Brief Online Interventions for Alcohol Use

Study Overview
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Brief Summary
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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
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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.

Official Title
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Brief Online Interventions for Alcohol Use: A Crowdsourced Study

Conditions
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Alcohol Use Disorder

Intervention / Treatment
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* Behavioral: Normative Feedback
* Behavioral: Inhibitory Control Training
* Behavioral: Working Memory Training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Attentional Control with Normative Feedback<br>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<br>* 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.<br>|
| Experimental: Inhibitory Control Training with Normative Feedback<br>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<br>* 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.<br>Behavioral: Inhibitory Control Training<br>* 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.<br>|
| Experimental: Working Memory Training with Normative Feedback<br>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<br>* 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.<br>Behavioral: Working Memory Training<br>* 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.<br>|
| No Intervention: Attentional Control without Normative Feedback<br>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<br>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<br>* 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.<br>|
| Experimental: Working Memory Training without Normative Feedback<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcohol Use | Self-report of percent of heavy alcohol drinking days | Past two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Sessions Completed (Feasibility) | Completion rates during intervention period | 2 weeks | 
| Treatment Acceptability Questionnaire | Total average ratings on a treatment acceptability questionnaire, rated from 0 (minimum) to 100 (maximum). Higher scores indicate greater treatment acceptability. | 2 weeks |