Task Completion Time

Time Frame: Baseline and Post-Training (3 weeks)

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.

Trail-Making Task B: Change From Baseline in Task Completion Time

Time Frame: Baseline and Post-Training (3 weeks)

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.

Digit Symbol Substitution: Change From Baseline in Translated Symbols

Time Frame: Baseline and Post-Training (3 weeks)

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.

Little Man Task: Change From Baseline in Response Accuracy.

Time Frame: Baseline and Post-Training (3 weeks)

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.

Wisconsin Card Sorting Task: Change From Baseline in Response Accuracy

Time Frame: Baseline and Post-Training (3 weeks)

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.

Sternberg Working Memory Task: Change From Baseline in Response Accuracy

Time Frame: Baseline and Post-Training (3 weeks)

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.

Stroop Color-Word Task: Change From Baseline in Response Time

Time Frame: Baseline and Post-Training (3 weeks)

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 \[positive change score\]).

Visual-Perceptual Analysis Task: Change From Baseline in Response Time

Time Frame: Baseline and Post-Training (3 weeks)

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.

Secondary Outcomes

  • 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 Sites (5)

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