Back to resultsCognitive Interference Task on Alcohol Craving and Consumption
Primary Purpose
Alcohol Drinking, Craving
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tetris and Assessments
Assessment Only
Sponsored by
About this trial
This is an interventional basic science trial for Alcohol Drinking focused on measuring ecological momentary assessment, cognitive interference
Eligibility Criteria
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 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
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cognitive Interference Task
Assessment Only
Arm Description
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.
Participants in this arm will complete random assessments of alcohol use and cravings on their phone.
Outcomes
Primary Outcome Measures
Changes on Craving for Alcohol Before and After Tetris Task
Participants will complete items from the Craving Experiences Questionnaire.
Changes in Alcohol Consumption Before and After Tetris Task
Participants will complete the Time Line Follow Back.
Changes in Alcohol Consumption Before and After Tetris Task
Participants will be asked to record the number of drinks they had before the last assessment.
Changes in Alcohol Craving Before and After Tetris Task
Participants will rate their craving on a single item from the Visual Analogue Craving Scale.
Changes in Alcohol Craving Before and After Cue Tetris Task
Participants will rate their craving on a single item from the Visual Analogue Craving Scale.
Secondary Outcome Measures
Changes in Alcohol Craving Before and After Task
Participants will rate their craving and drinking behavior on the Obsessive Compulsive Drinking Scale.
Changes in Drinking Motives Before and After Task
Participants will rate their drinking motives on the Drinking Motives Questionnaire.
Feasibility of Intervention
The proportion of prompts participants respond to, and the response time to complete prompts.
Acceptability Ratings
Participants will rate acceptability of the intervention on the Acceptability of Intervention Measure.
Full Information
NCT ID
NCT04924283
First Posted
June 6, 2021
Last Updated
February 1, 2023
Sponsor
Medical University of South Carolina
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT04924283
Brief Title
Cognitive Interference Task on Alcohol Craving and Consumption
Official Title
Effects of a Cognitive Interference Task on Alcohol Craving and Consumption Among Women
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 25, 2021 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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, and play the Tetris game on their phones daily for a 3-week period. Participants will also complete a cue-reactivity task, that involves viewing pictures of alcohol and rating cravings.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Craving
Keywords
ecological momentary assessment, cognitive interference
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Interference Task
Arm Type
Experimental
Arm Description
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.
Arm Title
Assessment Only
Arm Type
Active Comparator
Arm Description
Participants in this arm will complete random assessments of alcohol use and cravings on their phone.
Intervention Type
Behavioral
Intervention Name(s)
Tetris and Assessments
Intervention Description
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-rerate craving after the task.
Intervention Type
Other
Intervention Name(s)
Assessment Only
Intervention Description
Participants will complete assessments on their phone to rate cravings for alcohol.
Primary Outcome Measure Information:
Title
Changes on Craving for Alcohol Before and After Tetris Task
Description
Participants will complete items from the Craving Experiences Questionnaire.
Time Frame
Participants will report cravings at baseline, during the intervention phase, within one-week after the intervention, and one-month after the intervention.
Title
Changes in Alcohol Consumption Before and After Tetris Task
Description
Participants will complete the Time Line Follow Back.
Time Frame
Participants will report alcohol consumption at baseline, during the intervention phase, within one-week after the intervention, and one-month after the intervention.
Title
Changes in Alcohol Consumption Before and After Tetris Task
Description
Participants will be asked to record the number of drinks they had before the last assessment.
Time Frame
Participants will report alcohol consumption at baseline, during the intervention phase, within one-week after the intervention, and one-month after the intervention.
Title
Changes in Alcohol Craving Before and After Tetris Task
Description
Participants will rate their craving on a single item from the Visual Analogue Craving Scale.
Time Frame
Participants will report alcohol consumption at baseline, during the intervention phase, within one-week after the intervention, and one-month after the intervention.
Title
Changes in Alcohol Craving Before and After Cue Tetris Task
Description
Participants will rate their craving on a single item from the Visual Analogue Craving Scale.
Time Frame
Participants will report alcohol consumption at baseline, during the intervention phase, within one-week after the intervention, and one-month after the intervention.
Secondary Outcome Measure Information:
Title
Changes in Alcohol Craving Before and After Task
Description
Participants will rate their craving and drinking behavior on the Obsessive Compulsive Drinking Scale.
Time Frame
Participants will report alcohol consumption at baseline, within one-week after the intervention, and one-month after the intervention.
Title
Changes in Drinking Motives Before and After Task
Description
Participants will rate their drinking motives on the Drinking Motives Questionnaire.
Time Frame
Participants will report alcohol consumption at baseline, within one-week after the intervention, and one-month after the intervention..
Title
Feasibility of Intervention
Description
The proportion of prompts participants respond to, and the response time to complete prompts.
Time Frame
This will be recorded during the intervention phase.
Title
Acceptability Ratings
Description
Participants will rate acceptability of the intervention on the Acceptability of Intervention Measure.
Time Frame
This will be recorded within one-week after the intervention.
Other Pre-specified Outcome Measures:
Title
Mood Ratings
Description
Participants will rate their mood on a 100-point scale ranging from unpleasant to pleasant. A higher score indicates a better or more pleasant mood.
Time Frame
This will be recorded during the intervention phase.
Title
Stress Ratings
Description
Participants will rate their stress using a 100-point scale ranging from not at all to extremely. A higher score indicates greater stress.
Time Frame
This will be recorded during the intervention phase.
Title
Changes in Depression Symptoms
Description
Participants will rate their depression symptoms on the Patient Health Questionnaire
Time Frame
Participants will report depression symptoms at baseline, within one-week after the intervention, and one-month after the intervention..
Title
Changes in Post-traumatic Stress Disorder Symptoms
Description
Participants will rate symptoms of posttraumatic stress disorder on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5).
Time Frame
Participants will report depression symptoms at baseline, within one-week after the intervention, and one-month after the intervention..
Title
Alcohol Use Disorder Symptoms at Baseline
Description
Participants will rate symptoms of alcohol use disorder on the the Alcohol Use Disorder Identification Test (AUDIT),
Time Frame
Participants will report depression symptoms at baseline.
Title
Alcohol Use Disorder Symptoms at Baseline
Description
Participants will complete a structured interview to assess alcohol use disorder symptoms using the DIAMOND.
Time Frame
Participants will report alcohol use disorder symptoms at baseline.
Title
COVID-19 Related Stress at Baseline
Description
Participants will report the impact of COVID-19 on stress and drinking.
Time Frame
Participants will report COVID-19 related stress at baseline.
Title
Impulsivity at Baseline
Description
Participants will report impulsivity on the Short Urgency, Premeditation, Perseverance, Sensation seeking, and Positive Urgency Impulsive Behavior Scale.
Time Frame
Participants will report impulsvity at baseline.
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female-ADD RATIONALE
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cognitive Interference Task on Alcohol Craving and Consumption
We'll reach out to this number within 24 hrs