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Cognitive Interference Task on Alcohol Craving and Consumption

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04924283
Enrollment
40
Registered
2021-06-11
Start date
2021-06-25
Completion date
2022-12-30
Last updated
2024-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Drinking, Craving

Keywords

ecological momentary assessment, cognitive interference

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.

Interventions

BEHAVIORALTetris and Assessments

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.

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

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
Medical University of South Carolina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
21 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

1. Female, any race or ethnicity, age 21 to 65 years old. 2. Able to comprehend English. 3. At least one heavy drinking per week (i.e., consuming at least four or more drinks in one day) for the last two weeks 4. Internet access and reliable electronic device

Exclusion criteria

1. More than four heavy drinking days per week. 2. Currently engaged in treatment for Alcohol Use Disorder (AUD). 3. Current clinically significant bipolar affective disorder, schizophrenia, or psychotic disorder. 4. Pregnant. 5. Imminently suicidal or homicidal. 6. Participants taking psychoactive medications that may affect alcohol craving or consumption. 7. A score of 10 or higher on the Clinical Institute of Alcohol Withdrawal Revised (CIWA-R).24

Design outcomes

Primary

MeasureTime frameDescription
Alcohol CravingParticipants 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.
Changes in Alcohol Craving Before and After Cue Tetris TaskParticipants 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.
Changes in Alcohol Craving Before and After Tetris TaskParticipants 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.
Number of Standard DrinksParticipants 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.
Average Drinks Per OccasionParticipants 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.

Secondary

MeasureTime frameDescription
Obsessive Thoughts About AlcoholParticipants 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.
Drinking MotivesParticipants 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.
Feasibility of InterventionThis 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.
Acceptability RatingsRecorded 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).

Other

MeasureTime frameDescription
Post-traumatic Stress Disorder SymptomsParticipants reported posttraumatic stress symptoms at baseline.Participants rated symptoms of posttraumatic stress disorder on the Posttraumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5). Each symptom is rated on a 0 to 4 point scale. The 20 items are totaled and scores can range from 0 to 80. Higher scores indicate greater posttraumatic stress disorder symptoms.
Depression SymptomsParticipants reported depression symptoms at baseline.Participants responded to the Patient Health Questionnaire assessing symptoms of depression. The item assessing suicidal ideation was omitted. The 8 items included were rated on a 4 point scale ranging from 0 to 3 and totaled. Scores ranged from 0 to 24 and higher scores indicate greater symptoms of depression.
Stress RatingsThis will be recorded during the intervention phase.Participants will rate their stress using a 100-point scale ranging from not at all to extremely. A higher score indicates greater stress.
Alcohol Use Disorder at BaselineParticipants reported alcohol use disorder symptoms at baseline.Participants completed a structured interview to assess alcohol use disorder symptoms using the DIAMOND. The percent of participants who met criteria for an alcohol use disorder based on a clinical interview is reported.
Alcohol Use Disorder Symptoms at BaselineParticipants reported self-reported symptoms of alcohol use disorder at baseline.Participants rated symptoms of alcohol use disorder on the the Alcohol Use Disorder Identification Test (AUDIT). The AUDIT includes ten items assessing symptoms of alcohol use disorder. Each item is rated from 0 to 4 and items are added. Total scores on the Alcohol Use Disorder Identification Test (AUDIT) are reported. A score of 8 or higher is the suggested cut-off for harmful drinking.
COVID-19 Related Stress at BaselineParticipants reported COVID-19 related stress at baseline.Participants reported the impact of coronavirus disease 2019 (COVID-19) on stress and drinking. Average of self-reported stress due to COVID-19 on a single item rated on a 4 point scale (0 to 4) is reported. Higher scores indicate greater stress.
Impulsivity at BaselineParticipants reported impulsivity at baseline.Participants reported impulsivity on the Short Negative Urgency, Premeditation, Perseverance, Sensation Seeking, and Positive Urgency Impulsive Behavior Scale. The total scores for negative urgency is reported. Total scores were calculated for negative urgency (range 4 to 16) by adding 4 items assessing tendency to act rashly when feeling upset. Each item was rated on a 1 to 4 scale, with higher scores indicating greater tendency to act rashly when upset.
Mood RatingsThis will be recorded during the intervention phase.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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Cognitive Interference Task
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. Tetris and Assessments: 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.
20
Assessment Only
Participants in this arm will complete random assessments of alcohol use and cravings on their phone. Assessment Only: Participants will complete assessments on their phone to rate cravings for alcohol.
20
Total40

Baseline characteristics

CharacteristicCognitive Interference TaskAssessment OnlyTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
20 Participants20 Participants40 Participants
Age, Continuous30.90 years
STANDARD_DEVIATION 9.67
29.90 years
STANDARD_DEVIATION 7.8
30.40 years
STANDARD_DEVIATION 8.69
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
20 Participants20 Participants40 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants2 Participants2 Participants
Race (NIH/OMB)
More than one race
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
20 Participants17 Participants37 Participants
Region of Enrollment
United States
20 participants20 participants40 participants
Sex: Female, Male
Female
20 Participants20 Participants40 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 200 / 20
other
Total, other adverse events
0 / 200 / 20
serious
Total, serious adverse events
0 / 200 / 20

Outcome results

Primary

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.

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

ArmMeasureValue (MEAN)Dispersion
Cognitive Interference TaskAlcohol Craving2.51 units on a scaleStandard Deviation 2.65
Assessment OnlyAlcohol Craving2.79 units on a scaleStandard Deviation 2.57
Primary

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.

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

ArmMeasureValue (MEAN)Dispersion
Cognitive Interference TaskAverage Drinks Per Occasion3.31 average drinks per drinking occasionStandard Deviation 1.62
Assessment OnlyAverage Drinks Per Occasion2.75 average drinks per drinking occasionStandard Deviation 1.38
Primary

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.

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.

ArmMeasureValue (MEAN)Dispersion
Cognitive Interference TaskChanges in Alcohol Craving Before and After Cue Tetris Task0.30 units on a scaleStandard Deviation 17.93
Assessment OnlyChanges in Alcohol Craving Before and After Cue Tetris Task1.69 units on a scaleStandard Deviation 12.47
Primary

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.

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.

ArmMeasureValue (MEAN)Dispersion
Cognitive Interference TaskChanges in Alcohol Craving Before and After Tetris Task-10.16 units on a scaleStandard Deviation 20.56
Assessment OnlyChanges in Alcohol Craving Before and After Tetris Task-2.63 units on a scaleStandard Deviation 13.95
Primary

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.

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

ArmMeasureValue (MEAN)Dispersion
Cognitive Interference TaskNumber of Standard Drinks2.00 drinksStandard Deviation 2.87
Assessment OnlyNumber of Standard Drinks1.58 drinksStandard Deviation 2.06
Secondary

Acceptability Ratings

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).

Time frame: Recorded within one-week after the intervention.

Population: Only the experimental group rated acceptability of playing Tetris because the control did not play the game.

ArmMeasureValue (MEAN)Dispersion
Cognitive Interference TaskAcceptability Ratings14.3 units on a scaleStandard Deviation 4.243881
Secondary

Drinking Motives

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.

Time frame: Participants reported drinking motives at baseline.

ArmMeasureValue (MEAN)Dispersion
Cognitive Interference TaskDrinking Motives2.251786 score on a scaleStandard Deviation 0.6690041
Assessment OnlyDrinking Motives2.198214 score on a scaleStandard Deviation 0.6381906
Secondary

Feasibility of Intervention

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.

Time frame: This was recorded during the 14-day intervention phase.

Population: Surveys during the 14-day intervention phase. Each participant was sent 4 surveys per day for 14 days.

ArmMeasureValue (NUMBER)
Cognitive Interference TaskFeasibility of Intervention89.4 percentage of possible surveys completed
Assessment OnlyFeasibility of Intervention86.3 percentage of possible surveys completed
Secondary

Obsessive Thoughts About Alcohol

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.

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

ArmMeasureValue (MEAN)Dispersion
Cognitive Interference TaskObsessive Thoughts About Alcohol4.10 units on a scaleStandard Deviation 3.77
Assessment OnlyObsessive Thoughts About Alcohol2.55 units on a scaleStandard Deviation 2.44
Other Pre-specified

Alcohol Use Disorder at Baseline

Participants completed a structured interview to assess alcohol use disorder symptoms using the DIAMOND. The percent of participants who met criteria for an alcohol use disorder based on a clinical interview is reported.

Time frame: Participants reported alcohol use disorder symptoms at baseline.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Cognitive Interference TaskAlcohol Use Disorder at Baseline12 Participants
Assessment OnlyAlcohol Use Disorder at Baseline11 Participants
Other Pre-specified

Alcohol Use Disorder Symptoms at Baseline

Participants rated symptoms of alcohol use disorder on the the Alcohol Use Disorder Identification Test (AUDIT). The AUDIT includes ten items assessing symptoms of alcohol use disorder. Each item is rated from 0 to 4 and items are added. Total scores on the Alcohol Use Disorder Identification Test (AUDIT) are reported. A score of 8 or higher is the suggested cut-off for harmful drinking.

Time frame: Participants reported self-reported symptoms of alcohol use disorder at baseline.

ArmMeasureValue (MEAN)Dispersion
Cognitive Interference TaskAlcohol Use Disorder Symptoms at Baseline12.3 score on a scaleStandard Deviation 6.681475
Assessment OnlyAlcohol Use Disorder Symptoms at Baseline10.4 score on a scaleStandard Deviation 7.214021
Other Pre-specified

COVID-19 Related Stress at Baseline

Participants reported the impact of coronavirus disease 2019 (COVID-19) on stress and drinking. Average of self-reported stress due to COVID-19 on a single item rated on a 4 point scale (0 to 4) is reported. Higher scores indicate greater stress.

Time frame: Participants reported COVID-19 related stress at baseline.

ArmMeasureValue (MEAN)Dispersion
Cognitive Interference TaskCOVID-19 Related Stress at Baseline1.65 units on a scaleStandard Deviation 1.089423
Assessment OnlyCOVID-19 Related Stress at Baseline1.5 units on a scaleStandard Deviation 1.147079
Other Pre-specified

Depression Symptoms

Participants responded to the Patient Health Questionnaire assessing symptoms of depression. The item assessing suicidal ideation was omitted. The 8 items included were rated on a 4 point scale ranging from 0 to 3 and totaled. Scores ranged from 0 to 24 and higher scores indicate greater symptoms of depression.

Time frame: Participants reported depression symptoms at baseline.

ArmMeasureValue (MEAN)Dispersion
Cognitive Interference TaskDepression Symptoms5.25 score on a scaleStandard Deviation 3.971941
Assessment OnlyDepression Symptoms5.75 score on a scaleStandard Deviation 5.087394
Other Pre-specified

Impulsivity at Baseline

Participants reported impulsivity on the Short Negative Urgency, Premeditation, Perseverance, Sensation Seeking, and Positive Urgency Impulsive Behavior Scale. The total scores for negative urgency is reported. Total scores were calculated for negative urgency (range 4 to 16) by adding 4 items assessing tendency to act rashly when feeling upset. Each item was rated on a 1 to 4 scale, with higher scores indicating greater tendency to act rashly when upset.

Time frame: Participants reported impulsivity at baseline.

ArmMeasureValue (MEAN)Dispersion
Cognitive Interference TaskImpulsivity at Baseline11.5 score on a scaleStandard Deviation 2.800376
Assessment OnlyImpulsivity at Baseline11.7 score on a scaleStandard Deviation 3.599708
Other Pre-specified

Mood Ratings

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.

Other Pre-specified

Post-traumatic Stress Disorder Symptoms

Participants rated symptoms of posttraumatic stress disorder on the Posttraumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5). Each symptom is rated on a 0 to 4 point scale. The 20 items are totaled and scores can range from 0 to 80. Higher scores indicate greater posttraumatic stress disorder symptoms.

Time frame: Participants reported posttraumatic stress symptoms at baseline.

ArmMeasureValue (MEAN)Dispersion
Cognitive Interference TaskPost-traumatic Stress Disorder Symptoms17.9 score on a scaleStandard Deviation 14.06
Assessment OnlyPost-traumatic Stress Disorder Symptoms15.85 score on a scaleStandard Deviation 14.92
Other Pre-specified

Stress Ratings

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.

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026