Sex Differences, Cognitive Training & Emotion Processing

Alcohol Use Disorder Clinical Trial

Official title:

Sex Differences, Cognitive Training & Emotion Processing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03137654
• Other study ID #: IRB201700206-N
• Secondary ID: R03AA025430
• Status: Completed
• Phase: N/A
• Start date: August 16, 2017
• Est. completion date: February 8, 2021

Study information

• Verified date: April 2021
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: February 8, 2021
• Est. primary completion date: February 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	ASPIRE Healthcare Facilities	Gainesville	Florida
United States	The Sid Martin Bridge House	Gainesville	Florida
United States	UF Health Florida Recovery Center	Gainesville	Florida
United States	University of Florida	Gainesville	Florida
United States	Steward-Marchman-Act (SMA) Healthcare	Multiple Locations	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Timeline Follow-back	Measures frequency and quantity of daily substance use.	Approximately 30/60/90 days following post-training assessment
Secondary	Moos Health and Daily Living Scale	Measures social support and activities.	Approximately 30/60/90 days following post-training assessment
Secondary	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
Secondary	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