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Emotion Regulation Interventions for Alcohol-Related Sexual Aggression

Primary Purpose

Sexual Aggression, Heavy Drinking

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Restructuring
Mindfulness
Alcohol consumption
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sexual Aggression

Eligibility Criteria

21 Years - 30 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

No Intervention

Arm Label

Cognitive Restructuring & Alcohol Condition

Mindfulness & Alcohol Condition

Nutrition Information & Alcohol Condition

Cognitive Restructuring & No Alcohol Condition

Mindfulness & No Alcohol Condition

Nutrition Information & No Alcohol Condition

Arm Description

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.

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.

Participants will receive general information about nutrition. They will then consume an alcoholic beverage in the lab.

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.

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.

Participants will receive general information about nutrition. They will then consume a non-alcoholic beverage in the lab.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 12, 2017
Last Updated
July 24, 2019
Sponsor
University of Washington
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Arizona State University
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1. Study Identification

Unique Protocol Identification Number
NCT03159468
Brief Title
Emotion Regulation Interventions for Alcohol-Related Sexual Aggression
Official Title
Alcohol-Related Sexual Aggression: An Emotion Regulation Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
December 31, 2016 (Actual)
Primary Completion Date
June 29, 2018 (Actual)
Study Completion Date
June 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Arizona State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Aggression, Heavy Drinking

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
209 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Restructuring & Alcohol Condition
Arm Type
Experimental
Arm Description
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.
Arm Title
Mindfulness & Alcohol Condition
Arm Type
Experimental
Arm Description
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.
Arm Title
Nutrition Information & Alcohol Condition
Arm Type
Experimental
Arm Description
Participants will receive general information about nutrition. They will then consume an alcoholic beverage in the lab.
Arm Title
Cognitive Restructuring & No Alcohol Condition
Arm Type
Experimental
Arm Description
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.
Arm Title
Mindfulness & No Alcohol Condition
Arm Type
Experimental
Arm Description
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.
Arm Title
Nutrition Information & No Alcohol Condition
Arm Type
No Intervention
Arm Description
Participants will receive general information about nutrition. They will then consume a non-alcoholic beverage in the lab.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Restructuring
Intervention Description
Participants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness
Intervention Description
Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations.
Intervention Type
Other
Intervention Name(s)
Alcohol consumption
Intervention Description
Participants consume an alcoholic beverage in the lab.
Primary Outcome Measure Information:
Title
Sexual Aggression Intentions
Description
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

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Self-defined as male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Emotion Regulation Interventions for Alcohol-Related Sexual Aggression

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