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Brief Online Interventions for Alcohol Use

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03438539
Recruitment Status : Completed
First Posted : February 19, 2018
Results First Posted : January 29, 2020
Last Update Posted : January 29, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Craig Rush, University of Kentucky

Brief Summary:
The purpose of this study is to test the feasibility and acceptability of delivering cognitive training over mTurk. Subjects will be randomized to a 1) inhibitory control training condition, 2) working memory training condition, or 3) control training condition. Recent studies have also demonstrated the feasibility and potential efficacy of delivering brief normative feedback to reduce alcohol consumption through mTurk. In these brief interventions, subjects are provided information about their drinking compared to their same age and gendered peers. Approximately half of the subjects in each cognitive training group will receive normative feedback to evaluate effects on alcohol consumption and possible interactions with cognitive training. This study will focus on alcohol use given the ease and clinical acceptance of alcohol use self-report as a primary outcome.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Behavioral: Normative Feedback Behavioral: Inhibitory Control Training Behavioral: Working Memory Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 444 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: An Internet survey hosted by Amazon.com's Mechanical Turk and Qualtrics: Online Survey Software will be used in this protocol. Cognitive tasks will be coded using PsyToolKit, an open-source tool for programming and running cognitive-psychological experiments and surveys online (Stoet, 2017). A mixed-model design will be used such that subjects are randomly assigned to one of three cognitive training conditions and two information feedback conditions (i.e., between-subjects variables). The same subjects will be sampled at each time point in the study (i.e., repeated/longitudinal variables).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Brief Online Interventions for Alcohol Use: A Crowdsourced Study
Actual Study Start Date : February 22, 2018
Actual Primary Completion Date : July 27, 2018
Actual Study Completion Date : July 27, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Sham Comparator: Attentional Control with Normative Feedback
Control training tasks will include completion of basic arithmetic problems for approximately 5 minutes. 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.
Behavioral: 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.

Experimental: 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 will be directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender.
Behavioral: 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.

Behavioral: 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.

Experimental: Working Memory Training with Normative Feedback
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. 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.
Behavioral: 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.

Behavioral: 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.

No Intervention: Attentional Control without Normative Feedback
Control training tasks will include completion of basic arithmetic problems for approximately 5 minutes. Subjects assigned to not receive normative feedback will receive 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).
Experimental: 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 will receive 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).
Behavioral: 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.

Experimental: Working Memory Training without Normative Feedback
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. Subjects assigned to not receive normative feedback will receive 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).
Behavioral: 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.




Primary Outcome Measures :
  1. Alcohol Use [ Time Frame: Past two weeks ]
    Self-report of percent of heavy alcohol drinking days


Secondary Outcome Measures :
  1. Percentage of Sessions Completed (Feasibility) [ Time Frame: 2 weeks ]
    Completion rates during intervention period

  2. Treatment Acceptability Questionnaire [ Time Frame: 2 weeks ]
    Total average ratings on a treatment acceptability questionnaire, rated from 0 (minimum) to 100 (maximum). Higher scores indicate greater treatment acceptability.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Self-reported past week alcohol use.
  • Meet criteria for Alcohol Use Disorder (AUD), verified by computerized questionnaire for DSM-V AUD criteria (Appendix A).
  • Age 21 years or older.
  • Express interest in completing a 2-week study involving daily cognitive tasks.
  • Residence in the United States

Exclusion Criteria:

  • N/A

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438539


Locations
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United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40507
Sponsors and Collaborators
Craig Rush
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Craig R Rush, PhD University of Kentucky
  Study Documents (Full-Text)

Documents provided by Craig Rush, University of Kentucky:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Craig Rush, Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT03438539    
Other Study ID Numbers: mTurk 10
R34DA038869 ( U.S. NIH Grant/Contract )
First Posted: February 19, 2018    Key Record Dates
Results First Posted: January 29, 2020
Last Update Posted: January 29, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alcoholism
Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders