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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21AA023811-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
| Arizona State University | OTHER |
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Rates of sexual assault are alarmingly high, and alcohol is consistently implicated in the majority of these assaults. Despite well-intentioned prevention efforts, this pandemic continues unabated, warranting the development of novel and innovative approaches to the reduction of sexual aggression. The goal of this research is to evaluate the efficacy of two brief online emotion regulation interventions for reducing alcohol-related sexual aggression in heavy episodic drinking young men with a sexual aggression history. Previous research suggests that emotion regulation difficulties are associated with both alcohol consumption and aggressive behavior. Despite the potential prevention utility of improving sexually aggressive men's emotion regulation skills in order to reduce their alcohol-related sexual aggression, this approach has yet to be explored. Thus, this study evaluates the effects of two brief online ER interventions - cognitive restructuring and mindfulness - on men's emotion regulation during a sexual aggression-related analogue. Additionally, these effects will be evaluated during both sober and intoxicated states through a laboratory- based alcohol administration experiment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Restructuring & Alcohol Condition | Experimental | Participants will receive a brief online training regarding the use of cognitive restructuring skills to cope with negative emotions. They will then consume an alcoholic beverage in the lab. |
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| Mindfulness & Alcohol Condition | Experimental | Participants will receive a brief online training regarding the use of mindfulness skills to cope with negative emotions. They will then consume an alcoholic beverage in the lab. |
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| Nutrition Information & Alcohol Condition | Experimental | Participants will receive general information about nutrition. They will then consume an alcoholic beverage in the lab. |
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| Cognitive Restructuring & No Alcohol Condition | Experimental | Participants will receive a brief online training regarding the use of cognitive restructuring skills to cope with negative emotions. They will then consume a non-alcoholic beverage in the lab. |
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| Mindfulness & No Alcohol Condition | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Restructuring | Behavioral | Participants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations. |
| Measure | Description | Time Frame |
|---|---|---|
| Sexual Aggression Intentions | Sexual Aggression Intentions Scale. Construct: Self-reported ratings of sexual aggression likelihood in a hypothetical scenario. Minimum value of 1 ("Very unlikely"). Maximum value of 7 ("Very likely"). Higher scores mean a worse outcome. | Within one hour after receiving the intervention |
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Inclusion Criteria:
Exclusion Criteria:
Self-defined as male
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98105 | United States |
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All enrolled participants were assigned to one of the six arms.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive Restructuring & Alcohol Condition | Participants will receive a brief online training regarding the use of cognitive restructuring skills to cope with negative emotions, then consume an alcoholic beverage in the lab. Cognitive Restructuring: Participants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations. |
| FG001 | Mindfulness & Alcohol Condition | Participants will receive a brief online training regarding the use of mindfulness skills to cope with negative emotions, then receive an alcoholic beverage in the lab. Mindfulness: Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations. |
| FG002 | Nutrition Information & Alcohol Condition | Participants receive general information about nutrition, then receive an alcoholic beverage in the lab. |
| FG003 | Cognitive Restructuring & No Alcohol Condition | Participants will receive a brief online training regarding the use of cognitive restructuring skills to cope with negative emotions, then consume a non-alcoholic beverage in the lab. Cognitive Restructuring: Participants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations. |
| FG004 | Mindfulness & No Alcohol Condition | Participants will receive a brief online training regarding the use of mindfulness skills to cope with negative emotions, then receive a non-alcoholic beverage in the lab. Mindfulness: Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations. |
| FG005 | Nutrition Information & No Alcohol Condition | Participants receive general information about nutrition, then receive a non-alcoholic beverage in the lab. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive Restructuring & Alcohol Condition | Participants received a brief online training regarding the use of cognitive restructuring skills to cope with negative emotions, then received an alcoholic beverage in the lab. Cognitive Restructuring: Participants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations. |
| 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, Continuous | Mean |
| 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 | Sexual Aggression Intentions | Sexual Aggression Intentions Scale. Construct: Self-reported ratings of sexual aggression likelihood in a hypothetical scenario. Minimum value of 1 ("Very unlikely"). Maximum value of 7 ("Very likely"). Higher scores mean a worse outcome. | Posted | Mean | Standard Deviation | score on a scale | Within one hour after receiving the intervention |
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During the in-lab study experiment. There was no follow-up period.
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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 Restructuring & Alcohol Condition | Participants will receive a brief online training regarding the use of cognitive restructuring skills to cope with negative emotions, then receive an alcoholic beverage. Cognitive Restructuring: Participants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelly Cue Davis | Arizona State University | 602-496-3217 | Kelly.Cue.Davis@asu.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 | May 16, 2019 | Jul 18, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000088686 | Cognitive Restructuring |
| D064866 | Mindfulness |
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Participants will receive a brief online training regarding the use of mindfulness skills to cope with negative emotions. They will then consume a non-alcoholic beverage in the lab. |
|
| Nutrition Information & No Alcohol Condition | No Intervention | Participants will receive general information about nutrition. They will then consume a non-alcoholic beverage in the lab. |
| Mindfulness | Behavioral | Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations. |
|
| Alcohol consumption | Other | Participants consume an alcoholic beverage in the lab. |
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| BG001 | Mindfulness & Alcohol Condition | Participants received a brief online training regarding the use of mindfulness skills to cope with negative emotions, then received an alcoholic beverage in the lab. Mindfulness: Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations. |
| BG002 | Nutrition Information & Alcohol Condition | Participants received general information about nutrition, then received an alcoholic beverage in the lab. |
| BG003 | Cognitive Restructuring & No Alcohol Condition | Participants received a brief online training regarding the use of cognitive restructuring skills to cope with negative emotions, then received a non-alcoholic beverage in the lab. Cognitive Restructuring: Participants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations. |
| BG004 | Mindfulness & No Alcohol Condition | Participants received a brief online training regarding the use of mindfulness skills to cope with negative emotions, then received a non-alcoholic beverage in the lab. Mindfulness: Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations. |
| BG005 | Nutrition Information & No Alcohol Condition | Participants received general information about nutrition, then received a non-alcoholic beverage in the lab. |
| BG006 | Total | Total of all reporting groups |
| 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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| Body Weight | Mean | Standard Deviation | pounds |
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Participants received a brief online training regarding the use of mindfulness skills to cope with negative emotions, then received an alcoholic beverage in the lab. Mindfulness: Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations. |
| OG002 | Nutrition Information & Alcohol Condition | Participants received general information about nutrition, then received an alcoholic beverage in the lab. |
| OG003 | Cognitive Restructuring & No Alcohol Condition | Participants received a brief online training regarding the use of cognitive restructuring skills to cope with negative emotions, then received a non-alcoholic beverage in the lab. Cognitive Restructuring: Participants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations. |
| OG004 | Mindfulness & No Alcohol Condition | Participants received a brief online training regarding the use of mindfulness skills to cope with negative emotions, then received a non-alcoholic beverage in the lab. Mindfulness: Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations. |
| OG005 | Nutrition Information & No Alcohol Condition | Participants received general information about nutrition, then received a non-alcoholic beverage in the lab. |
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|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Mindfulness & Alcohol Condition | Participants will receive a brief online training regarding the use of mindfulness skills to cope with negative emotions, then receive an alcoholic beverage. Mindfulness: Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations. | 0 | 35 | 0 | 35 | 0 | 35 |
| EG002 | Nutrition Information & Alcohol Condition | Participants will receive general information about nutrition, then receive an alcoholic beverage. | 0 | 37 | 0 | 37 | 0 | 37 |
| EG003 | Cognitive Restrucuring & No Alcohol Condition | Participants will receive a brief online training regarding the use of cognitive restructuring skills to cope with negative emotions, then receive a non-alcoholic beverage. Cognitive Restructuring: Participants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations. | 0 | 34 | 0 | 34 | 0 | 34 |
| EG004 | Mindfulness & No Alcohol Condition | Participants will receive a brief online training regarding the use of mindfulness skills to cope with negative emotions, then receive a non-alcoholic beverage. Mindfulness: Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations. | 0 | 34 | 0 | 34 | 0 | 34 |
| EG005 | Nutrition Information & No Alcohol Condition | Participants will receive general information about nutrition, then receive a non-alcoholic beverage. | 0 | 34 | 0 | 34 | 0 | 34 |
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| D000438 | Alcohols |
| D009930 | Organic Chemicals |