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Alcohol Use DisorderNCT03438539

Brief Online Interventions for Alcohol Use

A study testing Normative Feedback and Working Memory Training in people with Alcohol Use Disorder, run by Craig Rush at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for
Alcohol Use Disorder
What is being tested?
Normative Feedback and Working Memory Training
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
444 participants
Where
1 siteUnited States
Study dates
22 Feb 2018to 27 Jul 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • N/A

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Kentucky

    Lexington, Kentucky, 40507

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Normative Feedback, Inhibitory Control Training, Working Memory Training
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Normative FeedbackBehavioural

    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 TrainingBehavioural

    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 TrainingBehavioural

    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.

Study groups in NCT03438539
Study groupRoleWhat they receive
Attentional Control with Normative FeedbackSham comparatorControl 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.
Receives: Behavioral: Normative Feedback
Inhibitory Control Training with Normative FeedbackExperimentalThe 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.
Receives: Behavioral: Normative Feedback; Behavioral: Inhibitory Control Training
Working Memory Training with Normative FeedbackExperimentalA 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.
Receives: Behavioral: Normative Feedback; Behavioral: Working Memory Training
Attentional Control without Normative FeedbackNo interventionControl 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).
Inhibitory Control Training without Normative FeedbackExperimentalThe 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).
Receives: Behavioral: Inhibitory Control Training
Working Memory Training without Normative FeedbackExperimentalA 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).
Receives: Behavioral: Working Memory Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Alcohol Use

    Self-report of percent of heavy alcohol drinking days

    Measured: Past two weeks

Secondary outcomes (2)
  1. Percentage of Sessions Completed (Feasibility)

    Completion rates during intervention period

    Measured: 2 weeks

  2. Treatment Acceptability Questionnaire

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

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2018
  2. Study start22 Feb 2018
  3. Primary completion27 Jul 2018
  4. Study completion27 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
444 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03438539
Sponsor's protocol ID
mTurk 10
Other IDs
R34DA038869
Status last verified
Jan 2020
First submitted
12 Feb 2018
Last updated
29 Jan 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30888705

Questions about this trial

What is this clinical trial studying?

A study testing Normative Feedback and Working Memory Training in people with Alcohol Use Disorder, run by Craig Rush at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Alcohol Use (time frame: Past two weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03438539, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2020; AzTrials last refreshed its copy on 27 Oct 2026.

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