Sex Differences, Cognitive Training & Emotion Processing

University of Florida

Status: Completed

Conditions: Alcohol Use Disorder

Treatments: Other: Neutral Training; Other: Affective Training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03137654

R03AA025430 (U.S. NIH Grant/Contract)

IRB201700206-N

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 3 patient groups

Affective Training

Active Comparator group

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.

Treatment:

Other: Affective Training

Neutral Training

Active Comparator group

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.

Treatment:

Other: Neutral Training

Control (Non-active)

No Intervention group

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.