Alcohol Use Disorder
Conditions
Keywords
Cognitive Training, Emotion Processing
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.
Interventions
OTHERAffective 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.
OTHERNeutral 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.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
The primary design is a 3 (Training Condition: Neutral, Affective, Control) by 2 (Time: Baseline, Post-training) repeated measures design.
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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 \[positive change score\]). |
| 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 \[positive change score\]). |
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Recruitment details
82 individuals were enrolled in the study. 5 were enrolled, but not started. 77 individuals were started.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| 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. | 13 |
| 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. | 14 |
| Total | 42 |
Baseline characteristics
| Characteristic | Control (Non-active) | Affective Training | Neutral Training | Total |
|---|---|---|---|---|
| Age, Continuous | 39.23 years STANDARD_DEVIATION 11.64 | 42.93 years STANDARD_DEVIATION 11.7 | 45.62 years STANDARD_DEVIATION 12.86 | 42.61 years STANDARD_DEVIATION 12.04 |
| Anxiety Symptoms | 68.43 units on a scale STANDARD_DEVIATION 10.27 | 63.40 units on a scale STANDARD_DEVIATION 18.06 | 56.83 units on a scale STANDARD_DEVIATION 16.19 | 63.20 units on a scale STANDARD_DEVIATION 15.56 |
| Depressive Symptoms | 20.92 units on a scale STANDARD_DEVIATION 20.37 | 22.36 units on a scale STANDARD_DEVIATION 12.01 | 17.18 units on a scale STANDARD_DEVIATION 9.47 | 20.37 units on a scale STANDARD_DEVIATION 11.33 |
| Drinks/day | 22.30 drinks per day STANDARD_DEVIATION 20.49 | 20.84 drinks per day STANDARD_DEVIATION 19.71 | 16.34 drinks per day STANDARD_DEVIATION 13.96 | 19.94 drinks per day STANDARD_DEVIATION 18.14 |
| Maximum Drinks | 35.52 maximum drinks STANDARD_DEVIATION 30.04 | 31.75 maximum drinks STANDARD_DEVIATION 19.55 | 26.46 maximum drinks STANDARD_DEVIATION 23.93 | 31.26 maximum drinks STANDARD_DEVIATION 24.39 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) White | 11 Participants | 9 Participants | 9 Participants | 29 Participants |
| Sex: Female, Male Female | 1 Participants | 4 Participants | 4 Participants | 9 Participants |
| Sex: Female, Male Male | 13 Participants | 11 Participants | 9 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 13 | 0 / 14 |
| other Total, other adverse events | 0 / 15 | 0 / 13 | 0 / 14 |
| serious Total, serious adverse events | 0 / 15 | 0 / 13 | 0 / 14 |
Outcome results
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.
Time frame: Baseline and Post-Training (3 weeks)
Population: Due to time constraints involved with testing, we removed this tast from the protocol prior to study initiation
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 \[positive change score\]).
Time frame: Baseline and Post-Training (3 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Affective Training | Emotional Stroop: Change From Baseline in Reaction Time | 336 milliseconds | Standard Deviation 378 |
| Neutral Training | Emotional Stroop: Change From Baseline in Reaction Time | 162 milliseconds | Standard Deviation 713 |
| Control (Non-active) | Emotional Stroop: Change From Baseline in Reaction Time | 78.3 milliseconds | Standard Deviation 190 |
p-value: 0.0078Linear Mixed Model
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.
Time frame: Baseline and Post-Training (3 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Affective Training | Little Man Task: Change From Baseline in Response Accuracy. | -.0045 proportion of correct responses | Standard Deviation 0.129 |
| Neutral Training | Little Man Task: Change From Baseline in Response Accuracy. | .125 proportion of correct responses | Standard Deviation 0.192 |
| Control (Non-active) | Little Man Task: Change From Baseline in Response Accuracy. | .0483 proportion of correct responses | Standard Deviation 0.174 |
p-value: 0.393ANOVA
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.
