Trial Outcomes & Findings for Brief Online Interventions for Alcohol Use (NCT NCT03438539)

NCT ID: NCT03438539

Last Updated: 2020-01-29

Results Overview

Self-report of percent of heavy alcohol drinking days

Recruitment status

COMPLETED

Study phase

Target enrollment

444 participants

Primary outcome timeframe

Past two weeks

Results posted on

2020-01-29

Participant Flow

Participant milestones

Participant milestones
Measure	Attentional Control With Normative Feedback Control training tasks included completion of basic arithmetic problems for approximately 5 minutes. Subjects assigned to normative feedback were directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender. Normative Feedback: Subjects assigned to normative feedback will be directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender.	Inhibitory Control Training With Normative Feedback The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control. Subjects assigned to normative feedback were directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender. Normative Feedback: Subjects assigned to normative feedback will be directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender. Inhibitory Control Training: The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control.	Working Memory Training With Normative Feedback A battery of working memory tasks was used during the intervention period. These tasks were selected from previous research evaluating working memory training in substance use disorder (Bickel et al., 2011b; Houben et al., 2011b). Tasks included visuospatial working memory task, digit span task, letter span task, and the n-back task. Subjects assigned to normative feedback were directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender.	Attentional Control Without Normative Feedback Control training tasks included completion of basic arithmetic problems for approximately 5 minutes. Subjects assigned to not receive normative feedback received feedback on time spent doing a non-alcohol related activity as an attention/informational control (e.g., time spent watching television; LaBrie et al., 2013).	Inhibitory Control Training Without Normative Feedback The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control. Subjects assigned to not receive normative feedback received feedback on time spent doing a non-alcohol related activity as an attention/informational control (e.g., time spent watching television; LaBrie et al., 2013). Inhibitory Control Training: The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control.	Working Memory Training Without Normative Feedback A battery of working memory tasks was used during the intervention period. These tasks were selected from previous research evaluating working memory training in substance use disorder (Bickel et al., 2011b; Houben et al., 2011b). Tasks included visuospatial working memory task, digit span task, letter span task, and the n-back task. Subjects assigned to not receive normative feedback received feedback on time spent doing a non-alcohol related activity as an attention/informational control (e.g., time spent watching television; LaBrie et al., 2013). Working Memory Training: A battery of working memory tasks will be used during the intervention period. These tasks were selected from previous research evaluating working memory training in substance use disorder (Bickel et al., 2011b; Houben et al., 2011b). Tasks will include visuospatial working memory task, digit span task, letter span task, and the n-back task.
Overall Study STARTED	76	72	76	73	73	74
Overall Study COMPLETED	68	68	66	64	70	66
Overall Study NOT COMPLETED	8	4	10	9	3	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Attentional Control With Normative Feedback Control training tasks included completion of basic arithmetic problems for approximately 5 minutes. Subjects assigned to normative feedback were directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender. Normative Feedback: Subjects assigned to normative feedback will be directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender.	Inhibitory Control Training With Normative Feedback The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control. Subjects assigned to normative feedback were directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender. Normative Feedback: Subjects assigned to normative feedback will be directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender. Inhibitory Control Training: The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control.	Working Memory Training With Normative Feedback A battery of working memory tasks was used during the intervention period. These tasks were selected from previous research evaluating working memory training in substance use disorder (Bickel et al., 2011b; Houben et al., 2011b). Tasks included visuospatial working memory task, digit span task, letter span task, and the n-back task. Subjects assigned to normative feedback were directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender.	Attentional Control Without Normative Feedback Control training tasks included completion of basic arithmetic problems for approximately 5 minutes. Subjects assigned to not receive normative feedback received feedback on time spent doing a non-alcohol related activity as an attention/informational control (e.g., time spent watching television; LaBrie et al., 2013).	Inhibitory Control Training Without Normative Feedback The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control. Subjects assigned to not receive normative feedback received feedback on time spent doing a non-alcohol related activity as an attention/informational control (e.g., time spent watching television; LaBrie et al., 2013). Inhibitory Control Training: The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control.	Working Memory Training Without Normative Feedback A battery of working memory tasks was used during the intervention period. These tasks were selected from previous research evaluating working memory training in substance use disorder (Bickel et al., 2011b; Houben et al., 2011b). Tasks included visuospatial working memory task, digit span task, letter span task, and the n-back task. Subjects assigned to not receive normative feedback received feedback on time spent doing a non-alcohol related activity as an attention/informational control (e.g., time spent watching television; LaBrie et al., 2013). Working Memory Training: A battery of working memory tasks will be used during the intervention period. These tasks were selected from previous research evaluating working memory training in substance use disorder (Bickel et al., 2011b; Houben et al., 2011b). Tasks will include visuospatial working memory task, digit span task, letter span task, and the n-back task.
Overall Study Lost to Follow-up	8	4	10	9	3	8

