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Clinical Trials/NCT04924283
NCT04924283CompletedNot Applicable

Effects of a Cognitive Interference Task on Alcohol Craving and Consumption Among Women

Medical University of South Carolina1 site in 1 country40 target enrollmentStarted: June 25, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Average Drinks Per Occasion

Study Overview

Brief Summary

The purpose of this study is to test a brief task of playing the game Tetris to reduce alcohol cravings and alcohol use. Women who are seen at primary care and recruited through the community will be asked to rate alcohol craving and use for a 1-week baseline period. Then they will be randomly assigned to play the Tetris game on their phones daily or to a control condition for a 2-week period. Participants will also complete a cue-reactivity task, that involves viewing pictures of alcohol and rating cravings.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
21 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Female, any race or ethnicity, age 21 to 65 years old.
  • •Able to comprehend English.
  • •At least one heavy drinking per week (i.e., consuming at least four or more drinks in one day) for the last two weeks
  • •Internet access and reliable electronic device

Exclusion Criteria

  • •More than four heavy drinking days per week.
  • •Currently engaged in treatment for Alcohol Use Disorder (AUD).
  • •Current clinically significant bipolar affective disorder, schizophrenia, or psychotic disorder.
  • •Imminently suicidal or homicidal.
  • •Participants taking psychoactive medications that may affect alcohol craving or consumption.
  • •A score of 10 or higher on the Clinical Institute of Alcohol Withdrawal Revised (CIWA-R).24

Arms & Interventions

Cognitive Interference Task

Experimental

Participants in this arm will complete random assessments of alcohol use and cravings on their phone, and be prompted to play Tetris on their phone after reporting cravings for alcohol.

Intervention: Tetris and Assessments (Behavioral)

Assessment Only

Active Comparator

Participants in this arm will complete random assessments of alcohol use and cravings on their phone.

Intervention: Assessment Only (Other)

Outcomes

Primary Outcomes

Average Drinks Per Occasion

Time Frame: Participants reported alcohol consumption one month after the intervention.

Participants completed the Timeline Follow Back, which assesses past-month alcohol consumption. The outcome measure is average drinks per drinking occasion. Scores ranged from 0 to 6.29 drinks. Higher scores indicate greater average drinks consumed per occasion.

Number of Standard Drinks

Time Frame: Participants reported number of standard drinks each morning at a scheduled time for 14 days.

Participants reported the number of standard drinks consumed yesterday. The scale ranged from 0 to more than 20. Higher scores indicate more drinks consumed. A single value for number of standard drinks reported each day for 14 days was averaged across all participants.

Changes in Alcohol Craving Before and After Tetris Task

Time Frame: Participants reported pre- and post-task alcohol craving up to three times per day for a 14-day intervention period. Post-task craving was measured right after the Tetris task/control break and pre-task craving was measured directly before.

During the intervention phase, participants received up to three daily random in-vivo assessments assessing craving. Participants in the experimental group completed a Tetris task if they reported a positive response to craving and participants in the control group took an equivalently long break. Participants then re-rated their craving. Both craving assessments used a single item from the Visual Analogue Craving Scale ("How strong is your craving for alcohol RIGHT NOW?"), ranging from 0 to 100. The outcome measure represents change in craving, calculated as post-task craving minus pre-task craving. The change score was the difference in craving before and after the experimental task or the wait period. A single value for change in alcohol craving reported at each assessment during the 14 days was averaged across all participants.

Changes in Alcohol Craving Before and After Cue Tetris Task

Time Frame: Participants reported pre- and post-task alcohol craving up to once a day for a 14-day intervention period. Post-task craving was measured right after the CREMA/wait period and pre-task craving was measured directly before.

During the intervention phase, participants received a daily Cue Reactivity Ecological Momentary Assessment (CREMA), which provides real-time responses to alcohol-related imagery. After the CREMA, participants in the experimental group completed a Tetris task and participants in the control group took an equivalently long break. Participants then re-rated their craving. Both craving assessments used a single item from the Visual Analogue Craving Scale ("How strong is your craving for alcohol RIGHT NOW?"), ranging from 0 to 100. The outcome measure represents change in craving, calculated as post-task craving minus pre-task craving. A single value for change in alcohol craving reported at each cue reactivity assessment during the 14 days was averaged across all participants.

Alcohol Craving

Time Frame: Participants reported cravings one-month after the intervention.

Participants completed the 4-item imagery subscale of the Craving Experiences Questionnaire, which measures craving/intense desire. Items are rated on a 0 to 10 point scale. A mean was calculated from the 4-item imagery subscale, with a possible range of 0 to 10. Higher scores indicate greater alcohol craving.

Secondary Outcomes

  • Drinking Motives(Participants reported drinking motives at baseline.)
  • Obsessive Thoughts About Alcohol(Participants reported obsessive thoughts about alcohol at a single baseline assessment, which occurred the day before the EMA period began.)
  • Acceptability Ratings(Recorded within one-week after the intervention.)
  • Feasibility of Intervention(This was recorded during the 14-day intervention phase.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Christine Hahn

Research Assistant Professor

Medical University of South Carolina

Study Sites (1)

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