Time frame: Baseline and Post-Training (3 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Affective Training | Sternberg Working Memory Task: Change From Baseline in Response Accuracy | .0021 proportion of correct responses | Standard Deviation 0.142 |
| Neutral Training | Sternberg Working Memory Task: Change From Baseline in Response Accuracy | 0.0298 proportion of correct responses | Standard Deviation 0.0623 |
| Control (Non-active) | Sternberg Working Memory Task: Change From Baseline in Response Accuracy | 0.148 proportion of correct responses | Standard Deviation 0.121 |
p-value: 0.0344ANOVA
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 \[positive change score\]).
Time frame: Baseline and Post-Training (3 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Affective Training | Stroop Color-Word Task: Change From Baseline in Response Time | 5 seconds | Standard Deviation 25.9 |
| Neutral Training | Stroop Color-Word Task: Change From Baseline in Response Time | -11.5 seconds | Standard Deviation 67.2 |
| Control (Non-active) | Stroop Color-Word Task: Change From Baseline in Response Time | 22 seconds | Standard Deviation 77.1 |
p-value: 0.0344ANOVA
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.
Time frame: Baseline and Post-Training (3 weeks)
Population: Due to time constraints involved with testing, we removed this tast from the protocol prior to study initiation
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.
Time frame: Baseline and Post-Training (3 weeks)
Population: Due to time constraints involved with testing, we removed this tast from the protocol prior to study initiation
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.
Time frame: Baseline and Post-Training (3 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Affective Training | Visual-Perceptual Analysis Task: Change From Baseline in Response Time | -1270 milliseconds | Standard Deviation 1111 |
| Neutral Training | Visual-Perceptual Analysis Task: Change From Baseline in Response Time | 121 milliseconds | Standard Deviation 1512 |
| Control (Non-active) | Visual-Perceptual Analysis Task: Change From Baseline in Response Time | -377 milliseconds | Standard Deviation 772 |
p-value: 0.0365ANOVA
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.
Time frame: Baseline and Post-Training (3 weeks)
Population: Data from this task were corrupted, precluding any analysis
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.
Time frame: Approximately 30 days following post-training assessment, up to 1.5 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Affective Training | Change in Profile of Mood States | -12.7 score on a scale | Standard Deviation 37.9 |
| Neutral Training | Change in Profile of Mood States | 6.67 score on a scale | Standard Deviation 15.6 |
| Control (Non-active) | Change in Profile of Mood States | 1.25 score on a scale | Standard Deviation 12.3 |
p-value: 0.445ANOVA
Secondary
Mini Alcohol Craving Experience Questionnaire
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.
Time frame: 30 days following post-training assessment, up to 1.5 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Affective Training | Mini Alcohol Craving Experience Questionnaire | 15.7 units on a scale | Standard Deviation 10.7 |
| Neutral Training | Mini Alcohol Craving Experience Questionnaire | 10 units on a scale | Standard Deviation 9.65 |
| Control (Non-active) | Mini Alcohol Craving Experience Questionnaire | 5.2 units on a scale | Standard Deviation 8.98 |
p-value: 0.245ANOVA
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.
Time frame: 30 days following post-training assessment, up to 1.5 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Affective Training | Moos Health and Daily Living Scale | 1.33 units on a scale (disagreements) | Standard Deviation 1.03 |
| Neutral Training | Moos Health and Daily Living Scale | .4 units on a scale (disagreements) | Standard Deviation 0.548 |
| Control (Non-active) | Moos Health and Daily Living Scale | .25 units on a scale (disagreements) | Standard Deviation 0.5 |
p-value: <0.001ANOVA
Secondary
Timeline Follow-back
Measures frequency and quantity of daily alcohol use, measured as average ounces of alcohol consumed per day.
Time frame: 30 days following post-training assessment, up to 1.5 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Affective Training | Timeline Follow-back | .06 ounces of absolute ethanol per day | Standard Deviation 0.134 |
| Neutral Training | Timeline Follow-back | .131 ounces of absolute ethanol per day | Standard Deviation 0.181 |
| Control (Non-active) | Timeline Follow-back | .4 ounces of absolute ethanol per day | Standard Deviation 0.465 |
p-value: 0.212ANOVA