Trial Outcomes & Findings for Cognitive Interference Task on Alcohol Craving and Consumption (NCT NCT04924283)

NCT ID: NCT04924283

Last Updated: 2024-04-25

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: Participants reported cravings one-month after the intervention.
• Results posted on: 2024-04-25

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	20	20
Overall Study COMPLETED	20	17
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cognitive Interference Task on Alcohol Craving and Consumption

Baseline characteristics by cohort

Measure	Cognitive Interference Task n=20 Participants 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.	Assessment Only n=20 Participants 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.	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	30.90 years STANDARD_DEVIATION 9.67 • n=5 Participants	29.90 years STANDARD_DEVIATION 7.80 • n=7 Participants	30.40 years STANDARD_DEVIATION 8.69 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	17 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Cognitive Interference Task n=20 Participants 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.	Assessment Only n=20 Participants 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.
Alcohol Craving	2.51 units on a scale Standard Deviation 2.65	2.79 units on a scale Standard Deviation 2.57

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Cognitive Interference Task n=20 Participants 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.	Assessment Only n=20 Participants 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.
Average Drinks Per Occasion	3.31 average drinks per drinking occasion Standard Deviation 1.62	2.75 average drinks per drinking occasion Standard Deviation 1.38

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Cognitive Interference Task n=20 Participants 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.	Assessment Only n=20 Participants 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.
Number of Standard Drinks	2.00 drinks Standard Deviation 2.87	1.58 drinks Standard Deviation 2.06

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Cognitive Interference Task n=20 Participants 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.	Assessment Only n=20 Participants 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.
Changes in Alcohol Craving Before and After Tetris Task	-10.16 units on a scale Standard Deviation 20.56	-2.63 units on a scale Standard Deviation 13.95

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Cognitive Interference Task n=20 Participants 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.	Assessment Only n=20 Participants 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.
Changes in Alcohol Craving Before and After Cue Tetris Task	0.30 units on a scale Standard Deviation 17.93	1.69 units on a scale Standard Deviation 12.47

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Cognitive Interference Task n=20 Participants 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.	Assessment Only n=20 Participants 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.
Obsessive Thoughts About Alcohol	4.10 units on a scale Standard Deviation 3.77	2.55 units on a scale Standard Deviation 2.44

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Cognitive Interference Task n=20 Participants 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.	Assessment Only n=20 Participants 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.
Drinking Motives	2.251786 score on a scale Standard Deviation .6690041	2.198214 score on a scale Standard Deviation .6381906

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Cognitive Interference Task n=1120 surveys 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.	Assessment Only n=1120 surveys 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.
Feasibility of Intervention	89.4 percentage of possible surveys completed	86.3 percentage of possible surveys completed

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	Cognitive Interference Task n=20 Participants 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.	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.
Acceptability Ratings	14.3 units on a scale Standard Deviation 4.243881	—

OTHER_PRE_SPECIFIED outcome

Timeframe: This 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: This 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Participants 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.

Outcome measures

Measure	Cognitive Interference Task n=20 Participants 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.	Assessment Only n=20 Participants 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.
Depression Symptoms	5.25 score on a scale Standard Deviation 3.971941	5.75 score on a scale Standard Deviation 5.087394

OTHER_PRE_SPECIFIED outcome

Timeframe: Participants 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.

Outcome measures

Measure	Cognitive Interference Task n=20 Participants 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.	Assessment Only n=20 Participants 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.
Post-traumatic Stress Disorder Symptoms	17.9 score on a scale Standard Deviation 14.06	15.85 score on a scale Standard Deviation 14.92

OTHER_PRE_SPECIFIED outcome

Timeframe: Participants 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.

Outcome measures

Measure	Cognitive Interference Task n=20 Participants 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.	Assessment Only n=20 Participants 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.
Alcohol Use Disorder Symptoms at Baseline	12.3 score on a scale Standard Deviation 6.681475	10.4 score on a scale Standard Deviation 7.214021

OTHER_PRE_SPECIFIED outcome

Timeframe: Participants 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.

Outcome measures

Measure	Cognitive Interference Task n=20 Participants 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.	Assessment Only n=20 Participants 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.
Alcohol Use Disorder at Baseline	12 Participants	11 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Participants 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.

Outcome measures

Measure	Cognitive Interference Task n=20 Participants 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.	Assessment Only n=20 Participants 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.
COVID-19 Related Stress at Baseline	1.65 units on a scale Standard Deviation 1.089423	1.5 units on a scale Standard Deviation 1.147079

OTHER_PRE_SPECIFIED outcome

Timeframe: Participants 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.

Outcome measures

Measure	Cognitive Interference Task n=20 Participants 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.	Assessment Only n=20 Participants 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.
Impulsivity at Baseline	11.5 score on a scale Standard Deviation 2.800376	11.7 score on a scale Standard Deviation 3.599708

Adverse Events

Cognitive Interference Task

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Assessment Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Christine Hahn

Medical University of South Carolina

Phone: 843-518-2875

Email: hahnc@musc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place