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| ID | Type | Description | Link |
|---|---|---|---|
| R03AA025430 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Affective Training | Active Comparator | 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. |
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| Neutral Training | Active Comparator | 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. |
|
| Control (Non-active) | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Affective Training | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. 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]). | Baseline and Post-Training (3 weeks) |
| 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) |
| 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) |
| 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) |
| Little Man Task: Change From Baseline in Response Accuracy. |
| Measure | Description | Time Frame |
|---|---|---|
| Timeline Follow-back | Measures frequency and quantity of daily alcohol use, measured as average ounces of alcohol consumed per day. | 30 days following post-training assessment, up to 1.5 months |
| Moos Health and Daily Living Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara Jo Nixon, PhD | University of Florida | Principal Investigator |
| Ben Lewis, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASPIRE Healthcare Facilities | Gainesville | Florida | 32607 | United States | ||
| The Sid Martin Bridge House |
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82 individuals were enrolled in the study. 5 were enrolled, but not started. 77 individuals were started.
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| ID | Title | Description |
|---|---|---|
| FG000 | Affective Training | 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. 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. |
| FG001 | Neutral Training | 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. 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. |
| FG002 | Control (Non-active) | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Affective Training | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. 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]). | Posted | Mean | Standard Deviation | milliseconds | Baseline and Post-Training (3 weeks) |
|
Through study completion, an average of 3 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Affective Training | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ben Lewis, Assistant Professor, UF Department of Psychiatry | UFlorida | 3522948724 | benlewis@ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 10, 2018 | Apr 23, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 10, 2020 | Apr 5, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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The primary design is a 3 (Training Condition: Neutral, Affective, Control) by 2 (Time: Baseline, Post-training) repeated measures design.
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| Neutral Training | Other | 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. |
|
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.
| Baseline and Post-Training (3 weeks) |
| 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) |
| 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 (proportion of correct responses) from baseline to post-training assessment. Positive values indicate greater proportions of correct responses at post-test, relative to baseline. | Baseline and Post-Training (3 weeks) |
| 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. 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]). | Baseline and Post-Training (3 weeks) |
| Visual-Perceptual Analysis Task: Change From Baseline in Response Time | 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. | Baseline and Post-Training (3 weeks) |
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.
| 30 days following post-training assessment, up to 1.5 months |
| Change in 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". The outcome reflects a difference in total score from pre- to post-test, with negative values reflecting improvements. | Approximately 30 days following post-training assessment, up to 1.5 months |
| Mini Alcohol Craving Experience Questionnaire | Indexes alcohol craving frequencies. Questions include:
Participants respond on a scale from 1-10 for each question. Responses are summed. Thus, scores range from 5-50. | 30 days following post-training assessment, up to 1.5 months |
| Gainesville |
| Florida |
| 32608 |
| United States |
| UF Health Florida Recovery Center | Gainesville | Florida | 32608 | United States |
| University of Florida | Gainesville | Florida | 32611 | United States |
| Steward-Marchman-Act (SMA) Healthcare | Multiple Locations | Florida | 32177 | United States |
| BG001 | Neutral Training | 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. 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. |
| BG002 | Control (Non-active) | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Depressive Symptoms | Beck Depression Inventory-II Total Range = 0-63 Higher values represent greater depressive symptomatology | Mean | Standard Deviation | units on a scale |
|
| Anxiety Symptoms | Spielberger State Anxiety Index (age-adjusted) Total Range = 20-80 Higher scores indicate greater anxiety symptomatology | Mean | Standard Deviation | units on a scale |
|
| Drinks/day | Standard drinks of alcohol per day (averaged over 6 months) | Mean | Standard Deviation | drinks per day |
|
| Maximum Drinks | Greatest number of standard drinks consumed within a 24-hour period and occuring within the 6 months prior to treatment initiation | Mean | Standard Deviation | maximum drinks |
|
| OG001 | Neutral Training | 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. 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. |
| OG002 | Control (Non-active) | 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. |
|
|
|
| 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. | Due to time constraints involved with testing, we removed this tast from the protocol prior to study initiation | Posted | 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. | Due to time constraints involved with testing, we removed this tast from the protocol prior to study initiation | Posted | 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. | Due to time constraints involved with testing, we removed this tast from the protocol prior to study initiation | Posted | 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. 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. | Posted | Mean | Standard Deviation | proportion of correct responses | Baseline and Post-Training (3 weeks) |
|
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|
|
| 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. | Data from this task were corrupted, precluding any analysis | Posted | 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 (proportion of correct responses) from baseline to post-training assessment. Positive values indicate greater proportions of correct responses at post-test, relative to baseline. | Posted | Mean | Standard Deviation | proportion of correct responses | Baseline and Post-Training (3 weeks) |
|
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| 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. 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]). | Posted | Mean | Standard Deviation | seconds | Baseline and Post-Training (3 weeks) |
|
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| Primary | Visual-Perceptual Analysis Task: Change From Baseline in Response Time | 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. | Posted | Mean | Standard Deviation | milliseconds | Baseline and Post-Training (3 weeks) |
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| Secondary | Timeline Follow-back | Measures frequency and quantity of daily alcohol use, measured as average ounces of alcohol consumed per day. | Posted | Mean | Standard Deviation | ounces of absolute ethanol per day | 30 days following post-training assessment, up to 1.5 months |
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| Secondary | Moos Health and Daily Living Scale | 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. | Posted | Mean | Standard Deviation | units on a scale (disagreements) | 30 days following post-training assessment, up to 1.5 months |
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| Secondary | Change in 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". The outcome reflects a difference in total score from pre- to post-test, with negative values reflecting improvements. | Posted | Mean | Standard Deviation | score on a scale | Approximately 30 days following post-training assessment, up to 1.5 months |
|
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|
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| Secondary | Mini Alcohol Craving Experience Questionnaire | Indexes alcohol craving frequencies. Questions include:
Participants respond on a scale from 1-10 for each question. Responses are summed. Thus, scores range from 5-50. | Posted | Mean | Standard Deviation | units on a scale | 30 days following post-training assessment, up to 1.5 months |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Neutral Training | 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. 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. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG002 | Control (Non-active) | 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. | 0 | 14 | 0 | 14 | 0 | 14 |
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