Cognitive Interference Task on Alcohol Craving and Consumption

Sponsor
Medical University of South Carolina (Other)
Overall Status
Recruiting
CT.gov ID
NCT04924283
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
40
1
2
15.2
2.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Tetris and Assessments
  • Other: Assessment Only
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Effects of a Cognitive Interference Task on Alcohol Craving and Consumption Among Women
Actual Study Start Date :
Jun 25, 2021
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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-rerate craving after the task.

Active Comparator: Assessment Only

Participants in this arm will complete random assessments of alcohol use and cravings on their phone.

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

Outcome Measures

Primary Outcome Measures

  1. Changes on Craving for Alcohol Before and After Tetris Task [Participants will report cravings at baseline, during the intervention phase, within one-week after the intervention, and one-month after the intervention.]

    Participants will complete items from the Craving Experiences Questionnaire.

  2. Changes in Alcohol Consumption Before and After Tetris Task [Participants will report alcohol consumption at baseline, during the intervention phase, within one-week after the intervention, and one-month after the intervention.]

    Participants will complete the Time Line Follow Back.

  3. Changes in Alcohol Consumption Before and After Tetris Task [Participants will report alcohol consumption at baseline, during the intervention phase, within one-week after the intervention, and one-month after the intervention.]

    Participants will be asked to record the number of drinks they had before the last assessment.

  4. Changes in Alcohol Craving Before and After Tetris Task [Participants will report alcohol consumption at baseline, during the intervention phase, within one-week after the intervention, and one-month after the intervention.]

    Participants will rate their craving on a single item from the Visual Analogue Craving Scale.

  5. Changes in Alcohol Craving Before and After Cue Tetris Task [Participants will report alcohol consumption at baseline, during the intervention phase, within one-week after the intervention, and one-month after the intervention.]

    Participants will rate their craving on a single item from the Visual Analogue Craving Scale.

Secondary Outcome Measures

  1. Changes in Alcohol Craving Before and After Task [Participants will report alcohol consumption at baseline, within one-week after the intervention, and one-month after the intervention.]

    Participants will rate their craving and drinking behavior on the Obsessive Compulsive Drinking Scale.

  2. Changes in Drinking Motives Before and After Task [Participants will report alcohol consumption at baseline, within one-week after the intervention, and one-month after the intervention..]

    Participants will rate their drinking motives on the Drinking Motives Questionnaire.

  3. Feasibility of Intervention [This will be recorded during the intervention phase.]

    The proportion of prompts participants respond to, and the response time to complete prompts.

  4. Acceptability Ratings [This will be recorded within one-week after the intervention.]

    Participants will rate acceptability of the intervention on the Acceptability of Intervention Measure.

Other Outcome Measures

  1. Mood Ratings [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.

  2. Stress Ratings [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.

  3. Changes in Depression Symptoms [Participants will report depression symptoms at baseline, within one-week after the intervention, and one-month after the intervention..]

    Participants will rate their depression symptoms on the Patient Health Questionnaire

  4. Changes in Post-traumatic Stress Disorder Symptoms [Participants will report depression symptoms at baseline, within one-week after the intervention, and one-month after the intervention..]

    Participants will rate symptoms of posttraumatic stress disorder on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5).

  5. Alcohol Use Disorder Symptoms at Baseline [Participants will report depression symptoms at baseline.]

    Participants will rate symptoms of alcohol use disorder on the the Alcohol Use Disorder Identification Test (AUDIT),

  6. Alcohol Use Disorder Symptoms at Baseline [Participants will report alcohol use disorder symptoms at baseline.]

    Participants will complete a structured interview to assess alcohol use disorder symptoms using the DIAMOND.

  7. COVID-19 Related Stress at Baseline [Participants will report COVID-19 related stress at baseline.]

    Participants will report the impact of COVID-19 on stress and drinking.

  8. Impulsivity at Baseline [Participants will report impulsvity at baseline.]

    Participants will report impulsivity on the Short Urgency, Premeditation, Perseverance, Sensation seeking, and Positive Urgency Impulsive Behavior Scale.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts 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 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University of South Carolina Charleston South Carolina United States 29425

Sponsors and Collaborators

  • Medical University of South Carolina
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Christine Hahn, Research Assistant Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT04924283
Other Study ID Numbers:
  • 00102351
First Posted:
Jun 11, 2021
Last Update Posted:
Jul 27, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Christine Hahn, Research Assistant Professor, Medical University of South Carolina
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 27, 2022