Cognitive Interference Task on Alcohol Craving and Consumption

Not Applicable

Completed

Conditions: Alcohol Drinking
Craving

Interventions: Other: Assessment Only
Behavioral: Tetris and Assessments

Registration Number: NCT04924283

Lead Sponsor: Medical University of South Carolina

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 40

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.
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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Assessment Only	Assessment Only	Participants in this arm will complete random assessments of alcohol use and cravings on their phone.
Cognitive Interference Task	Tetris and Assessments	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.

Primary Outcome Measures

Name	Time	Method
Average Drinks Per Occasion	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	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	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	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	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 Outcome Measures

Name	Time	Method
Drinking Motives	Participants reported drinking motives at baseline.	Participants rated their motivations for drinking alcohol on the Drinking Motives Questionnaire. The Drinking Motives Questionnaire consists of 28 items, each rated on a 1 to 5 scale. A mean score was calculated using all 28 items, with a total score range of 1 to 5. Higher scores indicate higher endorsement of motives to drink alcohol.
Obsessive Thoughts About Alcohol	Participants reported obsessive thoughts about alcohol at a single baseline assessment, which occurred the day before the EMA period began.	Participants rated their craving and drinking behavior on the 6-item Obsessive subscale of the Obsessive Compulsive Drinking Scale, which measures obsessive thoughts about alcohol. Each item is provided on a scale from 0 to 4. A total score was calculated, with a range of 0 to 24. Higher scores represent more obsessive thoughts of drinking.
Acceptability Ratings	Recorded within one-week after the intervention.	Participants rated acceptability of the intervention on the Acceptability of Intervention Measure. Each item was rated on a 1 to 5 point scale. Total scores of 4 items were calculated with higher scores indicating greater acceptability (range 4-20).
Feasibility of Intervention	This was recorded during the 14-day intervention phase.	The percentage of prompts participants responded to, calculated by the number of surveys participants responded to divided by the number of all possible surveys multiplied by 100%. Higher numbers indicate a greater number of responses.