Emotion Regulation Interventions for Alcohol-Related Sexual Aggression

Heavy Drinking Clinical Trial

Official title:

Alcohol-Related Sexual Aggression: An Emotion Regulation Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03159468
• Other study ID #: STUDY00002103
• Secondary ID: 1R21AA023811-01A
• Status: Completed
• Phase: N/A
• Start date: December 31, 2016
• Est. completion date: June 29, 2018

Study information

• Verified date: July 2019
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: June 29, 2018
• Est. primary completion date: June 29, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Aggression
• Heavy Drinking
• Sexual Aggression

Intervention

Behavioral:
• Cognitive Restructuring
Participants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations.
• Mindfulness
Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations.

Other:
• Alcohol consumption
Participants consume an alcoholic beverage in the lab.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	Arizona State University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Within one hour after receiving the intervention