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Brief Online Interventions for Alcohol Use

Primary Purpose

Alcohol Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Normative Feedback
Inhibitory Control Training
Working Memory Training
Sponsored by
Craig Rush
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Kentucky

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Sham Comparator

Experimental

Experimental

No Intervention

Experimental

Experimental

Arm Label

Attentional Control with Normative Feedback

Inhibitory Control Training with Normative Feedback

Working Memory Training with Normative Feedback

Attentional Control without Normative Feedback

Inhibitory Control Training without Normative Feedback

Working Memory Training without Normative Feedback

Arm Description

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.

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.

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.

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).

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).

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).

Outcomes

Primary Outcome Measures

Alcohol Use
Self-report of percent of heavy alcohol drinking days

Secondary Outcome Measures

Percentage of Sessions Completed (Feasibility)
Completion rates during intervention period
Treatment Acceptability Questionnaire
Total average ratings on a treatment acceptability questionnaire, rated from 0 (minimum) to 100 (maximum). Higher scores indicate greater treatment acceptability.

Full Information

First Posted
February 12, 2018
Last Updated
January 16, 2020
Sponsor
Craig Rush
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03438539
Brief Title
Brief Online Interventions for Alcohol Use
Official Title
Brief Online Interventions for Alcohol Use: A Crowdsourced Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 22, 2018 (Actual)
Primary Completion Date
July 27, 2018 (Actual)
Study Completion Date
July 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Craig Rush
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Alcohol use disorder is a persistent public health concern. Approximately 16 million Americans met criteria for alcohol use disorder in 2015, with the annual economic impact of excessive drinking estimated at $250 billion. Alcohol use can also interact with other licit (e.g., cigarettes) and illicit (e.g., cocaine) substances to increase health risks . At least half of all violent crimes involve alcohol consumption and problem drinking plays an important role in domestic abuse and intimate partner violence . These evident economic, health, and social implications of alcohol misuse highlight the importance of understanding determinants of alcohol use behaviors and developing interventions designed to address maladaptive patterns of use. Cognitive training to address alcohol and other substance use disorders has received a great deal of attention in the interventions development literature. Training may be broadly divided into two classes: 1) cognitive bias modification and response inhibition (i.e., inhibitory control) and 2) working memory interventions. Inhibitory control training attempts to retrain prepotent responses away from drug-related cues by specifically pairing those cues with no-go signals in training tasks. Working memory training uses cognitive-behavioral tasks (e.g., letter/digit strings, visual search, n-back) to improve information maintenance and manipulation. These brief interventions hold particular appeal because they may be easily incorporated into comprehensive approaches to substance use treatment. For example, cognitive improvements due to brief training may improve engagement with and attention to cognitive-behavioral therapy and compliance with homework and other program-related activities. Generally speaking, training has consistently demonstrated improvements on the trained or similar tasks as well as related concepts (e.g., delay discounting is improved after working memory training). Improvements in dissimilar tasks or different domains are not consistently observed, however, and clinical measures, such as drug use, have seen mixed outcomes. A significant limitation of the extant literature is the relatively small samples typically evaluated (i.e., 20-40 subjects per condition). It is likely that the effects of cognitive training are of a small-to-medium effect size, however, the relatively low costs of training procedures mean that small effect sizes may not preclude clinical utility. It is also likely that individual characteristics will moderate the utility of these interventions for impacting substance use or related negative health behaviors. The use of small samples precludes testing these types of moderators with adequate statistical power as does the recruitment of comparably homogeneous samples (e.g., student samples, individuals from a single addiction clinic). An emerging method addressing these concerns is crowdsourcing. Crowdsourcing, such as on Amazon.com's Mechanical Turk (mTurk), allows for the effective and efficient sampling of diverse subjects. We have previously demonstrated a close correspondence between in-person and online findings using mTurk in substance use research providing support for the validity of the resource. We have also recently demonstrated feasibility, acceptability, and validity of conducting intensive longitudinal research related to substance use on this platform. Demonstrating the feasibility and acceptability of applying cognitive training methods through mTurk would help establish this setting for future large sample studies testing novel interventions and/or individual characteristic moderating intervention efficacy. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
444 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Attentional Control with Normative Feedback
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Inhibitory Control Training with Normative Feedback
Arm Type
Experimental
Arm Description
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.
Arm Title
Working Memory Training with Normative Feedback
Arm Type
Experimental
Arm Description
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.
Arm Title
Attentional Control without Normative Feedback
Arm Type
No Intervention
Arm Description
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).
Arm Title
Inhibitory Control Training without Normative Feedback
Arm Type
Experimental
Arm Description
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).
Arm Title
Working Memory Training without Normative Feedback
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Normative Feedback
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Inhibitory Control Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Working Memory Training
Intervention Description
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 Measure Information:
Title
Alcohol Use
Description
Self-report of percent of heavy alcohol drinking days
Time Frame
Past two weeks
Secondary Outcome Measure Information:
Title
Percentage of Sessions Completed (Feasibility)
Description
Completion rates during intervention period
Time Frame
2 weeks
Title
Treatment Acceptability Questionnaire
Description
Total average ratings on a treatment acceptability questionnaire, rated from 0 (minimum) to 100 (maximum). Higher scores indicate greater treatment acceptability.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig R Rush, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40507
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30888705
Citation
Strickland JC, Hill JC, Stoops WW, Rush CR. Feasibility, Acceptability, and Initial Efficacy of Delivering Alcohol Use Cognitive Interventions via Crowdsourcing. Alcohol Clin Exp Res. 2019 May;43(5):888-899. doi: 10.1111/acer.13987. Epub 2019 Mar 19.
Results Reference
derived

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Brief Online Interventions for Alcohol Use

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