NCT03137654

Sex Differences, Cognitive Training & Emotion Processing

Completed NA Results posted Last updated 31 May 2025

What this trial tests

NA trial testing Affective Training in Alcohol Use Disorder in 82 participants. Completed in 8 February 2021.

Timeline

16 August 2017

Primary endpoint
8 February 2021

8 February 2021

Quick facts

Lead sponsor	University of Florida
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	82
Start date	16 August 2017
Primary completion	8 February 2021
Estimated completion	8 February 2021
Sites	5 locations across United States

Drugs / interventions tested

• Affective Training
• Neutral Training

Conditions studied

• Alcohol Use Disorder — all drugs for Alcohol Use Disorder →

Sponsor

University of Florida

Who can join

Adults 25 to 65, any sex, with Alcohol Use Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Emotional Stroop: Change From Baseline in Reaction Time Primary · 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. Change scores are calculated by subtracting reaction time at post-training assessment from reaction time at baseline, thus positive values indicate improvements in processing speed from pre- to post-training (e.g., 500ms \[baseline score\] - 300ms \[post-training score\] = 200ms \[positive change score\]).

Group	Value	95% CI
Affective Training	336	± 378
Neutral Training	162	± 713
Control (Non-active)	78.3	± 190

Little Man Task: Change From Baseline in Response Accuracy. Primary · 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. This change was calculated as the difference between the proportion of correct responses at baseline and post-training asssessments. Positive values represent gains in accuracy. Negative values represent decreases in accuracy.

Group	Value	95% CI
Affective Training	-.0045	± .129
Neutral Training	.125	± .192
Control (Non-active)	.0483	± .174

Sternberg Working Memory Task: Change From Baseline in Response Accuracy Primary · 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 (proportion of correct responses) from baseline to post-training assessment. Positive values indicate greater proportions of correct responses at post-test, relative to baseline.

Group	Value	95% CI
Affective Training	.0021	± .142
Neutral Training	0.0298	± .0623
Control (Non-active)	0.148	± 0.121

Stroop Color-Word Task: Change From Baseline in Response Time Primary · 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. Change scores are calculated by subtracting reaction time at post-training assessment from reaction time at baseline, thus positive values indicate improvements in processing speed from pre- to post-training (e.g., 500ms \[baseline score\] - 300ms \[post-training score\] = 200ms \[positive change score\]).

Group	Value	95% CI
Affective Training	5	± 25.9
Neutral Training	-11.5	± 67.2
Control (Non-active)	22	± 77.1

Visual-Perceptual Analysis Task: Change From Baseline in Response Time Primary · 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. Outcomes reflect the difference in response times from baseline to post-test assessments, with negative values corresponding to improved speed at post-test.

Group	Value	95% CI
Affective Training	-1270	± 1111
Neutral Training	121	± 1512
Control (Non-active)	-377	± 772

Timeline Follow-back Secondary · 30 days following post-training assessment, up to 1.5 months

Measures frequency and quantity of daily alcohol use, measured as average ounces of alcohol consumed per day.

Group	Value	95% CI
Affective Training	.06	± .134
Neutral Training	.131	± .181
Control (Non-active)	.4	± .465

Moos Health and Daily Living Scale Secondary · 30 days following post-training assessment, up to 1.5 months

Summarizes responses to 14 different topics that may cause disagreements in the participants' family. Response to each topic is binarized (Yes = 1; No = 0). Single summary score is generated by summing across all topics. The maximum score is 14; the minimum score is 0. Higher values represent a worse outcome.

Group	Value	95% CI
Affective Training	1.33	± 1.03
Neutral Training	.4	± .548
Control (Non-active)	.25	± .5

Change in Profile of Mood States Secondary · Approximately 30 days following post-training assessment, up to 1.5 months

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". The outcome reflects a difference in total score from pre- to post-test, with negative values reflecting improvements.

Group	Value	95% CI
Affective Training	-12.7	± 37.9
Neutral Training	6.67	± 15.6
Control (Non-active)	1.25	± 12.3

Mini Alcohol Craving Experience Questionnaire Secondary · 30 days following post-training assessment, up to 1.5 months

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? Higher scores reflect greater craving. 5. Over the past week, how often were these thoughts intrusive? Participants respond on a scale from 1-10 for each question. Responses are summed. Thus, scores range from 5-50.

Group	Value	95% CI
Affective Training	15.7	± 10.7
Neutral Training	10	± 9.65
Control (Non-active)	5.2	± 8.98

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Cognitive training in recently-abstinent individuals with alcohol use disorder improves emotional stroop performance: Evidence from a randomized pilot trial.
   Lewis B, Garcia CC, Price JL, Schweizer S, et al · · 2022 · cited 7× · PMID 34998253 · DOI 10.1016/j.drugalcdep.2021.109239