Alcohol Use DisorderNCT03137654
Sex Differences, Cognitive Training & Emotion Processing
A study testing Affective Training and Neutral Training in people with Alcohol Use Disorder, run by University of Florida at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Affective Training and Neutral Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 5 sitesUnited States
- Study dates
- 16 Aug 2017to 8 Feb 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
ASPIRE Healthcare Facilities
Gainesville, Florida, 32607
The Sid Martin Bridge House
Gainesville, Florida, 32608
UF Health Florida Recovery Center
Gainesville, Florida, 32608
University of Florida
Gainesville, Florida, 32611
Steward-Marchman-Act (SMA) Healthcare
Multiple Locations, Florida, 32177
About this study
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.
Read the 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.
- Conditions
- Alcohol Use Disorder
- Being tested
- Affective Training, Neutral Training
- Keywords
- Cognitive Training, Emotion Processing
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Affective TrainingOther
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.
Neutral TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Affective Training |
| 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. Receives: Other: Neutral Training |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Post-Training (3 weeks)
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.
Measured: 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.
Measured: 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.
Measured: 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]).
Measured: 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.
Measured: Baseline and Post-Training (3 weeks)
Secondary outcomes (4)
Timeline Follow-back
Measures frequency and quantity of daily alcohol use, measured as average ounces of alcohol consumed per day.
Measured: 30 days following post-training assessment, up to 1.5 months
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.
Measured: 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.
Measured: Approximately 30 days following post-training assessment, up to 1.5 months
Mini Alcohol Craving Experience Questionnaire
Indexes alcohol craving frequencies. Questions include:
- Over the past week, how often did you have a strong urge to drink?
- Over the past week, how often did you picture alcohol or drinking?
- Over the past week, how often did you imagine what it would taste like?
- Over the past week, how often did you imagine how your body would feel if you had a drink? Higher scores reflect greater craving.
- 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.
Measured: 30 days following post-training assessment, up to 1.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start16 Aug 2017
- Primary completion8 Feb 2021
- Study completion8 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The primary design is a 3 (Training Condition: Neutral, Affective, Control) by 2 (Time: Baseline, Post-training) repeated measures design.
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Sara Jo Nixon, PhD, Principal investigator, University of FloridaBen Lewis, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03137654
- Sponsor's protocol ID
- IRB201700206-N
- Other IDs
- R03AA025430
- Status last verified
- May 2025
- First submitted
- 28 Apr 2017
- Last updated
- 31 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex Differences, Cognitive Training & Emotion Processing
- ClinicalTrials.gov ID
- NCT03137654
- Acronym / sponsor ID
- IRB201700206-N
- Conditions
- Alcohol Use Disorder
- Keywords
- Cognitive Training, Emotion Processing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 16 Aug 2017 (actual)
- Primary completion
- 8 Feb 2021 (actual)
- Study completion
- 8 Feb 2021 (actual)
- First posted
- 3 May 2017 (actual)
- Results
- Posted 31 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The primary design is a 3 (Training Condition: Neutral, Affective, Control) by 2 (Time: Baseline, Post-training) repeated measures design.
| Arm | Type | Receives |
|---|---|---|
| Affective Training | Active comparator | Other: Affective TrainingSubjects 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. |
| Neutral Training | Active comparator | Other: Neutral TrainingSubjects 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. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Affective TrainingIntervention 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. | Other | Affective Training |
| Neutral TrainingIntervention 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. | Other | Neutral Training |
Primary outcome
Emotional Stroop: Change From Baseline in Reaction Time
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Little Man Task: Change From Baseline in Response Accuracy.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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]).
Visual-Perceptual Analysis Task: Change From Baseline in Response Time
Time frame: 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.
4 secondary outcomes
Timeline Follow-back
Time frame: 30 days following post-training assessment, up to 1.5 months
Moos Health and Daily Living Scale
Time frame: 30 days following post-training assessment, up to 1.5 months
Change in Profile of Mood States
Time frame: Approximately 30 days following post-training assessment, up to 1.5 months
Mini Alcohol Craving Experience Questionnaire
Time frame: 30 days following post-training assessment, up to 1.5 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Jo Nixon, PhD principal investigator
University of Florida
Ben Lewis, PhD principal investigator
University of Florida
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Affective Training and Neutral Training in people with Alcohol Use Disorder, run by University of Florida at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotional Stroop: Change From Baseline in Reaction Time (time frame: Baseline and Post-Training (3 weeks)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.