Baseline Characteristics

Brief Online Interventions for Alcohol Use

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Attentional Control With Normative Feedback n=76 Participants Control training tasks included completion of basic arithmetic problems for approximately 5 minutes. Subjects assigned to normative feedback were directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender. Normative Feedback: Subjects assigned to normative feedback will be directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender.	Inhibitory Control Training With Normative Feedback n=72 Participants The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control. Subjects assigned to normative feedback were directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender. Normative Feedback: Subjects assigned to normative feedback will be directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender. Inhibitory Control Training: The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control.	Working Memory Training With Normative Feedback n=76 Participants A battery of working memory tasks was used during the intervention period. These tasks were selected from previous research evaluating working memory training in substance use disorder (Bickel et al., 2011b; Houben et al., 2011b). Tasks included visuospatial working memory task, digit span task, letter span task, and the n-back task. Subjects assigned to normative feedback were directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender.	Attentional Control Without Normative Feedback n=73 Participants Control training tasks included completion of basic arithmetic problems for approximately 5 minutes. Subjects assigned to not receive normative feedback received feedback on time spent doing a non-alcohol related activity as an attention/informational control (e.g., time spent watching television; LaBrie et al., 2013).	Inhibitory Control Training Without Normative Feedback n=73 Participants The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control. Subjects assigned to not receive normative feedback received feedback on time spent doing a non-alcohol related activity as an attention/informational control (e.g., time spent watching television; LaBrie et al., 2013). Inhibitory Control Training: The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control.	Working Memory Training Without Normative Feedback n=74 Participants A battery of working memory tasks was used during the intervention period. These tasks were selected from previous research evaluating working memory training in substance use disorder (Bickel et al., 2011b; Houben et al., 2011b). Tasks included visuospatial working memory task, digit span task, letter span task, and the n-back task. Subjects assigned to not receive normative feedback received feedback on time spent doing a non-alcohol related activity as an attention/informational control (e.g., time spent watching television; LaBrie et al., 2013). Working Memory Training: A battery of working memory tasks will be used during the intervention period. These tasks were selected from previous research evaluating working memory training in substance use disorder (Bickel et al., 2011b; Houben et al., 2011b). Tasks will include visuospatial working memory task, digit span task, letter span task, and the n-back task.	Total n=444 Participants Total of all reporting groups
Age, Continuous	34.1 years STANDARD_DEVIATION 8.7 • n=99 Participants	32.5 years STANDARD_DEVIATION 9.3 • n=107 Participants	35.2 years STANDARD_DEVIATION 9.5 • n=206 Participants	35.8 years STANDARD_DEVIATION 11.0 • n=157 Participants	34.3 years STANDARD_DEVIATION 10.9 • n=390 Participants	33.7 years STANDARD_DEVIATION 8.5 • n=16 Participants	34.3 years STANDARD_DEVIATION 9.7 • n=3 Participants
Sex: Female, Male Female	39 Participants n=99 Participants	40 Participants n=107 Participants	41 Participants n=206 Participants	41 Participants n=157 Participants	36 Participants n=390 Participants	30 Participants n=16 Participants	227 Participants n=3 Participants
Sex: Female, Male Male	37 Participants n=99 Participants	32 Participants n=107 Participants	35 Participants n=206 Participants	32 Participants n=157 Participants	37 Participants n=390 Participants	44 Participants n=16 Participants	217 Participants n=3 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants	0 Participants n=390 Participants	0 Participants n=16 Participants	0 Participants n=3 Participants
Race (NIH/OMB) Asian	5 Participants n=99 Participants	6 Participants n=107 Participants	6 Participants n=206 Participants	5 Participants n=157 Participants	1 Participants n=390 Participants	3 Participants n=16 Participants	26 Participants n=3 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants	0 Participants n=390 Participants	0 Participants n=16 Participants	0 Participants n=3 Participants
Race (NIH/OMB) Black or African American	5 Participants n=99 Participants	3 Participants n=107 Participants	6 Participants n=206 Participants	4 Participants n=157 Participants	5 Participants n=390 Participants	5 Participants n=16 Participants	28 Participants n=3 Participants
Race (NIH/OMB) White	62 Participants n=99 Participants	59 Participants n=107 Participants	62 Participants n=206 Participants	61 Participants n=157 Participants	66 Participants n=390 Participants	64 Participants n=16 Participants	374 Participants n=3 Participants
Race (NIH/OMB) More than one race	3 Participants n=99 Participants	4 Participants n=107 Participants	0 Participants n=206 Participants	3 Participants n=157 Participants	0 Participants n=390 Participants	2 Participants n=16 Participants	12 Participants n=3 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants	0 Participants n=157 Participants	1 Participants n=390 Participants	0 Participants n=16 Participants	4 Participants n=3 Participants
Region of Enrollment United States	76 participants n=99 Participants	72 participants n=107 Participants	76 participants n=206 Participants	73 participants n=157 Participants	73 participants n=390 Participants	74 participants n=16 Participants	444 participants n=3 Participants

