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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Interference Task | Experimental | 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. |
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| Assessment Only | Active Comparator | Participants in this arm will complete random assessments of alcohol use and cravings on their phone. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tetris and Assessments | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Stress Ratings |
Inclusion Criteria:
Exclusion Criteria:
Female-ADD RATIONALE
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Participants reported cravings one-month after the intervention. |
|
Potential adverse events were collected during a 15 month period.
It does not differ.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine Hahn | Medical University of South Carolina | 843-518-2875 | hahnc@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 15, 2022 | Jan 16, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 25, 2022 | Jan 16, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
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| Assessment Only | Other | Participants will complete assessments on their phone to rate cravings for alcohol. |
|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | 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. |
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| 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. | Posted | Mean | Standard Deviation | average drinks per drinking occasion | Participants reported alcohol consumption one month after the intervention. |
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| 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. | Posted | Mean | Standard Deviation | drinks | Participants reported number of standard drinks each morning at a scheduled time for 14 days. |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | 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. |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | 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. |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Participants reported obsessive thoughts about alcohol at a single baseline assessment, which occurred the day before the EMA period began. |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Participants reported drinking motives at baseline. |
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| 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. | Surveys during the 14-day intervention phase. Each participant was sent 4 surveys per day for 14 days. | Posted | Number | percentage of possible surveys completed | This was recorded during the 14-day intervention phase. | surveys | surveys |
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| 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). | Only the experimental group rated acceptability of playing Tetris because the control did not play the game. | Posted | Mean | Standard Deviation | units on a scale | Recorded within one-week after the intervention. |
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| 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. | Not Posted | This will be recorded during the intervention phase. | Participants |
| 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. | Not Posted | This will be recorded during the intervention phase. | Participants |
| 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. | Posted | Mean | Standard Deviation | score on a scale | Participants reported depression symptoms at baseline. |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Participants reported posttraumatic stress symptoms at baseline. |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Participants reported self-reported symptoms of alcohol use disorder at baseline. |
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| 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. | Posted | Count of Participants | Participants | Participants reported alcohol use disorder symptoms at baseline. |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Participants reported COVID-19 related stress at baseline. |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Participants reported impulsivity at baseline. |
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| 20 |
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| 20 |
| EG001 | 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. | 0 | 20 | 0 | 20 | 0 | 20 |
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