Cognitive Interference Task on Alcohol Craving and Consumption

Alcohol Drinking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04924283
• Other study ID #: 00102351
• Status: Completed
• Phase: N/A
• Start date: June 25, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: April 2024
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Craving

Intervention

Behavioral:
• 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-rate craving after the task.

Other:
• Assessment Only
Participants will complete assessments on their phone to rate cravings for alcohol.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	This will be recorded during the intervention phase.
Other	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.	This will be recorded during the intervention phase.
Other	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.	Participants reported depression symptoms at baseline.
Other	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.	Participants reported posttraumatic stress symptoms at baseline.
Other	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.	Participants reported self-reported symptoms of alcohol use disorder at baseline.
Other	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.	Participants reported alcohol use disorder symptoms at baseline.
Other	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.	Participants reported COVID-19 related stress at baseline.
Other	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.	Participants reported impulsivity at baseline.
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.	Participants reported cravings one-month after the intervention.
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.	Participants reported alcohol consumption one month after the intervention.
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.	Participants reported number of standard drinks each morning at a scheduled time for 14 days.
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.	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.
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.	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.
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.	Participants reported obsessive thoughts about alcohol at a single baseline assessment, which occurred the day before the EMA period began.
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.	Participants reported drinking motives at baseline.
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.	This was recorded during the 14-day intervention phase.
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).	Recorded within one-week after the intervention.