PRIMARY outcome

Timeframe: Past two weeks

Population: These data include only participants that were randomized and completed the follow-up assessment providing valid alcohol use data.

Self-report of percent of heavy alcohol drinking days

Outcome measures

Outcome measures
Measure	Attentional Control With Normative Feedback n=50 Participants Control training tasks included completion of basic arithmetic problems for approximately 5 minutes. Subjects assigned to normative feedback were directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender. Normative Feedback: Subjects assigned to normative feedback will be directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender.	Inhibitory Control Training With Normative Feedback n=50 Participants The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control. Subjects assigned to normative feedback were directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender. Normative Feedback: Subjects assigned to normative feedback will be directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender. Inhibitory Control Training: The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control.	Working Memory Training With Normative Feedback n=50 Participants A battery of working memory tasks was used during the intervention period. These tasks were selected from previous research evaluating working memory training in substance use disorder (Bickel et al., 2011b; Houben et al., 2011b). Tasks included visuospatial working memory task, digit span task, letter span task, and the n-back task. Subjects assigned to normative feedback were directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender.	Attentional Control Without Normative Feedback n=51 Participants Control training tasks included completion of basic arithmetic problems for approximately 5 minutes. Subjects assigned to not receive normative feedback received feedback on time spent doing a non-alcohol related activity as an attention/informational control (e.g., time spent watching television; LaBrie et al., 2013).	Inhibitory Control Training Without Normative Feedback n=58 Participants The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control. Subjects assigned to not receive normative feedback received feedback on time spent doing a non-alcohol related activity as an attention/informational control (e.g., time spent watching television; LaBrie et al., 2013). Inhibitory Control Training: The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control.	Working Memory Training Without Normative Feedback n=50 Participants A battery of working memory tasks was used during the intervention period. These tasks were selected from previous research evaluating working memory training in substance use disorder (Bickel et al., 2011b; Houben et al., 2011b). Tasks included visuospatial working memory task, digit span task, letter span task, and the n-back task. Subjects assigned to not receive normative feedback received feedback on time spent doing a non-alcohol related activity as an attention/informational control (e.g., time spent watching television; LaBrie et al., 2013). Working Memory Training: A battery of working memory tasks will be used during the intervention period. These tasks were selected from previous research evaluating working memory training in substance use disorder (Bickel et al., 2011b; Houben et al., 2011b). Tasks will include visuospatial working memory task, digit span task, letter span task, and the n-back task.
Alcohol Use	19.4 percentage heavy drinking days Standard Deviation 30.3	16.3 percentage heavy drinking days Standard Deviation 29.4	15.3 percentage heavy drinking days Standard Deviation 25.0	19.1 percentage heavy drinking days Standard Deviation 29.7	19.6 percentage heavy drinking days Standard Deviation 26.7	21.0 percentage heavy drinking days Standard Deviation 30.7

SECONDARY outcome

Timeframe: 2 weeks

Completion rates during intervention period

Outcome measures

Outcome measures
Measure	Attentional Control With Normative Feedback n=76 Participants Control training tasks included completion of basic arithmetic problems for approximately 5 minutes. Subjects assigned to normative feedback were directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender. Normative Feedback: Subjects assigned to normative feedback will be directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender.	Inhibitory Control Training With Normative Feedback n=72 Participants The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control. Subjects assigned to normative feedback were directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender. Normative Feedback: Subjects assigned to normative feedback will be directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender. Inhibitory Control Training: The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control.	Working Memory Training With Normative Feedback n=76 Participants A battery of working memory tasks was used during the intervention period. These tasks were selected from previous research evaluating working memory training in substance use disorder (Bickel et al., 2011b; Houben et al., 2011b). Tasks included visuospatial working memory task, digit span task, letter span task, and the n-back task. Subjects assigned to normative feedback were directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender.	Attentional Control Without Normative Feedback n=73 Participants Control training tasks included completion of basic arithmetic problems for approximately 5 minutes. Subjects assigned to not receive normative feedback received feedback on time spent doing a non-alcohol related activity as an attention/informational control (e.g., time spent watching television; LaBrie et al., 2013).	Inhibitory Control Training Without Normative Feedback n=73 Participants The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control. Subjects assigned to not receive normative feedback received feedback on time spent doing a non-alcohol related activity as an attention/informational control (e.g., time spent watching television; LaBrie et al., 2013). Inhibitory Control Training: The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control.	Working Memory Training Without Normative Feedback n=74 Participants A battery of working memory tasks was used during the intervention period. These tasks were selected from previous research evaluating working memory training in substance use disorder (Bickel et al., 2011b; Houben et al., 2011b). Tasks included visuospatial working memory task, digit span task, letter span task, and the n-back task. Subjects assigned to not receive normative feedback received feedback on time spent doing a non-alcohol related activity as an attention/informational control (e.g., time spent watching television; LaBrie et al., 2013). Working Memory Training: A battery of working memory tasks will be used during the intervention period. These tasks were selected from previous research evaluating working memory training in substance use disorder (Bickel et al., 2011b; Houben et al., 2011b). Tasks will include visuospatial working memory task, digit span task, letter span task, and the n-back task.
Percentage of Sessions Completed (Feasibility)	68.6 percentage of sessions completed Standard Deviation 35.1	63.3 percentage of sessions completed Standard Deviation 35.5	56.5 percentage of sessions completed Standard Deviation 39	66.1 percentage of sessions completed Standard Deviation 35.3	74.7 percentage of sessions completed Standard Deviation 32.6	59.9 percentage of sessions completed Standard Deviation 37

SECONDARY outcome

Timeframe: 2 weeks

Population: These data include only participants that were randomized and completed the follow-up assessment providing valid acceptability data.

Total average ratings on a treatment acceptability questionnaire, rated from 0 (minimum) to 100 (maximum). Higher scores indicate greater treatment acceptability.