Alcohol-Related Sexual Aggression: An Emotion Regulation Intervention
Phase: NA
Conditions: Sexual Aggression, Heavy Drinking
Sponsor: University of Washington

Emotion Regulation Interventions for Alcohol-Related Sexual Aggression 
NCT: STUDY00002103 
Date: May 16, 2019 

Study Protocol and Statistical Analysis Plan 
Study Protocol 
The objective of this protocol was to evaluate the efficacy of two brief online emotion regulation 
interventions (compared to control) for reducing alcohol-related sexual aggression in heavy 
episodic drinking young men with a sexual aggression history. The study involved a proximal 
change experiment assessing the effects of two brief online interventions – cognitive 
restructuring and mindfulness – on men’s sexual aggression during an sexual aggression-
related analogue. 
Recruitment. Participants were recruited from the community through advertisements 
placed in online classifieds, social networking websites, community newspapers, and local 
venues that target the young adult population. Ads stated that single men 21-30 years old were 
needed for a study of alcohol and male-female relationships. We also used flyers, brochures, 
and postcards in locations likely to reach young single men, such as local community colleges, 
coffee shops, and bars. All advertising materials included a URL for a website that provided 
information about the study. Interested participants then completed an initial online eligibility 
screening followed by an eligibility verification telephone call.  
Retention. Participation involved a one-time visit to the study laboratory. Participants were 
enrolled into the study and completed the study in the same visit. As such, longitudinal retention 
efforts were not required.  
Study Design. After providing informed consent, participants completed questionnaires 
assessing information about sexual risk behavior, drinking behavior, sexual aggression, and 
emotion regulation skills. They were then randomized to receive one of the three intervention 
arms (cognitive restructuring, mindfulness, or control). A randomized block design was used to 
assign participants to experimental conditions based on their sexual aggression history so that 
aggression backgrounds were evenly distributed across the cells. After the intervention, 
participants received either no alcohol (control beverage) or a high alcohol dose (target peak 
BAC = .08%), read a sexual aggression analogue, and rated their sexual aggression intentions. 
Statistical Analysis Plan 
Sexual Aggression Intentions. For the sexual risk intentions outcome, we enrolled 209 
subjects. The sexual aggression intentions variable includes scores from a scale on which 
participants rate their likelihood of continuing with sexual activity after a hypothetical woman 
refused further sexual contact. To test our hypotheses, a series of ANOVAs were conducted to 
examine the main and interactive effects of intervention condition and beverage condition on 
sexual aggression-related intentions with planned pairwise comparisons examined for both the 
cognitive restructuring and mindfulness conditions compared to the control condition using the 
Sidak procedure to control for alpha inflation and protect against Type 1 error. Similarly, with 
pairwise comparisons, we explored whether there are any differences between the cognitive 
restructuring and mindfulness conditions on intervention efficacy. 
Power and Sample Size. The study was powered to detect the moderation of beverage 
condition (sober vs. alcohol) on the association between the interventions (cognitive 

restructuring, mindfulness, control) and sexual aggression-related intentions. Using G*Power 
3.1, we used an alpha of .05 and power of .80. Based on a medium effect size f = .21, this 
would require a sample size of 222, whereas f = .22 required 203 participants. As such, we 
obtained a sample of 209 participants.