NCT03438539

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
444

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

February 22, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2018

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

January 29, 2020

Completed
Last Updated

January 29, 2020

Status Verified

January 1, 2020

Enrollment Period

5 months

First QC Date

February 12, 2018

Results QC Date

May 10, 2019

Last Update Submit

January 16, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Alcohol Use

    Self-report of percent of heavy alcohol drinking days

    Past two weeks

Secondary Outcomes (2)

  • Percentage of Sessions Completed (Feasibility)

    2 weeks

  • Treatment Acceptability Questionnaire

    2 weeks

Study Arms (6)

Attentional Control with Normative Feedback

SHAM COMPARATOR

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

Inhibitory Control Training with Normative Feedback

EXPERIMENTAL

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 FeedbackBehavioral: Inhibitory Control Training

Working Memory Training with Normative Feedback

EXPERIMENTAL

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 FeedbackBehavioral: Working Memory Training

Attentional Control without Normative Feedback

NO INTERVENTION

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).

Inhibitory Control Training without Normative Feedback

EXPERIMENTAL

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

Working Memory Training without Normative Feedback

EXPERIMENTAL

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

Interventions

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.

Attentional Control with Normative FeedbackInhibitory Control Training with Normative FeedbackWorking Memory 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.

Inhibitory Control Training with Normative FeedbackInhibitory Control 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.

Working Memory Training with Normative FeedbackWorking Memory Training without Normative Feedback

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40507, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Craig Rush, Ph.D.
Organization
University of Kentucky

Study Officials

  • Craig R Rush, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 12, 2018

First Posted

February 19, 2018

Study Start

February 22, 2018

Primary Completion

July 27, 2018

Study Completion

July 27, 2018

Last Updated

January 29, 2020

Results First Posted

January 29, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations