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Sex Differences, Cognitive Training & Emotion Processing

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ClinicalTrials.gov Identifier: NCT03137654
Recruitment Status : Recruiting
First Posted : May 3, 2017
Last Update Posted : February 25, 2019
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE April 28, 2017
First Posted Date  ICMJE May 3, 2017
Last Update Posted Date February 25, 2019
Actual Study Start Date  ICMJE August 16, 2017
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2017)
  • 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.
  • 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.
  • 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 from baseline to post-training assessment.
  • 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.
  • Visual-Perceptual Analysis Task: Change from baseline in response accuracy [ 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03137654 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2017)
  • Timeline Follow-back [ Time Frame: Approximately 30/60/90 days following post-training assessment ]
    Measures frequency and quantity of daily substance use.
  • Moos Health and Daily Living Scale [ Time Frame: Approximately 30/60/90 days following post-training assessment ]
    Measures social support and activities.
  • Profile of Mood States [ Time Frame: Approximately 30/60/90 days following post-training assessment ]
    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 [ Time Frame: Approximately 30/60/90 days following post-training assessment ]
    Indexes alcohol craving frequencies. Questions include:
    1. Over the past week, how often did you have a strong urge to drink?
    2. Over the past week, how often did you picture alcohol or drinking?
    3. Over the past week, how often did you imagine what it would taste like?
    4. Over the past week, how often did you imagine how your body would feel if you had a drink?
    5. Over the past week, how often were these thoughts intrusive?
    Participants respond on a scale from 1-10 for each question.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sex Differences, Cognitive Training & Emotion Processing
Official Title  ICMJE Sex Differences, Cognitive Training & Emotion Processing
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Other
Condition  ICMJE Alcohol Use Disorder
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Affective Training
  • 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.
    Intervention: Other: Neutral Training
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 28, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Ben Lewis, PhD 352- 294-4920 Benlewis@ufl.edu
Contact: Layla Lincoln, BS 352-294-4920 laylal@ufl.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03137654
Other Study ID Numbers  ICMJE IRB201700206-N
R03AA025430 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators  ICMJE
Principal Investigator: Sara Jo Nixon, PhD University of Florida
Principal Investigator: Ben Lewis, PhD University of Florida
PRS Account University of Florida
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP