Sex Differences, Cognitive Training & Emotion Processing
NCT03137654, Not applicable, Completed, University of Florida; results first posted 2025-05-31
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Sex Differences, Cognitive Training & Emotion Processing | ClinicalTrials.gov |
| NCT number | NCT03137654 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 82 participants, actual | ClinicalTrials.gov |
| Lead sponsor | University of Florida | ClinicalTrials.gov |
| Conditions | Alcohol Use Disorder | ClinicalTrials.gov |
| Interventions | Affective Training, Neutral Training | ClinicalTrials.gov |
| First posted | 2017-05-03 | ClinicalTrials.gov |
| Last updated | 2025-05-31 | ClinicalTrials.gov |
| Results first posted | 2025-05-31 | ClinicalTrials.gov |
Registered outcomes 13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Emotional Stroop: Change From Baseline in Reaction Time | 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 \[positive change score\]). | ClinicalTrials.gov |
| Primary | Trail-Making Task A: Change From Baseline in Task Completion Time | Baseline and Post-Training (3 weeks) | 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. | ClinicalTrials.gov |
| Primary | Trail-Making Task B: Change From Baseline in Task Completion Time | Baseline and Post-Training (3 weeks) | 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. | ClinicalTrials.gov |
| Primary | Digit Symbol Substitution: Change From Baseline in Translated Symbols | Baseline and Post-Training (3 weeks) | 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. | ClinicalTrials.gov |
| Primary | Little Man Task: Change From Baseline in Response Accuracy. | 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. | ClinicalTrials.gov |
| Primary | Wisconsin Card Sorting Task: Change From Baseline in Response Accuracy | Baseline and Post-Training (3 weeks) | 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. | ClinicalTrials.gov |
| Primary | Sternberg Working Memory Task: Change From Baseline in Response Accuracy | 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. | ClinicalTrials.gov |
| Primary | Stroop Color-Word Task: Change From Baseline in Response Time | 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 \[positive change score\]). | ClinicalTrials.gov |
| Primary | Visual-Perceptual Analysis Task: Change From Baseline in Response Time | 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. | ClinicalTrials.gov |
| Secondary | Timeline Follow-back | 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. | ClinicalTrials.gov |
| Secondary | Moos Health and Daily Living Scale | 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. | ClinicalTrials.gov |
| Secondary | Change in Profile of Mood States | 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. | ClinicalTrials.gov |
| Secondary | Mini Alcohol Craving Experience Questionnaire | 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. | ClinicalTrials.gov |
Outcomes 13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Emotional Stroop: Change From Baseline in Reaction Time | Baseline and Post-Training (3 weeks) | milliseconds | MEAN | ClinicalTrials.gov | |
| PRIMARY | Trail-Making Task A: Change From Baseline in Task Completion Time | Baseline and Post-Training (3 weeks) | Due to time constraints involved with testing, we removed this tast from the protocol prior to study initiation | ClinicalTrials.gov | ||
| PRIMARY | Trail-Making Task B: Change From Baseline in Task Completion Time | Baseline and Post-Training (3 weeks) | Due to time constraints involved with testing, we removed this tast from the protocol prior to study initiation | ClinicalTrials.gov | ||
| PRIMARY | Digit Symbol Substitution: Change From Baseline in Translated Symbols | Baseline and Post-Training (3 weeks) | Due to time constraints involved with testing, we removed this tast from the protocol prior to study initiation | ClinicalTrials.gov | ||
| PRIMARY | Little Man Task: Change From Baseline in Response Accuracy. | Baseline and Post-Training (3 weeks) | proportion of correct responses | MEAN | ClinicalTrials.gov | |
| PRIMARY | Wisconsin Card Sorting Task: Change From Baseline in Response Accuracy | Baseline and Post-Training (3 weeks) | Data from this task were corrupted, precluding any analysis | ClinicalTrials.gov | ||
| PRIMARY | Sternberg Working Memory Task: Change From Baseline in Response Accuracy | Baseline and Post-Training (3 weeks) | proportion of correct responses | MEAN | ClinicalTrials.gov | |
| PRIMARY | Stroop Color-Word Task: Change From Baseline in Response Time | Baseline and Post-Training (3 weeks) | seconds | MEAN | ClinicalTrials.gov | |
| PRIMARY | Visual-Perceptual Analysis Task: Change From Baseline in Response Time | Baseline and Post-Training (3 weeks) | milliseconds | MEAN | ClinicalTrials.gov | |
| SECONDARY | Timeline Follow-back | 30 days following post-training assessment, up to 1.5 months | ounces of absolute ethanol per day | MEAN | ClinicalTrials.gov | |
| SECONDARY | Moos Health and Daily Living Scale | 30 days following post-training assessment, up to 1.5 months | units on a scale (disagreements) | MEAN | ClinicalTrials.gov | |
| SECONDARY | Change in Profile of Mood States | Approximately 30 days following post-training assessment, up to 1.5 months | score on a scale | MEAN | ClinicalTrials.gov | |
| SECONDARY | Mini Alcohol Craving Experience Questionnaire | 30 days following post-training assessment, up to 1.5 months | units on a scale | MEAN | ClinicalTrials.gov |
Results by group 27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Emotional Stroop: Change From Baseline in Reaction Time | Affective Training | 336 | Standard Deviation 378 | milliseconds | ClinicalTrials.gov | |
| Emotional Stroop: Change From Baseline in Reaction Time | Neutral Training | 162 | Standard Deviation 713 | milliseconds | ClinicalTrials.gov | |
| Emotional Stroop: Change From Baseline in Reaction Time | Control (Non-active) | 78.3 | Standard Deviation 190 | milliseconds | ClinicalTrials.gov | |
| Little Man Task: Change From Baseline in Response Accuracy. | Affective Training | -.0045 | Standard Deviation .129 | proportion of correct responses | ClinicalTrials.gov | |
| Little Man Task: Change From Baseline in Response Accuracy. | Neutral Training | .125 | Standard Deviation .192 | proportion of correct responses | ClinicalTrials.gov | |
| Little Man Task: Change From Baseline in Response Accuracy. | Control (Non-active) | .0483 | Standard Deviation .174 | proportion of correct responses | ClinicalTrials.gov | |
| Sternberg Working Memory Task: Change From Baseline in Response Accuracy | Affective Training | .0021 | Standard Deviation .142 | proportion of correct responses | ClinicalTrials.gov | |
| Sternberg Working Memory Task: Change From Baseline in Response Accuracy | Neutral Training | 0.0298 | Standard Deviation .0623 | proportion of correct responses | ClinicalTrials.gov | |
| Sternberg Working Memory Task: Change From Baseline in Response Accuracy | Control (Non-active) | 0.148 | Standard Deviation 0.121 | proportion of correct responses | ClinicalTrials.gov | |
| Stroop Color-Word Task: Change From Baseline in Response Time | Affective Training | 5 | Standard Deviation 25.9 | seconds | ClinicalTrials.gov | |
| Stroop Color-Word Task: Change From Baseline in Response Time | Neutral Training | -11.5 | Standard Deviation 67.2 | seconds | ClinicalTrials.gov | |
| Stroop Color-Word Task: Change From Baseline in Response Time | Control (Non-active) | 22 | Standard Deviation 77.1 | seconds | ClinicalTrials.gov | |
| Visual-Perceptual Analysis Task: Change From Baseline in Response Time | Affective Training | -1270 | Standard Deviation 1111 | milliseconds | ClinicalTrials.gov | |
| Visual-Perceptual Analysis Task: Change From Baseline in Response Time | Neutral Training | 121 | Standard Deviation 1512 | milliseconds | ClinicalTrials.gov | |
| Visual-Perceptual Analysis Task: Change From Baseline in Response Time | Control (Non-active) | -377 | Standard Deviation 772 | milliseconds | ClinicalTrials.gov | |
| Timeline Follow-back | Affective Training | .06 | Standard Deviation .134 | ounces of absolute ethanol per day | ClinicalTrials.gov | |
| Timeline Follow-back | Neutral Training | .131 | Standard Deviation .181 | ounces of absolute ethanol per day | ClinicalTrials.gov | |
| Timeline Follow-back | Control (Non-active) | .4 | Standard Deviation .465 | ounces of absolute ethanol per day | ClinicalTrials.gov | |
| Moos Health and Daily Living Scale | Affective Training | 1.33 | Standard Deviation 1.03 | units on a scale (disagreements) | ClinicalTrials.gov | |
| Moos Health and Daily Living Scale | Neutral Training | .4 | Standard Deviation .548 | units on a scale (disagreements) | ClinicalTrials.gov |
Participant flow 9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Affective Training | 23 | ClinicalTrials.gov | |
| Overall Study | STARTED | Neutral Training | 25 | ClinicalTrials.gov | |
| Overall Study | STARTED | Control (Non-active) | 29 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Affective Training | 15 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Neutral Training | 13 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Control (Non-active) | 14 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Affective Training | 8 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Neutral Training | 12 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Control (Non-active) | 15 | ClinicalTrials.gov |
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 9
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Affective Training | 0 | 15 | ClinicalTrials.gov |
| Total, all-cause mortality | Neutral Training | 0 | 13 | ClinicalTrials.gov |
| Total, all-cause mortality | Control (Non-active) | 0 | 14 | ClinicalTrials.gov |
| Total, other adverse events | Affective Training | 0 | 15 | ClinicalTrials.gov |
| Total, other adverse events | Neutral Training | 0 | 13 | ClinicalTrials.gov |
| Total, other adverse events | Control (Non-active) | 0 | 14 | ClinicalTrials.gov |
| Total, serious adverse events | Affective Training | 0 | 15 | ClinicalTrials.gov |
| Total, serious adverse events | Neutral Training | 0 | 13 | ClinicalTrials.gov |
| Total, serious adverse events | Control (Non-active) | 0 | 14 | ClinicalTrials.gov |
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| R03AA025430 | Sex Differences, Cognitive Training & Emotion Processing: A pilot study of Treatment-Seeking Men and Women with Alcohol Use Disorder | NIXON, SARA JO | UNIVERSITY OF FLORIDA | NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM | 2017 to 2018 | NIH RePORTER |
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 8
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Card Sorting Test (Berg) | Primary outcome | ConductCognition |
| Emotional Stroop Task | Primary outcome | ConductCognition |
| Mental Rotation | Primary outcome | ConductCognition |
| Sternberg Memory Scanning | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Symbol Coding | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)