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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03159468
Other study ID # STUDY00002103
Secondary ID 1R21AA023811-01A
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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