Cognitive Interference Task on Alcohol Craving and Consumption

NCT04924283 | Completed Results

• 1 other identifier: 00102351
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Drinking; Craving

Keywords

ecological momentary assessment; cognitive interference

Outcome Measures

Primary Outcomes (5)

• Alcohol Craving

  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.

  Participants reported cravings one-month after the intervention.

• Average Drinks Per Occasion

  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.

  Participants reported alcohol consumption one month after the intervention.

• Number of Standard Drinks

  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.

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

• Changes in Alcohol Craving Before and After Tetris Task

  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.

  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.

• Changes in Alcohol Craving Before and After Cue Tetris Task

  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.

  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.

Secondary Outcomes (4)

• Obsessive Thoughts About Alcohol

  Participants reported obsessive thoughts about alcohol at a single baseline assessment, which occurred the day before the EMA period began.

• Drinking Motives

  Participants reported drinking motives at baseline.

• Feasibility of Intervention

  This was recorded during the 14-day intervention phase.

• Acceptability Ratings

  Recorded within one-week after the intervention.

Other Outcomes (8)

• Mood Ratings

  This will be recorded during the intervention phase.

• Stress Ratings

  This will be recorded during the intervention phase.

• Depression Symptoms

  Participants reported depression symptoms at baseline.

Study Arms (2)

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.

Behavioral: Tetris and Assessments

Assessment Only

ACTIVE COMPARATOR

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

Other: Assessment Only

Interventions

Tetris and Assessments BEHAVIORAL

Participants will complete assessments on their phone to rate cravings for alcohol. Participants will complete a visual cognitive interference task (i.e., play Tetris on their phone) after endorsing a alcohol craving, and then re-rate craving after the task.

Cognitive Interference Task

Assessment Only OTHER

Participants will complete assessments on their phone to rate cravings for alcohol.

Assessment Only

Eligibility Criteria

• Age: 21 Years - 65 Years
• Gender Eligibility Details: Female-ADD RATIONALE
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Pregnant.
• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Results Point of Contact

• Title: Christine Hahn
• Organization: Medical University of South Carolina

hahnc@musc.edu

843-518-2875

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: June 6, 2021
• First Posted: June 11, 2021
• Study Start: June 25, 2021
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: April 25, 2024
• Results First Posted: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)