Sex Differences, Cognitive Training & Emotion Processing

Study 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.

Official Title
-----------------
Sex Differences, Cognitive Training & Emotion Processing

Conditions
-----------------
Alcohol Use Disorder

Intervention / Treatment
-----------------
* Other: Affective Training
* Other: Neutral Training


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Affective Training<br>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<br>* 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.<br>|
| Active Comparator: Neutral Training<br>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<br>* 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.<br>|
| No Intervention: Control (Non-active)<br>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. | 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. | 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 from baseline to post-training assessment. | 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. | Baseline and Post-Training (3 weeks) | 
| 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. | Baseline and Post-Training (3 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timeline Follow-back | Measures frequency and quantity of daily substance use. | Approximately 30/60/90 days following post-training assessment | 
| Moos Health and Daily Living Scale | Measures social support and activities. | Approximately 30/60/90 days following post-training assessment | 
| 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. | Approximately 30/60/90 days following post-training assessment | 
| 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. | Approximately 30/60/90 days following post-training assessment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cognitive Training, Emotion Processing