Clinical trial NCT03137654: Sex Differences, Cognitive Training & Emotion Processing
Official title: Sex Differences, Cognitive Training & Emotion Processing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: Cognitive Training
Emotion Processing
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2017-05-03
Enrollment: 82
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The primary design is a 3 (Training Condition: Neutral, Affective, Control) by 2 (Time: Baseline, Post-training) repeated measures design.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Emotional Stroop: Change From Baseline in Reaction Time
timeFrame: Baseline and Post-Training (3 weeks)
measure: Trail-Making Task A: Change From Baseline in Task Completion Time
timeFrame: Baseline and Post-Training (3 weeks)
measure: Trail-Making Task B: Change From Baseline in Task Completion Time
timeFrame: Baseline and Post-Training (3 weeks)
measure: Digit Symbol Substitution: Change From Baseline in Translated Symbols
timeFrame: Baseline and Post-Training (3 weeks)
measure: Little Man Task: Change From Baseline in Response Accuracy.
timeFrame: Baseline and Post-Training (3 weeks)
measure: Wisconsin Card Sorting Task: Change From Baseline in Response Accuracy
timeFrame: Baseline and Post-Training (3 weeks)
measure: Sternberg Working Memory Task: Change From Baseline in Response Accuracy
timeFrame: Baseline and Post-Training (3 weeks)
measure: Stroop Color-Word Task: Change From Baseline in Response Time
timeFrame: Baseline and Post-Training (3 weeks)
measure: Visual-Perceptual Analysis Task: Change From Baseline in Response Time
timeFrame: Baseline and Post-Training (3 weeks)
Secondary outcomes:
measure: Timeline Follow-back
timeFrame: 30 days following post-training assessment, up to 1.5 months
measure: Moos Health and Daily Living Scale
timeFrame: 30 days following post-training assessment, up to 1.5 months
measure: Change in Profile of Mood States
timeFrame: Approximately 30 days following post-training assessment, up to 1.5 months
measure: Mini Alcohol Craving Experience Questionnaire
timeFrame: 30 days following post-training assessment, up to 1.5 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: ASPIRE Healthcare Facilities
state: Florida
city: Gainesville
country: United States
facility: The Sid Martin Bridge House
state: Florida
city: Gainesville
country: United States
facility: UF Health Florida Recovery Center
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Multiple Locations
country: United States
facility: Steward-Marchman-Act (SMA) Healthcare
state: Florida
Study officials:
affiliation: University of Florida
name: Sara Jo Nixon, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Ben Lewis, PhD
role: PRINCIPAL_INVESTIGATOR
References: