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Emotion Regulation Interventions for Alcohol-Related Sexual Aggression

Alcohol-Related Sexual Aggression: An Emotion Regulation Intervention

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03159468
Enrollment
209
Registered
2017-05-18
Start date
2016-12-31
Completion date
2018-06-29
Last updated
2019-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sexual Aggression, Heavy Drinking

Brief summary

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.

Interventions

Participants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations.

BEHAVIORALMindfulness

Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations.

OTHERAlcohol consumption

Participants consume an alcoholic beverage in the lab.

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
Arizona State University
CollaboratorOTHER
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
21 Years to 30 Years
Healthy volunteers
No

Inclusion criteria

* Single * Male * Age 21-30 * Heterosexually active within past year * Heavy episodic drinker * Self-reported history of sexual aggression

Exclusion criteria

* History of alcohol problems * Medical condition or medications that contraindicate alcohol consumption

Design outcomes

Primary

MeasureTime frameDescription
Sexual Aggression IntentionsWithin one hour after receiving the interventionSexual 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.

Countries

United States

Participant flow

Pre-assignment details

All enrolled participants were assigned to one of the six arms.

Participants by arm

ArmCount
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.
35
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.
35
Nutrition Information & Alcohol Condition
Participants received general information about nutrition, then received an alcoholic beverage in the lab.
37
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.
34
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.
34
Nutrition Information & No Alcohol Condition
Participants received general information about nutrition, then received a non-alcoholic beverage in the lab.
34
Total209

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005
Overall StudyWithdrawal by Subject003000

Baseline characteristics

CharacteristicCognitive Restructuring & Alcohol ConditionMindfulness & Alcohol ConditionNutrition Information & Alcohol ConditionCognitive Restructuring & No Alcohol ConditionMindfulness & No Alcohol ConditionNutrition Information & No Alcohol ConditionTotal
Age, Continuous24.67 years
STANDARD_DEVIATION 2.88
24.06 years
STANDARD_DEVIATION 2.78
25.09 years
STANDARD_DEVIATION 3.03
25.32 years
STANDARD_DEVIATION 2.58
24.35 years
STANDARD_DEVIATION 2.6
25.08 years
STANDARD_DEVIATION 2.68
24.76 years
STANDARD_DEVIATION 2.77
Body Weight175.29 pounds
STANDARD_DEVIATION 26.54
170.34 pounds
STANDARD_DEVIATION 24.66
170.26 pounds
STANDARD_DEVIATION 26.75
184.09 pounds
STANDARD_DEVIATION 48.79
173.53 pounds
STANDARD_DEVIATION 21.29
170.97 pounds
STANDARD_DEVIATION 21
174.07 pounds
STANDARD_DEVIATION 29.72
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants4 Participants3 Participants3 Participants6 Participants3 Participants21 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
33 Participants31 Participants34 Participants31 Participants28 Participants30 Participants187 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
4 Participants5 Participants8 Participants6 Participants7 Participants7 Participants37 Participants
Race (NIH/OMB)
Black or African American
1 Participants4 Participants2 Participants0 Participants2 Participants5 Participants14 Participants
Race (NIH/OMB)
More than one race
3 Participants4 Participants6 Participants2 Participants4 Participants4 Participants23 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants3 Participants1 Participants3 Participants2 Participants10 Participants
Race (NIH/OMB)
White
26 Participants22 Participants18 Participants25 Participants18 Participants16 Participants125 Participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Sex: Female, Male
Male
35 Participants35 Participants37 Participants34 Participants34 Participants34 Participants209 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
deaths
Total, all-cause mortality
0 / 350 / 350 / 370 / 340 / 340 / 34
other
Total, other adverse events
0 / 350 / 350 / 370 / 340 / 340 / 34
serious
Total, serious adverse events
0 / 350 / 350 / 370 / 340 / 340 / 34

Outcome results

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.

Time frame: Within one hour after receiving the intervention

ArmMeasureValue (MEAN)Dispersion
Cognitive Restructuring & Alcohol ConditionSexual Aggression Intentions1.58 score on a scaleStandard Deviation 1.12
Mindfulness & Alcohol ConditionSexual Aggression Intentions1.90 score on a scaleStandard Deviation 1.28
Nutrition Information & Alcohol ConditionSexual Aggression Intentions2.18 score on a scaleStandard Deviation 1.59
Cognitive Restructuring & No Alcohol ConditionSexual Aggression Intentions1.53 score on a scaleStandard Deviation 1.16
Mindfulness & No Alcohol ConditionSexual Aggression Intentions1.38 score on a scaleStandard Deviation 0.9
Nutrition Information & No Alcohol ConditionSexual Aggression Intentions1.70 score on a scaleStandard Deviation 1.15
p-value: 0.041ANOVA
p-value: 0.16ANOVA
p-value: 0.462ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026