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Sex Differences, Cognitive Training & Emotion Processing

Primary Purpose

Alcohol Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Affective Training
Neutral Training
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alcohol Use Disorder focused on measuring Cognitive Training, Emotion Processing

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • ASPIRE Healthcare Facilities
  • The Sid Martin Bridge House
  • UF Health Florida Recovery Center
  • University of Florida
  • Steward-Marchman-Act (SMA) Healthcare

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Affective Training

Neutral Training

Control (Non-active)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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 from baseline to post-training assessment.
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.
Visual-Perceptual Analysis Task: Change from baseline in response accuracy
A discrimination task in which participants are asked to determine which complex shape differs among a set of three.

Secondary Outcome Measures

Timeline Follow-back
Measures frequency and quantity of daily substance use.
Moos Health and Daily Living Scale
Measures social support and activities.
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".
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? Over the past week, how often were these thoughts intrusive? Participants respond on a scale from 1-10 for each question.

Full Information

First Posted
April 28, 2017
Last Updated
April 21, 2021
Sponsor
University of Florida
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT03137654
Brief Title
Sex Differences, Cognitive Training & Emotion Processing
Official Title
Sex Differences, Cognitive Training & Emotion Processing
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
August 16, 2017 (Actual)
Primary Completion Date
February 8, 2021 (Actual)
Study Completion Date
February 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder
Keywords
Cognitive Training, Emotion Processing

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The primary design is a 3 (Training Condition: Neutral, Affective, Control) by 2 (Time: Baseline, Post-training) repeated measures design.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Affective Training
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Neutral Training
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control (Non-active)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Affective Training
Intervention Description
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
Intervention Name(s)
Neutral Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Emotional Stroop: Change from baseline in reaction time
Description
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.
Time Frame
Baseline and Post-Training (3 weeks)
Title
Trail-Making Task A: Change from baseline in task completion time
Description
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.
Time Frame
Baseline and Post-Training (3 weeks)
Title
Trail-Making Task B: Change from baseline in task completion time
Description
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.
Time Frame
Baseline and Post-Training (3 weeks)
Title
Digit Symbol Substitution: Change from baseline in translated symbols
Description
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.
Time Frame
Baseline and Post-Training (3 weeks)
Title
Little Man Task: Change from baseline in response accuracy.
Description
A visual perception task involving mental rotation. The primary dependent measure is the change in response accuracy from baseline to post-training assessment.
Time Frame
Baseline and Post-Training (3 weeks)
Title
Wisconsin Card Sorting Task: Change from baseline in response accuracy
Description
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.
Time Frame
Baseline and Post-Training (3 weeks)
Title
Sternberg Working Memory Task: Change from baseline in response accuracy
Description
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 from baseline to post-training assessment.
Time Frame
Baseline and Post-Training (3 weeks)
Title
Stroop Color-Word Task: Change from baseline in response time
Description
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.
Time Frame
Baseline and Post-Training (3 weeks)
Title
Visual-Perceptual Analysis Task: Change from baseline in response accuracy
Description
A discrimination task in which participants are asked to determine which complex shape differs among a set of three.
Time Frame
Baseline and Post-Training (3 weeks)
Secondary Outcome Measure Information:
Title
Timeline Follow-back
Description
Measures frequency and quantity of daily substance use.
Time Frame
Approximately 30/60/90 days following post-training assessment
Title
Moos Health and Daily Living Scale
Description
Measures social support and activities.
Time Frame
Approximately 30/60/90 days following post-training assessment
Title
Profile of Mood States
Description
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".
Time Frame
Approximately 30/60/90 days following post-training assessment
Title
Mini Alcohol Craving Experience questionnaire
Description
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? Over the past week, how often were these thoughts intrusive? Participants respond on a scale from 1-10 for each question.
Time Frame
Approximately 30/60/90 days following post-training assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Jo Nixon, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ben Lewis, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
ASPIRE Healthcare Facilities
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
The Sid Martin Bridge House
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
UF Health Florida Recovery Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Facility Name
Steward-Marchman-Act (SMA) Healthcare
City
Multiple Locations
State/Province
Florida
ZIP/Postal Code
32177
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Sex Differences, Cognitive Training & Emotion Processing

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