NCT03159468

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
209

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 31, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 18, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 26, 2019

Completed
Last Updated

July 26, 2019

Status Verified

July 1, 2019

Enrollment Period

1.5 years

First QC Date

May 12, 2017

Results QC Date

June 17, 2019

Last Update Submit

July 24, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (6)

Cognitive Restructuring & Alcohol Condition

EXPERIMENTAL

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.

Behavioral: Cognitive RestructuringOther: Alcohol consumption

Mindfulness & Alcohol Condition

EXPERIMENTAL

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.

Behavioral: MindfulnessOther: Alcohol consumption

Nutrition Information & Alcohol Condition

EXPERIMENTAL

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

Other: Alcohol consumption

Cognitive Restructuring & No Alcohol Condition

EXPERIMENTAL

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.

Behavioral: Cognitive Restructuring

Mindfulness & No Alcohol Condition

EXPERIMENTAL

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.

Behavioral: Mindfulness

Nutrition Information & No Alcohol Condition

NO INTERVENTION

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

Interventions

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

Cognitive Restructuring & Alcohol ConditionCognitive Restructuring & No Alcohol Condition
MindfulnessBEHAVIORAL

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

Mindfulness & Alcohol ConditionMindfulness & No Alcohol Condition

Participants consume an alcoholic beverage in the lab.

Cognitive Restructuring & Alcohol ConditionMindfulness & Alcohol ConditionNutrition Information & Alcohol Condition

Eligibility Criteria

Age21 Years - 30 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsSelf-defined as male
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98105, United States

Location

MeSH Terms

Interventions

Cognitive RestructuringMindfulnessEthanol

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesAlcoholsOrganic Chemicals

Results Point of Contact

Title
Kelly Cue Davis
Organization
Arizona State University

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 12, 2017

First Posted

May 18, 2017

Study Start

December 31, 2016

Primary Completion

June 29, 2018

Study Completion

June 29, 2018

Last Updated

July 26, 2019

Results First Posted

July 26, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations