NCT04924283

Cognitive Interference Task on Alcohol Craving and Consumption

Completed NA Results posted Last updated 25 April 2024

What this trial tests

NA trial testing Tetris and Assessments in Alcohol Drinking in 40 participants. Completed in 30 December 2022.

Timeline

25 June 2021

Primary endpoint
30 December 2022

30 December 2022

Quick facts

Lead sponsor	Medical University of South Carolina
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	40
Start date	25 June 2021
Primary completion	30 December 2022
Estimated completion	30 December 2022
Sites	1 location across United States

Drugs / interventions tested

• Tetris and Assessments
• Assessment Only

Conditions studied

• Alcohol Drinking — all drugs for Alcohol Drinking →
• Craving — all drugs for Craving →

Sponsor

Medical University of South Carolina

Who can join

Adults 21 to 65, female only, with Alcohol Drinking or Craving. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Alcohol Craving Primary · 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.

Group	Value	95% CI
Cognitive Interference Task	2.51	± 2.65
Assessment Only	2.79	± 2.57

Average Drinks Per Occasion Primary · 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.

Group	Value	95% CI
Cognitive Interference Task	3.31	± 1.62
Assessment Only	2.75	± 1.38

Number of Standard Drinks Primary · 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.

Group	Value	95% CI
Cognitive Interference Task	2.00	± 2.87
Assessment Only	1.58	± 2.06

Changes in Alcohol Craving Before and After Tetris Task Primary · 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 c

Group	Value	95% CI
Cognitive Interference Task	-10.16	± 20.56
Assessment Only	-2.63	± 13.95

Changes in Alcohol Craving Before and After Cue Tetris Task Primary · 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 po

Group	Value	95% CI
Cognitive Interference Task	0.30	± 17.93
Assessment Only	1.69	± 12.47

Obsessive Thoughts About Alcohol Secondary · 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.

Group	Value	95% CI
Cognitive Interference Task	4.10	± 3.77
Assessment Only	2.55	± 2.44

Drinking Motives Secondary · 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.

Group	Value	95% CI
Cognitive Interference Task	2.251786	± .6690041
Assessment Only	2.198214	± .6381906

Feasibility of Intervention Secondary · 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.

Group	Value	95% CI
Cognitive Interference Task	89.4
Assessment Only	86.3

Acceptability Ratings Secondary · 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).

Group	Value	95% CI
Cognitive Interference Task	14.3	± 4.243881

Depression Symptoms Secondary · 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.

Group	Value	95% CI
Cognitive Interference Task	5.25	± 3.971941
Assessment Only	5.75	± 5.087394

Post-traumatic Stress Disorder Symptoms Secondary · 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.

Group	Value	95% CI
Cognitive Interference Task	17.9	± 14.06
Assessment Only	15.85	± 14.92

Alcohol Use Disorder Symptoms at Baseline Secondary · 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.

Group	Value	95% CI
Cognitive Interference Task	12.3	± 6.681475
Assessment Only	10.4	± 7.214021

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.