Trial Outcomes & Findings for Sex Differences, Cognitive Training & Emotion Processing (NCT NCT03137654)

NCT ID: NCT03137654

Last Updated: 2025-05-31

Results Overview

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 \[positive change score\]).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 82 participants
• Primary outcome timeframe: Baseline and Post-Training (3 weeks)
• Results posted on: 2025-05-31

Participant Flow

82 individuals were enrolled in the study. 5 were enrolled, but not started. 77 individuals were started.

Participant milestones

Measure	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.	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.	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.
Overall Study STARTED	23	25	29
Overall Study COMPLETED	15	13	14
Overall Study NOT COMPLETED	8	12	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sex Differences, Cognitive Training & Emotion Processing

Baseline characteristics by cohort

Measure	Affective Training n=15 Participants 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.	Neutral Training n=13 Participants 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.	Control (Non-active) n=14 Participants 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.	Total n=42 Participants Total of all reporting groups
Age, Continuous	42.93 years STANDARD_DEVIATION 11.70 • n=5 Participants	45.62 years STANDARD_DEVIATION 12.86 • n=7 Participants	39.23 years STANDARD_DEVIATION 11.64 • n=5 Participants	42.61 years STANDARD_DEVIATION 12.04 • n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	9 Participants n=4 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants	33 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants	29 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Depressive Symptoms	22.36 units on a scale STANDARD_DEVIATION 12.01 • n=5 Participants	17.18 units on a scale STANDARD_DEVIATION 9.47 • n=7 Participants	20.92 units on a scale STANDARD_DEVIATION 20.37 • n=5 Participants	20.37 units on a scale STANDARD_DEVIATION 11.33 • n=4 Participants
Anxiety Symptoms	63.40 units on a scale STANDARD_DEVIATION 18.06 • n=5 Participants	56.83 units on a scale STANDARD_DEVIATION 16.19 • n=7 Participants	68.43 units on a scale STANDARD_DEVIATION 10.27 • n=5 Participants	63.20 units on a scale STANDARD_DEVIATION 15.56 • n=4 Participants
Drinks/day	20.84 drinks per day STANDARD_DEVIATION 19.71 • n=5 Participants	16.34 drinks per day STANDARD_DEVIATION 13.96 • n=7 Participants	22.30 drinks per day STANDARD_DEVIATION 20.49 • n=5 Participants	19.94 drinks per day STANDARD_DEVIATION 18.14 • n=4 Participants
Maximum Drinks	31.75 maximum drinks STANDARD_DEVIATION 19.55 • n=5 Participants	26.46 maximum drinks STANDARD_DEVIATION 23.93 • n=7 Participants	35.52 maximum drinks STANDARD_DEVIATION 30.04 • n=5 Participants	31.26 maximum drinks STANDARD_DEVIATION 24.39 • n=4 Participants

PRIMARY outcome

Timeframe: 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]).

Outcome measures

Measure	Control (Non-active) n=14 Participants 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.	Affective Training n=15 Participants 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.	Neutral Training n=13 Participants 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.
Emotional Stroop: Change From Baseline in Reaction Time	78.3 milliseconds Standard Deviation 190	336 milliseconds Standard Deviation 378	162 milliseconds Standard Deviation 713

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Control (Non-active) n=11 Participants 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.	Affective Training n=7 Participants 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.	Neutral Training n=6 Participants 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.
Little Man Task: Change From Baseline in Response Accuracy.	.0483 proportion of correct responses Standard Deviation .174	-.0045 proportion of correct responses Standard Deviation .129	.125 proportion of correct responses Standard Deviation .192

PRIMARY outcome

Timeframe: Baseline and Post-Training (3 weeks)

Population: Data from this task were corrupted, precluding any analysis

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Control (Non-active) n=9 Participants 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.	Affective Training n=10 Participants 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.	Neutral Training n=7 Participants 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.
Sternberg Working Memory Task: Change From Baseline in Response Accuracy	0.148 proportion of correct responses Standard Deviation 0.121	.0021 proportion of correct responses Standard Deviation .142	0.0298 proportion of correct responses Standard Deviation .0623

PRIMARY outcome

Timeframe: 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]).

Outcome measures

Measure	Control (Non-active) n=9 Participants 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.	Affective Training n=7 Participants 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.	Neutral Training n=2 Participants 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.
Stroop Color-Word Task: Change From Baseline in Response Time	22 seconds Standard Deviation 77.1	5 seconds Standard Deviation 25.9	-11.5 seconds Standard Deviation 67.2

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Control (Non-active) n=8 Participants 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.	Affective Training n=12 Participants 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.	Neutral Training n=9 Participants 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.
Visual-Perceptual Analysis Task: Change From Baseline in Response Time	-377 milliseconds Standard Deviation 772	-1270 milliseconds Standard Deviation 1111	121 milliseconds Standard Deviation 1512

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control (Non-active) n=4 Participants 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.	Affective Training n=5 Participants 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.	Neutral Training n=5 Participants 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.
Timeline Follow-back	.4 ounces of absolute ethanol per day Standard Deviation .465	.06 ounces of absolute ethanol per day Standard Deviation .134	.131 ounces of absolute ethanol per day Standard Deviation .181

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control (Non-active) n=4 Participants 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.	Affective Training n=6 Participants 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.	Neutral Training n=5 Participants 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.
Moos Health and Daily Living Scale	.25 units on a scale (disagreements) Standard Deviation .5	1.33 units on a scale (disagreements) Standard Deviation 1.03	.4 units on a scale (disagreements) Standard Deviation .548

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control (Non-active) n=4 Participants 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.	Affective Training n=6 Participants 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.	Neutral Training n=6 Participants 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.
Change in Profile of Mood States	1.25 score on a scale Standard Deviation 12.3	-12.7 score on a scale Standard Deviation 37.9	6.67 score on a scale Standard Deviation 15.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control (Non-active) n=5 Participants 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.	Affective Training n=6 Participants 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.	Neutral Training n=6 Participants 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.
Mini Alcohol Craving Experience Questionnaire	5.2 units on a scale Standard Deviation 8.98	15.7 units on a scale Standard Deviation 10.7	10 units on a scale Standard Deviation 9.65

Adverse Events

Affective Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Neutral Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control (Non-active)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ben Lewis, Assistant Professor, UF Department of Psychiatry

UFlorida

Phone: 3522948724

Email: benlewis@ufl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place