Trial Outcomes & Findings for Men, Mood, and Attention Study: Examination of Alcohol, State Anger, and Emotion Regulation Sexual Aggression (NCT NCT04192448)
NCT ID: NCT04192448
Last Updated: 2024-05-29
Results Overview
Mean score of 22 items assessing behavioral intentions (1 = Not at Likely to 7 = Very Likely) to act sexually aggressively against a hypothetical female
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
3 participants
Primary outcome timeframe
20 minutes
Results posted on
2024-05-29
Participant Flow
Recruitment for the study began in September 2020 after IRB approval was obtained for study modifications necessary to comply with COVID-related safety precautions. Advertisements were placed in local business, emphasizing alcohol-serving establishments, and authorized posting areas in local community colleges and four-year universities. Online advertisements were posted in social media sites (e.g., Facebook, Instagram) and forums (e.g., Reddit, Craiglist). Recruitment continued until May 2021.
After enrollment, participants completed baseline measures. Participants were block randomized to condition arm based upon their past sexual assault perpetration status, such that an equal number of participants who had previously perpetrated sexual assault were assigned to each condition arm. No participants were excluded prior to group assignment.
Participant milestones
| Measure |
AlcoholxAnger
Participant will receive alcohol, the dose of which will be administered to result in a BAC of .08%. Participants will also receive an anger emotion induction, in which the experience of frustration and irritability is induced.
Alcohol Administration: The clinical trial does not involve any treatment. Participant will be randomly assigned to receive alcohol (BAC = .08%) or water (BAC = .00%).
Mood Induction: The clinical trial does not involve any treatment. Participants will be randomly assigned to receive an anger emotion induction or a control (neutral) mood induction.
|
AlcoholxControl
Participant will receive alcohol, the dose of which will be administered to result in a BAC of .08%. Participants will also receive a control emotion induction, in which they are exposed to a neutral mood induction.
Alcohol Administration: The clinical trial does not involve any treatment. Participant will be randomly assigned to receive alcohol (BAC = .08%) or water (BAC = .00%).
Mood Induction: The clinical trial does not involve any treatment. Participants will be randomly assigned to receive an anger emotion induction or a control (neutral) mood induction.
|
SoberxAnger
Participant will not receive alcohol, therefore their BAC will be .00%. Participants will also receive an anger emotion induction, in which the experience of frustration and irritability is induced.
Alcohol Administration: The clinical trial does not involve any treatment. Participant will be randomly assigned to receive alcohol (BAC = .08%) or water (BAC = .00%).
Mood Induction: The clinical trial does not involve any treatment. Participants will be randomly assigned to receive an anger emotion induction or a control (neutral) mood induction.
|
SoberxControl
Participant will not receive alcohol, therefore their BAC will be .00%. Participants will also receive a control emotion induction, in which they are exposed to a neutral mood induction.
Alcohol Administration: The clinical trial does not involve any treatment. Participant will be randomly assigned to receive alcohol (BAC = .08%) or water (BAC = .00%).
Mood Induction: The clinical trial does not involve any treatment. Participants will be randomly assigned to receive an anger emotion induction or a control (neutral) mood induction.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
0
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Men, Mood, and Attention Study: Examination of Alcohol, State Anger, and Emotion Regulation Sexual Aggression
Baseline characteristics by cohort
| Measure |
AlcoholxAnger
n=1 Participants
Participant will receive alcohol, the dose of which will be administered to result in a BAC of .08%. Participants will also receive an anger emotion induction, in which the experience of frustration and irritability is induced.
Alcohol Administration: The clinical trial does not involve any treatment. Participant will be randomly assigned to receive alcohol (BAC = .08%) or water (BAC = .00%).
Mood Induction: The clinical trial does not involve any treatment. Participants will be randomly assigned to receive an anger emotion induction or a control (neutral) mood induction.
|
AlcoholxControl
n=1 Participants
Participant will receive alcohol, the dose of which will be administered to result in a BAC of .08%. Participants will also receive a control emotion induction, in which they are exposed to a neutral mood induction.
Alcohol Administration: The clinical trial does not involve any treatment. Participant will be randomly assigned to receive alcohol (BAC = .08%) or water (BAC = .00%).
Mood Induction: The clinical trial does not involve any treatment. Participants will be randomly assigned to receive an anger emotion induction or a control (neutral) mood induction.
|
SoberxAnger
Participant will not receive alcohol, therefore their BAC will be .00%. Participants will also receive an anger emotion induction, in which the experience of frustration and irritability is induced.
Alcohol Administration: The clinical trial does not involve any treatment. Participant will be randomly assigned to receive alcohol (BAC = .08%) or water (BAC = .00%).
Mood Induction: The clinical trial does not involve any treatment. Participants will be randomly assigned to receive an anger emotion induction or a control (neutral) mood induction.
|
SoberxControl
n=1 Participants
Participant will not receive alcohol, therefore their BAC will be .00%. Participants will also receive a control emotion induction, in which they are exposed to a neutral mood induction.
Alcohol Administration: The clinical trial does not involve any treatment. Participant will be randomly assigned to receive alcohol (BAC = .08%) or water (BAC = .00%).
Mood Induction: The clinical trial does not involve any treatment. Participants will be randomly assigned to receive an anger emotion induction or a control (neutral) mood induction.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
31 years
STANDARD_DEVIATION 0 • n=93 Participants
|
35 years
STANDARD_DEVIATION 0 • n=4 Participants
|
—
|
30 years
STANDARD_DEVIATION 0 • n=483 Participants
|
32 years
STANDARD_DEVIATION 2.65 • n=36 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity · White/Non-Latino
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity · Black or African American/Non-Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
|
Sexual Experiences Survey
|
3 units on a scale
STANDARD_DEVIATION 0 • n=93 Participants
|
0 units on a scale
STANDARD_DEVIATION 0 • n=4 Participants
|
—
|
4 units on a scale
STANDARD_DEVIATION 0 • n=483 Participants
|
2.33 units on a scale
STANDARD_DEVIATION 2.08 • n=36 Participants
|
|
Difficulties in Emotion Regulation Scale
|
88 units on a scale
STANDARD_DEVIATION 0 • n=93 Participants
|
62 units on a scale
STANDARD_DEVIATION 0 • n=4 Participants
|
—
|
73 units on a scale
STANDARD_DEVIATION 0 • n=483 Participants
|
74.33 units on a scale
STANDARD_DEVIATION 13.05 • n=36 Participants
|
PRIMARY outcome
Timeframe: 20 minutesPopulation: The population analyzed is comprised of the three participants who were enrolled into the study. No participants were analyzed in the Sober x Anger arm because no participants were randomly assigned to that arm.
Mean score of 22 items assessing behavioral intentions (1 = Not at Likely to 7 = Very Likely) to act sexually aggressively against a hypothetical female
Outcome measures
| Measure |
AlcoholxAnger
n=1 Participants
Participant will receive alcohol, the dose of which will be administered to result in a BAC of .08%. Participants will also receive an anger emotion induction, in which the experience of frustration and irritability is induced.
Alcohol Administration: The clinical trial does not involve any treatment. Participant will be randomly assigned to receive alcohol (BAC = .08%) or water (BAC = .00%).
Mood Induction: The clinical trial does not involve any treatment. Participants will be randomly assigned to receive an anger emotion induction or a control (neutral) mood induction.
|
AlcoholxControl
n=1 Participants
Participant will receive alcohol, the dose of which will be administered to result in a BAC of .08%. Participants will also receive a control emotion induction, in which they are exposed to a neutral mood induction.
Alcohol Administration: The clinical trial does not involve any treatment. Participant will be randomly assigned to receive alcohol (BAC = .08%) or water (BAC = .00%).
Mood Induction: The clinical trial does not involve any treatment. Participants will be randomly assigned to receive an anger emotion induction or a control (neutral) mood induction.
|
SoberxAnger
Participant will not receive alcohol, therefore their BAC will be .00%. Participants will also receive an anger emotion induction, in which the experience of frustration and irritability is induced.
Alcohol Administration: The clinical trial does not involve any treatment. Participant will be randomly assigned to receive alcohol (BAC = .08%) or water (BAC = .00%).
Mood Induction: The clinical trial does not involve any treatment. Participants will be randomly assigned to receive an anger emotion induction or a control (neutral) mood induction.
|
SoberxControl
n=1 Participants
Participant will not receive alcohol, therefore their BAC will be .00%. Participants will also receive a control emotion induction, in which they are exposed to a neutral mood induction.
Alcohol Administration: The clinical trial does not involve any treatment. Participant will be randomly assigned to receive alcohol (BAC = .08%) or water (BAC = .00%).
Mood Induction: The clinical trial does not involve any treatment. Participants will be randomly assigned to receive an anger emotion induction or a control (neutral) mood induction.
|
|---|---|---|---|---|
|
Sexual Aggression Intentions
|
2.18 score on a scale
|
4.73 score on a scale
|
—
|
1.64 score on a scale
|
SECONDARY outcome
Timeframe: 20 minutesPopulation: The population analyze dis comprised of the three participants who were enrolled into the study. No participants were analyzed in the Sober x Anger arm because no participants were randomly assigned to that arm.
Mean score of 5 items assessing behavioral intentions (1 = Not at All to 7 = Extremely) of intentions to act physically aggressively against a hypothetical female
Outcome measures
| Measure |
AlcoholxAnger
n=1 Participants
Participant will receive alcohol, the dose of which will be administered to result in a BAC of .08%. Participants will also receive an anger emotion induction, in which the experience of frustration and irritability is induced.
Alcohol Administration: The clinical trial does not involve any treatment. Participant will be randomly assigned to receive alcohol (BAC = .08%) or water (BAC = .00%).
Mood Induction: The clinical trial does not involve any treatment. Participants will be randomly assigned to receive an anger emotion induction or a control (neutral) mood induction.
|
AlcoholxControl
n=1 Participants
Participant will receive alcohol, the dose of which will be administered to result in a BAC of .08%. Participants will also receive a control emotion induction, in which they are exposed to a neutral mood induction.
Alcohol Administration: The clinical trial does not involve any treatment. Participant will be randomly assigned to receive alcohol (BAC = .08%) or water (BAC = .00%).
Mood Induction: The clinical trial does not involve any treatment. Participants will be randomly assigned to receive an anger emotion induction or a control (neutral) mood induction.
|
SoberxAnger
Participant will not receive alcohol, therefore their BAC will be .00%. Participants will also receive an anger emotion induction, in which the experience of frustration and irritability is induced.
Alcohol Administration: The clinical trial does not involve any treatment. Participant will be randomly assigned to receive alcohol (BAC = .08%) or water (BAC = .00%).
Mood Induction: The clinical trial does not involve any treatment. Participants will be randomly assigned to receive an anger emotion induction or a control (neutral) mood induction.
|
SoberxControl
n=1 Participants
Participant will not receive alcohol, therefore their BAC will be .00%. Participants will also receive a control emotion induction, in which they are exposed to a neutral mood induction.
Alcohol Administration: The clinical trial does not involve any treatment. Participant will be randomly assigned to receive alcohol (BAC = .08%) or water (BAC = .00%).
Mood Induction: The clinical trial does not involve any treatment. Participants will be randomly assigned to receive an anger emotion induction or a control (neutral) mood induction.
|
|---|---|---|---|---|
|
Physical Aggression Intentions
|
1.0 score on a scale
|
1.25 score on a scale
|
—
|
1.0 score on a scale
|
SECONDARY outcome
Timeframe: 20 minutesPopulation: The population analyzed is compromised of the three participants who were enrolled into the study. No participants were analyzed in the Sober x Anger arm because no participants were randomly assigned to that arm.
Mean score of 3 items assessing behavioral intentions (1 = Not at All to 7 = Extremely) of intentions to act psychologically aggressively against a hypothetical female
Outcome measures
| Measure |
AlcoholxAnger
n=1 Participants
Participant will receive alcohol, the dose of which will be administered to result in a BAC of .08%. Participants will also receive an anger emotion induction, in which the experience of frustration and irritability is induced.
Alcohol Administration: The clinical trial does not involve any treatment. Participant will be randomly assigned to receive alcohol (BAC = .08%) or water (BAC = .00%).
Mood Induction: The clinical trial does not involve any treatment. Participants will be randomly assigned to receive an anger emotion induction or a control (neutral) mood induction.
|
AlcoholxControl
n=1 Participants
Participant will receive alcohol, the dose of which will be administered to result in a BAC of .08%. Participants will also receive a control emotion induction, in which they are exposed to a neutral mood induction.
Alcohol Administration: The clinical trial does not involve any treatment. Participant will be randomly assigned to receive alcohol (BAC = .08%) or water (BAC = .00%).
Mood Induction: The clinical trial does not involve any treatment. Participants will be randomly assigned to receive an anger emotion induction or a control (neutral) mood induction.
|
SoberxAnger
Participant will not receive alcohol, therefore their BAC will be .00%. Participants will also receive an anger emotion induction, in which the experience of frustration and irritability is induced.
Alcohol Administration: The clinical trial does not involve any treatment. Participant will be randomly assigned to receive alcohol (BAC = .08%) or water (BAC = .00%).
Mood Induction: The clinical trial does not involve any treatment. Participants will be randomly assigned to receive an anger emotion induction or a control (neutral) mood induction.
|
SoberxControl
n=1 Participants
Participant will not receive alcohol, therefore their BAC will be .00%. Participants will also receive a control emotion induction, in which they are exposed to a neutral mood induction.
Alcohol Administration: The clinical trial does not involve any treatment. Participant will be randomly assigned to receive alcohol (BAC = .08%) or water (BAC = .00%).
Mood Induction: The clinical trial does not involve any treatment. Participants will be randomly assigned to receive an anger emotion induction or a control (neutral) mood induction.
|
|---|---|---|---|---|
|
Psychological Aggression Intentions
|
1.67 score on a scale
|
2.33 score on a scale
|
—
|
1.33 score on a scale
|
Adverse Events
AlcoholxAnger
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AlcoholxControl
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SoberxAnger
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SoberxControl
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place